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Trial record 1 of 1 for:    LPS16473
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A Study to Evaluate Efficacy of rFVIIIFc for Immune Tolerance Induction (ITI) in Severe Hemophilia A Participants With Inhibitors Undergoing the First ITI Treatment (verITI-8 Study)

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: NCT03093480
Recruitment Status : Completed
First Posted : March 28, 2017
Results First Posted : July 7, 2021
Last Update Posted : March 28, 2022
Sponsor:
Collaborator:
Swedish Orphan Biovitrum
Information provided by (Responsible Party):
Sanofi ( Bioverativ, a Sanofi company )

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hemophilia A With Inhibitors
Intervention Biological: rFVIIIFc
Enrollment 16
Recruitment Details The study was conducted at 14 active centers in 7 countries between 08-Dec-2017 to 16-Feb-2021.
Pre-assignment Details Total 16 participants were screened, enrolled and received drug.
Arm/Group Title Recombinant Coagulation Factor VIII Fc (rFVIIIFc)
Hide Arm/Group Description Participants were to receive rFVIIIFc at a dose of 200 international units (IU)/kilogram (kg) as once daily injections or divided on several injections per day at the discretion of the Investigator, starting at baseline visit up to maximum of 48 Weeks in ITI Period. Participants who met the criteria for immune tolerance induction (ITI) success entered the tapering period and received rFVIIIFc at a dose adjusted according to Investigator judgment based on the FVIII activity levels and with the aim of tapering the rFVIIIFc dose to reach a prophylactic dosing regimen within 16 weeks (4 months). Follow-Up was for 32 weeks under an adjusted prophylactic regimen according to Investigator judgment.
Period Title: Overall Study
Started [1] 16
Tapering Period [2] 10
Follow-up Period [3] 10
Completed 16
Not Completed 0
[1]
Immune Tolerance Induction (ITI) Full Analysis Set (ITIFAS): includes all participants who received at least 1 infusion of rFVIIIFc.
[2]
Tapering Period Full Analysis Set (TPFAS): includes participants entering the tapering phase of the study
[3]
Follow-Up Period Full Analysis Set: includes all participants entering the follow-up phase in the study.
Arm/Group Title Recombinant Coagulation Factor VIII Fc (rFVIIIFc)
Hide Arm/Group Description Participants were to receive rFVIIIFc at a dose of 200 international units (IU)/kilogram (kg) as once daily injections or divided on several injections per day at the discretion of the Investigator, starting at baseline visit up to maximum of 48 Weeks in ITI Period. Participants who met the criteria for immune tolerance induction (ITI) success entered the tapering period and received rFVIIIFc at a dose adjusted according to Investigator judgment based on the FVIII activity levels and with the aim of tapering the rFVIIIFc dose to reach a prophylactic dosing regimen within 16 weeks (4 months). Follow-Up was for 32 weeks under an adjusted prophylactic regimen according to Investigator judgment.
Overall Number of Baseline Participants 16
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 16 participants
3.8  (4.06)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants
Female NA [1] 
Male
16
 100.0%
[1]
Based on inclusion criteria, only male participants were included
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
2
  12.5%
White
12
  75.0%
More than one race
0
   0.0%
Unknown or Not Reported
2
  12.5%
1.Primary Outcome
Title Time to Tolerization With rFVIIIFc
Hide Description Time required for participants to achieve immune tolerance induction (ITI) success where ITI success is defined as achieving all 3 of the following criteria: confirmed negative titers consisting of 2 consecutive negative inhibitor assessments within 2 weeks (less than [<] 0.6 Bethesda units/milliliter [mL] by the Nijmegen-modified Bethesda assay); incremental recovery (IR) greater than or equal to (>=) 66 percent (%) of the expected IR in 2 consecutive assessments; half-life (t½) >= 7 hours.
