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Safety and Tolerability of Higher Infusion Parameters of IgPro20 (Hizentra) in Subjects With Primary Immunodeficiency (PID)

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: NCT03033745
Recruitment Status : Completed
First Posted : January 27, 2017
Results First Posted : January 13, 2020
Last Update Posted : March 25, 2020
Sponsor:
Information provided by (Responsible Party):
CSL Behring

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Primary Immunodeficiency
Intervention Drug: IgPro20
Enrollment 49
Recruitment Details  
Pre-assignment Details  
Arm/Group Title IgPro20 (Pump-Assisted Volume Cohort) IgPro20 (Pump Assisted Flow Rate Cohort) IgPro20 (Manual Push Flow Rate Cohort)
Hide Arm/Group Description

Volumes per injection site of 25 mL up to 50 mL administered subcutaneously.

IgPro20: A liquid formulation of normal human IgG at a concentration of 20% administered as a weekly subcutaneous infusion at a dose prescribed by subject's physician prior to study entry.

Flow rates per injection site of 25 mL/hour up to 100 mL/hour administered subcutaneously.

IgPro20: A liquid formulation of normal human IgG at a concentration of 20% administered as a weekly subcutaneous infusion at a dose prescribed by subject's physician prior to study entry.

Frequent infusions per week (2 to 7 times) with flow rates per injection site of approximately 25 to 30 mL/hour up to approximately 120 mL/hour (equivalent of approximately 0.5 mL/minute up to 2 mL/minute) administered subcutaneously.

IgPro20: A liquid formulation of normal human IgG at a concentration of 20% administered as a subcutaneous infusion at a dose prescribed by subject's physician prior to study entry.

Period Title: Overall Study
Started 15 18 16
Completed 14 17 14
Not Completed 1 1 2
Reason Not Completed
Protocol Violation             0             0             1
Adverse Event             1             0             1
Withdrawal by Subject             0             1             0
Arm/Group Title IgPro20 (Pump-Assisted Volume Cohort) IgPro20 (Pump Assisted Flow Rate Cohort) IgPro20 (Manual Push Flow Rate Cohort) Total
Hide Arm/Group Description

Volumes per injection site of 25 mL up to 50 mL administered subcutaneously.

IgPro20: A liquid formulation of normal human IgG at a concentration of 20% administered as a weekly subcutaneous infusion at a dose prescribed by subject's physician prior to study entry.

Flow rates per injection site of 25 mL/hour up to 100 mL/hour administered subcutaneously.

IgPro20: A liquid formulation of normal human IgG at a concentration of 20% administered as a weekly subcutaneous infusion at a dose prescribed by subject's physician prior to study entry.

Frequent infusions per week (2 to 7 times) with flow rates per injection site of approximately 25 to 30 mL/hour up to approximately 120 mL/hour (equivalent of approximately 0.5 mL/minute up to 2 mL/minute) administered subcutaneously.

IgPro20: A liquid formulation of normal human IgG at a concentration of 20% administered as a subcutaneous infusion at a dose prescribed by subject's physician prior to study entry.

Total of all reporting groups
Overall Number of Baseline Participants 15 18 16 49
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 18 participants 16 participants 49 participants
<=18 years
0
   0.0%
11
  61.1%
1
   6.3%
12
  24.5%
Between 18 and 65 years
14
  93.3%
5
  27.8%
14
  87.5%
33
  67.3%
>=65 years
1
   6.7%
2
  11.1%
1
   6.3%
4
   8.2%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants 18 participants 16 participants 49 participants
49.1  (14.18) 26.7  (24.52) 47.9  (13.28) 40.5  (20.97)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 18 participants 16 participants 49 participants
Female
9
  60.0%
10
  55.6%
10
  62.5%
29
  59.2%
Male
6
  40.0%
8
  44.4%
6
  37.5%
20
  40.8%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 18 participants 16 participants 49 participants
American Indian or Alaska Native
0
   0.0%
1
   5.6%
0
   0.0%
1
   2.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
1
   5.6%
1
   6.3%
2
   4.1%
White
14
  93.3%
16
  88.9%
12
  75.0%
42
  85.7%
More than one race
1
   6.7%
0
   0.0%
2
  12.5%
3
   6.1%
Unknown or Not Reported
0
   0.0%
0
   0.0%
1
   6.3%
1
   2.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 15 participants 18 participants 16 participants 49 participants
Canada 3 0 6 9
United States 12 18 10 40
1.Primary Outcome
Title Percentage of Responders
Hide Description A responder is a subject within the Pump-Assisted Cohorts that performs at least 3 out of 4 valid infusions at a certain infusion parameter level (weekly volumes per injection site of 25-50 mL; weekly flow rates per injection site of 25-100 mL/hour). Determination of a responder in the Manual Push Cohort is more complex due to the expected variable frequency of infusions per week (ie, 5-17) for different subjects. A responder within the Manual Push Cohort is a subject that performs a minimum number of valid infusions during 4 weeks corresponding to a certain flow rate level ([ie, 2-7 times per week], flow rates per injection site of 30-120 mL/hour). Valid infusions do not need to be consecutive, but each subject needs to adhere to the same schedule (number of infusions per week) throughout the study. An infusion parameter will be considered successful if at least one third (≥ 33%) of the subjects in the corresponding cohort are responders at that infusion parameter level.
Time Frame At the end of 4 weeks for each planned infusion parameter
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Analysis Set (SAS) comprised all subjects in the Full Analysis Set who received ≥ 1 dose or a partial dose of IgPro20 in the study.
Arm/Group Title IgPro20 (Pump-Assisted Volume Cohort) IgPro20 (Pump Assisted Flow Rate Cohort) IgPro20 (Manual Push Flow Rate Cohort)
Hide Arm/Group Description:

Volumes per injection site of 25 mL up to 50 mL administered subcutaneously.

