We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study to Assess the Efficacy and Safety of BIVV009 (Sutimlimab) in Participants With Primary Cold Agglutinin Disease Without A Recent History of Blood Transfusion (Cadenza)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03347422
Recruitment Status : Completed
First Posted : November 20, 2017
Results First Posted : December 23, 2022
Last Update Posted : December 23, 2022
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Bioverativ, a Sanofi company )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Cold Agglutinin Disease
Interventions Drug: sutimlimab (BIVV009)
Drug: placebo
Enrollment 42
Recruitment Details The study was conducted at 27 sites in 13 countries. Out of 66 screened participants, a total of 42 participants were enrolled and randomized from 17 March 2018 to 30 March 2020. This study consisted of 2 Parts: Part A and Part B.
Pre-assignment Details Participants were stratified based on baseline body weight to receive BIVV009 6.5 grams (g) (if <75 kg) or 7.5 g (if >=75 kg). As planned, data presented as: 1) Dose-wise (2 dose cohorts: BIVV009 6.5 g & BIVV009 7.5 g) for safety outcome measures and adverse events (AEs). 2) combined population (BIVV009 at any dose) for efficacy outcome measures.
Arm/Group Title BIVV009/BIVV009 Placebo/BIVV009
Hide Arm/Group Description Participants with primary Cold Agglutinin Disease (CAD) and without a recent history of blood transfusion during the last 6 months prior to enrollment in this study, received an intravenous (IV) infusion of BIVV009 6.5 g (for participants less than [<]75 kilograms [kg]) or 7.5 g dose (for participants greater than or equal to [>=]75 kg) on Day 0 and Day 7 and every 14 days thereafter in Part A up to Week 25. Participants who completed Part A per protocol through the end of treatment visit (Week 26), received placebo on Week 26 and continued to receive BIVV009 6.5 or 7.5 g in Part B, every 2 weeks starting at Week 27 for up to an additional 149 weeks (for 6.5 g) or 121 weeks (for 7.5 g). All participants who completed Part A elected to continue in Part B. Participants with primary CAD and without a recent history of blood transfusion during the last 6 months prior to enrollment in this study, received an IV infusion of placebo matched to BIVV009 on Day 0 and Day 7 and every 14 days thereafter in Part A up to Week 25. Participants who completed Part A per protocol through the end of treatment visit (Week 26) received BIVV009 6.5 (if <75 kg) or 7.5 g (if >=75 kg) in Part B, on Week 26 and Week 27 and every 2 weeks thereafter for up to an additional 123 weeks (for 6.5 g) or 137 weeks (for 7.5 g). All participants who completed Part A elected to continue in Part B.
Period Title: Part A (26 Weeks)
Started 22 20
Completed 19 20
Not Completed 3 0
Reason Not Completed
Adverse Event             3             0
Period Title: Part B (149 Weeks)
Started 19 20
Completed 16 16
Not Completed 3 4
Reason Not Completed
Lack of Efficacy             1             2
Adverse Event             0             1
Withdrawal by Subject             1             1
Other             1             0
Arm/Group Title BIVV009/BIVV009 Placebo/BIVV009 Total
Hide Arm/Group Description Participants with primary CAD and without a recent history of blood transfusion during the last 6 months prior to enrollment in this study, received an IV infusion of BIVV009 6.5 g (for participants <75 kg) or 7.5 g dose (for participants >=75 kg) on Day 0 and Day 7 and every 14 days thereafter in Part A up to Week 25. Participants who completed Part A per protocol through the end of treatment visit (Week 26), received placebo on Week 26 and continued to receive BIVV009 6.5 or 7.5 g in Part B, every 2 weeks starting at Week 27 for up to an additional 149 weeks (for 6.5 g) or 121 weeks (for 7.5 g). All participants who completed Part A elected to continue in Part B. Participants with primary CAD and without a recent history of blood transfusion during the last 6 months prior to enrollment in this study, received an IV infusion of placebo matched to BIVV009 on Day 0 and Day 7 and every 14 days thereafter in Part A up to Week 25. Participants who completed Part A per protocol through the end of treatment visit (Week 26) received BIVV009 6.5 (if <75 kg) or 7.5 g (if >=75 kg) in Part B, on Week 26 and Week 27 and every 2 weeks thereafter for up to an additional 123 weeks (for 6.5 g) or 137 weeks (for 7.5 g). All participants who completed Part A elected to continue in Part B. Total of all reporting groups
Overall Number of Baseline Participants 22 20 42
Hide Baseline Analysis Population Description
Analysis was performed on full analysis set (FAS) which included all randomized participants who received at least 1 dose (including partial dose) of study drug (BIVV009 or placebo).
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 22 participants 20 participants 42 participants
65.3  (10.9) 68.2  (10.1) 66.7  (10.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 20 participants 42 participants
Female
17
  77.3%
16
  80.0%
33
  78.6%
Male
5
  22.7%
4
  20.0%
9
  21.4%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 20 participants 42 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
5
  22.7%
2
  10.0%
7
  16.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
0
   0.0%
4
  20.0%
4
   9.5%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
17
  77.3%
14
  70.0%
31
  73.8%
1.Primary Outcome
Title Part A: Percentage of Participants With Response to Treatment
Hide Description A participant was considered a responder: if he or she did not receive blood transfusion from Week 5 through Week 26 (end of treatment) and did not receive treatment for CAD beyond what was permitted per protocol. Additionally, participant's hemoglobin (Hgb) level must have increased to >=1.5 grams per deciliter (g/dL) from baseline (defined as last Hgb value before administration of first dose of study drug) at treatment assessment timepoint (defined as average of values from the Week 23, 25, and 26 visits). Percentage of responders was calculated together with 95% exact Clopper-Pearson confidence interval (CI).
Time Frame From Week 5 through Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on Part A-full analysis set (FAS) which included all randomized participants who received at least 1 dose (including partial dose) of study drug (BIVV009 or placebo). Data for this outcome measure was planned to be collected and analyzed for combined population of BIVV009 (i.e., all participants who received BIVV009 [either at 6.5 or 7.5 g] and placebo in Part A.
Arm/Group Title BIVV009 Placebo
Hide Arm/Group Description:
Participants with primary CAD and without a recent history of blood transfusion during the last 6 months prior to enrollment in this study, received an IV infusion of BIVV009 6.5 g (for participants <75 kg) or 7.5 g dose (for participants >=75 kg) on Day 0 and Day 7 and every 14 days thereafter in Part A up to Week 25.
Participants with primary CAD and without a recent history of blood transfusion during the last 6 months prior to enrollment in this study, received an IV infusion of placebo matched to BIVV009 on Day 0 and Day 7 and every 14 days thereafter in Part A up to Week 25.
Overall Number of Participants Analyzed 22 20
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
72.7
(49.8 to 89.3)
15.0
(3.2 to 37.9)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection BIVV009, Placebo
Comments A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when primary outcome measure was statistically significant at two-sided 0.05 level.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Threshold for significance was 0.05.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 15.94
Confidence Interval (2-Sided) 95%
2.88 to 88.04
Estimation Comments Stratified by baseline hemoglobin (< median versus >=median) and geographic region (Asia/Other, North America, and Europe).
2.Primary Outcome
Title Part B: Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious AEs (SAEs)
Hide Description Adverse Event (AE): any untoward medical occurrence in a participant who received study drug and did not necessarily have to have a causal relationship with the treatment. Treatment emergent serious adverse events (TESAEs) was defined as any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was congenital anomaly/birth defect, was medically important event. Treatment emergent adverse events (TEAEs): AEs that developed, worsened or became serious during the treatment-emergent (TE) period (from first investigational medicinal product [IMP] administration in Part B to last IMP administration + 9 weeks follow-up period).
Time Frame Part B, 6.5 g cohort: From first dose (Week 26) up to 149 weeks of treatment + 9 weeks of follow-up (i.e., up to Week 184); Part B, 7.5 g cohort: From first dose (Week 26) up to 137 weeks of treatment + 9 weeks of follow-up (i.e., up to Week 172)
Hide Outcome Measure Data
Hide Analysis Population Description
Analyzed on Part B safety analysis set (SAS) which included all participants who received at least 1 dose (including partial dose) of study drug in Part B. Data for this outcome measures was planned to be collected and analyzed separately for each dose of BIVV009 (6.5 g and 7.5 g).
Arm/Group Title Part B: BIVV009 6.5 g Part B: BIVV009 7.5 g
Hide Arm/Group Description:
Participants who completed Part A per protocol through the end of treatment visit (Week 26) were eligible to be enrolled in Part B where they were treated for up to an additional 149 weeks. Participants who received placebo in Part A received BIVV009 6.5 g on Week 26, Week 27 and every 2 weeks thereafter; participants who received BIVV009 6.5 g in Part A received placebo on Week 26, BIVV009 6.5 g on Week 27 and every 2 weeks thereafter for up to an additional 149 weeks.
Participants who completed Part A per protocol through the end of treatment visit (Week 26) were eligible to be enrolled in Part B where they were treated for up to an additional 137 weeks. Participants who received placebo in Part A received BIVV009 7.5 g on Week 26, Week 27 and every 2 weeks thereafter; participants who received BIVV009 7.5 g in Part A received placebo on Week 26, BIVV009 7.5 g on Week 27 and every 2 weeks thereafter for up to an additional 137 weeks.
Overall Number of Participants Analyzed 32 7
Measure Type: Count of Participants
Unit of Measure: Participants
TEAEs
29
  90.6%
7
 100.0%
TESAEs
6
  18.8%
1
  14.3%
3.Secondary Outcome
Title Part A: Mean Change From Baseline in Hemoglobin (Hgb) Level at the Treatment Assessment Timepoint
Hide Description Mean change from baseline (Week 0) in Hemoglobin (Hgb) at the treatment assessment timepoint is reported in this outcome measure. Treatment assessment timepoint was defined as the average of the values from the Week 23, 25, and 26 visits. Least squares (LS) mean and 95 % confidence interval (CI) was assessed by Mixed Model for Repeated Measures (MMRM) approach using heterogeneous Toeplitz (TOEPH) covariance matrix with change from baseline as the dependent variable and baseline value and visits as independent variables. Baseline was defined as the last non-missing value prior to the first administration of study drug.
Time Frame Baseline (Week 0), treatment assessment timepoint (i.e., average of Week 23, 25 and 26)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on Part A-FAS. Data for this outcome measure was planned to be collected and analyzed for combined population of BIVV009 (i.e., all participants who received BIVV009 [either at 6.5 or 7.5 g] and placebo in Part A.
Arm/Group Title BIVV009 Placebo
Hide Arm/Group Description:
Participants with primary CAD and without a recent history of blood transfusion during the last 6 months prior to enrollment in this study, received an IV infusion of BIVV009 6.5 g (for participants <75 kg) or 7.5 g dose (for participants >=75 kg) on Day 0 and Day 7 and every 14 days thereafter in Part A up to Week 25.
Participants with primary CAD and without a recent history of blood transfusion during the last 6 months prior to enrollment in this study, received an IV infusion of placebo matched to BIVV009 on Day 0 and Day 7 and every 14 days thereafter in Part A up to Week 25.
Overall Number of Participants Analyzed 22 20
Least Squares Mean (95% Confidence Interval)
Unit of Measure: grams per deciliter
2.66
(2.09 to 3.22)
0.09
(-0.50 to 0.68)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection BIVV009, Placebo
Comments A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.05 level.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Threshold of significance at 0.05 level.
Method Mixed model for repeated measures
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 2.56
Confidence Interval (2-Sided) 95%
1.75 to 3.38
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.408
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Part A: Mean Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale Score at the Treatment Assessment Timepoint
Hide Description FACIT-Fatigue scale consists of 13 questions assessed using a 5-point scale (0=not at all; 1 = a little bit, 2 = somewhat, 3 = quite a bit and 4 = very much). Responses to each question were added to obtain a total score. Total score ranged from 0 to 52, with higher score indicating more fatigue. Treatment assessment timepoint was defined as the average of the values from the Week 23, 25, and 26 visits. LS mean and 95% CI was assessed by MMRM approach using TOEPH covariance matrix with change from baseline (Week 0) as the dependent variable and baseline value and visits as independent variables. Baseline was defined as the last non-missing value prior to the first administration of study drug.
Time Frame Baseline (Week 0), treatment assessment timepoint (i.e., average of Week 23, 25 and 26)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on Part A-FAS. Data for this outcome measure was planned to be collected and analyzed for combined population of BIVV009 (i.e., all participants who received BIVV009 [either 6.5 g or 7.5 g]) and placebo in Part A.
Arm/Group Title BIVV009 Placebo
Hide Arm/Group Description:
Participants with primary CAD and without a recent history of blood transfusion during the last 6 months prior to enrollment in this study, received an IV infusion of BIVV009 6.5 g (for participants <75 kg) or 7.5 g dose (for participants >=75 kg) on Day 0 and Day 7 and every 14 days thereafter in Part A up to Week 25.
Participants with primary CAD and without a recent history of blood transfusion during the last 6 months prior to enrollment in this study, received an IV infusion of placebo matched to BIVV009 on Day 0 and Day 7 and every 14 days thereafter in Part A up to Week 25.
Overall Number of Participants Analyzed 22 20
Least Squares Mean (95% Confidence Interval)
Unit of Measure: score on a scale
10.83
(7.45 to 14.22)
1.91
(-1.65 to 5.46)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection BIVV009, Placebo
Comments A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.05 level.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Threshold of significance at 0.05 level.
Method Mixed model for repeated measures
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 8.93
Confidence Interval (2-Sided) 95%
4.00 to 13.85
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.450
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Part A: Mean Change From Baseline in Total Bilirubin Levels at the Treatment Assessment Timepoint
Hide Description Mean change from baseline (Week 0) in total bilirubin at the treatment assessment timepoint is reported in this outcome measure. Treatment assessment timepoint was defined as the average of the values from the Week 23, 25, and 26 visits. Baseline was defined as the last non-missing value prior to the first administration of study drug.
Time Frame Baseline (Week 0), treatment assessment timepoint (i.e., average of Week 23, 25 and 26)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on Part A-FAS. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure. Data for this outcome measure was planned to be collected and analyzed for combined population of BIVV009 (i.e., all participants who received BIVV009 [either at 6.5 or 7.5 g] and placebo in Part A.
Arm/Group Title BIVV009 Placebo
Hide Arm/Group Description:
Participants with primary CAD and without a recent history of blood transfusion during the last 6 months prior to enrollment in this study, received an IV infusion of BIVV009 6.5 g (for participants <75 kg) or 7.5 g dose (for participants >=75 kg) on Day 0 and Day 7 and every 14 days thereafter in Part A up to Week 25.
Participants with primary CAD and without a recent history of blood transfusion during the last 6 months prior to enrollment in this study, received an IV infusion of placebo matched to BIVV009 on Day 0 and Day 7 and every 14 days thereafter in Part A up to Week 25.
