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Trial record 20 of 49 for:    CIDP

Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) and Treatment With Subcutaneous Immunoglobulin (IgPro20)

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: NCT01545076
Recruitment Status : Completed
First Posted : March 6, 2012
Results First Posted : July 4, 2018
Last Update Posted : July 4, 2018
Sponsor:
Collaborator:
ICON Clinical Research
Information provided by (Responsible Party):
CSL Behring

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Chronic Inflammatory Demyelinating Polyneuropathy
Polyradiculoneuropathy
Interventions Biological: IgPro20 (low dose)
Biological: Placebo
Biological: IgPro10
Biological: IgPro20 (high dose)
Enrollment 208
Recruitment Details  
Pre-assignment Details  
Arm/Group Title IgPro10 Re-stabilization IgPro20 (0.4) IgPro20 (0.2) Placebo IgPro10 Rescue
Hide Arm/Group Description Subjects who experienced CIDP qualified for IVIG re-stabilization treatment with IgPro10 (10% IgG preparation for intravenous administration). Subjects completing IVIG re-stabilization went on to the IgPro20 Subcutaneous (SC) Treatment. IgPro20 [0.4 g/kg body weight (bw)]: 20% liquid formulation (200 mg/mL) of human normal immunoglobulin for subcutaneous use administered weekly. Subjects completing IVIG re-stabilization went on to the IgPro20 Subcutaneous (SC) Treatment. IgPro20 [0.2 g/kg body weight (bw)]: 20% liquid formulation (200 mg/mL) of human normal immunoglobulin for subcutaneous use administered weekly. Subjects completing IVIG re-stabilization went on to the IgPro20 Subcutaneous (SC) Treatment. Placebo: 2% human albumin administered by weekly SC infusions. Subjects with CIDP relapse during the SC Treatment Period received IgPro10 (10% IgG preparation for intravenous administration) as rescue medication.
Period Title: IgPro10 Restabilization Period
Started 208 0 0 0 0
Completed 172 0 0 0 0
Not Completed 36 0 0 0 0
Reason Not Completed
Adverse Event             4             0             0             0             0
Physician Decision             2             0             0             0             0
Protocol Violation             1             0             0             0             0
Failure to meet randomization criteria             22             0             0             0             0
Withdrawal by Subject             7             0             0             0             0
Period Title: IgPro20 Subcutaneous Treatment Period
Started 0 58 57 57 0
Completed 0 39 36 21 0
Not Completed 0 19 21 36 0
Reason Not Completed
Physician Decision             0             0             0             1             0
Lack of Efficacy             0             10             18             32             0
Adverse Event             0             1             1             0             0
Withdrawal by Subject             0             8             2             3             0
Period Title: IgPro10 Rescue Period
Started 0 0 0 0 60
Completed 0 0 0 0 60
Not Completed 0 0 0 0 0
Arm/Group Title Pre-randomization Safety Data Set (PSDS)
Hide Arm/Group Description Pre-randomization Safety Data Set (PSDS): The PSDS was based on all subjects enrolled into the study who received at least 1 dose of IgPro10 (in the re-stabilization period) before randomization into the subcutaneous period. One subject withdrew from the re-stabilization period prior to receiving IgPro10, therefore n=207 for the PSDS.
Overall Number of Baseline Participants 207
Hide Baseline Analysis Population Description
Pre-randomization Safety Data Set (PSDS): The PSDS was based on all subjects enrolled into the study who received at least 1 dose of IgPro10 (in the re-stabilization period) before randomization into the subcutaneous period. One subject withdrew from the re-stabilization period prior to receiving IgPro10, therefore n=207 for the PSDS.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 207 participants
<=18 years
0
   0.0%
Between 18 and 65 years
150
  72.5%
>=65 years
57
  27.5%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 207 participants
56.5  (12.76)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 207 participants
Female
76
  36.7%
Male
131
  63.3%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 207 participants
United States
25
  12.1%
Czechia
6
   2.9%
Japan
15
   7.2%
United Kingdom
6
   2.9%
Spain
16
   7.7%
Canada
19
   9.2%
Netherlands
7
   3.4%
Belgium
2
   1.0%
Finland
1
   0.5%
Poland
8
   3.9%
Italy
32
  15.5%
Israel
2
   1.0%
Australia
6
   2.9%
France
9
   4.3%
Germany
51
  24.6%
Estonia
2
   1.0%
1.Primary Outcome
Title Percentage (%) of Subjects With CIDP Relapse or Are Withdrawn for Any Other Reason During the Subcutaneous (SC) Treatment Period
Hide Description Relapse is defined as an increase of at least 1 INCAT score point (except for the increase from 0 to 1 in the upper limb score). The INCAT score is a 10-point scale that covers the functionality of legs and arms, and has been successfully used to measure treatment effects in various CIDP studies. Scores for arm disability range from 0 (“No upper limb problems”) to 5 (“Inability to use either arm for any purposeful movement”), and scores for leg disability range from 0 (“Walking not affected”) to 5 (“Restricted to wheelchair, unable to stand and walk a few steps with help”). The INCAT (total) score is the sum of these 2 scores and ranges from 0 to 10. For the “adjusted” INCAT score, changes in the function of the upper limbs from 0 (normal) to 1 (minor symptoms) or from 1 to 0 were not recorded as deterioration or improvement because these changes are not considered clinically significant.
Time Frame Up to 25 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat Set (ITTS): The ITTS consists of all randomized subjects who received at least 1 dose of IgPro20 / placebo and satisfied inclusion criterion #1 (diagnosis of CIDP).
Arm/Group Title IgPro20 (0.4) IgPro20 (0.2) Placebo
Hide Arm/Group Description:
IgPro20 (0.4 g/kg body weight): 20% liquid formulation (200 mg/mL) of human normal immunoglobulin for subcutaneous use administered weekly during the SC treatment period of the study according to the randomization.
IgPro20 (0.2 g/kg body weight): 20% liquid formulation (200 mg/mL) of human normal immunoglobulin for subcutaneous use administered weekly during the SC treatment period of the study according to the randomization.
Placebo: 2% human albumin administered by weekly SC infusions during the SC treatment period of the study.
Overall Number of Participants Analyzed 58 57 57
Measure Type: Number
Unit of Measure: percentage of subjects
32.8 38.6 63.2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IgPro20 (0.2), Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.007