IgPro20: A liquid formulation of normal human IgG at a concentration of 20% administered as a weekly subcutaneous infusion at a dose prescribed by subject's physician prior to study entry.

Flow rates per injection site of 25 mL/hour up to 100 mL/hour administered subcutaneously.

IgPro20: A liquid formulation of normal human IgG at a concentration of 20% administered as a weekly subcutaneous infusion at a dose prescribed by subject's physician prior to study entry.

Frequent infusions per week (2 to 7 times) with flow rates per injection site of approximately 25 to 30 mL/hour up to approximately 120 mL/hour (equivalent of approximately 0.5 mL/minute up to 2 mL/minute) administered subcutaneously.

IgPro20: A liquid formulation of normal human IgG at a concentration of 20% administered as a subcutaneous infusion at a dose prescribed by subject's physician prior to study entry.

Overall Number of Participants Analyzed 15 18 16
Measure Type: Number
Unit of Measure: percentage of responders
25 ml Number Analyzed 15 participants 0 participants 0 participants
86.7
40 ml Number Analyzed 15 participants 0 participants 0 participants
73.3
50 ml Number Analyzed 15 participants 0 participants 0 participants
73.3
25 ml/h Number Analyzed 0 participants 18 participants 0 participants
77.8
50 ml/h Number Analyzed 0 participants 18 participants 0 participants
77.8
75 ml/h Number Analyzed 0 participants 18 participants 0 participants
66.7
100 ml/h Number Analyzed 0 participants 18 participants 0 participants
61.1
30 ml/h Number Analyzed 0 participants 0 participants 16 participants
100
60 ml/h Number Analyzed 0 participants 0 participants 16 participants
100
120 ml/h Number Analyzed 0 participants 0 participants 16 participants
87.5
2.Secondary Outcome
Title Rate of Treatment-emergent Adverse Events (TEAEs) Per Infusion
Hide Description Adverse event rate per infusion = number of adverse events/total number of infusions prior to subject's start date of non-response. Only events are included which start prior to subject's start date of non-response.
Time Frame At the end of 4 weeks for each planned infusion parameter
Hide Outcome Measure Data
Hide Analysis Population Description
SAS
Arm/Group Title IgPro20 (Pump-Assisted Volume Cohort) IgPro20 (Pump Assisted Flow Rate Cohort) IgPro20 (Manual Push Flow Rate Cohort)
Hide Arm/Group Description:

Volumes per injection site of 25 mL up to 50 mL administered subcutaneously.

IgPro20: A liquid formulation of normal human IgG at a concentration of 20% administered as a weekly subcutaneous infusion at a dose prescribed by subject's physician prior to study entry.

Flow rates per injection site of 25 mL/hour up to 100 mL/hour administered subcutaneously.

IgPro20: A liquid formulation of normal human IgG at a concentration of 20% administered as a weekly subcutaneous infusion at a dose prescribed by subject's physician prior to study entry.

Frequent infusions per week (2 to 7 times) with flow rates per injection site of approximately 25 to 30 mL/hour up to approximately 120 mL/hour (equivalent of approximately 0.5 mL/minute up to 2 mL/minute) administered subcutaneously.

IgPro20: A liquid formulation of normal human IgG at a concentration of 20% administered as a subcutaneous infusion at a dose prescribed by subject's physician prior to study entry.

Overall Number of Participants Analyzed 15 18 16
Overall Number of Units Analyzed
Type of Units Analyzed: Infusions
152 222 626
Measure Type: Number
Unit of Measure: Number of TEAEs/infusion
25 ml Number Analyzed 60 Infusions 0 Infusions [1]  0 Infusions [1] 
0.183
40 ml Number Analyzed 48 Infusions [2]  0 Infusions [1]  0 Infusions [1] 
0.188
50 ml Number Analyzed 44 Infusions [3]  0 Infusions [1]  0 Infusions [1] 
0.023
25 ml/h Number Analyzed 0 Infusions [1]  70 Infusions 0 Infusions [1] 
0.329
50 ml/h Number Analyzed 0 Infusions [1]  55 Infusions [4]  0 Infusions [1] 
0.255
75 ml/h Number Analyzed 0 Infusions [1]  50 Infusions [5]  0 Infusions [1] 
0.140
100 ml/h Number Analyzed 0 Infusions [1]  47 Infusions [2]  0 Infusions [1] 
0.085
30 ml/h Number Analyzed 0 Infusions [1]  0 Infusions [1]  220 Infusions
0.064
60 ml/h Number Analyzed 0 Infusions [1]  0 Infusions [1]  208 Infusions
0.111
120 ml/h Number Analyzed 0 Infusions [1]  0 Infusions [1]  198 Infusions [4] 
0.081
[1]
0 participants
[2]
12 participants
[3]
11 participants
[4]
14 participants
[5]
13 participants
3.Secondary Outcome
Title Rate of Local TEAEs Per Infusion
Hide Description Local adverse event rate per infusion = number of local adverse events/total number of infusions prior to subject's start date of non-response. Local Adverse Events: comprises all events reported within the MedDRA high level terms "administration site reactions NEC (Not Elsewhere Classified)", "infusion site reactions", and "injection site reactions". Only events are included which start prior to subject's start date of non-response.
Time Frame At the end of 4 weeks for each planned infusion parameter
Hide Outcome Measure Data
Hide Analysis Population Description
SAS
Arm/Group Title IgPro20 (Pump-Assisted Volume Cohort) IgPro20 (Pump Assisted Flow Rate Cohort) IgPro20 (Manual Push Flow Rate Cohort)
Hide Arm/Group Description:

Volumes per injection site of 25 mL up to 50 mL administered subcutaneously.