Overall Number of Participants Analyzed 19 20
Mean (Standard Deviation)
Unit of Measure: micromoles per liter
-22.881  (10.401) -1.388  (13.901)
6.Secondary Outcome
Title Part A: Mean Change From Baseline in Lactate Dehydrogenase (LDH) at the Treatment Assessment Timepoint
Hide Description Mean change from baseline (Week 0) in LDH at the treatment assessment timepoint is reported in this outcome measure. Treatment assessment timepoint was defined as the average of the values from the Week 23, 25, and 26 visits. Baseline was defined as the last non-missing value prior to the first administration of study drug.
Time Frame Baseline (Week 0), treatment assessment timepoint (i.e., average of Week 23, 25 and 26)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on Part A-FAS. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure. Data for this outcome measure was planned to be collected and analyzed for combined population of BIVV009 (i.e., all participants who received BIVV009 [either 6.5 g or 7.5 g]) and placebo in Part A.
Arm/Group Title BIVV009 Placebo
Hide Arm/Group Description:
Participants with primary CAD and without a recent history of blood transfusion during the last 6 months prior to enrollment in this study, received an IV infusion of BIVV009 6.5 g (for participants <75 kg) or 7.5 g dose (for participants >=75 kg) on Day 0 and Day 7 and every 14 days thereafter in Part A up to Week 25.
Participants with primary CAD and without a recent history of blood transfusion during the last 6 months prior to enrollment in this study, received an IV infusion of placebo matched to BIVV009 on Day 0 and Day 7 and every 14 days thereafter in Part A up to Week 25.
Overall Number of Participants Analyzed 19 20
Mean (Standard Deviation)
Unit of Measure: units per liter
-150.833  (160.824) 7.600  (212.690)
7.Secondary Outcome
Title Part A: Percentage of Participants With Solicited Symptomatic Anemia at Week 26
Hide Description Symptomatic anemia was defined as having following symptoms: i. Fatigue; ii. Weakness; iii. Shortness of breath; iv. Palpitations, fast heartbeat; v. Light headedness and/or vi. Chest pain. Percentage of participants with solicited symptomatic anemia symptoms was reported in this outcome measure.
Time Frame Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on Part A-FAS. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure. Data for this outcome measure was planned to be collected and analyzed for combined population of BIVV009 (i.e., all participants who received BIVV009 [either 6.5 g or 7.5 g]) and placebo in Part A.
Arm/Group Title BIVV009 Placebo
Hide Arm/Group Description:
Participants with primary CAD and without a recent history of blood transfusion during the last 6 months prior to enrollment in this study, received an IV infusion of BIVV009 6.5 g (for participants <75 kg) or 7.5 g dose (for participants >=75 kg) on Day 0 and Day 7 and every 14 days thereafter in Part A up to Week 25.
Participants with primary CAD and without a recent history of blood transfusion during the last 6 months prior to enrollment in this study, received an IV infusion of placebo matched to BIVV009 on Day 0 and Day 7 and every 14 days thereafter in Part A up to Week 25.
Overall Number of Participants Analyzed 19 19
Measure Type: Number
Unit of Measure: percentage of participants
Fatigue 31.6 68.4
Weakness 5.3 31.6
Shortness of breath 5.3 36.8
Palpitations 0 15.8
Light headedness 5.3 15.8
Chest pain 0 5.3
8.Secondary Outcome
Title Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points
Hide Description Change from baseline (Week 0) in Hgb levels at each specified time points (i.e., Week 27, 29, 31, 33, 35, 37, 39, 41, 43,45, 47, 49, 51, 53, 55, 57, 59, 61, 63, 65, 67, 69, 71, 73, 75, 77, 79, 81, 83,85,87, 89,91, 93, 95, 97, 99,101,103, 105, 107,109, 111,113,115,117,119, 121,123, 125, 127,129,131,133,135,137,139,141,143,145,147,149,151,153, 155,157,159,161,163,165,167,169,171,173,175 and ET/SFU Visit) is reported in this outcome measure. Baseline was defined as the last non-missing value prior to the first administration of study drug in Part A. Early Termination (ET) visit/safety follow up (SFU) visit was 9 weeks after administration of last dose (i.e., up to Week 184). Here, "0" in the number analyzed field signifies that none of participants were available for assessment at the specified timepoints.
Time Frame Baseline (Week 0), every 2 weeks starting from Week 27 till Week 175 and at ET/SFU visit (i.e., up to Week 184)
Hide Outcome Measure Data
Hide Analysis Population Description
Analyzed on Part B-FAS which included all participants who enrolled in Part B and received at least 1 dose (including partial dose) of study drug (BIVV009). Here, 'number analyzed' = participants with available data for each specified category. Data for this outcome measure was planned to be collected and analyzed for combined population of BIVV009 (i.e., all participants who received BIVV009 [either 6.5 g or 7.5 g]).
Arm/Group Title BIVV009/BIVV009 Placebo/BIVV009
Hide Arm/Group Description:
Participants with primary CAD and without a recent history of blood transfusion during the last 6 months prior to enrollment in this study, received an IV infusion of BIVV009 6.5 g (for participants <75 kg) or 7.5 g dose (for participants >=75 kg) on Day 0 and Day 7 and every 14 days thereafter in Part A up to Week 25. Participants who completed Part A per protocol through the end of treatment visit (Week 26), received placebo on Week 26 and continued to receive BIVV009 6.5 or 7.5 g in Part B, every 2 weeks starting at Week 27 for up to an additional 149 weeks (for 6.5 g) or 121 weeks (for 7.5 g). All participants who completed Part A elected to continue in Part B.
Participants with primary CAD and without a recent history of blood transfusion during the last 6 months prior to enrollment in this study, received an IV infusion of placebo matched to BIVV009 on Day 0 and Day 7 and every 14 days thereafter in Part A up to Week 25. Participants who completed Part A per protocol through the end of treatment visit (Week 26) received BIVV009 6.5 (if <75 kg) or 7.5 g (if >=75 kg) in Part B, on Week 26 and Week 27 and every 2 weeks thereafter for up to an additional 123 weeks (for 6.5 g) or 137 weeks (for 7.5 g). All participants who completed Part A elected to continue in Part B.
Overall Number of Participants Analyzed 19 20
Mean (Standard Deviation)
Unit of Measure: grams per deciliter
Week 27 Number Analyzed 19 participants 20 participants
2.647  (1.348) 1.125  (1.545)
Week 29 Number Analyzed 17 participants 18 participants
2.507  (1.669) 1.947  (1.467)
Week 31 Number Analyzed 18 participants 19 participants
2.490  (1.550) 2.358  (1.471)
Week 33 Number Analyzed 18 participants 19 participants
2.519  (1.520) 1.987  (2.054)
Week 35 Number Analyzed 17 participants 19 participants
2.611  (1.522) 1.977  (2.010)
Week 37 Number Analyzed 18 participants 19 participants
2.197  (1.461) 2.469  (1.550)
Week 39 Number Analyzed 17 participants 18 participants
2.528  (1.607) 2.368  (1.835)
Week 41 Number Analyzed 19 participants 19 participants
2.162  (1.636) 2.074  (1.825)
Week 43 Number Analyzed 17 participants 19 participants
2.436  (1.103) 2.182  (1.643)
Week 45 Number Analyzed 18 participants 20 participants
2.644  (1.688) 2.249  (1.858)
Week 47 Number Analyzed 16 participants 19 participants
2.335  (1.108) 2.315  (2.129)
Week 49 Number Analyzed 16 participants 18 participants
2.531  (1.280) 2.121  (1.883)
Week 51 Number Analyzed 16 participants 19 participants
2.349  (1.260) 2.394  (1.870)
Week 53 Number Analyzed 16 participants 18 participants
2.346  (1.182) 2.411  (1.786)
Week 55 Number Analyzed 17 participants 18 participants
2.438  (1.396) 2.539  (1.403)
Week 57 Number Analyzed 16 participants 17 participants
2.531  (1.446) 2.250  (1.774)
Week 59 Number Analyzed 17 participants 17 participants
2.590  (1.397) 2.008  (2.615)
Week 61 Number Analyzed 17 participants 18 participants
4.073  (6.761) 2.059  (1.911)
Week 63 Number Analyzed 17 participants 17 participants
2.382  (1.546) 2.102  (1.780)
Week 65 Number Analyzed 16 participants 17 participants
2.925  (1.447) 2.311  (1.986)
Week 67 Number Analyzed 17 participants 17 participants
4.170  (6.509) 2.534  (2.036)
Week 69 Number Analyzed 16 participants 17 participants
2.777  (1.411) 2.505  (2.093)
Week 71 Number Analyzed 14 participants 15 participants
2.654  (1.495) 2.357  (1.758)
Week 73 Number Analyzed 15 participants 16 participants
2.800  (2.132) 2.197  (1.989)
Week 75 Number Analyzed 15 participants 16 participants
2.391  (1.700) 2.175  (2.151)
Week 77 Number Analyzed 14 participants 16 participants
3.074  (2.088) 2.451  (1.878)
Week 79 Number Analyzed 13 participants 15 participants
2.614  (1.874) 2.419  (2.247)
Week 81 Number Analyzed 14 participants 17 participants
2.598  (1.801) 2.458  (1.579)
Week 83 Number Analyzed 14 participants 13 participants
2.469  (1.777) 2.762  (1.539)
Week 85 Number Analyzed 12 participants 15 participants
2.755  (1.942) 2.489  (1.375)
Week 87 Number Analyzed 13 participants 15 participants
2.477  (1.779) 2.765  (1.605)
Week 89 Number Analyzed 12 participants 13 participants
2.551  (1.835) 2.482  (2.004)
Week 91 Number Analyzed 11 participants 12 participants
2.380  (2.084) 2.556  (1.538)
Week 93 Number Analyzed 11 participants 12 participants
2.931  (2.386) 2.655  (2.033)
Week 95 Number Analyzed 11 participants 12 participants
2.262  (2.014) 2.578  (1.970)
Week 97 Number Analyzed 11 participants 12 participants
2.413  (2.262) 2.551  (1.544)
Week 99 Number Analyzed 11 participants 13 participants
2.019  (1.799) 2.412  (1.822)
Week 101 Number Analyzed 11 participants 12 participants
2.276  (1.986) 2.171  (1.852)
Week 103 Number Analyzed 11 participants 13 participants
2.378  (2.342) 2.527  (1.807)
Week 105 Number Analyzed 11 participants 12 participants
2.291  (1.719) 2.321  (1.805)
Week 107 Number Analyzed 11 participants 13 participants
2.319  (1.511) 2.560  (1.858)
Week 109 Number Analyzed 11 participants 11 participants
2.509  (1.772) 2.645  (1.608)
Week 111 Number Analyzed 11 participants 12 participants
2.416  (1.908) 2.750  (1.707)
Week 113 Number Analyzed 11 participants 12 participants
2.860  (1.832) 2.268  (1.497)
Week 115 Number Analyzed 10 participants 10 participants
2.622  (1.986) 2.326  (1.809)
Week 117 Number Analyzed 9 participants 11 participants
3.135  (1.598) 2.474  (1.808)
Week 119 Number Analyzed 9 participants 10 participants
3.106  (1.493) 2.608  (2.045)
Week 121 Number Analyzed 9 participants 8 participants
3.388  (1.616) 2.325  (2.223)
Week 123 Number Analyzed 9 participants 9 participants
3.255  (1.346) 2.878  (2.667)
Week 125 Number Analyzed 8 participants 7 participants
3.197  (1.366) 1.700  (2.684)
Week 127 Number Analyzed 7 participants 8 participants
3.371  (1.551) 2.102  (3.211)
Week 129 Number Analyzed 7 participants 7 participants
3.171  (1.566) 2.129  (2.739)
Week 131 Number Analyzed 6 participants 6 participants
3.453  (1.823) 1.423  (3.184)
Week 133 Number Analyzed 5 participants 4 participants
3.520  (1.707) 2.025  (1.167)
Week 135 Number Analyzed 5 participants 5 participants
3.611  (1.458) 3.048  (1.620)
Week 137 Number Analyzed 4 participants 3 participants
4.074  (2.392) 2.400  (1.808)
Week 139 Number Analyzed 5 participants 3 participants
3.929  (1.889) 3.334  (2.669)
Week 141 Number Analyzed 3 participants 3 participants
3.500  (0.656) 2.733  (1.674)
Week 143 Number Analyzed 4 participants 3 participants
3.220  (1.064) 2.985  (1.904)
Week 145 Number Analyzed 2 participants 3 participants
3.350  (0.636) 3.467  (2.108)
Week 147 Number Analyzed 3 participants 2 participants
3.202  (0.591) 2.300  (0.566)
Week 149 Number Analyzed 1 participants 2 participants
2.900 2.550  (0.778)
Week 151 Number Analyzed 2 participants 1 participants
2.961  (0.370) 3.000
Week 153 Number Analyzed 1 participants 1 participants
2.800 2.800
Week 155 Number Analyzed 1 participants 1 participants
2.700 3.600
Week 157 Number Analyzed 1 participants 1 participants
2.700 3.000
Week 159 Number Analyzed 1 participants 1 participants
3.300 2.300
Week 161 Number Analyzed 1 participants 1 participants
4.100 2.400
Week 163 Number Analyzed 1 participants 1 participants
4.100 2.600
Week 165 Number Analyzed 1 participants 0 participants
3.800
Week 167 Number Analyzed 1 participants 0 participants
4.700
Week 169 Number Analyzed 1 participants 0 participants
4.300
Week 171 Number Analyzed 1 participants 0 participants
4.200
Week 173 Number Analyzed 1 participants 0 participants
4.000
Week 175 Number Analyzed 1 participants 0 participants
2.500
ET/SFU Visit Number Analyzed 17 participants 18 participants
0.149  (2.073) 0.359  (1.872)
9.Secondary Outcome
Title Part B: Change From Baseline in Total Bilirubin Levels at Each Specified Time Points
Hide Description Change from baseline (Week 0) in total bilirubin levels at each specified time points (i.e., Week 27, 29, 31, 33, 35, 37, 39, 41, 43, 45, 47, 49, 51, 53, 55, 57, 59, 61, 63, 65,67,69,71,73,75, 77, 79, 81,83, 85, 87, 89, 91, 93, 95, 97, 99,101,103, 105, 107,109, 111,113,115,117,119, 121, 123, 125, 127,129,131,133,135,137,139,141,143, 145,147,149,151,153,155,157,159, 161,163,165,167,169,171,173,175 and ET/SFU Visit) is reported in this outcome measure. Baseline was defined as the last non-missing value prior to the first administration of study drug in Part A. ET visit/SFU visit was 9 weeks after administration of last dose (i.e., up to Week 184). Here, "0" in the number analyzed field signifies that none of participants were available for assessment at the specified timepoints.