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percent
Estimated Value -24.6
Confidence Interval (2-Sided) 95%
-40.7 to -6.21
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection IgPro20 (0.4), Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percent
Estimated Value -30.4
Confidence Interval (2-Sided) 95%
-46.0 to -12.2
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change in Inflammatory Neuropathy Cause and Treatment (INCAT) Scores During the SC Treatment Period
Hide Description The INCAT score is a 10-point scale that covers the functionality of legs and arms, and has been successfully used to measure treatment effects in various CIDP studies. Scores for arm disability range from 0 (“No upper limb problems”) to 5 (“Inability to use either arm for any purposeful movement”), and scores for leg disability range from 0 (“Walking not affected”) to 5 (“Restricted to wheelchair, unable to stand and walk a few steps with help”). The INCAT (total) score is the sum of these 2 scores and ranges from 0 to 10. For the “adjusted” INCAT score, changes in the function of the upper limbs from 0 (normal) to 1 (minor symptoms) or from 1 to 0 were not recorded as deterioration or improvement because these changes are not considered clinically significant.
Time Frame Baseline and up to 25 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITTS. Not all subjects from the ITTS were available for data collection for this outcome measure.
Arm/Group Title IgPro20 (0.4) IgPro20 (0.2) Placebo
Hide Arm/Group Description:
IgPro20 (0.4 g/kg body weight): 20% liquid formulation (200 mg/mL) of human normal immunoglobulin for subcutaneous use administered weekly during the SC treatment period of the study according to the randomization.
IgPro20 (0.2 g/kg body weight): 20% liquid formulation (200 mg/mL) of human normal immunoglobulin for subcutaneous use administered weekly during the SC treatment period of the study according to the randomization.
Placebo: 2% human albumin administered by weekly SC infusions during the SC treatment period of the study.
Overall Number of Participants Analyzed 57 56 57
Median (Full Range)
Unit of Measure: units on a scale
0
(-2 to 3)
0
(-2 to 5)
1
(-1 to 4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IgPro20 (0.2), Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.005
Comments [Not Specified]
Method Wilcoxon rank sum
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Net)
Estimated Value 0
Confidence Interval (2-Sided) 95%
-1 to 0
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection IgPro20 (0.4), Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Wilcoxon rank sum
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Net)
Estimated Value -1
Confidence Interval (2-Sided) 95%
-1 to 0
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Median Change From Baseline in the Mean Grip Strength Scores of the Dominant Hand During the SC Treatment Period
Hide Description The hand-held Vigorimeter is a device that measures the strength of small muscles in the hand; ie, grip strength. Subjects squeezed a rubber bulb lying between the palm of the hand and the thumb and index fingers. The pressure was recorded via a rubber tube on a nanometer and expressed in kilopascal. At each assessment, the subjects squeezed 3 times with each hand. The mean grip strength median score of the dominant hand was determined.
Time Frame Baseline and up to 25 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITTS. Not all subjects from the ITTS were available for data collection for this outcome measure..
Arm/Group Title IgPro20 (0.4) IgPro20 (0.2) Placebo
Hide Arm/Group Description:
IgPro20 (0.4 g/kg body weight): 20% liquid formulation (200 mg/mL) of human normal immunoglobulin for subcutaneous use administered weekly during the SC treatment period of the study according to the randomization.
IgPro20 (0.2 g/kg body weight): 20% liquid formulation (200 mg/mL) of human normal immunoglobulin for subcutaneous use administered weekly during the SC treatment period of the study according to the randomization.
Placebo: 2% human albumin administered by weekly SC infusions during the SC treatment period of the study.
Overall Number of Participants Analyzed 57 56 57
Median (Full Range)
Unit of Measure: Kilopascal (kPa)
-2.7
(-80 to 55)
-0.6
(-80 to 55)
-6.6
(-51 to 22)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IgPro20 (0.2), Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.004
Comments [Not Specified]
Method Wilcoxon rank sum
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Net)
Estimated Value 7.6
Confidence Interval (2-Sided) 95%
2 to 14
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection IgPro20 (0.4), Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.014
Comments [Not Specified]
Method Wilcoxon rank sum
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Net)
Estimated Value 5.7
Confidence Interval (2-Sided) 95%
0.7 to 11.7
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Change in the Medical Research Council (MRC) Sum Scores During the SC Treatment Period
Hide Description An adapted version of the MRC sum score was used in the study. The MRC sum score is the sum of all 16 muscle scores, and ranges from 0 (paralysis) to 80 (normal strength).
Time Frame Baseline and up to 25 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITTS. Not all subjects from the ITTS were available for data collection for this outcome measure.
Arm/Group Title IgPro20 (0.4) IgPro20 (0.2) Placebo
Hide Arm/Group Description:
IgPro20 (0.4 g/kg body weight): 20% liquid formulation (200 mg/mL) of human normal immunoglobulin for subcutaneous use administered weekly during the SC treatment period of the study according to the randomization.
IgPro20 (0.2 g/kg body weight): 20% liquid formulation (200 mg/mL) of human normal immunoglobulin for subcutaneous use administered weekly during the SC treatment period of the study according to the randomization.
Placebo: 2% human albumin administered by weekly SC infusions during the SC treatment period of the study.
Overall Number of Participants Analyzed 57 56 57
Median (Full Range)
Unit of Measure: units on a scale
0
(-12 to 7)
0
(-16 to 14)
-2
(-19 to 6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IgPro20 (0.2), Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.003
Comments [Not Specified]
Method Wilcoxon rank sum
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value 2
Confidence Interval (2-Sided) 95%
1 to 4
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection IgPro20 (0.4), Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.002
Comments [Not Specified]
Method Wilcoxon rank sum
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value 2
Confidence Interval (2-Sided) 95%
1 to 4