IgPro20: A liquid formulation of normal human IgG at a concentration of 20% administered as a weekly subcutaneous infusion at a dose prescribed by subject's physician prior to study entry.

Flow rates per injection site of 25 mL/hour up to 100 mL/hour administered subcutaneously.

IgPro20: A liquid formulation of normal human IgG at a concentration of 20% administered as a weekly subcutaneous infusion at a dose prescribed by subject's physician prior to study entry.

Frequent infusions per week (2 to 7 times) with flow rates per injection site of approximately 25 to 30 mL/hour up to approximately 120 mL/hour (equivalent of approximately 0.5 mL/minute up to 2 mL/minute) administered subcutaneously.

IgPro20: A liquid formulation of normal human IgG at a concentration of 20% administered as a subcutaneous infusion at a dose prescribed by subject's physician prior to study entry.

Overall Number of Participants Analyzed 15 18 16
Overall Number of Units Analyzed
Type of Units Analyzed: Infusions
152 222 626
Measure Type: Number
Unit of Measure: Number of local TEAEs/infusion
25 ml Number Analyzed 60 Infusions 0 Infusions [1]  0 Infusions [1] 
0.150
40 ml Number Analyzed 48 Infusions [2]  0 Infusions [1]  0 Infusions [1] 
0.063
50 ml Number Analyzed 44 Infusions [3]  0 Infusions [1]  0 Infusions [1] 
0.0
25 ml/h Number Analyzed 0 Infusions [1]  70 Infusions 0 Infusions [1] 
0.286
50 ml/h Number Analyzed 0 Infusions [1]  55 Infusions [4]  0 Infusions [1] 
0.145
75 ml/h Number Analyzed 0 Infusions [1]  50 Infusions [5]  0 Infusions [1] 
0.040
100 ml/h Number Analyzed 0 Infusions [1]  47 Infusions [2]  0 Infusions [1] 
0.021
30 ml/h Number Analyzed 0 Infusions [1]  0 Infusions [1]  220 Infusions
0.027
60 ml/h Number Analyzed 0 Infusions [1]  0 Infusions [1]  208 Infusions
0.082
120 ml/h Number Analyzed 0 Infusions [1]  0 Infusions [1]  198 Infusions [4] 
0.025
[1]
0 participants
[2]
12 participants
[3]
11 participants
[4]
14 participants
[5]
13 participants
4.Secondary Outcome
Title Time to Onset of Local TEAEs
Hide Description Local Adverse Events: comprises all events reported within the MedDRA high level terms "administration site reactions NEC", "infusion site reactions", and "injection site reactions". Only events are included which start prior to subject's start date of non-response.
Time Frame At the end of 4 weeks for each planned infusion parameter
Hide Outcome Measure Data
Hide Analysis Population Description
SAS
Arm/Group Title IgPro20 (Pump-Assisted Volume Cohort) IgPro20 (Pump Assisted Flow Rate Cohort) IgPro20 (Manual Push Flow Rate Cohort)
Hide Arm/Group Description:

Volumes per injection site of 25 mL up to 50 mL administered subcutaneously.

IgPro20: A liquid formulation of normal human IgG at a concentration of 20% administered as a weekly subcutaneous infusion at a dose prescribed by subject's physician prior to study entry.

Flow rates per injection site of 25 mL/hour up to 100 mL/hour administered subcutaneously.

IgPro20: A liquid formulation of normal human IgG at a concentration of 20% administered as a weekly subcutaneous infusion at a dose prescribed by subject's physician prior to study entry.

Frequent infusions per week (2 to 7 times) with flow rates per injection site of approximately 25 to 30 mL/hour up to approximately 120 mL/hour (equivalent of approximately 0.5 mL/minute up to 2 mL/minute) administered subcutaneously.

IgPro20: A liquid formulation of normal human IgG at a concentration of 20% administered as a subcutaneous infusion at a dose prescribed by subject's physician prior to study entry.