Time Frame Baseline (Week 0), every 2 weeks starting from Week 27 till Week 175 and at ET/SFU visit (i.e., up to Week 184)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on Part B-FAS. Here, 'overall number of participants analyzed'=participants with available data for this outcome measure and 'number analyzed' = participants with available data for each specified category. Data for this outcome measure was planned to be collected and analyzed for combined population of BIVV009 (i.e., all participants who received BIVV009 [either 6.5 g or 7.5 g]).
Arm/Group Title BIVV009/BIVV009 Placebo/BIVV009
Hide Arm/Group Description:
Participants with primary CAD and without a recent history of blood transfusion during the last 6 months prior to enrollment in this study, received an IV infusion of BIVV009 6.5 g (for participants <75 kg) or 7.5 g dose (for participants >=75 kg) on Day 0 and Day 7 and every 14 days thereafter in Part A up to Week 25. Participants who completed Part A per protocol through the end of treatment visit (Week 26), received placebo on Week 26 and continued to receive BIVV009 6.5 or 7.5 g in Part B, every 2 weeks starting at Week 27 for up to an additional 149 weeks (for 6.5 g) or 121 weeks (for 7.5 g). All participants who completed Part A elected to continue in Part B.
Participants with primary CAD and without a recent history of blood transfusion during the last 6 months prior to enrollment in this study, received an IV infusion of placebo matched to BIVV009 on Day 0 and Day 7 and every 14 days thereafter in Part A up to Week 25. Participants who completed Part A per protocol through the end of treatment visit (Week 26) received BIVV009 6.5 (if <75 kg) or 7.5 g (if >=75 kg) in Part B, on Week 26 and Week 27 and every 2 weeks thereafter for up to an additional 123 weeks (for 6.5 g) or 137 weeks (for 7.5 g). All participants who completed Part A elected to continue in Part B.
Overall Number of Participants Analyzed 17 18
Mean (Standard Deviation)
Unit of Measure: micromoles per liter
Week 27 Number Analyzed 17 participants 18 participants
-22.965  (9.899) -18.761  (13.353)
Week 29 Number Analyzed 16 participants 18 participants
-20.119  (12.170) -19.889  (14.500)
Week 31 Number Analyzed 16 participants 17 participants
-21.675  (11.025) -22.153  (14.962)
Week 33 Number Analyzed 15 participants 16 participants
-19.860  (11.527) -24.263  (15.169)
Week 35 Number Analyzed 15 participants 16 participants
-20.540  (10.557) -21.888  (13.930)
Week 37 Number Analyzed 16 participants 15 participants
-21.350  (13.234) -22.527  (16.315)
Week 39 Number Analyzed 15 participants 15 participants
-23.493  (11.425) -21.173  (15.901)
Week 41 Number Analyzed 16 participants 16 participants
-18.694  (12.189) -21.138  (16.150)
Week 43 Number Analyzed 15 participants 16 participants
-20.593  (11.449) -21.544  (16.603)
Week 45 Number Analyzed 16 participants 18 participants
-18.556  (11.213) -20.156  (16.757)
Week 47 Number Analyzed 14 participants 18 participants
-20.400  (9.803) -20.250  (15.536)
Week 49 Number Analyzed 14 participants 17 participants
-21.450  (10.271) -21.024  (13.630)
Week 51 Number Analyzed 14 participants 16 participants
-19.686  (11.072) -19.444  (15.942)
Week 53 Number Analyzed 15 participants 17 participants
-19.107  (11.267) -20.335  (17.126)
Week 55 Number Analyzed 13 participants 16 participants
-19.354  (12.209) -23.481  (12.300)
Week 57 Number Analyzed 13 participants 15 participants
-21.708  (10.467) -18.953  (15.825)
Week 59 Number Analyzed 14 participants 15 participants
-19.979  (9.706) -19.820  (16.209)
Week 61 Number Analyzed 13 participants 15 participants
-18.254  (10.541) -21.073  (17.457)
Week 63 Number Analyzed 15 participants 15 participants
-21.587  (9.680) -21.753  (16.663)
Week 65 Number Analyzed 14 participants 14 participants
-20.400  (9.866) -20.950  (19.833)
Week 67 Number Analyzed 15 participants 14 participants
-22.680  (10.317) -20.150  (20.250)
Week 69 Number Analyzed 14 participants 15 participants
-21.279  (9.423) -17.827  (22.194)
Week 71 Number Analyzed 12 participants 13 participants
-19.008  (8.255) -20.585  (21.125)
Week 73 Number Analyzed 12 participants 15 participants
-23.058  (7.766) -20.080  (17.803)
Week 75 Number Analyzed 12 participants 14 participants
-21.492  (7.453) -20.771  (20.261)
Week 77 Number Analyzed 12 participants 14 participants
-23.267  (8.972) -19.814  (19.337)
Week 79 Number Analyzed 12 participants 15 participants
-21.125  (12.701) -21.027  (19.830)
Week 81 Number Analyzed 11 participants 13 participants
-19.255  (9.478) -22.331  (20.117)
Week 83 Number Analyzed 12 participants 11 participants
-16.567  (12.565) -25.091  (13.838)
Week 85 Number Analyzed 11 participants 13 participants
-18.045  (12.183) -23.292  (12.976)
Week 87 Number Analyzed 10 participants 11 participants
-19.990  (12.043) -21.473  (14.444)
Week 89 Number Analyzed 10 participants 11 participants
-17.790  (11.036) -24.782  (13.390)
Week 91 Number Analyzed 9 participants 11 participants
-16.944  (13.476) -23.091  (14.949)
Week 93 Number Analyzed 9 participants 10 participants
-18.300  (11.132) -24.970  (13.852)
Week 95 Number Analyzed 8 participants 11 participants
-18.613  (12.265) -23.564  (11.122)
Week 97 Number Analyzed 9 participants 9 participants
-18.656  (11.462) -26.122  (11.870)
Week 99 Number Analyzed 9 participants 11 participants
-17.389  (10.932) -23.700  (12.919)
Week 101 Number Analyzed 9 participants 10 participants
-18.411  (10.175) -25.940  (12.309)
Week 103 Number Analyzed 9 participants 11 participants
-18.178  (11.156) -22.655  (11.308)
Week 105 Number Analyzed 9 participants 10 participants
-19.422  (8.444) -26.920  (10.996)
Week 107 Number Analyzed 9 participants 11 participants
-18.100  (9.955) -23.018  (12.755)
Week 109 Number Analyzed 9 participants 9 participants
-18.456  (10.606) -25.422  (14.100)
Week 111 Number Analyzed 9 participants 10 participants
-19.767  (9.992) -24.380  (12.298)
Week 113 Number Analyzed 9 participants 10 participants
-19.389  (9.192) -23.940  (15.514)
Week 115 Number Analyzed 9 participants 9 participants
-19.622  (8.194) -21.533  (14.215)
Week 117 Number Analyzed 8 participants 8 participants
-22.088  (10.247) -22.225  (15.256)
Week 119 Number Analyzed 8 participants 8 participants
-20.038  (8.529) -22.713  (14.859)
Week 121 Number Analyzed 8 participants 6 participants
-22.063  (7.215) -21.183  (10.750)
Week 123 Number Analyzed 8 participants 7 participants
-21.438  (8.058) -22.029  (12.421)
Week 125 Number Analyzed 7 participants 5 participants
-20.657  (8.889) -19.560  (12.997)
Week 127 Number Analyzed 6 participants 6 participants
-20.550  (9.782) -21.433  (15.850)
Week 129 Number Analyzed 6 participants 5 participants
-22.883  (11.291) -19.020  (11.749)
Week 131 Number Analyzed 5 participants 5 participants
-19.420  (12.936) -23.100  (15.797)
Week 133 Number Analyzed 4 participants 4 participants
-27.600  (7.477) -17.450  (16.917)
Week 135 Number Analyzed 4 participants 5 participants
-29.500  (7.816) -21.900  (19.552)
Week 137 Number Analyzed 3 participants 2 participants
-28.833  (8.615) -11.650  (18.173)
Week 139 Number Analyzed 4 participants 3 participants
-25.800  (9.081) -24.733  (17.470)
Week 141 Number Analyzed 2 participants 3 participants
-34.400  (2.404) -13.833  (16.669)
Week 143 Number Analyzed 3 participants 3 participants
-26.967  (9.235) -20.033  (22.861)
Week 145 Number Analyzed 2 participants 3 participants
-32.900  (3.677) -18.100  (27.217)
Week 147 Number Analyzed 3 participants 2 participants
-29.300  (7.418) -3.300  (34.083)
Week 149 Number Analyzed 1 participants 2 participants
-31.700 -7.300  (28.284)
Week 151 Number Analyzed 2 participants 1 participants
-21.500  (0.566) 0.300
Week 153 Number Analyzed 1 participants 1 participants
-30.800 -11.400
Week 155 Number Analyzed 1 participants 1 participants
-35.300 0.700
Week 157 Number Analyzed 1 participants 1 participants
-32.400 -0.100
Week 159 Number Analyzed 1 participants 1 participants
-32.500 4.700
Week 161 Number Analyzed 1 participants 1 participants
-36.800 5.500
Week 163 Number Analyzed 1 participants 1 participants
-37.100 13.000
Week 165 Number Analyzed 1 participants 0 participants
-36.300
Week 167 Number Analyzed 1 participants 0 participants
-34.300
Week 169 Number Analyzed 1 participants 0 participants
-32.700
Week 171 Number Analyzed 1 participants 0 participants
-33.100
Week 173 Number Analyzed 1 participants 0 participants
-32.100
Week 175 Number Analyzed 1 participants 0 participants
-28.400
ET/SFU Visit Number Analyzed 17 participants 17 participants
1.976  (9.444) 1.165  (18.773)
10.Secondary Outcome
Title Part B: Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale Score (Quality of Life) at Each Specified Time Points
Hide Description FACIT-Fatigue scale consists of 13 questions assessed using a 5-point scale (0=not at all; 1 = a little bit, 2 = somewhat, 3 = quite a bit and 4 = very much). Responses to each question were added to obtain a total score. The Total score ranged from 0 to 52, with higher score indicating more fatigue. Baseline (Week 0) was defined as the last non-missing value prior to the first administration of study drug in Part A. ET visit/SFU visit was 9 weeks after administration of last dose (i.e., up to Week 184).
Time Frame Baseline (Week 0), Weeks 39, 51, 63, 75, 87, 99, 111, 123, 135, 147, 159, 171 and ET Visit/SFU visit (i.e., up to Week 184)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on Part B-FAS. Here, 'number analyzed'=participants with available data for each specified category and "0" in the number analyzed field signifies that none of participants were available for assessment at the specified timepoints. Data for this outcome measure was planned to be collected and analyzed for combined population of BIVV009 (i.e., all participants who received BIVV009 [either 6.5 g or 7.5 g]).
Arm/Group Title BIVV009/BIVV009 Placebo/BIVV009
Hide Arm/Group Description:
Participants with primary CAD and without a recent history of blood transfusion during the last 6 months prior to enrollment in this study, received an IV infusion of BIVV009 6.5 g (for participants <75 kg) or 7.5 g dose (for participants >=75 kg) on Day 0 and Day 7 and every 14 days thereafter in Part A up to Week 25. Participants who completed Part A per protocol through the end of treatment visit (Week 26), received placebo on Week 26 and continued to receive BIVV009 6.5 or 7.5 g in Part B, every 2 weeks starting at Week 27 for up to an additional 149 weeks (for 6.5 g) or 121 weeks (for 7.5 g). All participants who completed Part A elected to continue in Part B.
Participants with primary CAD and without a recent history of blood transfusion during the last 6 months prior to enrollment in this study, received an IV infusion of placebo matched to BIVV009 on Day 0 and Day 7 and every 14 days thereafter in Part A up to Week 25. Participants who completed Part A per protocol through the end of treatment visit (Week 26) received BIVV009 6.5 (if <75 kg) or 7.5 g (if >=75 kg) in Part B, on Week 26 and Week 27 and every 2 weeks thereafter for up to an additional 123 weeks (for 6.5 g) or 137 weeks (for 7.5 g). All participants who completed Part A elected to continue in Part B.
Overall Number of Participants Analyzed 19 20
Mean (Standard Deviation)
Unit of Measure: score on a scale
Week 39 Number Analyzed 18 participants 18 participants
11.048  (12.333) 7.958  (12.003)
Week 51 Number Analyzed 15 participants 16 participants
10.080  (11.506) 6.354  (9.680)
Week 63 Number Analyzed 16 participants 16 participants
10.672  (13.225) 8.499  (11.146)
Week 75 Number Analyzed 13 participants 14 participants
9.861  (12.953) 10.304  (9.722)
Week 87 Number Analyzed 13 participants 15 participants
11.015  (13.972) 8.483  (11.323)
Week 99 Number Analyzed 11 participants 13 participants
12.109  (14.786) 8.788  (10.985)
Week 111 Number Analyzed 11 participants 12 participants
11.563  (13.411) 10.688  (11.768)
Week 123 Number Analyzed 9 participants 9 participants
10.806  (13.736) 6.583  (16.613)
Week 135 Number Analyzed 5 participants 5 participants
16.683  (18.953) 12.650  (15.243)
Week 147 Number Analyzed 2 participants 2 participants
9.208  (1.120) 0.500  (2.121)
Week 159 Number Analyzed 1 participants 1 participants
20.000 10.000
Week 171 Number Analyzed 1 participants 0 participants
15.000
ET/SFU Visit Number Analyzed 19 participants 18 participants
-1.257  (10.399) -1.551  (12.840)
11.Secondary Outcome
Title Part B: Change From Baseline in 12-Item Short-Form Survey (SF-12) Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores at Each Specified Time Points
Hide Description SF-12: 12 item-questionnaire assessed health-related quality of life (HRQOL), contained 12 items, categorized into 8 domains (subscales) of functioning and well-being: physical functioning, role-physical, role emotional, mental health, bodily pain, general health, vitality and social functioning, with each domain score ranged from 0 (poor health) to 100 (better health). Higher scores = good health condition. These 8 domains were further summarized into 2 summary scores, PCS and MCS that ranged from 0 (poor health) to 100 (better health). Higher scores = better HRQOL. Baseline (Week 0): last non-missing value prior to first administration of study drug in Part A. ET visit/SFU visit: 9 weeks after administration of last dose (i.e., up to Week 184).
Time Frame Baseline (Week 0), Weeks 39, 51, 63, 75, 87, 99, 111, 123, 135, 147, 159, 171 and ET Visit/SFU visit (i.e., up to Week 184)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on Part B-FAS. Here, 'number analyzed'=participants with available data for each specified category and "0" in the number analyzed field signifies that none of participants were available for assessment at the specified timepoints. Data for this outcome measure was planned to be collected and analyzed for combined population of BIVV009 (i.e., all participants who received BIVV009 [either 6.5 g or 7.5 g]).