Time Frame Up to 48 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who are in ITI full analysis set (includes all participants receiving at least 1 infusion of rFVIIIFc) and achieved ITI success
Arm/Group Title Recombinant Coagulation Factor VIII Fc (rFVIIIFc)
Hide Arm/Group Description:
Participants were to receive rFVIIIFc at a dose of 200 international units (IU)/kilogram (kg) as once daily injections or divided on several injections per day at the discretion of the Investigator, starting at baseline visit up to maximum of 48 Weeks in ITI Period. Participants who met the criteria for immune tolerance induction (ITI) success entered the tapering period and received rFVIIIFc at a dose adjusted according to Investigator judgment based on the FVIII activity levels and with the aim of tapering the rFVIIIFc dose to reach a prophylactic dosing regimen within 16 weeks (4 months). Follow-Up was for 32 weeks under an adjusted prophylactic regimen according to Investigator judgment.
Overall Number of Participants Analyzed 10
Median (Inter-Quartile Range)
Unit of Measure: weeks
11.7
(9.8 to 26.2)
2.Secondary Outcome
Title Number of Participants With Immune Tolerance Induction (ITI) Success
Hide Description Number of participants who achieve ITI success where ITI success is defined as achieving all 3 of the following criteria: confirmed negative titers consisting of 2 consecutive negative inhibitor assessments within 2 weeks (<0.6 Bethesda units/mL by the Nijmegen-modified Bethesda assay); incremental recovery (IR) >= 66% of the expected IR at 2 consecutive assessments; half-life (t½) >=7 hours.
Time Frame Up to 48 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITI full analysis set
Arm/Group Title Recombinant Coagulation Factor VIII Fc (rFVIIIFc)
Hide Arm/Group Description:
Participants were to receive rFVIIIFc at a dose of 200 international units (IU)/kilogram (kg) as once daily injections or divided on several injections per day at the discretion of the Investigator, starting at baseline visit up to maximum of 48 Weeks in ITI Period. Participants who met the criteria for immune tolerance induction (ITI) success entered the tapering period and received rFVIIIFc at a dose adjusted according to Investigator judgment based on the FVIII activity levels and with the aim of tapering the rFVIIIFc dose to reach a prophylactic dosing regimen within 16 weeks (4 months). Follow-Up was for 32 weeks under an adjusted prophylactic regimen according to Investigator judgment.
Overall Number of Participants Analyzed 16
Measure Type: Count of Participants
Unit of Measure: Participants
10
3.Secondary Outcome
Title Number of Participants Who Experienced Relapse
Hide Description Number of Participants with ITI success who reaches the criteria for relapse (defined as confirmed positive inhibitor titer >= 0.6 BU/mL or abnormal recovery after tolerance is achieved, and t½ less than [<] 7 hours) evaluated during the Tapering or Follow-Up Periods
Time Frame Up to 48 weeks (16 weeks Tapering period and 32 weeks follow-up period)
Hide Outcome Measure Data
Hide Analysis Population Description
Tapering Full analysis set
Arm/Group Title Recombinant Coagulation Factor VIII Fc (rFVIIIFc)
Hide Arm/Group Description:
Participants were to receive rFVIIIFc at a dose of 200 international units (IU)/kilogram (kg) as once daily injections or divided on several injections per day at the discretion of the Investigator, starting at baseline visit up to maximum of 48 Weeks in ITI Period. Participants who met the criteria for immune tolerance induction (ITI) success entered the tapering period and received rFVIIIFc at a dose adjusted according to Investigator judgment based on the FVIII activity levels and with the aim of tapering the rFVIIIFc dose to reach a prophylactic dosing regimen within 16 weeks (4 months). Follow-Up was for 32 weeks under an adjusted prophylactic regimen according to Investigator judgment.
Overall Number of Participants Analyzed 10
Measure Type: Count of Participants
Unit of Measure: Participants
0
4.Secondary Outcome
Title Annualized Bleeding Rates During ITI Period
Hide Description A bleeding episode started from the first sign of a bleed and ended no more than 72 hours after the last treatment for the bleed, within which any symptoms of bleeding at the same location or injections less than or equal to 72 hours apart were considered the same bleeding episode. Annualized bleeding rate for a patient during the ITI period is defined as the number of bleeding episodes divided by the length of the ITI period in days* 365.25.