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Change in Rasch-built Overall Disability Scale (R-ODS) Scores During the SC Treatment Period
Hide Description The R-ODS centile score captures activity and social participation in subjects with CIDP. The R-ODS centile score ranges from 0 (most severe activity and social participation limitations) to 100 (no activity and social participation limitations).
Time Frame Baseline and up to 25 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITTS. Not all subjects from the ITTS were available for data collection for this outcome measure.
Arm/Group Title IgPro20 (0.4) IgPro20 (0.2) Placebo
Hide Arm/Group Description:
IgPro20 (0.4 g/kg body weight): 20% liquid formulation (200 mg/mL) of human normal immunoglobulin for subcutaneous use administered weekly during the SC treatment period of the study according to the randomization.
IgPro20 (0.2 g/kg body weight): 20% liquid formulation (200 mg/mL) of human normal immunoglobulin for subcutaneous use administered weekly during the SC treatment period of the study according to the randomization.
Placebo: 2% human albumin administered by weekly SC infusions during the SC treatment period of the study.
Overall Number of Participants Analyzed 53 53 52
Median (Full Range)
Unit of Measure: units on a scale
0
(-49 to 17)
-2
(-41 to 100)
-3
(-43 to 13)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IgPro20 (0.2), Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.03
Comments [Not Specified]
Method Wilcoxon rank sum
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Net)
Estimated Value 3
Confidence Interval (2-Sided) 95%
0 to 9
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection IgPro20 (0.4), Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Wilcoxon rank sum
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Net)
Estimated Value 5
Confidence Interval (2-Sided) 95%
2 to 9
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Time to CIDP Relapse or Withdrawal Due to Any Other Reason During the SC Treatment Period
Hide Description [Not Specified]
Time Frame Up to 25 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITTS
Arm/Group Title IgPro20 (0.4) IgPro20 (0.2) Placebo
Hide Arm/Group Description:
IgPro20 (0.4 g/kg body weight): 20% liquid formulation (200 mg/mL) of human normal immunoglobulin for subcutaneous use administered weekly during the SC treatment period of the study according to the randomization.
IgPro20 (0.2 g/kg body weight): 20% liquid formulation (200 mg/mL) of human normal immunoglobulin for subcutaneous use administered weekly during the SC treatment period of the study according to the randomization.
Placebo: 2% human albumin administered by weekly SC infusions during the SC treatment period of the study.
Overall Number of Participants Analyzed 58 57 57
Median (95% Confidence Interval)
Unit of Measure: Days
NA [1] 
(NA to NA)
NA [1] 
(113.0 to NA)
79.0
(57.0 to 125.0)
[1]
Median times could not be calculated due to insufficient number of participants with events
7.Secondary Outcome
Title Number of Adverse Events Per IgPro20 Infusion During the SC Treatment Period
Hide Description [Not Specified]
Time Frame Up to 28 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Data Set (SDS): The SDS consists of all randomized subjects who received at least 1 dose of IgPro20 or placebo.
Arm/Group Title IgPro20 (0.4) IgPro20 (0.2) Placebo
Hide Arm/Group Description:
IgPro20 (0.4 g/kg body weight): 20% liquid formulation (200 mg/mL) of human normal immunoglobulin for subcutaneous use administered weekly during the SC treatment period of the study according to the randomization.
IgPro20 (0.2 g/kg body weight): 20% liquid formulation (200 mg/mL) of human normal immunoglobulin for subcutaneous use administered weekly during the SC treatment period of the study according to the randomization.
Placebo: 2% human albumin administered by weekly SC infusions during the SC treatment period of the study.
Overall Number of Participants Analyzed 58 57 57
Measure Type: Number
Unit of Measure: Adverse events/Infusion
0.051 0.079 0.034
8.Secondary Outcome
Title Number of Subjects With Adverse Events During the SC Treatment Period
Hide Description [Not Specified]
Time Frame Up to 28 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
SDS
Arm/Group Title IgPro20 (0.4) IgPro20 (0.2) Placebo
Hide Arm/Group Description:
IgPro20 (0.4 g/kg body weight): 20% liquid formulation (200 mg/mL) of human normal immunoglobulin for subcutaneous use administered weekly during the SC treatment period of the study according to the randomization.
IgPro20 (0.2 g/kg body weight): 20% liquid formulation (200 mg/mL) of human normal immunoglobulin for subcutaneous use administered weekly during the SC treatment period of the study according to the randomization.
Placebo: 2% human albumin administered by weekly SC infusions during the SC treatment period of the study.
Overall Number of Participants Analyzed 58 57 57
Measure Type: Count of Participants
Unit of Measure: Participants
30
  51.7%
33
  57.9%
21
  36.8%
9.Secondary Outcome
Title Percentage of Subjects With Adverse Events During the SC Treatment Period
Hide Description [Not Specified]
Time Frame Up to 28 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
SDS
Arm/Group Title IgPro20 (0.4) IgPro20 (0.2) Placebo
Hide Arm/Group Description:
IgPro20 (0.4 g/kg body weight): 20% liquid formulation (200 mg/mL) of human normal immunoglobulin for subcutaneous use administered weekly during the SC treatment period of the study according to the randomization.
IgPro20 (0.2 g/kg body weight): 20% liquid formulation (200 mg/mL) of human normal immunoglobulin for subcutaneous use administered weekly during the SC treatment period of the study according to the randomization.
Placebo: 2% human albumin administered by weekly SC infusions during the SC treatment period of the study.
Overall Number of Participants Analyzed 58 57 57
Measure Type: Number
Unit of Measure: percentage of subjects
51.7 57.9 36.8
10.Secondary Outcome
Title Time to Improvement During IgPro10 Re-stabilization Therapy
Hide Description Improvement is defined as an INCAT score decrease by 1 point (except for the decrease from 1 to 0 in the upper limb score), R-ODS improvement by at least 4 points, Mean Grip strength improvement by at least 8 kPa in one hand, or MRC Sum score >=3.
Time Frame Up to 13 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Pre-randomization Safety Data Set (PSDS): The PSDS was based on all subjects enrolled into the study who received at least 1 dose of IgPro10 (in the re-stabilization period) before randomization into the subcutaneous period. One subject withdrew from the re-stabilization period prior to receiving IgPro10, therefore n=207 for the PSDS.
Arm/Group Title IgPro10
Hide Arm/Group Description:

Subjects who experienced CIDP deterioration during IgG Dependency received IVIG treatment with IgPro10 during IgPro10 Restabilization.

IgPro10 as 1 loading dose of 2 g/kg bw, followed by 3 or 4 maintenance doses (depending on time needed for restabilization) of 1 g/kg bw every 3 weeks.

Overall Number of Participants Analyzed 207
Median (95% Confidence Interval)
Unit of Measure: Days
23
(22 to 23)
11.Secondary Outcome
Title Change in Mean Grip Strength During IgPro10 Re-stabilization Therapy
Hide Description The hand-held Vigorimeter is a device that measures the strength of small muscles in the hand; ie, grip strength. Subjects squeezed a rubber bulb lying between the palm of the hand and the thumb and index fingers. The pressure was recorded via a rubber tube on a nanometer and expressed in kilopascal. At each assessment, the subjects squeezed 3 times with each hand. The mean grip strength median score of the dominant hand was determined.
Time Frame Reference visit and up to 13 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
PSDS. Not all subjects from the PSDS were available for data collection for this outcome measure.
Arm/Group Title IgPro10
Hide Arm/Group Description:

Subjects who experienced CIDP deterioration during IgG Dependency received IVIG treatment with IgPro10 during the IgPro10 Restabilization.

IgPro10 as 1 loading dose of 2 g/kg bw, followed by 3 or 4 maintenance doses (depending on time needed for restabilization) of 1 g/kg bw every 3 weeks.

Overall Number of Participants Analyzed 202
Mean (Standard Deviation)
Unit of Measure: kPa
11.27  (16.89)
12.Secondary Outcome
Title Change in MRC Sum Score During IgPro10 Re-stabilization Therapy
Hide Description An adapted version of the MRC sum score was used in the study. The MRC sum score is the sum of all 16 muscle scores, and ranges from 0 (paralysis) to 80 (normal strength).
Time Frame Reference visit and up to 13 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
PSDS. Not all subjects from the PSDS were available for data collection for this outcome measure.
Arm/Group Title IgPro10
Hide Arm/Group Description:

Subjects who experienced CIDP deterioration during IgG Dependency received IVIG treatment with IgPro10 during the IgPro10 Restabilization.

IgPro10 as 1 loading dose of 2 g/kg bw, followed by 3 or 4 maintenance doses (depending on time needed for restabilization) of 1 g/kg bw every 3 weeks.

Overall Number of Participants Analyzed 203
Mean (Standard Deviation)
Unit of Measure: units on a scale
3.4  (4.9)
13.Secondary Outcome
Title Change in R-ODS During IgPro10 Re-stabilization Therapy
Hide Description The R-ODS centile score captures activity and social participation in subjects with CIDP. The R-ODS centile score ranges from 0 (most severe activity and social participation limitations) to 100 (no activity and social participation limitations).
Time Frame Reference visit and up to 13 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
PSDS. Not all subjects from the PSDS were available for data collection for this outcome measure.
Arm/Group Title IgPro10
Hide Arm/Group Description:

Subjects who experienced CIDP deterioration during IgG Dependency received IVIG treatment with IgPro10 during the IgPro10 Restabilization.

IgPro10 as 1 loading dose of 2 g/kg bw, followed by 3 or 4 maintenance doses (depending on time needed for restabilization) of 1 g/kg bw every 3 weeks.