Arm/Group Title BIVV009/BIVV009 Placebo/BIVV009
Hide Arm/Group Description:
Participants with primary CAD and without a recent history of blood transfusion during the last 6 months prior to enrollment in this study, received an IV infusion of BIVV009 6.5 g (for participants <75 kg) or 7.5 g dose (for participants >=75 kg) on Day 0 and Day 7 and every 14 days thereafter in Part A up to Week 25. Participants who completed Part A per protocol through the end of treatment visit (Week 26), received placebo on Week 26 and continued to receive BIVV009 6.5 or 7.5 g in Part B, every 2 weeks starting at Week 27 for up to an additional 149 weeks (for 6.5 g) or 121 weeks (for 7.5 g). All participants who completed Part A elected to continue in Part B.
Participants with primary CAD and without a recent history of blood transfusion during the last 6 months prior to enrollment in this study, received an IV infusion of placebo matched to BIVV009 on Day 0 and Day 7 and every 14 days thereafter in Part A up to Week 25. Participants who completed Part A per protocol through the end of treatment visit (Week 26) received BIVV009 6.5 (if <75 kg) or 7.5 g (if >=75 kg) in Part B, on Week 26 and Week 27 and every 2 weeks thereafter for up to an additional 123 weeks (for 6.5 g) or 137 weeks (for 7.5 g). All participants who completed Part A elected to continue in Part B.
Overall Number of Participants Analyzed 19 20
Mean (Standard Deviation)
Unit of Measure: score on a scale
Week 39-PCS Number Analyzed 18 participants 18 participants
4.814  (8.830) 6.745  (11.255)
Week 39-MCS Number Analyzed 18 participants 18 participants
8.543  (9.155) 1.151  (11.591)
Week 51-PCS Number Analyzed 14 participants 16 participants
5.320  (6.913) 5.654  (8.527)
Week 51-MCS Number Analyzed 14 participants 16 participants
8.461  (6.754) 1.704  (8.813)
Week 63-PCS Number Analyzed 16 participants 16 participants
5.840  (6.916) 6.216  (9.514)
Week 63-MCS Number Analyzed 16 participants 16 participants
8.117  (9.955) 1.722  (10.175)
Week 75-PCS Number Analyzed 12 participants 15 participants
5.723  (7.563) 7.661  (10.418)
Week 75-MCS Number Analyzed 12 participants 15 participants
7.932  (9.279) 3.519  (7.891)
Week 87-PCS Number Analyzed 12 participants 15 participants
5.226  (8.196) 8.778  (12.405)
Week 87-MCS Number Analyzed 12 participants 15 participants
6.058  (10.981) 2.219  (9.111)
Week 99-PCS Number Analyzed 10 participants 13 participants
3.945  (7.463) 8.262  (12.534)
Week 99-MCS Number Analyzed 10 participants 13 participants
7.136  (11.850) 4.682  (7.698)
Week 111-PCS Number Analyzed 10 participants 12 participants
4.800  (7.985) 8.080  (12.302)
Week 111-MCS Number Analyzed 10 participants 12 participants
8.705  (7.777) 4.411  (10.249)
Week 123-PCS Number Analyzed 9 participants 9 participants
4.147  (7.110) 7.973  (13.200)
Week 123-MCS Number Analyzed 9 participants 9 participants
8.650  (8.323) -2.538  (13.136)
Week 135-PCS Number Analyzed 5 participants 4 participants
6.660  (9.096) 6.070  (13.819)
Week 135-MCS Number Analyzed 5 participants 4 participants
8.860  (9.817) 2.790  (6.170)
Week 147-PCS Number Analyzed 2 participants 2 participants
-1.655  (3.769) -3.740  (1.824)
Week 147-MCS Number Analyzed 2 participants 2 participants
11.220  (6.095) -1.110  (0.679)
Week 159-PCS Number Analyzed 1 participants 1 participants
5.620 -10.410
Week 159-MCS Number Analyzed 1 participants 1 participants
16.400 9.590
Week 171-PCS Number Analyzed 1 participants 0 participants
11.980
Week 171-MCS Number Analyzed 1 participants 0 participants
0.250
ET/SFU Visit-PCS Number Analyzed 18 participants 18 participants
-3.478  (10.875) -0.429  (10.922)
ET/SFU Visit-MCS Number Analyzed 18 participants 18 participants
1.835  (11.882) -2.137  (10.148)
12.Secondary Outcome
Title Part B: Change From Baseline in 5-level European Quality of Life 5- Dimensions 5-Level Questionnaire (EQ-5D-5L) Health State Utility Index and VAS Scores at Each Specified Time Points
Hide Description EQ-5D-5L included 2 components: health state utility index (descriptive system) and Visual Analog Scale (VAS). EQ-5D descriptive system comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 response option: no problem, slight problem, moderate problem, severe problem and extreme problems measured with Likert scale. EQ-5D-5L responses converted into single index utility score between 0 to 1. Higher score=better health. EQ-5D-5L VAS rated participant's current health state on scale from 0 (worst imaginable health) to 100 (best imaginable health). Baseline (Week 0): last non-missing value prior to first administration of study drug in Part A. ET visit/SFU visit: 9 weeks after administration of last dose (i.e., up to Week 184).
Time Frame Baseline (Week 0), Weeks 39, 51, 63, 75, 87, 99, 111, 123, 135, 147, 159, 171 and ET Visit/SFU visit (i.e., up to Week 184)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on Part B-FAS. Here, 'number analyzed'=participants with available data for each specified category and "0" in the number analyzed field signifies that none of participants were available for assessment at the specified timepoints. Data for this outcome measure was planned to be collected and analyzed for combined population of BIVV009 (i.e., all participants who received BIVV009 [either 6.5 g or 7.5 g]).
Arm/Group Title BIVV009/BIVV009 Placebo/BIVV009
Hide Arm/Group Description:
Participants with primary CAD and without a recent history of blood transfusion during the last 6 months prior to enrollment in this study, received an IV infusion of BIVV009 6.5 g (for participants <75 kg) or 7.5 g dose (for participants >=75 kg) on Day 0 and Day 7 and every 14 days thereafter in Part A up to Week 25. Participants who completed Part A per protocol through the end of treatment visit (Week 26), received placebo on Week 26 and continued to receive BIVV009 6.5 or 7.5 g in Part B, every 2 weeks starting at Week 27 for up to an additional 149 weeks (for 6.5 g) or 121 weeks (for 7.5 g). All participants who completed Part A elected to continue in Part B.
Participants with primary CAD and without a recent history of blood transfusion during the last 6 months prior to enrollment in this study, received an IV infusion of placebo matched to BIVV009 on Day 0 and Day 7 and every 14 days thereafter in Part A up to Week 25. Participants who completed Part A per protocol through the end of treatment visit (Week 26) received BIVV009 6.5 (if <75 kg) or 7.5 g (if >=75 kg) in Part B, on Week 26 and Week 27 and every 2 weeks thereafter for up to an additional 123 weeks (for 6.5 g) or 137 weeks (for 7.5 g). All participants who completed Part A elected to continue in Part B.
Overall Number of Participants Analyzed 19 20
Mean (Standard Deviation)
Unit of Measure: score on a scale
Week 39-Index score Number Analyzed 17 participants 18 participants
0.020  (0.165) 0.054  (0.135)
Week 51-Index score Number Analyzed 15 participants 16 participants
0.075  (0.173) -0.008  (0.197)
Week 63-Index score Number Analyzed 16 participants 16 participants
0.060  (0.214) 0.015  (0.157)
Week 75-Index score Number Analyzed 13 participants 15 participants
-0.004  (0.144) 0.063  (0.152)
Week 87-Index score Number Analyzed 13 participants 15 participants
-0.034  (0.240) 0.059  (0.158)
Week 99-Index score Number Analyzed 11 participants 13 participants
-0.058  (0.216) 0.058  (0.146)
Week 111-Index score Number Analyzed 11 participants 12 participants
-0.033  (0.205) 0.050  (0.194)
Week 123-Index score Number Analyzed 9 participants 9 participants
-0.020  (0.235) 0.031  (0.221)
Week 135-Index score Number Analyzed 5 participants 5 participants
0.008  (0.351) 0.094  (0.245)
Week 147-Index score Number Analyzed 2 participants 2 participants
0.054  (0.037) -0.087  (0.222)
Week 159-Index score Number Analyzed 1 participants 1 participants
0.174 0.087
Week 171-Index score Number Analyzed 1 participants 0 participants
0.053
ET/SFU Visit-Index score Number Analyzed 19 participants 18 participants
-0.108  (0.238) -0.077  (0.169)
Week 39-VAS Number Analyzed 17 participants 18 participants
20.647  (16.871) 12.000  (17.146)
Week 51-VAS Number Analyzed 15 participants 16 participants
14.800  (27.589) 9.125  (21.112)
Week 63-VAS Number Analyzed 15 participants 16 participants
19.867  (21.603) 14.375  (15.573)
Week 75-VAS Number Analyzed 13 participants 15 participants
16.846  (22.120) 18.933  (20.243)
Week 87-VAS Number Analyzed 13 participants 15 participants
14.077  (25.221) 16.867  (17.912)
Week 99-VAS Number Analyzed 11 participants 13 participants
19.364  (20.796) 18.385  (20.706)
Week 111-VAS Number Analyzed 11 participants 12 participants
18.273  (19.463) 22.833  (20.621)
Week 123-VAS Number Analyzed 9 participants 9 participants
21.667  (18.371) 18.000  (30.389)
Week 135-VAS Number Analyzed 5 participants 5 participants
26.000  (20.433) 23.400  (27.574)
Week 147-VAS Number Analyzed 2 participants 2 participants
17.500  (17.678) 3.500  (26.163)
Week 159-VAS Number Analyzed 1 participants 1 participants
40.000 27.000
Week 171-VAS Number Analyzed 1 participants 0 participants
35.000
ET/SFU Visit-VAS Number Analyzed 19 participants 18 participants
1.526  (17.976) -2.056  (14.957)
13.Secondary Outcome
Title Part B: Number of Participants With Response to Participant's Global Impression of (Fatigue) Severity (PGIS) Questionnaire at Each Specified Time Points
Hide Description The PGIS is a self-reported scale. The PGIS is a 1-item questionnaire designed to assess participant's impression of disease severity using a 5-point scale ranging from 1 to 5, where 1=none, 2=mild, 3=moderate, 4=severe, 5=very severe. Higher scores indicated greater severity. ET visit/SFU visit was 9 weeks after administration of last dose (i.e., up to Week 184).
Time Frame Baseline (Week 0), Weeks 39, 51, 63, 75, 87, 99, 111, 123, 135, 147, 159, 171 and ET Visit/SFU visit (i.e., up to Week 184)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on Part B-FAS. Here, 'number analyzed' = participants with available data for each specified category and "0" in the number analyzed field signifies that none of participants were available for assessment at the specified timepoints. Data for this outcome measure was planned to be collected and analyzed for combined population of BIVV009 (i.e., all participants who received BIVV009 [either 6.5 g or 7.5 g]).
Arm/Group Title BIVV009/BIVV009 Placebo/BIVV009
Hide Arm/Group Description:
Participants with primary CAD and without a recent history of blood transfusion during the last 6 months prior to enrollment in this study, received an IV infusion of BIVV009 6.5 g (for participants <75 kg) or 7.5 g dose (for participants >=75 kg) on Day 0 and Day 7 and every 14 days thereafter in Part A up to Week 25. Participants who completed Part A per protocol through the end of treatment visit (Week 26), received placebo on Week 26 and continued to receive BIVV009 6.5 or 7.5 g in Part B, every 2 weeks starting at Week 27 for up to an additional 149 weeks (for 6.5 g) or 121 weeks (for 7.5 g). All participants who completed Part A elected to continue in Part B.
Participants with primary CAD and without a recent history of blood transfusion during the last 6 months prior to enrollment in this study, received an IV infusion of placebo matched to BIVV009 on Day 0 and Day 7 and every 14 days thereafter in Part A up to Week 25. Participants who completed Part A per protocol through the end of treatment visit (Week 26) received BIVV009 6.5 (if <75 kg) or 7.5 g (if >=75 kg) in Part B, on Week 26 and Week 27 and every 2 weeks thereafter for up to an additional 123 weeks (for 6.5 g) or 137 weeks (for 7.5 g). All participants who completed Part A elected to continue in Part B.