Time Frame Up to 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITI full analysis set which excludes participants who were observed for less than 90 days during the period
Arm/Group Title Recombinant Coagulation Factor VIII Fc (rFVIIIFc)
Hide Arm/Group Description:
Participants were to receive rFVIIIFc at a dose of 200 international units (IU)/kilogram (kg) as once daily injections or divided on several injections per day at the discretion of the Investigator, starting at baseline visit up to maximum of 48 Weeks in ITI Period. Participants who met the criteria for immune tolerance induction (ITI) success entered the tapering period and received rFVIIIFc at a dose adjusted according to Investigator judgment based on the FVIII activity levels and with the aim of tapering the rFVIIIFc dose to reach a prophylactic dosing regimen within 16 weeks (4 months). Follow-Up was for 32 weeks under an adjusted prophylactic regimen according to Investigator judgment.
Overall Number of Participants Analyzed 13
Mean (Standard Deviation)
Unit of Measure: episodes per participant per year
6.6  (9.50)
5.Secondary Outcome
Title Annualized Bleeding Rates After ITI Period
Hide Description A bleeding episode started from the first sign of a bleed and ended no more than 72 hours after the last treatment for the bleed, within which any symptoms of bleeding at the same location or injections less than or equal to 72 hours apart were considered the same bleeding episode. Annualized bleeding rate for a patient after the ITT period (for tapering and follow-up period) is defined as the number of bleeding episodes divided by the length of the period after the ITI period in days* 365.25.
Time Frame Up to 48 weeks (16 weeks Tapering period and 32 weeks follow-up period)
Hide Outcome Measure Data
Hide Analysis Population Description
Tapering period full analysis set excluding participants who were observed for less than 90 days in the period.
Arm/Group Title Recombinant Coagulation Factor VIII Fc (rFVIIIFc)
Hide Arm/Group Description:
Participants were to receive rFVIIIFc at a dose of 200 international units (IU)/kilogram (kg) as once daily injections or divided on several injections per day at the discretion of the Investigator, starting at baseline visit up to maximum of 48 Weeks in ITI Period. Participants who met the criteria for immune tolerance induction (ITI) success entered the tapering period and received rFVIIIFc at a dose adjusted according to Investigator judgment based on the FVIII activity levels and with the aim of tapering the rFVIIIFc dose to reach a prophylactic dosing regimen within 16 weeks (4 months). Follow-Up was for 32 weeks under an adjusted prophylactic regimen according to Investigator judgment.
Overall Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: episodes per participant per year
Tapering period 1.0  (1.27)
Follow-up Period 1.2  (2.91)
6.Secondary Outcome
Title Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (TESAEs) as a Measure of Safety and Tolerability
Hide Description An AE is any untoward medical occurrence that does not necessarily have a causal relationship with this treatment. An SAE is any untoward medical occurrence that at any dose: results in death; in the view of the Investigator, places the participant at immediate risk of death (a life-threatening event); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; results in a congenital anomaly/birth defect; any other medically important event that, in the opinion of the Investigator, may jeopardize the participant or may require intervention to prevent one of the other outcomes listed in the definition.
Time Frame Up to 2 Years
Hide Outcome Measure Data
Hide Analysis Population Description
ITI full analysis set
Arm/Group Title Recombinant Coagulation Factor VIII Fc (rFVIIIFc)
Hide Arm/Group Description:
Participants were to receive rFVIIIFc at a dose of 200 international units (IU)/kilogram (kg) as once daily injections or divided on several injections per day at the discretion of the Investigator, starting at baseline visit up to maximum of 48 Weeks in ITI Period. Participants who met the criteria for immune tolerance induction (ITI) success entered the tapering period and received rFVIIIFc at a dose adjusted according to Investigator judgment based on the FVIII activity levels and with the aim of tapering the rFVIIIFc dose to reach a prophylactic dosing regimen within 16 weeks (4 months). Follow-Up was for 32 weeks under an adjusted prophylactic regimen according to Investigator judgment.