Overall Number of Participants Analyzed 166
Mean (Standard Deviation)
Unit of Measure: units on a scale
4.7  (14.14)
14.Secondary Outcome
Title Change in INCAT During IgPro10 Re-stabilization Therapy
Hide Description The INCAT score is a 10-point scale that covers the functionality of legs and arms, and has been successfully used to measure treatment effects in various CIDP studies. Scores for arm disability range from 0 (“No upper limb problems”) to 5 (“Inability to use either arm for any purposeful movement”), and scores for leg disability range from 0 (“Walking not affected”) to 5 (“Restricted to wheelchair, unable to stand and walk a few steps with help”). The INCAT (total) score is the sum of these 2 scores and ranges from 0 to 10. For the “adjusted” INCAT score, changes in the function of the upper limbs from 0 (normal) to 1 (minor symptoms) or from 1 to 0 were not recorded as deterioration or improvement because these changes are not considered clinically significant.
Time Frame Reference visit and up to 13 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
PSDS. Not all subjects from the PSDS were available for data collection for this outcome measure.
Arm/Group Title IgPro10
Hide Arm/Group Description:

Subjects who experienced CIDP deterioration during IgG Dependency received IVIG treatment with IgPro10 during the IgPro10 Restabilization.

IgPro10 as 1 loading dose of 2 g/kg bw, followed by 3 or 4 maintenance doses (depending on time needed for restabilization) of 1 g/kg bw every 3 weeks.

Overall Number of Participants Analyzed 205
Mean (Standard Deviation)
Unit of Measure: units on a scale
-1.1  (1.2)
15.Secondary Outcome
Title Number of Adverse Events Per IgPro10 Infusion During Re-stabilization Therapy
Hide Description [Not Specified]
Time Frame Up to 13 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
PSDS
Arm/Group Title IgPro10
Hide Arm/Group Description:

Subjects who experienced CIDP deterioration during IgG Dependency received IVIG treatment with IgPro10 during the IgPro10 Restabilization.

IgPro10 as 1 loading dose of 2 g/kg bw, followed by 3 or 4 maintenance doses (depending on time needed for restabilization) of 1 g/kg bw every 3 weeks.

Overall Number of Participants Analyzed 207
Measure Type: Number
Unit of Measure: Adverse events/Infusion
0.175
16.Secondary Outcome
Title Number of Subjects With Adverse Events During IgPro10 Re-stabilization Therapy
Hide Description [Not Specified]
Time Frame Up to 13 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
PSDS
Arm/Group Title IgPro10
Hide Arm/Group Description:

Subjects who experienced CIDP deterioration during IgG Dependency received IVIG treatment with IgPro10 during the IgPro10 Restabilization.

IgPro10 as 1 loading dose of 2 g/kg bw, followed by 3 or 4 maintenance doses (depending on time needed for restabilization) of 1 g/kg bw every 3 weeks.

Overall Number of Participants Analyzed 207
Measure Type: Number
Unit of Measure: participants
100
17.Secondary Outcome
Title Percent of Subjects With Adverse Events During IgPro10 Re-stabilization Therapy
Hide Description [Not Specified]
Time Frame Up to 13 weeks
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PSDS
Arm/Group Title IgPro10
Hide Arm/Group Description:

Subjects who experienced CIDP deterioration during IgG Dependency received IVIG treatment with IgPro10 during the IgPro10 Restabilization.

IgPro10 as 1 loading dose of 2 g/kg bw, followed by 3 or 4 maintenance doses (depending on time needed for restabilization) of 1 g/kg bw every 3 weeks.

Overall Number of Participants Analyzed 207
Measure Type: Number
Unit of Measure: percentage of subjects
48.3
18.Secondary Outcome
Title Time to Improvement After CIDP Relapse During IgPro10 Rescue Therapy
Hide Description Improvement is defined as a decrease in INCAT score (except for the decrease from 1 to 0 in the upper limb score) back to or below the baseline score..The INCAT score is a 10-point scale that covers the functionality of legs and arms, and has been successfully used to measure treatment effects in various CIDP studies. Scores for arm disability range from 0 (“No upper limb problems”) to 5 (“Inability to use either arm for any purposeful movement”), and scores for leg disability range from 0 (“Walking not affected”) to 5 (“Restricted to wheelchair, unable to stand and walk a few steps with help”). The INCAT (total) score is the sum of these 2 scores and ranges from 0 to 10. For the “adjusted” INCAT score, changes in the function of the upper limbs from 0 (normal) to 1 (minor symptoms) or from 1 to 0 were not recorded as deterioration or improvement because these changes are not considered clinically significant.
Time Frame Up to 13 weeks
Hide Outcome Measure Data
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Rescue Medication Safety Data Set (RSDS): The RSDS consists of subjects of the SDS who received at least 1 dose of IgPro10 rescue medication.
Arm/Group Title IgPro10
Hide Arm/Group Description:

Subjects who experienced CIDP relapse during the IgPro20 SC Period received IVIG treatment with IgPro10 during the IgPro10 Rescue.

IgPro10 as 1 loading dose of 2 g/kg bw, followed by 3 or 4 maintenance doses of 1 g/kg bw every 3 weeks.

Overall Number of Participants Analyzed 60
Median (95% Confidence Interval)
Unit of Measure: Days
23
(22 to 49)
19.Secondary Outcome
Title Number of Adverse Events Per IgPro10 Infusion During Rescue Therapy
Hide Description [Not Specified]
Time Frame Up to 13 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
RSDS
Arm/Group Title IgPro10
Hide Arm/Group Description:

Subjects who experienced CIDP relapse during the IgPro20 SC Period received IVIG treatment with IgPro10 during the IgPro10 Rescue.