Overall Number of Participants Analyzed 19 20
Measure Type: Count of Participants
Unit of Measure: Participants
Week 39 - None Number Analyzed 17 participants 17 participants
7
  41.2%
5
  29.4%
Week 39 - Mild Number Analyzed 17 participants 17 participants
8
  47.1%
7
  41.2%
Week 39 - Moderate Number Analyzed 17 participants 17 participants
1
   5.9%
5
  29.4%
Week 39 - Severe Number Analyzed 17 participants 17 participants
1
   5.9%
0
   0.0%
Week 39 - Very Severe Number Analyzed 17 participants 17 participants
0
   0.0%
0
   0.0%
Week 51 - None Number Analyzed 15 participants 16 participants
5
  33.3%
4
  25.0%
Week 51 - Mild Number Analyzed 15 participants 16 participants
8
  53.3%
7
  43.8%
Week 51 - Moderate Number Analyzed 15 participants 16 participants
2
  13.3%
5
  31.3%
Week 51 - Severe Number Analyzed 15 participants 16 participants
0
   0.0%
0
   0.0%
Week 51 - Very Severe Number Analyzed 15 participants 16 participants
0
   0.0%
0
   0.0%
Week 63 - None Number Analyzed 17 participants 16 participants
6
  35.3%
4
  25.0%
Week 63 - Mild Number Analyzed 17 participants 16 participants
8
  47.1%
7
  43.8%
Week 63 - Moderate Number Analyzed 17 participants 16 participants
3
  17.6%
5
  31.3%
Week 63 - Severe Number Analyzed 17 participants 16 participants
0
   0.0%
0
   0.0%
Week 63 - Very Severe Number Analyzed 17 participants 16 participants
0
   0.0%
0
   0.0%
Week 75 - None Number Analyzed 13 participants 15 participants
5
  38.5%
6
  40.0%
Week 75 - Mild Number Analyzed 13 participants 15 participants
6
  46.2%
6
  40.0%
Week 75 - Moderate Number Analyzed 13 participants 15 participants
2
  15.4%
3
  20.0%
Week 75 - Severe Number Analyzed 13 participants 15 participants
0
   0.0%
0
   0.0%
Week 75 - Very Severe Number Analyzed 13 participants 15 participants
0
   0.0%
0
   0.0%
Week 87 - None Number Analyzed 13 participants 15 participants
6
  46.2%
7
  46.7%
Week 87 - Mild Number Analyzed 13 participants 15 participants
5
  38.5%
4
  26.7%
Week 87 - Moderate Number Analyzed 13 participants 15 participants
1
   7.7%
3
  20.0%
Week 87 - Severe Number Analyzed 13 participants 15 participants
1
   7.7%
1
   6.7%
Week 87 - Very Severe Number Analyzed 13 participants 15 participants
0
   0.0%
0
   0.0%
Week 99 - None Number Analyzed 11 participants 13 participants
5
  45.5%
8
  61.5%
Week 99 - Mild Number Analyzed 11 participants 13 participants
5
  45.5%
3
  23.1%
Week 99 - Moderate Number Analyzed 11 participants 13 participants
1
   9.1%
2
  15.4%
Week 99 - Severe Number Analyzed 11 participants 13 participants
0
   0.0%
0
   0.0%
Week 99 - Very Severe Number Analyzed 11 participants 13 participants
0
   0.0%
0
   0.0%
Week 111 - None Number Analyzed 11 participants 12 participants
5
  45.5%
7
  58.3%
Week 111 - Mild Number Analyzed 11 participants 12 participants
4
  36.4%
3
  25.0%
Week 111 - Moderate Number Analyzed 11 participants 12 participants
2
  18.2%
2
  16.7%
Week 111 - Severe Number Analyzed 11 participants 12 participants
0
   0.0%
0
   0.0%
Week 111 - Very Severe Number Analyzed 11 participants 12 participants
0
   0.0%
0
   0.0%
Week 123 - None Number Analyzed 9 participants 9 participants
2
  22.2%
5
  55.6%
Week 123 - Mild Number Analyzed 9 participants 9 participants
6
  66.7%
2
  22.2%
Week 123 - Moderate Number Analyzed 9 participants 9 participants
1
  11.1%
2
  22.2%
Week 123 - Severe Number Analyzed 9 participants 9 participants
0
   0.0%
0
   0.0%
Week 123 - Very Severe Number Analyzed 9 participants 9 participants
0
   0.0%
0
   0.0%
Week 135 - None Number Analyzed 5 participants 5 participants
0
   0.0%
2
  40.0%
Week 135 - Mild Number Analyzed 5 participants 5 participants
3
  60.0%
1
  20.0%
Week 135 - Moderate Number Analyzed 5 participants 5 participants
2
  40.0%
2
  40.0%
Week 135 - Severe Number Analyzed 5 participants 5 participants
0
   0.0%
0
   0.0%
Week 135 - Very Severe Number Analyzed 5 participants 5 participants
0
   0.0%
0
   0.0%
Week 147 - None Number Analyzed 2 participants 2 participants
0
   0.0%
1
  50.0%
Week 147 - Mild Number Analyzed 2 participants 2 participants
1
  50.0%
0
   0.0%
Week 147 - Moderate Number Analyzed 2 participants 2 participants
1
  50.0%
1
  50.0%
Week 147 - Severe Number Analyzed 2 participants 2 participants
0
   0.0%
0
   0.0%
Week 147 - Very Severe Number Analyzed 2 participants 2 participants
0
   0.0%
0
   0.0%
Week 159 - None Number Analyzed 1 participants 1 participants
0
   0.0%
0
   0.0%
Week 159 - Mild Number Analyzed 1 participants 1 participants
0
   0.0%
0
   0.0%
Week 159 - Moderate Number Analyzed 1 participants 1 participants
1
 100.0%
1
 100.0%
Week 159 - Severe Number Analyzed 1 participants 1 participants
0
   0.0%
0
   0.0%
Week 159 - Very Severe Number Analyzed 1 participants 1 participants
0
   0.0%
0
   0.0%
Week 171 - None Number Analyzed 1 participants 0 participants
0
   0.0%
0
Week 171 - Mild Number Analyzed 1 participants 0 participants
1
 100.0%
0
Week 171 - Moderate Number Analyzed 1 participants 0 participants
0
   0.0%
0
Week 171 - Severe Number Analyzed 1 participants 0 participants
0
   0.0%
0
Week 171 - Very Severe Number Analyzed 1 participants 0 participants
0
   0.0%
0
ET/SFU - None Number Analyzed 19 participants 18 participants
2
  10.5%
4
  22.2%
ET/SFU - Mild Number Analyzed 19 participants 18 participants
5
  26.3%
3
  16.7%
ET/SFU - Moderate Number Analyzed 19 participants 18 participants
7
  36.8%
5
  27.8%
ET/SFU - Severe Number Analyzed 19 participants 18 participants
3
  15.8%
5
  27.8%
ET/SFU - Very Severe Number Analyzed 19 participants 18 participants
2
  10.5%
1
   5.6%
14.Secondary Outcome
Title Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points
Hide Description PGIC is a self-administered questionnaire to evaluate the improvement or worsening compared to the start of the study. PGIC was assessed on a 7-point Likert scale ranged from 1 (greatly improved) to 7 (greatly worsened). Categories were defined based on the PGIC scores as follows: 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse and 7=very much worsen. Higher scores indicated greater severity. ET visit/SFU visit was 9 weeks after administration of last dose (i.e., up to Week 184).
Time Frame Baseline (Week 0), Weeks 39, 51, 63, 75, 87, 99, 111, 123, 135, 147, 159, 171 and ET Visit/SFU visit (i.e., up to Week 184)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on Part B-FAS. Here, 'number analyzed' = participants with available data for each specified category and "0" in the number analyzed field signifies that none of participants were available for assessment at the specified timepoints. Data for this outcome measure was planned to be collected and analyzed for combined population of BIVV009 (i.e., all participants who received BIVV009 [either 6.5 g or 7.5 g]).
Arm/Group Title BIVV009/BIVV009 Placebo/BIVV009
Hide Arm/Group Description:
Participants with primary CAD and without a recent history of blood transfusion during the last 6 months prior to enrollment in this study, received an IV infusion of BIVV009 6.5 g (for participants <75 kg) or 7.5 g dose (for participants >=75 kg) on Day 0 and Day 7 and every 14 days thereafter in Part A up to Week 25. Participants who completed Part A per protocol through the end of treatment visit (Week 26), received placebo on Week 26 and continued to receive BIVV009 6.5 or 7.5 g in Part B, every 2 weeks starting at Week 27 for up to an additional 149 weeks (for 6.5 g) or 121 weeks (for 7.5 g). All participants who completed Part A elected to continue in Part B.
Participants with primary CAD and without a recent history of blood transfusion during the last 6 months prior to enrollment in this study, received an IV infusion of placebo matched to BIVV009 on Day 0 and Day 7 and every 14 days thereafter in Part A up to Week 25. Participants who completed Part A per protocol through the end of treatment visit (Week 26) received BIVV009 6.5 (if <75 kg) or 7.5 g (if >=75 kg) in Part B, on Week 26 and Week 27 and every 2 weeks thereafter for up to an additional 123 weeks (for 6.5 g) or 137 weeks (for 7.5 g). All participants who completed Part A elected to continue in Part B.
Overall Number of Participants Analyzed 19 20
Measure Type: Count of Participants
Unit of Measure: Participants
Week 39 - Very much improved Number Analyzed 17 participants 16 participants
4
  23.5%
3
  18.8%
Week 39 - Much improved Number Analyzed 17 participants 16 participants
8
  47.1%
6
  37.5%
Week 39 - Minimally improved Number Analyzed 17 participants 16 participants
2
  11.8%
6
  37.5%
Week 39 - No Change Number Analyzed 17 participants 16 participants
2
  11.8%
1
   6.3%
Week 39 - Minimally worse Number Analyzed 17 participants 16 participants
1
   5.9%
0
   0.0%
Week 39 - Much worse Number Analyzed 17 participants 16 participants
0
   0.0%
0
   0.0%
Week 39 - Very much worse Number Analyzed 17 participants 16 participants
0
   0.0%
0
   0.0%
Week 51 - Very much improved Number Analyzed 15 participants 16 participants
5
  33.3%
3
  18.8%
Week 51 - Much improved Number Analyzed 15 participants 16 participants
3
  20.0%
6
  37.5%
Week 51 - Minimally improved Number Analyzed 15 participants 16 participants
2
  13.3%
4
  25.0%
Week 51 - No Change Number Analyzed 15 participants 16 participants
5
  33.3%
2
  12.5%
Week 51 - Minimally worse Number Analyzed 15 participants 16 participants
0
   0.0%
0
   0.0%
Week 51 - Much worse Number Analyzed 15 participants 16 participants
0
   0.0%
1
   6.3%
Week 51 - Very much worse Number Analyzed 15 participants 16 participants
0
   0.0%
0
   0.0%
Week 63 - Very much improved Number Analyzed 17 participants 16 participants
5
  29.4%
3
  18.8%
Week 63 - Much improved Number Analyzed 17 participants 16 participants
8
  47.1%
4
  25.0%
Week 63 - Minimally improved Number Analyzed 17 participants 16 participants
0
   0.0%
5
  31.3%
Week 63 - No change Number Analyzed 17 participants 16 participants
4
  23.5%
3
  18.8%
Week 63 - Minimally worse Number Analyzed 17 participants 16 participants
0
   0.0%
0
   0.0%
Week 63 - Much worse Number Analyzed 17 participants 16 participants
0
   0.0%
1
   6.3%
Week 63 - Very much worse Number Analyzed 17 participants 16 participants
0
   0.0%
0
   0.0%
Week 75 - Very much improved Number Analyzed 13 participants 15 participants
6
  46.2%
6
  40.0%
Week 75 - Much improved Number Analyzed 13 participants 15 participants
2
  15.4%
3
  20.0%
Week 75 - Minimally improved Number Analyzed 13 participants 15 participants
1
   7.7%
5
  33.3%
Week 75 - No Change Number Analyzed 13 participants 15 participants
4
  30.8%
1
   6.7%
Week 75 - Minimally worse Number Analyzed 13 participants 15 participants
0
   0.0%
0
   0.0%
Week 75 - Much worse Number Analyzed 13 participants 15 participants
0
   0.0%
0
   0.0%
Week 75 - Very much worse Number Analyzed 13 participants 15 participants
0
   0.0%
0
   0.0%
Week 87 - Very much improved Number Analyzed 13 participants 15 participants
7
  53.8%
7
  46.7%
Week 87 - Much improved Number Analyzed 13 participants 15 participants
0
   0.0%
3
  20.0%
Week 87 - Minimally improved Number Analyzed 13 participants 15 participants
2
  15.4%
1
   6.7%
Week 87 - No Change Number Analyzed 13 participants 15 participants
2
  15.4%
3
  20.0%
Week 87 - Minimally worse Number Analyzed 13 participants 15 participants
1
   7.7%
1
   6.7%
Week 87 - Much worse Number Analyzed 13 participants 15 participants
1
   7.7%
0
   0.0%
Week 87 - Very much worse Number Analyzed 13 participants 15 participants
0
   0.0%
0
   0.0%
Week 99 - Very much improved Number Analyzed 11 participants 13 participants
3
  27.3%
8
  61.5%
Week 99 - Much improved Number Analyzed 11 participants 13 participants
3
  27.3%
2
  15.4%
Week 99 - Minimally improved Number Analyzed 11 participants 13 participants
1
   9.1%
3
  23.1%
Week 99 - No change Number Analyzed 11 participants 13 participants
3
  27.3%
0
   0.0%
Week 99 - Minimally worse Number Analyzed 11 participants 13 participants
1
   9.1%
0
   0.0%
Week 99 - Much worse Number Analyzed 11 participants 13 participants
0
   0.0%
0
   0.0%
Week 99 - Very much worse Number Analyzed 11 participants 13 participants
0
   0.0%
0
   0.0%
Week 111 - Very much improved Number Analyzed 11 participants 12 participants
3
  27.3%
6
  50.0%
Week 111 - Much improved Number Analyzed 11 participants 12 participants
5
  45.5%
4
  33.3%
Week 111 - Minimally improved Number Analyzed 11 participants 12 participants
1
   9.1%
1
   8.3%
Week 111 - No Change Number Analyzed 11 participants 12 participants
2
  18.2%
1
   8.3%
Week 111 - Minimally worse Number Analyzed 11 participants 12 participants
0
   0.0%
0
   0.0%
Week 111 - Much worse Number Analyzed 11 participants 12 participants
0
   0.0%
0
   0.0%
Week 111 - Very much worse Number Analyzed 11 participants 12 participants
0
   0.0%
0
   0.0%
Week 123 - Very much improved Number Analyzed 9 participants 9 participants
3
  33.3%
4
  44.4%
Week 123 - Much improved Number Analyzed 9 participants 9 participants
3
  33.3%
3
  33.3%
Week 123 - Minimally improved Number Analyzed 9 participants 9 participants
2
  22.2%
1
  11.1%
Week 123 - No Change Number Analyzed 9 participants 9 participants
1
  11.1%
1
  11.1%
Week 123 - Minimally worse Number Analyzed 9 participants 9 participants
0
   0.0%
0
   0.0%
Week 123 - Much worse Number Analyzed 9 participants 9 participants
0
   0.0%
0
   0.0%
Week 123 - Very much worse Number Analyzed 9 participants 9 participants
0
   0.0%
0
   0.0%
Week 135 - Very much improved Number Analyzed 5 participants 5 participants
2
  40.0%
2
  40.0%
Week 135 - Much improved Number Analyzed 5 participants 5 participants
2
  40.0%
1
  20.0%
Week 135 - Minimally improved Number Analyzed 5 participants 5 participants
0
   0.0%
1
  20.0%
Week 135 - No Change Number Analyzed 5 participants 5 participants
0
   0.0%
1
  20.0%
Week 135 - Minimally worse Number Analyzed 5 participants 5 participants
1
  20.0%
0
   0.0%
Week 135 - Much worse Number Analyzed 5 participants 5 participants
0
   0.0%
0
   0.0%
Week 135 - Very much worse Number Analyzed 5 participants 5 participants
0
   0.0%
0
   0.0%
Week 147 - Very much improved Number Analyzed 2 participants 2 participants
1
  50.0%
0
   0.0%
Week 147 - Much improved Number Analyzed 2 participants 2 participants
0
   0.0%
1
  50.0%
Week 147 - Minimally improved Number Analyzed 2 participants 2 participants
0
   0.0%
1
  50.0%
Week 147 - No Change Number Analyzed 2 participants 2 participants
1
  50.0%
0
   0.0%
Week 147 - Minimally worse Number Analyzed 2 participants 2 participants
0
   0.0%
0
   0.0%
Week 147 - Much worse Number Analyzed 2 participants 2 participants
0
   0.0%
0
   0.0%
Week 147 - Very much worse Number Analyzed 2 participants 2 participants
0
   0.0%
0
   0.0%
Week 159 - Very much improved Number Analyzed 1 participants 1 participants
1
 100.0%
0
   0.0%
Week 159 - Much improved Number Analyzed 1 participants 1 participants
0
   0.0%
0
   0.0%
Week 159 - Minimally improved Number Analyzed 1 participants 1 participants
0
   0.0%
1
 100.0%
Week 159 - No Change Number Analyzed 1 participants 1 participants
0
   0.0%
0
   0.0%
Week 159 - Minimally worse Number Analyzed 1 participants 1 participants
0
   0.0%
0
   0.0%
Week 159 - Much worse Number Analyzed 1 participants 1 participants
0
   0.0%
0
   0.0%
Week 159 - Very much worse Number Analyzed 1 participants 1 participants
0
   0.0%
0
   0.0%
Week 171- Very much improved Number Analyzed 1 participants 0 participants
1
 100.0%
0
Week 171- Much improved Number Analyzed 1 participants 0 participants
0
   0.0%
0
Week 171- Minimally improved Number Analyzed 1 participants 0 participants
0
   0.0%
0
Week 171- No Change Number Analyzed 1 participants 0 participants
0
   0.0%
0
Week 171- Minimally worse Number Analyzed 1 participants 0 participants
0
   0.0%
0
Week 171- Much worse Number Analyzed 1 participants 0 participants
0
   0.0%
0
Week 171- Very much worse Number Analyzed 1 participants 0 participants
0
   0.0%
0
ET/SFU Visit- Very much improved Number Analyzed 19 participants 18 participants
3
  15.8%
3
  16.7%
ET/SFU Visit- Much improved Number Analyzed 19 participants 18 participants
5
  26.3%
6
  33.3%
ET/SFU Visit- Minimally improved Number Analyzed 19 participants 18 participants
4
  21.1%
1
   5.6%
ET/SFU Visit- No Change Number Analyzed 19 participants 18 participants
3
  15.8%
3
  16.7%
ET/SFU Visit- Minimally worse Number Analyzed 19 participants 18 participants
1
   5.3%
2
  11.1%
ET/SFU Visit- Much worse Number Analyzed 19 participants 18 participants
3
  15.8%
3
  16.7%
ET/SFU Visit- Very much worse Number Analyzed 19 participants 18 participants
0
   0.0%
0
   0.0%
15.Secondary Outcome
Title Part B: Mean Change From Baseline in Lactate Dehydrogenase (LDH) Level at Each Specified Time Points
Hide Description Change from baseline (Week 0) in LDH levels at each specified time points (i.e., Week 27, 29, 31, 33, 35, 37, 39, 41, 43, 45, 47, 49, 51, 53, 55, 57, 59, 61, 63, 65, 67, 69, 71, 73, 75, 77, 79, 81, 83, 85, 87, 89, 91, 93, 95, 97, 99, 101, 103, 105, 107,109, 111, 113, 115, 117, 119, 121,123, 125, 127,129,131,133,135,137,139,141,143,145,147, 149, 151,153,155,157,159,161,163,165,167,169, 171, 173, 175 and ET/SFU Visit) is reported in this outcome measure. Baseline was defined as the last non-missing value prior to the first administration of study drug in Part A. ET/SFU visit was 9 weeks after administration of last dose (i.e., up to Week 184).