Overall Number of Participants Analyzed 16
Measure Type: Count of Participants
Unit of Measure: Participants
at least one TEAE
16
 100.0%
at least one TESAE
9
  56.3%
Death
0
   0.0%
discontinuation of treatment and/or the study due to an AE
0
   0.0%
7.Secondary Outcome
Title Average Number of Days Missed From Work or School Per Month During ITI Period
Hide Description

Average number of days missed from school or work per month for a period (counting in non-missing diary days) is defined as number of the missing school/work days in the period divided by number of days with data entry in the period.

Number of days per month missed from school or work is reported for those who attend school or have a job.

Time Frame Up to 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants of ITI full analysis set and who attend school or have a job
Arm/Group Title Recombinant Coagulation Factor VIII Fc (rFVIIIFc)
Hide Arm/Group Description:
Participants were to receive rFVIIIFc at a dose of 200 international units (IU)/kilogram (kg) as once daily injections or divided on several injections per day at the discretion of the Investigator, starting at baseline visit up to maximum of 48 Weeks in ITI Period. Participants who met the criteria for immune tolerance induction (ITI) success entered the tapering period and received rFVIIIFc at a dose adjusted according to Investigator judgment based on the FVIII activity levels and with the aim of tapering the rFVIIIFc dose to reach a prophylactic dosing regimen within 16 weeks (4 months). Follow-Up was for 32 weeks under an adjusted prophylactic regimen according to Investigator judgment.
Overall Number of Participants Analyzed 3
Mean (Standard Deviation)
Unit of Measure: days
2.3  (1.21)
8.Secondary Outcome
Title Average Number of Days Missed From Work or School Per Month After ITI Period
Hide Description

Average number of days missed from school or work per month for a period (counting in non-missing diary days) is defined as number of the missing school/work days in the period divided by number of days with data entry in the period.

Number of days per month missed from school or work is reported for those who attend school or have a job.

Time Frame Up to 48 weeks (16 weeks Tapering period & 32 weeks Follow-up period)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants of Tapering full analysis set and who attended school or have a job
Arm/Group Title Recombinant Coagulation Factor VIII Fc (rFVIIIFc)
Hide Arm/Group Description:
Participants were to receive rFVIIIFc at a dose of 200 international units (IU)/kilogram (kg) as once daily injections or divided on several injections per day at the discretion of the Investigator, starting at baseline visit up to maximum of 48 Weeks in ITI Period. Participants who met the criteria for immune tolerance induction (ITI) success entered the tapering period and received rFVIIIFc at a dose adjusted according to Investigator judgment based on the FVIII activity levels and with the aim of tapering the rFVIIIFc dose to reach a prophylactic dosing regimen within 16 weeks (4 months). Follow-Up was for 32 weeks under an adjusted prophylactic regimen according to Investigator judgment.
Overall Number of Participants Analyzed 1
Mean (Standard Deviation)
Unit of Measure: days
0 [1]   (NA)
[1]
Standard deviation cannot be calculated with 1 participant
9.Secondary Outcome
Title Annualized Number of Hospitalization Days During ITI Period
Hide Description Annualized number of hospitalization days during a period for a patient is defined as the number of hospitalization days divided by the length of the period in days * 365.25.
Time Frame Up to 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITI Full analysis set but excluding patients who were observed for less than 90 days in the period.
Arm/Group Title Recombinant Coagulation Factor VIII Fc (rFVIIIFc)
Hide Arm/Group Description:
Participants were to receive rFVIIIFc at a dose of 200 international units (IU)/kilogram (kg) as once daily injections or divided on several injections per day at the discretion of the Investigator, starting at baseline visit up to maximum of 48 Weeks in ITI Period. Participants who met the criteria for immune tolerance induction (ITI) success entered the tapering period and received rFVIIIFc at a dose adjusted according to Investigator judgment based on the FVIII activity levels and with the aim of tapering the rFVIIIFc dose to reach a prophylactic dosing regimen within 16 weeks (4 months). Follow-Up was for 32 weeks under an adjusted prophylactic regimen according to Investigator judgment.