IgPro10 as 1 loading dose of 2 g/kg bw, followed by 3 or 4 maintenance doses of 1 g/kg bw every 3 weeks.

Overall Number of Participants Analyzed 60
Measure Type: Number
Unit of Measure: Adverse events/Infusion
0.142
20.Secondary Outcome
Title Number of Subjects With Adverse Events During IgPro10 Rescue Therapy
Hide Description [Not Specified]
Time Frame Up to 13 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
RSDS
Arm/Group Title IgPro10
Hide Arm/Group Description:

Subjects who experienced CIDP relapse during the IgPro20 SC Period received IVIG treatment with IgPro10 during the IgPro10 Rescue.

IgPro10 as 1 loading dose of 2 g/kg bw, followed by 3 or 4 maintenance doses of 1 g/kg bw every 3 weeks.

Overall Number of Participants Analyzed 60
Measure Type: Number
Unit of Measure: participants
17
21.Secondary Outcome
Title Percent of Subjects With Adverse Events During IgPro10 Rescue Therapy
Hide Description [Not Specified]
Time Frame Up to 13 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
RSDS
Arm/Group Title IgPro10
Hide Arm/Group Description:

Subjects who experienced CIDP relapse during the IgPro20 SC Period received IVIG treatment with IgPro10 during the IgPro10 Rescue.

IgPro10 as 1 loading dose of 2 g/kg bw, followed by 3 or 4 maintenance doses of 1 g/kg bw every 3 weeks.

Overall Number of Participants Analyzed 60
Measure Type: Number
Unit of Measure: percentage of subjects
28.3
22.Secondary Outcome
Title Change in Mean Grip Strength During IgPro10 Rescue Therapy
Hide Description The hand-held Vigorimeter is a device that measures the strength of small muscles in the hand; ie, grip strength. Subjects squeezed a rubber bulb lying between the palm of the hand and the thumb and index fingers. The pressure was recorded via a rubber tube on a nanometer and expressed in kilopascal. At each assessment, the subjects squeezed 3 times with each hand. The mean grip strength median score of the dominant hand was determined.
Time Frame Before first rescue IgPro10 infusion and up to 13 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
RSDS. Not all subjects from the RSDS were available for data collection for this outcome measure.
Arm/Group Title IgPro10
Hide Arm/Group Description:

Subjects who experienced CIDP relapse during the IgPro20 SC Period received IVIG treatment with IgPro10 during the IgPro10 Rescue.

IgPro10 as 1 loading dose of 2 g/kg bw, followed by 3 or 4 maintenance doses of 1 g/kg bw every 3 weeks.

Overall Number of Participants Analyzed 35
Mean (Standard Deviation)
Unit of Measure: kPa
16.3  (17.58)
23.Secondary Outcome
Title Change in MRC Sum Score During IgPro10 Rescue Therapy
Hide Description An adapted version of the MRC sum score was used in the study. The MRC sum score is the sum of all 16 muscle scores, and ranges from 0 (paralysis) to 80 (normal strength).
Time Frame Before first rescue IgPro10 infusion and up to 13 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
RSDS. Not all subjects from the RSDS were available for data collection for this outcome measure.
Arm/Group Title IgPro10
Hide Arm/Group Description:

Subjects who experienced CIDP relapse during the IgPro20 SC Period received IVIG treatment with IgPro10 during the IgPro10 Rescue.

IgPro10 as 1 loading dose of 2 g/kg bw, followed by 3 or 4 maintenance doses of 1 g/kg bw every 3 weeks.

Overall Number of Participants Analyzed 35
Mean (Standard Deviation)
Unit of Measure: units on a scale
6.8  (5.28)
24.Secondary Outcome
Title Change in R-ODS During IgPro10 Rescue Therapy
Hide Description The R-ODS centile score captures activity and social participation in subjects with CIDP. The R-ODS centile score ranges from 0 (most severe activity and social participation limitations) to 100 (no activity and social participation limitations).
Time Frame Before first rescue IgPro10 infusion and up to 13 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
RSDS. Not all subjects from the RSDS were available for data collection for this outcome measure.
Arm/Group Title IgPro10
Hide Arm/Group Description:

Subjects who experienced CIDP relapse during the IgPro20 SC Period received IVIG treatment with IgPro10 during the IgPro10 Rescue.

IgPro10 as 1 loading dose of 2 g/kg bw, followed by 3 or 4 maintenance doses of 1 g/kg bw every 3 weeks.

Overall Number of Participants Analyzed 29
Mean (Standard Deviation)
Unit of Measure: units on a scale
14.0  (14.69)
25.Secondary Outcome
Title Change in INCAT During IgPro10 Rescue Therapy
Hide Description The INCAT score is a 10-point scale that covers the functionality of legs and arms, and has been successfully used to measure treatment effects in various CIDP studies. Scores for arm disability range from 0 (“No upper limb problems”) to 5 (“Inability to use either arm for any purposeful movement”), and scores for leg disability range from 0 (“Walking not affected”) to 5 (“Restricted to wheelchair, unable to stand and walk a few steps with help”). The INCAT (total) score is the sum of these 2 scores and ranges from 0 to 10. For the “adjusted” INCAT score, changes in the function of the upper limbs from 0 (normal) to 1 (minor symptoms) or from 1 to 0 were not recorded as deterioration or improvement because these changes are not considered clinically significant.
Time Frame Before first rescue IgPro10 infusion and up to 13 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
RSDS. Not all subjects from the RSDS were available for data collection for this outcome measure.
Arm/Group Title IgPro10
Hide Arm/Group Description:

Subjects who experienced CIDP relapse during the IgPro20 SC Period received IVIG treatment with IgPro10 during the IgPro10 Rescue.