Time Frame Baseline (Week 0), every 2 weeks starting from Week 27 till Week 175 and at ET/SFU visit (i.e., up to Week 184)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on Part B-FAS. Here, 'number analyzed' = participants with available data for each specified category and "0" in the number analyzed field signifies that none of participants were available for assessment at the specified timepoints. Data for this outcome measure was planned to be collected and analyzed for combined population of BIVV009 (i.e., all participants who received BIVV009 [either 6.5 g or 7.5 g]).
Arm/Group Title BIVV009/BIVV009 Placebo/BIVV009
Hide Arm/Group Description:
Participants with primary CAD and without a recent history of blood transfusion during the last 6 months prior to enrollment in this study, received an IV infusion of BIVV009 6.5 g (for participants <75 kg) or 7.5 g dose (for participants >=75 kg) on Day 0 and Day 7 and every 14 days thereafter in Part A up to Week 25. Participants who completed Part A per protocol through the end of treatment visit (Week 26), received placebo on Week 26 and continued to receive BIVV009 6.5 or 7.5 g in Part B, every 2 weeks starting at Week 27 for up to an additional 149 weeks (for 6.5 g) or 121 weeks (for 7.5 g). All participants who completed Part A elected to continue in Part B.
Participants with primary CAD and without a recent history of blood transfusion during the last 6 months prior to enrollment in this study, received an IV infusion of placebo matched to BIVV009 on Day 0 and Day 7 and every 14 days thereafter in Part A up to Week 25. Participants who completed Part A per protocol through the end of treatment visit (Week 26) received BIVV009 6.5 (if <75 kg) or 7.5 g (if >=75 kg) in Part B, on Week 26 and Week 27 and every 2 weeks thereafter for up to an additional 123 weeks (for 6.5 g) or 137 weeks (for 7.5 g). All participants who completed Part A elected to continue in Part B.
Overall Number of Participants Analyzed 19 20
Mean (Standard Deviation)
Unit of Measure: units per liter
Week 27 Number Analyzed 19 participants 20 participants
-151.000  (184.640) 0.650  (208.051)
Week 29 Number Analyzed 18 participants 19 participants
-115.944  (226.913) 11.000  (222.383)
Week 31 Number Analyzed 18 participants 17 participants
-85.111  (247.506) 38.882  (211.386)
Week 33 Number Analyzed 17 participants 16 participants
-66.176  (324.145) 4.813  (203.939)
Week 35 Number Analyzed 18 participants 16 participants
-64.667  (261.431) -19.313  (142.989)
Week 37 Number Analyzed 16 participants 17 participants
4.438  (398.843) 25.765  (219.679)
Week 39 Number Analyzed 16 participants 16 participants
-88.500  (271.941) 27.313  (210.705)
Week 41 Number Analyzed 18 participants 17 participants
23.778  (342.195) -6.000  (173.810)
Week 43 Number Analyzed 17 participants 17 participants
-22.118  (310.381) -21.706  (181.668)
Week 45 Number Analyzed 17 participants 18 participants
26.529  (329.717) -13.500  (190.460)
Week 47 Number Analyzed 15 participants 18 participants
-22.600  (302.511) -24.944  (153.580)
Week 49 Number Analyzed 16 participants 18 participants
-29.250  (289.392) 15.722  (193.630)
Week 51 Number Analyzed 16 participants 18 participants
-12.563  (290.489) -9.556  (155.646)
Week 53 Number Analyzed 16 participants 17 participants
-16.938  (299.788) 12.529  (206.642)
Week 55 Number Analyzed 14 participants 16 participants
-89.500  (219.634) -11.250  (177.647)
Week 57 Number Analyzed 15 participants 16 participants
-78.200  (285.140) 64.188  (266.395)
Week 59 Number Analyzed 16 participants 17 participants
-84.438  (220.376) 31.647  (226.128)
Week 61 Number Analyzed 17 participants 17 participants
-74.353  (215.414) 20.588  (263.984)
Week 63 Number Analyzed 17 participants 17 participants
-98.235  (185.259) 38.059  (325.329)
Week 65 Number Analyzed 16 participants 15 participants
-97.438  (212.335) -16.467  (246.765)
Week 67 Number Analyzed 17 participants 15 participants
-127.824  (192.148) 29.667  (269.918)
Week 69 Number Analyzed 16 participants 16 participants
-113.625  (197.270) 36.563  (303.550)
Week 71 Number Analyzed 13 participants 15 participants
-101.692  (320.348) 4.067  (307.924)
Week 73 Number Analyzed 14 participants 16 participants
-174.500  (177.153) 7.063  (245.723)
Week 75 Number Analyzed 14 participants 15 participants
-157.429  (184.525) 7.067  (285.183)
Week 77 Number Analyzed 14 participants 15 participants
-142.857  (199.169) -24.867  (291.754)
Week 79 Number Analyzed 13 participants 16 participants
-98.077  (271.632) -20.063  (265.761)
Week 81 Number Analyzed 13 participants 15 participants
-127.846  (233.663) 7.200  (219.952)
Week 83 Number Analyzed 13 participants 11 participants
-59.000  (346.917) 8.818  (250.068)
Week 85 Number Analyzed 13 participants 15 participants
-72.000  (350.021) 28.400  (282.626)
Week 87 Number Analyzed 13 participants 13 participants
-101.385  (285.590) 83.385  (288.731)
Week 89 Number Analyzed 12 participants 12 participants
-78.667  (351.059) 10.833  (323.647)
Week 91 Number Analyzed 9 participants 13 participants
-143.000  (273.540) 0.846  (288.451)
Week 93 Number Analyzed 10 participants 11 participants
-133.500  (254.332) 10.818  (268.308)
Week 95 Number Analyzed 11 participants 13 participants
-59.364  (368.708) 18.231  (241.354)
Week 97 Number Analyzed 11 participants 10 participants
-53.364  (343.820) -38.500  (188.403)
Week 99 Number Analyzed 11 participants 12 participants
-80.909  (312.405) -12.917  (183.844)
Week 101 Number Analyzed 11 participants 11 participants
-90.273  (293.680) -17.182  (249.134)
Week 103 Number Analyzed 11 participants 13 participants
-50.273  (331.072) 5.692  (211.233)
Week 105 Number Analyzed 11 participants 12 participants
-96.455  (276.907) -34.250  (147.738)
Week 107 Number Analyzed 11 participants 13 participants
-28.091  (354.244) 20.769  (222.772)
Week 109 Number Analyzed 11 participants 11 participants
-50.727  (335.078) -2.000  (243.243)
Week 111 Number Analyzed 10 participants 12 participants
-83.000  (303.258) -5.583  (219.850)
Week 113 Number Analyzed 10 participants 12 participants
-80.700  (319.283) 0.667  (294.904)
Week 115 Number Analyzed 10 participants 10 participants
-109.500  (256.395) 44.700  (295.946)
Week 117 Number Analyzed 9 participants 10 participants
-140.444  (280.944) 12.700  (254.786)
Week 119 Number Analyzed 9 participants 10 participants
-149.556  (237.771) -26.500  (274.168)
Week 121 Number Analyzed 9 participants 8 participants
-195.778  (225.978) -42.375  (211.840)
Week 123 Number Analyzed 9 participants 9 participants
-185.000  (231.489) 22.222  (278.037)
Week 125 Number Analyzed 7 participants 7 participants
-99.429  (285.513) -85.143  (265.374)
Week 127 Number Analyzed 7 participants 8 participants
-154.714  (231.922) -28.875  (312.483)
Week 129 Number Analyzed 7 participants 7 participants
-136.429  (234.954) -18.571  (354.584)
Week 131 Number Analyzed 6 participants 6 participants
-120.833  (300.454) -2.000  (270.245)
Week 133 Number Analyzed 5 participants 4 participants
-179.000  (298.811) -47.500  (367.639)
Week 135 Number Analyzed 5 participants 5 participants
-211.800  (265.438) 58.000  (449.233)
Week 137 Number Analyzed 4 participants 2 participants
-252.500  (264.591) 46.500  (768.625)
Week 139 Number Analyzed 5 participants 3 participants
-181.800  (284.966) -48.667  (373.339)
Week 141 Number Analyzed 3 participants 3 participants
-259.667  (362.136) 30.667  (372.889)
Week 143 Number Analyzed 4 participants 2 participants
-160.250  (357.021) -7.500  (21.920)
Week 145 Number Analyzed 2 participants 2 participants
-340.500  (458.912) 290.000  (562.857)
Week 147 Number Analyzed 3 participants 2 participants
-248.667  (355.136) 311.000  (547.301)
Week 149 Number Analyzed 1 participants 2 participants
-78.000 116.000  (175.362)
Week 151 Number Analyzed 2 participants 1 participants
58.000  (32.527) 295.000
Week 153 Number Analyzed 1 participants 1 participants
7.000 75.000
Week 155 Number Analyzed 1 participants 0 participants
-50.000
Week 157 Number Analyzed 1 participants 1 participants
-50.000 369.000
Week 159 Number Analyzed 1 participants 1 participants
-155.000 365.000
Week 161 Number Analyzed 1 participants 0 participants
-175.000
Week 163 Number Analyzed 1 participants 1 participants
-149.000 782.000
Week 165 Number Analyzed 1 participants 0 participants
-155.000
Week 167 Number Analyzed 1 participants 0 participants
-162.000
Week 169 Number Analyzed 1 participants 0 participants
-180.000
Week 171 Number Analyzed 1 participants 0 participants
-167.000
Week 173 Number Analyzed 1 participants 0 participants
-171.000
Week 175 Number Analyzed 1 participants 0 participants
-121.000
ET/SFU Visit Number Analyzed 16 participants 17 participants
-2.500  (195.967) -11.706  (206.321)
16.Secondary Outcome
Title Part B: Number of Blood Transfusions Per Participant
Hide Description A participant was to receive a transfusion if his or her Hgb level met either of the following criteria: Hgb was <9 g/dL and the participant had symptoms of anemia or Hgb was <7 g/dL and the participant was asymptomatic.
Time Frame From Week 27 up to 149 weeks of treatment (i.e., up to Week 176)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on Part B-FAS. Data for this outcome measure was planned to be collected and analyzed for combined population of BIVV009 (i.e., all participants who received BIVV009 [either 6.5 g or 7.5 g]).
Arm/Group Title BIVV009/BIVV009 Placebo/BIVV009
Hide Arm/Group Description:
Participants with primary CAD and without a recent history of blood transfusion during the last 6 months prior to enrollment in this study, received an IV infusion of BIVV009 6.5 g (for participants <75 kg) or 7.5 g dose (for participants >=75 kg) on Day 0 and Day 7 and every 14 days thereafter in Part A up to Week 25. Participants who completed Part A per protocol through the end of treatment visit (Week 26), received placebo on Week 26 and continued to receive BIVV009 6.5 or 7.5 g in Part B, every 2 weeks starting at Week 27 for up to an additional 149 weeks (for 6.5 g) or 121 weeks (for 7.5 g). All participants who completed Part A elected to continue in Part B.
Participants with primary CAD and without a recent history of blood transfusion during the last 6 months prior to enrollment in this study, received an IV infusion of placebo matched to BIVV009 on Day 0 and Day 7 and every 14 days thereafter in Part A up to Week 25. Participants who completed Part A per protocol through the end of treatment visit (Week 26) received BIVV009 6.5 (if <75 kg) or 7.5 g (if >=75 kg) in Part B, on Week 26 and Week 27 and every 2 weeks thereafter for up to an additional 123 weeks (for 6.5 g) or 137 weeks (for 7.5 g). All participants who completed Part A elected to continue in Part B.
Overall Number of Participants Analyzed 19 20
Mean (Standard Deviation)
Unit of Measure: blood transfusions per participant
0.4  (0.8) 0.3  (0.4)
17.Secondary Outcome
Title Part B: Mean Change From Baseline in Haptoglobin Values at Each Specified Time Points
Hide Description Change from baseline (Week 0) in haptoglobin values at each specified time points (i.e., Week 27, 29, 31, 33, 35, 37, 39, 41, 43, 45, 47, 49, 51, 53, 55, 57, 59, 61, 63, 65, 67, 69, 71, 73, 75, 77, 79, 81, 83, 85, 87, 89, 91, 93, 95, 97,99,101,103, 105, 107,109, 111,113,115,117,119, 121,123, 125, 127, 129,131,133,135,137,139,141,143, 145,147,149,151,153,155,157,159, 161,163,165,167,169,171,173,175 and ET/SFU Visit) is reported in this outcome measure. Baseline was defined as the last non-missing value prior to the first administration of study drug in Part A. ET/SFU visit was 9 weeks after administration of last dose (i.e., up to Week 184). Haptoglobin values <0.2 were imputed as 0.2.