Overall Number of Participants Analyzed 13
Mean (Standard Deviation)
Unit of Measure: days
15.4  (32.24)
10.Secondary Outcome
Title Annualized Number of Hospitalization Days After ITI Period
Hide Description Annualized number of hospitalization days during a period for a patient is defined as the number of hospitalization days divided by the length of the period in days * 365.25.
Time Frame Up to 48 weeks (16 weeks Tapering period & 32 weeks Follow-up period)
Hide Outcome Measure Data
Hide Analysis Population Description
Tapering Period Full analysis set but excluding patients who were observed for less than 90 days in the period.
Arm/Group Title Recombinant Coagulation Factor VIII Fc (rFVIIIFc)
Hide Arm/Group Description:
Participants were to receive rFVIIIFc at a dose of 200 international units (IU)/kilogram (kg) as once daily injections or divided on several injections per day at the discretion of the Investigator, starting at baseline visit up to maximum of 48 Weeks in ITI Period. Participants who met the criteria for immune tolerance induction (ITI) success entered the tapering period and received rFVIIIFc at a dose adjusted according to Investigator judgment based on the FVIII activity levels and with the aim of tapering the rFVIIIFc dose to reach a prophylactic dosing regimen within 16 weeks (4 months). Follow-Up was for 32 weeks under an adjusted prophylactic regimen according to Investigator judgment.
Overall Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: days
2.7  (8.53)
11.Secondary Outcome
Title Adherence to Treatment Regimen Overall Study Period
Hide Description Adherence to treatment is based on prescribed daily dose for the overall study period which is defined as the percentage of administered doses versus the prescribed doses to a patient for the entire study duration.
Time Frame Up to 2 Years
Hide Outcome Measure Data
Hide Analysis Population Description
ITI full analysis set
Arm/Group Title Recombinant Coagulation Factor VIII Fc (rFVIIIFc)
Hide Arm/Group Description:
Participants were to receive rFVIIIFc at a dose of 200 international units (IU)/kilogram (kg) as once daily injections or divided on several injections per day at the discretion of the Investigator, starting at baseline visit up to maximum of 48 Weeks in ITI Period. Participants who met the criteria for immune tolerance induction (ITI) success entered the tapering period and received rFVIIIFc at a dose adjusted according to Investigator judgment based on the FVIII activity levels and with the aim of tapering the rFVIIIFc dose to reach a prophylactic dosing regimen within 16 weeks (4 months). Follow-Up was for 32 weeks under an adjusted prophylactic regimen according to Investigator judgment.
Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: percentage of doses
100.8  (7.76)
12.Secondary Outcome
Title Annualized rFVIIIFc Consumption for Overall Study Period
Hide Description Annualized rFVIIIFc consumption for a treatment period is the total nominal rFVIIIFc (IU/kg) / length of period in days * 365.25.
Time Frame Up to 2 Years
Hide Outcome Measure Data
Hide Analysis Population Description
ITI Full analysis set
Arm/Group Title Recombinant Coagulation Factor VIII Fc (rFVIIIFc)
Hide Arm/Group Description:
Participants were to receive rFVIIIFc at a dose of 200 international units (IU)/kilogram (kg) as once daily injections or divided on several injections per day at the discretion of the Investigator, starting at baseline visit up to maximum of 48 Weeks in ITI Period. Participants who met the criteria for immune tolerance induction (ITI) success entered the tapering period and received rFVIIIFc at a dose adjusted according to Investigator judgment based on the FVIII activity levels and with the aim of tapering the rFVIIIFc dose to reach a prophylactic dosing regimen within 16 weeks (4 months). Follow-Up was for 32 weeks under an adjusted prophylactic regimen according to Investigator judgment.
Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: international unit (IU)/kilograms (kg)
42713.4  (20938.08)
Time Frame All Adverse Events (AEs) were collected from signature of the informed consent form up to end of the study (up to 2 years) regardless of seriousness or relationship to investigational product.
Adverse Event Reporting Description Reported AEs are treatment-emergent AEs (TEAEs) i.e. defined as AEs that developed, worsened, or became serious on or after the first administration of rFVIIIFc. Analysis performed on ITI full analysis set (ITIFAS).