IgPro10 as 1 loading dose of 2 g/kg bw, followed by 3 or 4 maintenance doses of 1 g/kg bw every 3 weeks.

Overall Number of Participants Analyzed 45
Mean (Standard Deviation)
Unit of Measure: units on a scale
-1.3  (1.31)
Time Frame 4.5 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title IgPro10 Restabilization IgPro20 (0.4) IgPro20 (0.2) Placebo IgPro10 Rescue
Hide Arm/Group Description

IgPro10: 10% Immunoglobulin G (IgG) liquid formulation of human normal immunoglobulin (Privigen®) administered intravenously during restabilization.

IgPro10 as 1 loading dose of 2 g/kg bw, followed by 3 or 4 maintenance doses (depending on time needed for restabilization) of 1 g/kg bw every 3 weeks.

IgPro20 (0.4 g/kg body weight): 20% liquid formulation (200 mg/mL) of human normal immunoglobulin for subcutaneous use administered weekly. IgPro20 (0.2 g/kg body weight): 20% liquid formulation (200 mg/mL) of human normal immunoglobulin for subcutaneous use administered weekly. Placebo: 2% human albumin administered by weekly SC infusions during the IgPro20 SC treatment period of the study.

IgPro10: 10% Immunoglobulin G (IgG) liquid formulation of human normal immunoglobulin (Privigen®) administered intravenously during rescue.

IgPro10 as 1 loading dose of 2 g/kg bw, followed by 3 or 4 maintenance doses of 1 g/kg bw every 3 weeks.