Time Frame Baseline (Week 0), every 2 weeks starting from Week 27 till Week 175 and at ET/SFU visit (i.e., up to Week 184)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on Part B-FAS. Here, 'number analyzed' = participants with available data for each specified category and "0" in the number analyzed field signifies that none of participants were available for assessment at the specified timepoints. Data for this outcome measure was planned to be collected and analyzed for combined population of BIVV009 (i.e., all participants who received BIVV009 [either 6.5 g or 7.5 g]).
Arm/Group Title BIVV009/BIVV009 Placebo/BIVV009
Hide Arm/Group Description:
Participants with primary CAD and without a recent history of blood transfusion during the last 6 months prior to enrollment in this study, received an IV infusion of BIVV009 6.5 g (for participants <75 kg) or 7.5 g dose (for participants >=75 kg) on Day 0 and Day 7 and every 14 days thereafter in Part A up to Week 25. Participants who completed Part A per protocol through the end of treatment visit (Week 26), received placebo on Week 26 and continued to receive BIVV009 6.5 or 7.5 g in Part B, every 2 weeks starting at Week 27 for up to an additional 149 weeks (for 6.5 g) or 121 weeks (for 7.5 g). All participants who completed Part A elected to continue in Part B.
Participants with primary CAD and without a recent history of blood transfusion during the last 6 months prior to enrollment in this study, received an IV infusion of placebo matched to BIVV009 on Day 0 and Day 7 and every 14 days thereafter in Part A up to Week 25. Participants who completed Part A per protocol through the end of treatment visit (Week 26) received BIVV009 6.5 (if <75 kg) or 7.5 g (if >=75 kg) in Part B, on Week 26 and Week 27 and every 2 weeks thereafter for up to an additional 123 weeks (for 6.5 g) or 137 weeks (for 7.5 g). All participants who completed Part A elected to continue in Part B.
Overall Number of Participants Analyzed 19 20
Mean (Standard Deviation)
Unit of Measure: grams per liter
Week 27 Number Analyzed 19 participants 19 participants
0.219  (0.380) 0.082  (0.197)
Week 29 Number Analyzed 18 participants 20 participants
0.240  (0.317) 0.182  (0.482)
Week 31 Number Analyzed 19 participants 20 participants
0.183  (0.311) 0.256  (0.516)
Week 33 Number Analyzed 19 participants 17 participants
0.212  (0.423) 0.229  (0.379)
Week 35 Number Analyzed 18 participants 19 participants
0.207  (0.355) 0.151  (0.280)
Week 37 Number Analyzed 18 participants 18 participants
0.232  (0.419) 0.187  (0.291)
Week 39 Number Analyzed 16 participants 16 participants
0.213  (0.330) 0.165  (0.295)
Week 41 Number Analyzed 19 participants 18 participants
0.119  (0.238) 0.082  (0.168)
Week 43 Number Analyzed 18 participants 18 participants
0.100  (0.224) 0.161  (0.234)
Week 45 Number Analyzed 18 participants 20 participants
0.114  (0.205) 0.189  (0.275)
Week 47 Number Analyzed 15 participants 20 participants
0.135  (0.243) 0.255  (0.416)
Week 49 Number Analyzed 16 participants 18 participants
0.139  (0.205) 0.172  (0.345)
Week 51 Number Analyzed 15 participants 17 participants
0.083  (0.197) 0.207  (0.369)
Week 53 Number Analyzed 16 participants 19 participants
0.045  (0.137) 0.122  (0.296)
Week 55 Number Analyzed 17 participants 18 participants
0.149  (0.251) 0.179  (0.343)
Week 57 Number Analyzed 16 participants 17 participants
0.158  (0.234) 0.158  (0.362)
Week 59 Number Analyzed 17 participants 17 participants
0.132  (0.229) 0.131  (0.306)
Week 61 Number Analyzed 17 participants 18 participants
0.153  (0.286) 0.184  (0.350)
Week 63 Number Analyzed 17 participants 17 participants
0.202  (0.265) 0.177  (0.357)
Week 65 Number Analyzed 16 participants 16 participants
0.101  (0.232) 0.198  (0.384)
Week 67 Number Analyzed 17 participants 16 participants
0.178  (0.241) 0.162  (0.363)
Week 69 Number Analyzed 16 participants 17 participants
0.168  (0.255) 0.169  (0.348)
Week 71 Number Analyzed 14 participants 15 participants
0.220  (0.288) 0.236  (0.388)
Week 73 Number Analyzed 14 participants 16 participants
0.261  (0.335) 0.174  (0.348)
Week 75 Number Analyzed 15 participants 16 participants
0.275  (0.321) 0.197  (0.362)
Week 77 Number Analyzed 14 participants 16 participants
0.249  (0.374) 0.232  (0.398)
Week 79 Number Analyzed 14 participants 16 participants
0.299  (0.419) 0.290  (0.464)
Week 81 Number Analyzed 13 participants 16 participants
0.438  (0.463) 0.207  (0.421)
Week 83 Number Analyzed 14 participants 13 participants
0.297  (0.379) 0.233  (0.394)
Week 85 Number Analyzed 13 participants 15 participants
0.374  (0.374) 0.266  (0.426)
Week 87 Number Analyzed 12 participants 13 participants
0.334  (0.409) 0.344  (0.471)
Week 89 Number Analyzed 12 participants 13 participants
0.348  (0.482) 0.198  (0.351)
Week 91 Number Analyzed 11 participants 12 participants
0.313  (0.449) 0.279  (0.449)
Week 93 Number Analyzed 11 participants 12 participants
0.262  (0.383) 0.178  (0.373)
Week 95 Number Analyzed 11 participants 13 participants
0.263  (0.495) 0.198  (0.414)
Week 97 Number Analyzed 11 participants 12 participants
0.245  (0.306) 0.210  (0.407)
Week 99 Number Analyzed 11 participants 13 participants
0.266  (0.351) 0.213  (0.370)
Week 101 Number Analyzed 11 participants 12 participants
0.289  (0.289) 0.207  (0.417)
Week 103 Number Analyzed 11 participants 13 participants
0.219  (0.291) 0.212  (0.389)
Week 105 Number Analyzed 11 participants 12 participants
0.216  (0.291) 0.174  (0.399)
Week 107 Number Analyzed 11 participants 13 participants
0.182  (0.273) 0.245  (0.459)
Week 109 Number Analyzed 10 participants 11 participants
0.207  (0.311) 0.254  (0.507)
Week 111 Number Analyzed 11 participants 12 participants
0.282  (0.556) 0.263  (0.459)
Week 113 Number Analyzed 11 participants 12 participants
0.248  (0.366) 0.335  (0.614)
Week 115 Number Analyzed 10 participants 11 participants
0.324  (0.413) 0.165  (0.432)
Week 117 Number Analyzed 9 participants 10 participants
0.450  (0.492) 0.181  (0.489)
Week 119 Number Analyzed 9 participants 10 participants
0.348  (0.400) 0.187  (0.404)
Week 121 Number Analyzed 9 participants 8 participants
0.459  (0.414) 0.174  (0.479)
Week 123 Number Analyzed 9 participants 9 participants
0.350  (0.375) 0.192  (0.512)
Week 125 Number Analyzed 8 participants 7 participants
0.303  (0.425) 0.114  (0.298)
Week 127 Number Analyzed 7 participants 8 participants
0.309  (0.401) 0.220  (0.420)
Week 129 Number Analyzed 7 participants 7 participants
0.393  (0.506) 0.191  (0.506)
Week 131 Number Analyzed 6 participants 5 participants
0.480  (0.529) 0.222  (0.430)
Week 133 Number Analyzed 5 participants 4 participants
0.342  (0.469) 0.125  (0.155)
Week 135 Number Analyzed 5 participants 5 participants
0.454  (0.643) 0.280  (0.425)
Week 137 Number Analyzed 4 participants 3 participants
0.545  (0.631) 0.070  (0.121)
Week 139 Number Analyzed 5 participants 3 participants
0.494  (0.676) 0.293  (0.508)
Week 141 Number Analyzed 3 participants 2 participants
0.667  (0.583) 0.025  (0.035)
Week 143 Number Analyzed 4 participants 3 participants
0.513  (0.604) 0.270  (0.292)
Week 145 Number Analyzed 2 participants 3 participants
0.580  (0.820) 0.130  (0.141)
Week 147 Number Analyzed 3 participants 2 participants
0.400  (0.592) 0.195  (0.276)
Week 149 Number Analyzed 1 participants 2 participants
0.000 0.000  (0.000)
Week 151 Number Analyzed 2 participants 1 participants
0.000  (0.000) 0.000
Week 153 Number Analyzed 1 participants 1 participants
0.000 0.000
Week 155 Number Analyzed 1 participants 1 participants
0.000 0.000
Week 157 Number Analyzed 1 participants 1 participants
0.000 0.000
Week 159 Number Analyzed 1 participants 1 participants
0.000 0.000
Week 161 Number Analyzed 1 participants 1 participants
0.180 0.000
Week 163 Number Analyzed 1 participants 1 participants
0.000 0.000
Week 165 Number Analyzed 1 participants 0 participants
0.000
Week 167 Number Analyzed 1 participants 0 participants
0.000
Week 169 Number Analyzed 1 participants 0 participants
0.000
Week 171 Number Analyzed 1 participants 0 participants
0.000
Week 173 Number Analyzed 1 participants 0 participants
0.000
Week 175 Number Analyzed 1 participants 0 participants
0.000
ET/SFU Visit Number Analyzed 19 participants 18 participants
0.055  (0.200) 0.181  (0.426)
18.Secondary Outcome
Title Part B: Number of Healthcare Visits by Type
Hide Description In this outcome measure, number of healthcare visits which included non-study healthcare resource utilization visit (consisted mainly of extra visits to the office of the study doctor, visit to a generalist doctor or visit to a specialist doctor), hospitalization visit and visit to hospital emergency is reported.
Time Frame From Week 27 up to 149 weeks of treatment (i.e., up to Week 176)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on Part B-FAS. Data for this outcome measure was planned to be collected and analyzed for combined population of BIVV009 (i.e., all participants who received BIVV009 [either 6.5 g or 7.5 g]).
Arm/Group Title BIVV009/BIVV009 Placebo/BIVV009
Hide Arm/Group Description:
Participants with primary CAD and without a recent history of blood transfusion during the last 6 months prior to enrollment in this study, received an IV infusion of BIVV009 6.5 g (for participants <75 kg) or 7.5 g dose (for participants >=75 kg) on Day 0 and Day 7 and every 14 days thereafter in Part A up to Week 25. Participants who completed Part A per protocol through the end of treatment visit (Week 26), received placebo on Week 26 and continued to receive BIVV009 6.5 or 7.5 g in Part B, every 2 weeks starting at Week 27 for up to an additional 149 weeks (for 6.5 g) or 121 weeks (for 7.5 g). All participants who completed Part A elected to continue in Part B.
Participants with primary CAD and without a recent history of blood transfusion during the last 6 months prior to enrollment in this study, received an IV infusion of placebo matched to BIVV009 on Day 0 and Day 7 and every 14 days thereafter in Part A up to Week 25. Participants who completed Part A per protocol through the end of treatment visit (Week 26) received BIVV009 6.5 (if <75 kg) or 7.5 g (if >=75 kg) in Part B, on Week 26 and Week 27 and every 2 weeks thereafter for up to an additional 123 weeks (for 6.5 g) or 137 weeks (for 7.5 g). All participants who completed Part A elected to continue in Part B.
Overall Number of Participants Analyzed 19 20
Measure Type: Number
Unit of Measure: visits
Non-study healthcare resource utilization visits 13 12
Hospitalization 3 1
Visit to a hospital emergency room 1 3
Time Frame Part A (both 6.5 g and 7.5 g cohorts): first dose (Day 0) up to Week 25; Part B, 6.5 g cohort: From first dose (Week 26) up to 149 weeks of treatment + 9 weeks of follow-up (i.e., up to Week 184); Part B, 7.5 g cohort: From first dose (Week 26) up to 137 weeks of treatment + 9 weeks of follow-up (i.e., up to Week 172)
Adverse Event Reporting Description Reported AEs and SAEs including fatal AEs were TEAEs that developed/worsened or became serious during on-treatment period. Analysis was performed on SAS.
 
Arm/Group Title Part A: BIVV009 6.5 g Part A: BIVV009 7.5 g Part A: Placebo Part B: BIVV009 6.5 g Part B: BIVV009 7.5 g
Hide Arm/Group Description Participants with primary CAD and body weight <75 kg and without a recent history of blood transfusion during the last 6 months prior to enrollment in this study, received an IV infusion of BIVV009 6.5 g on Day 0 and Day 7 and every 14 days thereafter in Part A up to Week 25. Participants with primary CAD and body weight >=75 kg and without a recent history of blood transfusion during the last 6 months prior to enrollment in this study, received an IV infusion of BIVV009 7.5 g on Day 0 and Day 7 and every 14 days thereafter in Part A up to Week 25. Participants with primary CAD and without a recent history of blood transfusion during the last 6 months prior to enrollment in this study, received an IV infusion of placebo matched to BIVV009 on Day 0 and Day 7 and every 14 days thereafter in Part A up to Week 25. Participants who completed Part A per protocol through the end of treatment visit (Week 26) were eligible to be enrolled in Part B where they were treated for up to an additional 149 weeks. Participants who received placebo in Part A received BIVV009 6.5 g on Week 26, Week 27 and every 2 weeks thereafter; participants who received BIVV009 6.5 g in Part A received placebo on Week 26, BIVV009 6.5 g on Week 27 and every 2 weeks thereafter for up to an additional 149 weeks. Participants who completed Part A per protocol through the end of treatment visit (Week 26) were eligible to be enrolled in Part B where they were treated for up to an additional 137 weeks. Participants who received placebo in Part A received BIVV009 7.5 g on Week 26, Week 27 and every 2 weeks thereafter; participants who received BIVV009 7.5 g in Part A received placebo on Week 26, BIVV009 7.5 g on Week 27 and every 2 weeks thereafter for up to an additional 137 weeks.