 
Arm/Group Title Recombinant Coagulation Factor VIII Fc (rFVIIIFc)
Hide Arm/Group Description Participants were to receive rFVIIIFc at a dose of 200 international units (IU)/kilogram (kg) as once daily injections or divided on several injections per day at the discretion of the Investigator, starting at baseline visit up to maximum of 48 Weeks in ITI Period. Participants who met the criteria for immune tolerance induction (ITI) success entered the tapering period and received rFVIIIFc at a dose adjusted according to Investigator judgment based on the FVIII activity levels and with the aim of tapering the rFVIIIFc dose to reach a prophylactic dosing regimen within 16 weeks (4 months). Follow-Up was for 32 weeks under an adjusted prophylactic regimen according to Investigator judgment.
All-Cause Mortality
Recombinant Coagulation Factor VIII Fc (rFVIIIFc)
Affected / at Risk (%)
Total   0/16 (0.00%)    
Hide Serious Adverse Events
Recombinant Coagulation Factor VIII Fc (rFVIIIFc)
Affected / at Risk (%) # Events
Total   9/16 (56.25%)    
General disorders   
Complication associated with device  1  1/16 (6.25%)  1
Injection site haematoma  1  1/16 (6.25%)  1
Pyrexia  1  1/16 (6.25%)  1
Infections and infestations   
Vascular access site infection  1  1/16 (6.25%)  1
Vascular device infection  1  4/16 (25.00%)  10
Viral infection  1  1/16 (6.25%)  1
Injury, poisoning and procedural complications   
Contusion  1  2/16 (12.50%)  2
Head injury  1  1/16 (6.25%)  1
Mouth injury  1  1/16 (6.25%)  1
Post procedural oedema  1  1/16 (6.25%)  1
Musculoskeletal and connective tissue disorders   
Arthropathy  1  1/16 (6.25%)  1
Haemarthrosis  1  2/16 (12.50%)  4
Synovitis  1  1/16 (6.25%)  1
Nervous system disorders   
Focal dyscognitive seizures  1  1/16 (6.25%)  1
Product Issues   
Device breakage  1  1/16 (6.25%)  1
1
Term from vocabulary, MedDra 23.1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Recombinant Coagulation Factor VIII Fc (rFVIIIFc)
Affected / at Risk (%) # Events
Total   15/16 (93.75%)    
Blood and lymphatic system disorders   
Iron deficiency anaemia  1  4/16 (25.00%)  5
Lymphocytosis  1  1/16 (6.25%)  1
Monocytosis  1  1/16 (6.25%)  1
Neutropenia  1  2/16 (12.50%)  2
Ear and labyrinth disorders   
Ear pain  1  1/16 (6.25%)  2
Eye disorders   
Eye pruritus  1  1/16 (6.25%)  1
Gastrointestinal disorders   
Aphthous ulcer  1  1/16 (6.25%)  1
Diarrhoea  1  3/16 (18.75%)  8
Vomiting  1  3/16 (18.75%)  3
General disorders   
Administration site extravasation  1  1/16 (6.25%)  1
Asthenia  1  1/16 (6.25%)  1
Catheter site extravasation  1  1/16 (6.25%)  1
Catheter site haematoma  1  1/16 (6.25%)  4
Catheter site swelling  1  1/16 (6.25%)  2
Fatigue  1  1/16 (6.25%)  1
Injection site pain  1  1/16 (6.25%)  1
Pyrexia  1  7/16 (43.75%)  23
Immune system disorders   
Drug hypersensitivity  1  1/16 (6.25%)  1
Food allergy  1  1/16 (6.25%)  3
Seasonal allergy  1  2/16 (12.50%)  2
Infections and infestations   
Bronchitis  1  1/16 (6.25%)  1
Conjunctivitis  1  1/16 (6.25%)  3
Ear infection  1  2/16 (12.50%)  16
Gastritis viral  1  1/16 (6.25%)  1
Gastroenteritis viral  1  1/16 (6.25%)  1
Infectious mononucleosis  1  1/16 (6.25%)  1