Overall Number of Participants Analyzed 15 18 16
Overall Number of Units Analyzed
Type of Units Analyzed: Local TEAEs
12 31 28
Mean (Standard Deviation)
Unit of Measure: Days
25 ml Number Analyzed 9 Local TEAEs 0 Local TEAEs [1]  0 Local TEAEs [1] 
1.3  (2.45)
40 ml Number Analyzed 3 Local TEAEs [2]  0 Local TEAEs [1]  0 Local TEAEs [1] 
0  (0.0)
50 ml Number Analyzed 0 Local TEAEs [3]  0 Local TEAEs [1]  0 Local TEAEs [1] 
25 ml/h Number Analyzed 0 Local TEAEs [1]  20 Local TEAEs 0 Local TEAEs [1] 
1.7  (2.94)
50 ml/h Number Analyzed 0 Local TEAEs [1]  8 Local TEAEs [4]  0 Local TEAEs [1] 
0.0  (0.04)
75 ml/h Number Analyzed 0 Local TEAEs [1]  2 Local TEAEs [5]  0 Local TEAEs [1] 
0  (0.0)
100 ml/h Number Analyzed 0 Local TEAEs [1]  1 Local TEAEs [2]  0 Local TEAEs [1] 
0 [6]   (NA)
30 ml/h Number Analyzed 0 Local TEAEs [1]  0 Local TEAEs [1]  6 Local TEAEs
0.2  (0.41)
60 ml/h Number Analyzed 0 Local TEAEs [1]  0 Local TEAEs [1]  17 Local TEAEs
0.3  (0.59)
120 ml/h Number Analyzed 0 Local TEAEs [1]  0 Local TEAEs [1]  5 Local TEAEs [4] 
0.2  (0.45)
[1]
0 participants
[2]
12 participants
[3]
11 participants
[4]
14 participants
[5]
13 participants
[6]
Not estimable because events = 1
5.Secondary Outcome
Title Intensity of Local TEAEs
Hide Description Mild = A type of AE that is usually transient and may require only minimal treatment or therapeutic intervention. The event does not generally interfere with usual activities of daily living. Moderate = A type of AE that is usually alleviated with additional specific therapeutic intervention. The event interferes with usual activities of daily living, causing discomfort but poses no significant or permanent risk of harm to the subject. Severe = A type of AE that interrupts usual activities of daily living, or significantly affects clinical status, or may require intensive therapeutic intervention. Only events are included which start prior to subject's start date of non-response.
Time Frame At the end of 4 weeks for each planned infusion parameter
Hide Outcome Measure Data
Hide Analysis Population Description
SAS
Arm/Group Title IgPro20 (Pump-Assisted Volume Cohort) IgPro20 (Pump Assisted Flow Rate Cohort) IgPro20 (Manual Push Flow Rate Cohort)
Hide Arm/Group Description:

Volumes per injection site of 25 mL up to 50 mL administered subcutaneously.

IgPro20: A liquid formulation of normal human IgG at a concentration of 20% administered as a weekly subcutaneous infusion at a dose prescribed by subject's physician prior to study entry.

Flow rates per injection site of 25 mL/hour up to 100 mL/hour administered subcutaneously.

IgPro20: A liquid formulation of normal human IgG at a concentration of 20% administered as a weekly subcutaneous infusion at a dose prescribed by subject's physician prior to study entry.

Frequent infusions per week (2 to 7 times) with flow rates per injection site of approximately 25 to 30 mL/hour up to approximately 120 mL/hour (equivalent of approximately 0.5 mL/minute up to 2 mL/minute) administered subcutaneously.

IgPro20: A liquid formulation of normal human IgG at a concentration of 20% administered as a subcutaneous infusion at a dose prescribed by subject's physician prior to study entry.

Overall Number of Participants Analyzed 15 18 16
Measure Type: Count of Participants
Unit of Measure: Participants
25 ml (mild) Number Analyzed 15 participants 0 participants 0 participants
3
  20.0%
25 ml (moderate) Number Analyzed 15 participants 0 participants 0 participants
0
   0.0%
25 ml (severe) Number Analyzed 15 participants 0 participants 0 participants
0
   0.0%
40 ml (mild) Number Analyzed 12 participants 0 participants 0 participants
1
   8.3%
40 ml (moderate) Number Analyzed 12 participants 0 participants 0 participants
0
   0.0%
40 ml (severe) Number Analyzed 12 participants 0 participants 0 participants
0
   0.0%
50 ml (mild) Number Analyzed 11 participants 0 participants 0 participants
0
   0.0%
50 ml (moderate) Number Analyzed 11 participants 0 participants 0 participants
0
   0.0%
50 ml (severe) Number Analyzed 11 participants 0 participants 0 participants
0
   0.0%
25 ml/h (mild) Number Analyzed 0 participants 18 participants 0 participants
4
  22.2%
25 ml/h (moderate) Number Analyzed 0 participants 18 participants 0 participants
2
  11.1%
25 ml/h (severe) Number Analyzed 0 participants 18 participants 0 participants
0
   0.0%
50 ml/h (mild) Number Analyzed 0 participants 14 participants 0 participants
3
  21.4%
50 ml/h (moderate) Number Analyzed 0 participants 14 participants 0 participants
0
   0.0%
50 ml/h (severe) Number Analyzed 0 participants 14 participants 0 participants
0
   0.0%
75 ml/h (mild) Number Analyzed 0 participants 13 participants 0 participants
1
   7.7%
75 ml/h (moderate) Number Analyzed 0 participants 13 participants 0 participants
0
   0.0%
75 ml/h (severe) Number Analyzed 0 participants 13 participants 0 participants
0
   0.0%
100 ml/h (mild) Number Analyzed 0 participants 12 participants 0 participants
0
   0.0%
100 ml/h (moderate) Number Analyzed 0 participants 12 participants 0 participants
0
   0.0%
100 ml/h (severe) Number Analyzed 0 participants 12 participants 0 participants
1
   8.3%
30 ml/h (mild) Number Analyzed 0 participants 0 participants 16 participants
3
  18.8%
30 ml/h (moderate) Number Analyzed 0 participants 0 participants 16 participants
0
   0.0%
30 ml/h (severe) Number Analyzed 0 participants 0 participants 16 participants
0
   0.0%
60 ml/h (mild) Number Analyzed 0 participants 0 participants 16 participants
4
  25.0%
60 ml/h (moderate) Number Analyzed 0 participants 0 participants 16 participants
0
   0.0%
60 ml/h (severe) Number Analyzed 0 participants 0 participants 16 participants
0
   0.0%
120 ml/h (mild) Number Analyzed 0 participants 0 participants 14 participants
2
  14.3%
120 ml/h (moderate) Number Analyzed 0 participants 0 participants 14 participants
0
   0.0%
120 ml/h (severe) Number Analyzed 0 participants 0 participants 14 participants
0
   0.0%
6.Secondary Outcome
Title Duration of Local TEAEs
Hide Description Local Adverse Events: comprises all events reported within the MedDRA high level terms "administration site reactions NEC", "infusion site reactions", and "injection site reactions".
Time Frame At the end of 4 weeks for each planned infusion parameter
Hide Outcome Measure Data
Hide Analysis Population Description
SAS
Arm/Group Title IgPro20 (Pump-Assisted Volume Cohort) IgPro20 (Pump Assisted Flow Rate Cohort) IgPro20 (Manual Push Flow Rate Cohort)
Hide Arm/Group Description:

Volumes per injection site of 25 mL up to 50 mL administered subcutaneously.

IgPro20: A liquid formulation of normal human IgG at a concentration of 20% administered as a weekly subcutaneous infusion at a dose prescribed by subject's physician prior to study entry.

Flow rates per injection site of 25 mL/hour up to 100 mL/hour administered subcutaneously.

IgPro20: A liquid formulation of normal human IgG at a concentration of 20% administered as a weekly subcutaneous infusion at a dose prescribed by subject's physician prior to study entry.

Frequent infusions per week (2 to 7 times) with flow rates per injection site of approximately 25 to 30 mL/hour up to approximately 120 mL/hour (equivalent of approximately 0.5 mL/minute up to 2 mL/minute) administered subcutaneously.

IgPro20: A liquid formulation of normal human IgG at a concentration of 20% administered as a subcutaneous infusion at a dose prescribed by subject's physician prior to study entry.

Overall Number of Participants Analyzed 15 18 16
Overall Number of Units Analyzed
Type of Units Analyzed: Local TEAEs
12 31 28
Mean (Standard Deviation)
Unit of Measure: Days
25 ml Number Analyzed 9 Local TEAEs 0 Local TEAEs [1]  0 Local TEAEs [1] 
2.2  (1.30)
40 ml Number Analyzed 3 Local TEAEs [2]  0 Local TEAEs [1]  0 Local TEAEs [1] 
2.7  (2.08)
50 ml Number Analyzed 0 Local TEAEs [3]  0 Local TEAEs [1]  0 Local TEAEs [1] 
25 ml/h Number Analyzed 0 Local TEAEs [1]  20 Local TEAEs 0 Local TEAEs [1] 
1.2  (0.37)
50 ml/h Number Analyzed 0 Local TEAEs [1]  8 Local TEAEs [4]  0 Local TEAEs [1] 
1.6  (0.92)
75 ml/h Number Analyzed 0 Local TEAEs [1]  2 Local TEAEs [5]  0 Local TEAEs [1] 
1.0  (0.00)
100 ml/h Number Analyzed 0 Local TEAEs [1]  1 Local TEAEs [2]  0 Local TEAEs [1] 
1.0 [6]   (NA)
30 ml/h Number Analyzed 0 Local TEAEs [1]  0 Local TEAEs [1]  6 Local TEAEs
2.2  (2.86)
60 ml/h Number Analyzed 0 Local TEAEs [1]  0 Local TEAEs [1]  17 Local TEAEs
5.6  (12.91)
120 ml/h Number Analyzed 0 Local TEAEs [1]  0 Local TEAEs [1]  5 Local TEAEs [4] 
3.0  (2.12)
[1]
0 participants
[2]
12 participants
[3]
11 participants
[4]
14 participants
[5]
13 participants
[6]
Not estimable because events = 1
7.Secondary Outcome
Title Tolerability of Infusions
Hide Description Tolerability = number of infusions without severe local adverse events / total number of infusions. Severe = A type of AE that interrupts usual activities of daily living, or significantly affects clinical status, or may require intensive therapeutic intervention. Only events are included which start prior to subject's start date of non-response.
Time Frame At the end of 4 weeks for each planned infusion parameter
Hide Outcome Measure Data
Hide Analysis Population Description
SAS
Arm/Group Title IgPro20 (Pump-Assisted Volume Cohort) IgPro20 (Pump Assisted Flow Rate Cohort) IgPro20 (Manual Push Flow Rate Cohort)
Hide Arm/Group Description:

Volumes per injection site of 25 mL up to 50 mL administered subcutaneously.

IgPro20: A liquid formulation of normal human IgG at a concentration of 20% administered as a weekly subcutaneous infusion at a dose prescribed by subject's physician prior to study entry.

Flow rates per injection site of 25 mL/hour up to 100 mL/hour administered subcutaneously.

IgPro20: A liquid formulation of normal human IgG at a concentration of 20% administered as a weekly subcutaneous infusion at a dose prescribed by subject's physician prior to study entry.

Frequent infusions per week (2 to 7 times) with flow rates per injection site of approximately 25 to 30 mL/hour up to approximately 120 mL/hour (equivalent of approximately 0.5 mL/minute up to 2 mL/minute) administered subcutaneously.

IgPro20: A liquid formulation of normal human IgG at a concentration of 20% administered as a subcutaneous infusion at a dose prescribed by subject's physician prior to study entry.