All-Cause Mortality
Part A: BIVV009 6.5 g Part A: BIVV009 7.5 g Part A: Placebo Part B: BIVV009 6.5 g Part B: BIVV009 7.5 g
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/17 (0.00%)      0/5 (0.00%)      0/20 (0.00%)      1/32 (3.13%)      0/7 (0.00%)    
Hide Serious Adverse Events
Part A: BIVV009 6.5 g Part A: BIVV009 7.5 g Part A: Placebo Part B: BIVV009 6.5 g Part B: BIVV009 7.5 g
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/17 (11.76%)      1/5 (20.00%)      0/20 (0.00%)      6/32 (18.75%)      1/7 (14.29%)    
Blood and lymphatic system disorders           
Anaemia  1  0/17 (0.00%)  0 0/5 (0.00%)  0 0/20 (0.00%)  0 1/32 (3.13%)  1 0/7 (0.00%)  0
Congenital, familial and genetic disorders           
Polycystic Liver Disease  1  0/17 (0.00%)  0 0/5 (0.00%)  0 0/20 (0.00%)  0 1/32 (3.13%)  1 0/7 (0.00%)  0
Hepatobiliary disorders           
Cholelithiasis  1  0/17 (0.00%)  0 0/5 (0.00%)  0 0/20 (0.00%)  0 1/32 (3.13%)  1 0/7 (0.00%)  0
Infections and infestations           
Febrile Infection  1  0/17 (0.00%)  0 1/5 (20.00%)  1 0/20 (0.00%)  0 0/32 (0.00%)  0 0/7 (0.00%)  0
Urinary Tract Infection  1  0/17 (0.00%)  0 0/5 (0.00%)  0 0/20 (0.00%)  0 0/32 (0.00%)  0 1/7 (14.29%)  1
Injury, poisoning and procedural complications           
Hip Fracture  1  0/17 (0.00%)  0 0/5 (0.00%)  0 0/20 (0.00%)  0 1/32 (3.13%)  1 0/7 (0.00%)  0
Muscle Strain  1  0/17 (0.00%)  0 0/5 (0.00%)  0 0/20 (0.00%)  0 1/32 (3.13%)  1 0/7 (0.00%)  0
Investigations           
Blood Immunoglobulin M Increased  1  0/17 (0.00%)  0 1/5 (20.00%)  1 0/20 (0.00%)  0 0/32 (0.00%)  0 0/7 (0.00%)  0
Musculoskeletal and connective tissue disorders           
Lumbar Spinal Stenosis  1  0/17 (0.00%)  0 0/5 (0.00%)  0 0/20 (0.00%)  0 0/32 (0.00%)  0 1/7 (14.29%)  1
Osteoarthritis  1  0/17 (0.00%)  0 0/5 (0.00%)  0 0/20 (0.00%)  0 1/32 (3.13%)  1 1/7 (14.29%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)           
Squamous Cell Carcinoma Of Lung  1  0/17 (0.00%)  0 0/5 (0.00%)  0 0/20 (0.00%)  0 1/32 (3.13%)  1 0/7 (0.00%)  0
Nervous system disorders           
Cerebral Venous Sinus Thrombosis  1  1/17 (5.88%)  1 0/5 (0.00%)  0 0/20 (0.00%)  0 0/32 (0.00%)  0 0/7 (0.00%)  0
Vascular disorders           
Hypertension  1  0/17 (0.00%)  0 0/5 (0.00%)  0 0/20 (0.00%)  0 1/32 (3.13%)  1 0/7 (0.00%)  0
Raynaud's Phenomenon  1  1/17 (5.88%)  1 0/5 (0.00%)  0 0/20 (0.00%)  0 0/32 (0.00%)  0 0/7 (0.00%)  0
1
Term from vocabulary, MedDRA 24.1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Part A: BIVV009 6.5 g Part A: BIVV009 7.5 g Part A: Placebo Part B: BIVV009 6.5 g Part B: BIVV009 7.5 g
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   16/17 (94.12%)      5/5 (100.00%)      3/20 (15.00%)      28/32 (87.50%)      7/7 (100.00%)    
Blood and lymphatic system disorders           
Anaemia  1  0/17 (0.00%)  0 2/5 (40.00%)  2 0/20 (0.00%)  0 9/32 (28.13%)  11 2/7 (28.57%)  3
Blood Loss Anaemia  1  1/17 (5.88%)  1 0/5 (0.00%)  0 0/20 (0.00%)  0 0/32 (0.00%)  0 0/7 (0.00%)  0
Haemolysis  1  0/17 (0.00%)  0 0/5 (0.00%)  0 0/20 (0.00%)  0 2/32 (6.25%)  2 0/7 (0.00%)  0
Iron Deficiency Anaemia  1  0/17 (0.00%)  0 0/5 (0.00%)  0 0/20 (0.00%)  0 3/32 (9.38%)  4 1/7 (14.29%)  1
Leukocytosis  1  1/17 (5.88%)  1 0/5 (0.00%)  0 0/20 (0.00%)  0 0/32 (0.00%)  0 0/7 (0.00%)  0
Cardiac disorders           
Palpitations  1  0/17 (0.00%)  0 0/5 (0.00%)  0 0/20 (0.00%)  0 1/32 (3.13%)  1 2/7 (28.57%)  2
Tachycardia  1  0/17 (0.00%)  0 0/5 (0.00%)  0 0/20 (0.00%)  0 1/32 (3.13%)  1 1/7 (14.29%)  1
Ear and labyrinth disorders           
Tinnitus  1  1/17 (5.88%)  1 0/5 (0.00%)  0 0/20 (0.00%)  0 2/32 (6.25%)  2 0/7 (0.00%)  0
Eye disorders           
Visual Acuity Reduced  1  1/17 (5.88%)  1 0/5 (0.00%)  0 0/20 (0.00%)  0 0/32 (0.00%)  0 0/7 (0.00%)  0
Gastrointestinal disorders           
Abdominal Pain  1  0/17 (0.00%)  0 0/5 (0.00%)  0 0/20 (0.00%)  0 3/32 (9.38%)  3 0/7 (0.00%)  0
Abdominal Pain Upper  1  1/17 (5.88%)  1 1/5 (20.00%)  1 0/20 (0.00%)  0 2/32 (6.25%)  2 0/7 (0.00%)  0
Angular Cheilitis  1  1/17 (5.88%)  1 0/5 (0.00%)  0 0/20 (0.00%)  0 0/32 (0.00%)  0 0/7 (0.00%)  0
Colitis  1  0/17 (0.00%)  0 0/5 (0.00%)  0 0/20 (0.00%)  0 0/32 (0.00%)  0 1/7 (14.29%)  1
Constipation  1  2/17 (11.76%)  4 0/5 (0.00%)  0 0/20 (0.00%)  0 2/32 (6.25%)  3 0/7 (0.00%)  0
Dental Caries  1  0/17 (0.00%)  0 0/5 (0.00%)  0 0/20 (0.00%)  0 0/32 (0.00%)  0 1/7 (14.29%)  1
Diarrhoea  1  1/17 (5.88%)  1 1/5 (20.00%)  4 0/20 (0.00%)  0 6/32 (18.75%)  13 1/7 (14.29%)  1
Dyspepsia  1  0/17 (0.00%)  0 0/5 (0.00%)  0 0/20 (0.00%)  0 3/32 (9.38%)  4 0/7 (0.00%)  0
Faeces Discoloured  1  0/17 (0.00%)  0 1/5 (20.00%)  1 0/20 (0.00%)  0 0/32 (0.00%)  0 0/7 (0.00%)  0
Gastrooesophageal Reflux Disease  1  0/17 (0.00%)  0 0/5 (0.00%)  0 0/20 (0.00%)  0 0/32 (0.00%)  0 1/7 (14.29%)  1
Glossodynia  1  1/17 (5.88%)  1 0/5 (0.00%)  0 0/20 (0.00%)  0 0/32 (0.00%)  0 0/7 (0.00%)  0
Nausea  1  1/17 (5.88%)  2 0/5 (0.00%)  0 0/20 (0.00%)  0 3/32 (9.38%)  3 2/7 (28.57%)  2
Odynophagia  1  1/17 (5.88%)  1 0/5 (0.00%)  0 0/20 (0.00%)  0 0/32 (0.00%)  0 0/7 (0.00%)  0
Paraesthesia Oral  1  1/17 (5.88%)  1 0/5 (0.00%)  0 0/20 (0.00%)  0 0/32 (0.00%)  0 0/7 (0.00%)  0
Tongue Ulceration  1  1/17 (5.88%)  1 0/5 (0.00%)  0 0/20 (0.00%)  0 0/32 (0.00%)  0 0/7 (0.00%)  0
Toothache  1  1/17 (5.88%)  1 0/5 (0.00%)  0 0/20 (0.00%)  0 0/32 (0.00%)  0 0/7 (0.00%)  0
Vomiting  1  0/17 (0.00%)  0 0/5 (0.00%)  0 0/20 (0.00%)  0 2/32 (6.25%)  2 0/7 (0.00%)  0
General disorders           
Asthenia  1  0/17 (0.00%)  0 1/5 (20.00%)  1 0/20 (0.00%)  0 4/32 (12.50%)  6 2/7 (28.57%)  2
Catheter Site Dryness  1  0/17 (0.00%)  0 0/5 (0.00%)  0 0/20 (0.00%)  0 0/32 (0.00%)  0 1/7 (14.29%)  1
Chest Discomfort  1  1/17 (5.88%)  1 0/5 (0.00%)  0 0/20 (0.00%)  0 0/32 (0.00%)  0 0/7 (0.00%)  0
Chest Pain  1  0/17 (0.00%)  0 0/5 (0.00%)  0 0/20 (0.00%)  0 0/32 (0.00%)  0 1/7 (14.29%)  1
Chills  1  0/17 (0.00%)  0 0/5 (0.00%)  0 0/20 (0.00%)  0 0/32 (0.00%)  0 1/7 (14.29%)  1
Fatigue  1  1/17 (5.88%)  1 1/5 (20.00%)  2 0/20 (0.00%)  0 7/32 (21.88%)  7 5/7 (71.43%)  10
General Physical Health Deterioration  1  0/17 (0.00%)  0 0/5 (0.00%)  0 0/20 (0.00%)  0 1/32 (3.13%)  1 1/7 (14.29%)  1
Influenza Like Illness  1  1/17 (5.88%)  1 0/5 (0.00%)  0 0/20 (0.00%)  0 0/32 (0.00%)  0 1/7 (14.29%)  1
Injection Site Erythema  1  0/17 (0.00%)  0 0/5 (0.00%)  0 0/20 (0.00%)  0 2/32 (6.25%)  3 0/7 (0.00%)  0
Injection Site Pruritus  1  1/17 (5.88%)  1 0/5 (0.00%)  0 0/20 (0.00%)  0 0/32 (0.00%)  0 0/7 (0.00%)  0
Malaise  1  1/17 (5.88%)  1 0/5 (0.00%)  0 0/20 (0.00%)  0 0/32 (0.00%)  0 0/7 (0.00%)  0
Non-Cardiac Chest Pain  1  0/17 (0.00%)  0 0/5 (0.00%)  0 0/20 (0.00%)  0 1/32 (3.13%)  1 1/7 (14.29%)  1
Oedema Peripheral  1  1/17 (5.88%)  1 0/5 (0.00%)  0 0/20 (0.00%)  0 2/32 (6.25%)  2 1/7 (14.29%)  1
Pyrexia  1  0/17 (0.00%)  0 1/5 (20.00%)  1 0/20 (0.00%)  0 5/32 (15.63%)  6 1/7 (14.29%)  1
Vaccination Site Erythema  1  1/17 (5.88%)  1 0/5 (0.00%)  0 0/20 (0.00%)  0 0/32 (0.00%)  0 0/7 (0.00%)  0
Vaccination Site Pain  1  1/17 (5.88%)  1 1/5 (20.00%)  1 0/20 (0.00%)  0 2/32 (6.25%)  2 1/7 (14.29%)  1
Vaccination Site Rash  1  1/17 (5.88%)  1 0/5 (0.00%)  0 0/20 (0.00%)  0 0/32 (0.00%)  0 0/7 (0.00%)  0
Hepatobiliary disorders           
Biliary Colic  1  0/17 (0.00%)  0 0/5 (0.00%)  0 0/20 (0.00%)  0 0/32 (0.00%)  0 1/7 (14.29%)  1
Cholelithiasis  1  0/17 (0.00%)  0 1/5 (20.00%)  1 0/20 (0.00%)  0 0/32 (0.00%)  0 0/7 (0.00%)  0
Immune system disorders           
Seasonal Allergy  1  0/17 (0.00%)  0 1/5 (20.00%)  1 0/20 (0.00%)  0 1/32 (3.13%)  1 1/7 (14.29%)  1
Infections and infestations           
Anal Abscess  1  0/17 (0.00%)  0 0/5 (0.00%)  0 0/20 (0.00%)  0 0/32 (0.00%)  0 1/7 (14.29%)  1
Cystitis  1  0/17 (0.00%)  0 0/5 (0.00%)  0 0/20 (0.00%)  0 2/32 (6.25%)  2 2/7 (28.57%)  2
Diverticulitis  1  0/17 (0.00%)  0 0/5 (0.00%)  0 0/20 (0.00%)  0 2/32 (6.25%)  2 0/7 (0.00%)  0
Gastroenteritis  1  0/17 (0.00%)  0 0/5 (0.00%)  0 0/20 (0.00%)  0 3/32 (9.38%)  3 1/7 (14.29%)  1
Herpes Zoster  1  1/17 (5.88%)  1 0/5 (0.00%)  0 0/20 (0.00%)  0 1/32 (3.13%)  1 0/7 (0.00%)  0
Influenza  1  2/17 (11.76%)  2 0/5 (0.00%)  0 0/20 (0.00%)  0 0/32 (0.00%)  0 0/7 (0.00%)  0
Mastoiditis  1  1/17 (5.88%)  1 0/5 (0.00%)  0 0/20 (0.00%)  0 0/32 (0.00%)  0 0/7 (0.00%)  0
Nasopharyngitis  1  0/17 (0.00%)  0 2/5 (40.00%)  2 0/20 (0.00%)  0 5/32 (15.63%)  9 2/7 (28.57%)  3
Oral Candidiasis  1  0/17 (0.00%)  0 0/5 (0.00%)  0 0/20 (0.00%)  0 0/32 (0.00%)  0 1/7 (14.29%)  1
Oral Herpes  1  1/17 (5.88%)  1 0/5 (0.00%)  0 0/20 (0.00%)  0 1/32 (3.13%)  1 0/7 (0.00%)  0
Pneumonia  1  0/17 (0.00%)  0 1/5 (20.00%)  1 0/20 (0.00%)  0 0/32 (0.00%)  0 0/7 (0.00%)  0
Respiratory Tract Infection  1  0/17 (0.00%)  0 0/5 (0.00%)  0 1/20 (5.00%)  1 1/32 (3.13%)  1 1/7 (14.29%)  1
Rhinitis  1  3/17 (17.65%)  3 1/5 (20.00%)  1 0/20 (0.00%)  0 2/32 (6.25%)  4 1/7 (14.29%)  1
Sinusitis  1  1/17 (5.88%)  1 0/5 (0.00%)  0 0/20 (0.00%)  0 1/32 (3.13%)  1 0/7 (0.00%)  0
Skin Candida  1  1/17 (5.88%)  1 0/5 (0.00%)  0 0/20 (0.00%)  0 0/32 (0.00%)  0 0/7 (0.00%)  0
Staphylococcal Skin Infection  1  1/17 (5.88%)  2 0/5 (0.00%)  0 0/20 (0.00%)  0