Influenza  1  1/16 (6.25%)  1
Myringitis  1  1/16 (6.25%)  1
Nasopharyngitis  1  5/16 (31.25%)  7
Pharyngitis  1  1/16 (6.25%)  1
Rhinitis  1  1/16 (6.25%)  2
Tonsillitis  1  1/16 (6.25%)  1
Vascular device infection  1  2/16 (12.50%)  3
Viral upper respiratory tract infection  1  4/16 (25.00%)  4
Injury, poisoning and procedural complications   
Animal bite  1  1/16 (6.25%)  1
Arthropod sting  1  1/16 (6.25%)  1
Eye injury  1  1/16 (6.25%)  1
Face injury  1  1/16 (6.25%)  2
Fall  1  1/16 (6.25%)  2
Head injury  1  1/16 (6.25%)  1
Lip injury  1  1/16 (6.25%)  1
Mouth injury  1  2/16 (12.50%)  4
Muscle rupture  1  1/16 (6.25%)  1
Scratch  1  1/16 (6.25%)  1
Skin abrasion  1  1/16 (6.25%)  2
Skin laceration  1  1/16 (6.25%)  1
Soft tissue injury  1  1/16 (6.25%)  1
Traumatic haematoma  1  2/16 (12.50%)  2
Wound dehiscence  1  1/16 (6.25%)  1
Wrong product administered  1  1/16 (6.25%)  1
Investigations   
Blood alkaline phosphatase increased  1  1/16 (6.25%)  1
Cardiac murmur  1  1/16 (6.25%)  1
Serum ferritin decreased  1  1/16 (6.25%)  1
Metabolism and nutrition disorders   
Decreased appetite  1  1/16 (6.25%)  1
Vitamin d deficiency  1  1/16 (6.25%)  1
Musculoskeletal and connective tissue disorders   
Arthralgia  1  2/16 (12.50%)  2
Haemarthrosis  1  1/16 (6.25%)  1
Joint effusion  1  1/16 (6.25%)  1
Osteochondrosis  1  1/16 (6.25%)  1
Synovial disorder  1  1/16 (6.25%)  2
Synovitis  1  1/16 (6.25%)  1
Nervous system disorders   
Migraine  1  1/16 (6.25%)  1
Product Issues   
Device occlusion  1  1/16 (6.25%)  1
Renal and urinary disorders   
Micturition urgency  1  1/16 (6.25%)  1
Respiratory, thoracic and mediastinal disorders   
Cough  1  3/16 (18.75%)  11
Nasal congestion  1  1/16 (6.25%)  10
Pharyngeal erythema  1  3/16 (18.75%)  4
Rhinorrhoea  1  3/16 (18.75%)  9
Wheezing  1  1/16 (6.25%)  1
Skin and subcutaneous tissue disorders   
Eczema  1  4/16 (25.00%)  4
Eczema infantile  1  1/16 (6.25%)  1
Rash macular  1  1/16 (6.25%)  1
Red man syndrome  1  1/16 (6.25%)  1
Skin lesion  1  1/16 (6.25%)  1
Urticaria  1  2/16 (12.50%)  2
Urticaria contact  1  1/16 (6.25%)  1
1
Term from vocabulary, MedDra 23.1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The Sponsor supports publication of clinical trial results but may request that investigators temporarily delay or alter publications in order to protect proprietary information. The Sponsor may also require that the results of multicenter studies be published only in their entirety and not as individual site data
Results Point of Contact
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Name/Title: Trial Transparency Team
Organization: Bioverativ, a Sanofi company
Phone: 800-633-1610 ext 6
EMail: Contact-US@sanofi.com
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Responsible Party: Sanofi ( Bioverativ, a Sanofi company )
ClinicalTrials.gov Identifier: NCT03093480    
Other Study ID Numbers: LPS16473
2017-000373-36 ( EudraCT Number )
997HA402 ( Other Identifier: Bioverativ Therapeutics Inc. )
First Submitted: March 10, 2017
First Posted: March 28, 2017
Results First Submitted: May 3, 2021
Results First Posted: July 7, 2021
Last Update Posted: March 28, 2022