Overall Number of Participants Analyzed 15 18 16
Overall Number of Units Analyzed
Type of Units Analyzed: Infusions
152 222 626
Measure Type: Number
Unit of Measure: Ratio
25 ml Number Analyzed 60 Infusions 0 Infusions [1]  0 Infusions [1] 
1.00
40 ml Number Analyzed 48 Infusions [2]  0 Infusions [1]  0 Infusions [1] 
1.00
50 ml Number Analyzed 44 Infusions [3]  0 Infusions [1]  0 Infusions [1] 
1.00
25 ml/h Number Analyzed 0 Infusions [1]  70 Infusions 0 Infusions [1] 
1.00
50 ml/h Number Analyzed 0 Infusions [1]  55 Infusions [4]  0 Infusions [1] 
1.00
75 ml/h Number Analyzed 0 Infusions [1]  50 Infusions [5]  0 Infusions [1] 
1.00
100 ml/h Number Analyzed 0 Infusions [1]  47 Infusions [2]  0 Infusions [1] 
0.98
30 ml/h Number Analyzed 0 Infusions [1]  0 Infusions [1]  220 Infusions
1.00
60 ml/h Number Analyzed 0 Infusions [1]  0 Infusions [1]  208 Infusions
1.00
120 ml/h Number Analyzed 0 Infusions [1]  0 Infusions [1]  198 Infusions [4] 
1.00
[1]
0 participants
[2]
12 participants
[3]
11 participants
[4]
14 participants
[5]
13 participants
Time Frame Up to 17 weeks per participant
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title IgPro20 (Pump-assisted Volume) 25 mL IgPro20 (Pump-assisted Volume) 40 mL IgPro20 (Pump-assisted Volume) 50 mL IgPro20 (Pump-assisted Flow Rate) 25 mL/h IgPro20 (Pump-assisted Flow Rate) 50 mL/h IgPro20 (Pump-assisted Flow Rate) 75 mL/h IgPro20 (Pump-assisted Flow Rate) 100 mL/h IgPro20 (Manual Push Flow Rate) 30 mL/h IgPro20 (Manual Push Flow Rate) 60 mL/h IgPro20 (Manual Push Flow Rate) 120 mL/h
Hide Arm/Group Description Volumes per injection site of 25 mL administered subcutaneously. Volumes per injection site of 40 mL administered subcutaneously. Volumes per injection site of 50 mL administered subcutaneously. Flow rates per injection site of 25 mL/hour administered subcutaneously. Flow rates per injection site of 50 mL/hour administered subcutaneously. Flow rates per injection site of 75 mL/hour administered subcutaneously. Flow rates per injection site of 100 mL/hour administered subcutaneously. Flow rates per injection site of approximately 30 mL/hour administered subcutaneously. Flow rates per injection site of approximately 60 mL/hour administered subcutaneously. Flow rates per injection site of approximately 120 mL/hour administered subcutaneously.
All-Cause Mortality
IgPro20 (Pump-assisted Volume) 25 mL IgPro20 (Pump-assisted Volume) 40 mL IgPro20 (Pump-assisted Volume) 50 mL IgPro20 (Pump-assisted Flow Rate) 25 mL/h IgPro20 (Pump-assisted Flow Rate) 50 mL/h IgPro20 (Pump-assisted Flow Rate) 75 mL/h IgPro20 (Pump-assisted Flow Rate) 100 mL/h IgPro20 (Manual Push Flow Rate) 30 mL/h IgPro20 (Manual Push Flow Rate) 60 mL/h IgPro20 (Manual Push Flow Rate) 120 mL/h
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)      0/12 (0.00%)      0/11 (0.00%)      0/18 (0.00%)      0/14 (0.00%)      0/13 (0.00%)      0/12 (0.00%)      0/16 (0.00%)      0/16 (0.00%)      0/14 (0.00%)    
Hide Serious Adverse Events
IgPro20 (Pump-assisted Volume) 25 mL IgPro20 (Pump-assisted Volume) 40 mL IgPro20 (Pump-assisted Volume) 50 mL IgPro20 (Pump-assisted Flow Rate) 25 mL/h IgPro20 (Pump-assisted Flow Rate) 50 mL/h IgPro20 (Pump-assisted Flow Rate) 75 mL/h IgPro20 (Pump-assisted Flow Rate) 100 mL/h IgPro20 (Manual Push Flow Rate) 30 mL/h IgPro20 (Manual Push Flow Rate) 60 mL/h IgPro20 (Manual Push Flow Rate) 120 mL/h