All-Cause Mortality
IgPro10 Restabilization IgPro20 (0.4) IgPro20 (0.2) Placebo IgPro10 Rescue
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/207 (0.00%)      0/58 (0.00%)      0/57 (0.00%)      0/57 (0.00%)      0/60 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
IgPro10 Restabilization IgPro20 (0.4) IgPro20 (0.2) Placebo IgPro10 Rescue
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   11/207 (5.31%)      2/58 (3.45%)      3/57 (5.26%)      1/57 (1.75%)      2/60 (3.33%)    
Blood and lymphatic system disorders           
Anemia  1  0/207 (0.00%)  1/58 (1.72%)  0/57 (0.00%)  0/57 (0.00%)  0/60 (0.00%) 
Cardiac disorders           
Cardiac failure congestive  1  1/207 (0.48%)  0/58 (0.00%)  0/57 (0.00%)  0/57 (0.00%)  0/60 (0.00%) 
Pericarditis  1  1/207 (0.48%)  0/58 (0.00%)  0/57 (0.00%)  0/57 (0.00%)  0/60 (0.00%) 
Gastrointestinal disorders           
Inguinal hernia  1  0/207 (0.00%)  0/58 (0.00%)  0/57 (0.00%)  1/57 (1.75%)  0/60 (0.00%) 
Abdominal pain  1  0/207 (0.00%)  0/58 (0.00%)  0/57 (0.00%)  0/57 (0.00%)  1/60 (1.67%) 
Hepatobiliary disorders           
Choleithiasis  1  1/207 (0.48%)  0/58 (0.00%)  0/57 (0.00%)  0/57 (0.00%)  0/60 (0.00%) 
Cholecystitis acute  1  0/207 (0.00%)  1/58 (1.72%)  0/57 (0.00%)  0/57 (0.00%)  0/60 (0.00%) 
Immune system disorders           
Hypersensitivity  1  1/207 (0.48%)  0/58 (0.00%)  0/57 (0.00%)  0/57 (0.00%)  0/60 (0.00%) 
Infections and infestations           
Sepsis  1  0/207 (0.00%)  1/58 (1.72%)  0/57 (0.00%)  0/57 (0.00%)  0/60 (0.00%) 
Bacterial infection  1  0/207 (0.00%)  0/58 (0.00%)  1/57 (1.75%)  0/57 (0.00%)  0/60 (0.00%) 
Device related infection  1  0/207 (0.00%)  0/58 (0.00%)  1/57 (1.75%)  0/57 (0.00%)  0/60 (0.00%) 
Investigations           
Blood pressure diastolic increased  1  1/207 (0.48%)  0/58 (0.00%)  0/57 (0.00%)  0/57 (0.00%)  0/60 (0.00%) 
Musculoskeletal and connective tissue disorders           
Arthropathy  1  0/207 (0.00%)  1/58 (1.72%)  0/57 (0.00%)  0/57 (0.00%)  0/60 (0.00%) 
Arthralgia  1  0/207 (0.00%)  0/58 (0.00%)  1/57 (1.75%)  0/57 (0.00%)  0/60 (0.00%) 
Fracture nonunion  1  0/207 (0.00%)  0/58 (0.00%)  1/57 (1.75%)  0/57 (0.00%)  0/60 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)           
B-cell lymphoma  1  0/207 (0.00%)  0/58 (0.00%)  0/57 (0.00%)  0/57 (0.00%)  1/60 (1.67%) 
Nervous system disorders           
Migraine  1  1/207 (0.48%)  0/58 (0.00%)  0/57 (0.00%)  0/57 (0.00%)  0/60 (0.00%) 
Chronic inflammatory demyelinating polyradiculoneuropathy  1  2/207 (0.97%)  0/58 (0.00%)  0/57 (0.00%)  0/57 (0.00%)  0/60 (0.00%) 
Syncope  1  0/207 (0.00%)  0/58 (0.00%)  0/57 (0.00%)  0/57 (0.00%)  1/60 (1.67%) 
Respiratory, thoracic and mediastinal disorders           
Pulmonary embolism  1  1/207 (0.48%)  0/58 (0.00%)  0/57 (0.00%)  0/57 (0.00%)  0/60 (0.00%) 
Respiratory failure  1  1/207 (0.48%)  0/58 (0.00%)  0/57 (0.00%)  0/57 (0.00%)  0/60 (0.00%) 
Pulmonary hypertension  1  0/207 (0.00%)  0/58 (0.00%)  0/57 (0.00%)  0/57 (0.00%)  1/60 (1.67%) 
Skin and subcutaneous tissue disorders           
Rash  1  1/207 (0.48%)  0/58 (0.00%)  0/57 (0.00%)  0/57 (0.00%)  0/60 (0.00%) 
Dermatitis allergic  1  0/207 (0.00%)  0/58 (0.00%)  1/57 (1.75%)  0/57 (0.00%)  0/60 (0.00%) 
1
Term from vocabulary, MedDRA (14.1)
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
IgPro10 Restabilization IgPro20 (0.4) IgPro20 (0.2) Placebo IgPro10 Rescue
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   50/207 (24.15%)      20/58 (34.48%)      22/57 (38.60%)      15/57 (26.32%)      7/60 (11.67%)    
Gastrointestinal disorders           
Nausea  1  10/207 (4.83%)  12 1/58 (1.72%)  1 0/57 (0.00%)  0 2/57 (3.51%)  2 4/60 (6.67%)  4
General disorders           
Fatigue  1  5/207 (2.42%)  11 0/58 (0.00%)  0 5/57 (8.77%)  5 1/57 (1.75%)  1 0/60 (0.00%)  0
Infusion site erythema  1  0/207 (0.00%)  0 10/58 (17.24%)  28 5/57 (8.77%)  11 0/57 (0.00%)  0 0/60 (0.00%)  0
Infusion site swelling  1  0/207 (0.00%)  0 6/58 (10.34%)  8 5/57 (8.77%)  8 2/57 (3.51%)  2 0/60 (0.00%)  0
Infusion site induration  1  0/207 (0.00%)  0 3/58 (5.17%)  3 2/57 (3.51%)  10 1/57 (1.75%)  1 0/60 (0.00%)  0
Infusion site pain  1  0/207 (0.00%)  0 2/58 (3.45%)  2 3/57 (5.26%)  15 2/57 (3.51%)  2 0/60 (0.00%)  0
Infusion site warmth  1  0/207 (0.00%)  0 3/58 (5.17%)  3 0/57 (0.00%)  0 0/57 (0.00%)  0 0/60 (0.00%)  0
Infections and infestations           
Nasopharyngitis  1  12/207 (5.80%)  12 2/58 (3.45%)  2 4/57 (7.02%)  6 1/57 (1.75%)  1 1/60 (1.67%)  1
Urinary tract infection  1  1/207 (0.48%)  2 0/58 (0.00%)  0 1/57 (1.75%)  1 3/57 (5.26%)  3 0/60 (0.00%)  0
Upper respiratory tract infection  1  2/207 (0.97%)  2 2/58 (3.45%)  2 3/57 (5.26%)  3 2/57 (3.51%)  2 0/60 (0.00%)  0
Injury, poisoning and procedural complications           
Fall  1  5/207 (2.42%)  5 1/58 (1.72%)  1 3/57 (5.26%)  8 0/57 (0.00%)  0 0/60 (0.00%)  0
Musculoskeletal and connective tissue disorders           
Pain in extremity  1  3/207 (1.45%)  3 3/58 (5.17%)  3 1/57 (1.75%)  1 0/57 (0.00%)  0 0/60 (0.00%)  0
Arthralgia  1  3/207 (1.45%)  3 1/58 (1.72%)  1 3/57 (5.26%)  3 1/57 (1.75%)  1 0/60 (0.00%)  0
Back pain  1  5/207 (2.42%)  5 1/58 (1.72%)  1 3/57 (5.26%)  4 1/57 (1.75%)  1 1/60 (1.67%)  1
Nervous system disorders           
Headache  1  34/207 (16.43%)  53 4/58 (6.90%)  4 4/57 (7.02%)  5 2/57 (3.51%)  2 4/60 (6.67%)  6
1
Term from vocabulary, MedDRA (14.1)
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.
CSL agreements may vary with individual investigators; however, CSL will not prohibit any investigator from publishing. CSL supports the publication of results from all centers of a multi-center trial and requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Name/Title: Clinical Trial Disclosure Manager
Organization: CSL Behring
Phone: Use email contact
Responsible Party: CSL Behring
ClinicalTrials.gov Identifier: NCT01545076     History of Changes
Other Study ID Numbers: IgPro20_3003
First Submitted: March 1, 2012
First Posted: March 6, 2012
Results First Submitted: April 9, 2018
Results First Posted: July 4, 2018
Last Update Posted: July 4, 2018