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/15 (0.00%)      0/12 (0.00%)      0/11 (0.00%)      0/18 (0.00%)      0/14 (0.00%)      0/13 (0.00%)      0/12 (0.00%)      0/16 (0.00%)      1/16 (6.25%)      0/14 (0.00%)    
Psychiatric disorders                     
suicide attempt  1  0/15 (0.00%)  0 0/12 (0.00%)  0 0/11 (0.00%)  0 0/18 (0.00%)  0 0/14 (0.00%)  0 0/13 (0.00%)  0 0/12 (0.00%)  0 0/16 (0.00%)  0 1/16 (6.25%)  1 0/14 (0.00%)  0
1
Term from vocabulary, MedDRA (18.1)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
IgPro20 (Pump-assisted Volume) 25 mL IgPro20 (Pump-assisted Volume) 40 mL IgPro20 (Pump-assisted Volume) 50 mL IgPro20 (Pump-assisted Flow Rate) 25 mL/h IgPro20 (Pump-assisted Flow Rate) 50 mL/h IgPro20 (Pump-assisted Flow Rate) 75 mL/h IgPro20 (Pump-assisted Flow Rate) 100 mL/h IgPro20 (Manual Push Flow Rate) 30 mL/h IgPro20 (Manual Push Flow Rate) 60 mL/h IgPro20 (Manual Push Flow Rate) 120 mL/h
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/15 (26.67%)      4/12 (33.33%)      1/11 (9.09%)      7/18 (38.89%)      4/14 (28.57%)      3/13 (23.08%)      3/12 (25.00%)      5/16 (31.25%)      8/16 (50.00%)      7/14 (50.00%)    
Blood and lymphatic system disorders                     
Leukopenia  1  0/15 (0.00%)  0 0/12 (0.00%)  0 0/11 (0.00%)  0 0/18 (0.00%)  0 0/14 (0.00%)  0 0/13 (0.00%)  0 0/12 (0.00%)  0 0/16 (0.00%)  0 0/16 (0.00%)  0 1/14 (7.14%)  1
Endocrine disorders                     
Adrenal insufficiency  1  0/15 (0.00%)  0 0/12 (0.00%)  0 0/11 (0.00%)  0 0/18 (0.00%)  0 0/14 (0.00%)  0 0/13 (0.00%)  0 0/12 (0.00%)  0 0/16 (0.00%)  0 1/16 (6.25%)  1 0/14 (0.00%)  0
Gastrointestinal disorders                     
Gastrooesophageal reflux disease  1  0/15 (0.00%)  0 1/12 (8.33%)  1 0/11 (0.00%)  0 0/18 (0.00%)  0 0/14 (0.00%)  0 0/13 (0.00%)  0 0/12 (0.00%)  0 0/16 (0.00%)  0 0/16 (0.00%)  0 0/14 (0.00%)  0
Diarrhoea  1  0/15 (0.00%)  0 0/12 (0.00%)  0 0/11 (0.00%)  0 0/18 (0.00%)  0 0/14 (0.00%)  0 0/13 (0.00%)  0 0/12 (0.00%)  0 2/16 (12.50%)  3 1/16 (6.25%)  1 0/14 (0.00%)  0
Nausea  1  0/15 (0.00%)  0 0/12 (0.00%)  0 0/11 (0.00%)  0 0/18 (0.00%)  0 0/14 (0.00%)  0 0/13 (0.00%)  0 0/12 (0.00%)  0 2/16 (12.50%)  3 0/16 (0.00%)  0 0/14 (0.00%)  0
General disorders                     
Injection site swelling  1  1/15 (6.67%)  4 0/12 (0.00%)  0 0/11 (0.00%)  0 2/18 (11.11%)  3 0/14 (0.00%)  0 0/13 (0.00%)  0 0/12 (0.00%)  0 1/16 (6.25%)  1 1/16 (6.25%)  3 1/14 (7.14%)  1
Injection site erythema  1  1/15 (6.67%)  1 1/12 (8.33%)  2 0/11 (0.00%)  0 3/18 (16.67%)  8 0/14 (0.00%)  0 0/13 (0.00%)  0 0/12 (0.00%)  0 0/16 (0.00%)  0 1/16 (6.25%)  3 0/14 (0.00%)  0
Injection site pain  1  1/15 (6.67%)  2 0/12 (0.00%)  0 0/11 (0.00%)  0 2/18 (11.11%)  7 2/14 (14.29%)  5 0/13 (0.00%)  0 1/12 (8.33%)  1 1/16 (6.25%)  4 2/16 (12.50%)  4 1/14 (7.14%)  1
Injection site extravasation  1  1/15 (6.67%)  1 0/12 (0.00%)  0 0/11 (0.00%)  0 0/18 (0.00%)  0 0/14 (0.00%)  0 0/13 (0.00%)  0 0/12 (0.00%)  0 0/16 (0.00%)  0 0/16 (0.00%)  0 0/14 (0.00%)  0
Injection site hemorrhage  1  1/15 (6.67%)  1 0/12 (0.00%)  0 0/11 (0.00%)  0 0/18 (0.00%)  0 0/14 (0.00%)  0 1/13 (7.69%)  2 0/12 (0.00%)  0 1/16 (6.25%)  1 0/16 (0.00%)  0 0/14 (0.00%)  0
Injection site mass  1  0/15 (0.00%)  0 1/12 (8.33%)  1 0/11 (0.00%)  0 0/18 (0.00%)  0 0/14 (0.00%)  0 0/13 (0.00%)  0 0/12 (0.00%)  0 0/16 (0.00%)  0 0/16 (0.00%)  0 0/14 (0.00%)  0
Injection site pruritus  1  0/15 (0.00%)  0 0/12 (0.00%)  0 0/11 (0.00%)  0 2/18 (11.11%)  2 1/14 (7.14%)  2 0/13 (0.00%)  0 0/12 (0.00%)  0 0/16 (0.00%)  0 1/16 (6.25%)  2 0/14 (0.00%)  0
Injection site bruising  1  0/15 (0.00%)  0 0/12 (0.00%)  0 0/11 (0.00%)  0 0/18 (0.00%)  0 1/14 (7.14%)  1 0/13 (0.00%)  0 0/12 (0.00%)  0 0/16 (0.00%)  0 1/16 (6.25%)  2 1/14 (7.14%)  3
Injection site discoloration  1  0/15 (0.00%)  0 0/12 (0.00%)  0 0/11 (0.00%)  0 0/18 (0.00%)  0 0/14 (0.00%)  0 0/13 (0.00%)  0 0/12 (0.00%)  0 0/16 (0.00%)  0 1/16 (6.25%)  2 0/14 (0.00%)  0
Injection site reaction  1  0/15 (0.00%)  0 0/12 (0.00%)  0 0/11 (0.00%)  0 0/18 (0.00%)  0 0/14 (0.00%)  0 0/13 (0.00%)  0 0/12 (0.00%)  0 0/16 (0.00%)  0 1/16 (6.25%)  1 0/14 (0.00%)  0
Gait inability  1  0/15 (0.00%)  0 0/12 (0.00%)  0 0/11 (0.00%)  0 0/18 (0.00%)  0 0/14 (0.00%)  0 0/13 (0.00%)  0 1/12 (8.33%)  1 0/16 (0.00%)  0 0/16 (0.00%)  0 0/14 (0.00%)  0
Fatigue  1  0/15 (0.00%)  0 0/12 (0.00%)  0 0/11 (0.00%)  0 0/18 (0.00%)  0 0/14 (0.00%)  0 0/13 (0.00%)  0 0/12 (0.00%)  0 0/16 (0.00%)  0 0/16 (0.00%)  0 1/14 (7.14%)  1
Immune system disorders                     
Allergy to arthropod bite  1  0/15 (0.00%)  0 0/12 (0.00%)  0 0/11 (0.00%)  0 0/18 (0.00%)  0 1/14 (7.14%)  1 0/13 (0.00%)  0 0/12 (0.00%)  0 0/16 (0.00%)  0 0/16 (0.00%)  0 0/14 (0.00%)  0
Infections and infestations                     
Bronchitis viral  1  0/15 (0.00%)  0 1/12 (8.33%)  1 0/11 (0.00%)  0 0/18 (0.00%)  0 0/14 (0.00%)  0 0/13 (0.00%)  0 0/12 (0.00%)  0 0/16 (0.00%)  0 0/16 (0.00%)  0 0/14 (0.00%)  0
Bronchitis  1  0/15 (0.00%)  0 0/12 (0.00%)  0 0/11 (0.00%)  0 0/18 (0.00%)  0 1/14 (7.14%)  1 0/13 (0.00%)  0 0/12 (0.00%)  0 0/16 (0.00%)  0 0/16 (0.00%)  0 0/14 (0.00%)  0
Influenza  1  0/15 (0.00%)  0 1/12 (8.33%)  1 0/11 (0.00%)  0 1/18 (5.56%)  1 0/14 (0.00%)  0 1/13 (7.69%)  1 0/12 (0.00%)  0 0/16 (0.00%)  0 0/16 (0.00%)  0 0/14 (0.00%)  0
Respiratory tract infection viral  1  0/15 (0.00%)  0 0/12 (0.00%)  0 1/11 (9.09%)  1 0/18 (0.00%)  0 0/14 (0.00%)  0 0/13 (0.00%)  0 0/12 (0.00%)  0 0/16 (0.00%)  0 0/16 (0.00%)  0 0/14 (0.00%)  0
Tinea infection  1  1/15 (6.67%)  1 0/12 (0.00%)  0 0/11 (0.00%)  0 0/18 (0.00%)  0 0/14 (0.00%)  0 0/13 (0.00%)  0 0/12 (0.00%)  0 0/16 (0.00%)  0 0/16 (0.00%)  0 0/14 (0.00%)  0
Urinary tract infection  1  0/15 (0.00%)  0 1/12 (8.33%)  1 0/11 (0.00%)  0 0/18 (0.00%)  0 0/14 (0.00%)  0 0/13 (0.00%)  0 0/12 (0.00%)  0 0/16 (0.00%)  0 0/16 (0.00%)  0 0/14 (0.00%)  0
Herpes zoster  1  0/15 (0.00%)  0 0/12 (0.00%)  0 0/11 (0.00%)  0 0/18 (0.00%)  0 0/14 (0.00%)  0 0/13 (0.00%)  0 1/12 (8.33%)  1 0/16 (0.00%)  0 0/16 (0.00%)  0 0/14 (0.00%)  0
Oral candidiasis  1  0/15 (0.00%)  0 0/12 (0.00%)  0 0/11 (0.00%)  0 1/18 (5.56%)  1 0/14 (0.00%)  0 0/13 (0.00%)  0 0/12 (0.00%)  0 0/16 (0.00%)  0 0/16 (0.00%)  0 0/14 (0.00%)  0
Upper respiratory tract infection  1  0/15 (0.00%)  0 0/12 (0.00%)  0 0/11 (0.00%)  0 0/18 (0.00%)  0 0/14 (0.00%)  0 0/13 (0.00%)  0 0/12 (0.00%)  0 0/16 (0.00%)  0 0/16 (0.00%)  0 2/14 (14.29%)  2
Viral upper respiratory tract infection  1  0/15 (0.00%)  0 0/12 (0.00%)  0 0/11 (0.00%)  0 0/18 (0.00%)  0 0/14 (0.00%)  0 0/13 (0.00%)  0 0/12 (0.00%)  0 1/16 (6.25%)  1 1/16 (6.25%)  1 0/14 (0.00%)  0
Nasopharyngitis  1  0/15 (0.00%)  0 0/12 (0.00%)  0 0/11 (0.00%)  0 0/18 (0.00%)  0 0/14 (0.00%)  0 0/13 (0.00%)  0 0/12 (0.00%)  0 0/16 (0.00%)  0 0/16 (0.00%)  0 1/14 (7.14%)  1
Sinusitis  1  0/15 (0.00%)  0 0/12 (0.00%)  0 0/11 (0.00%)  0 0/18 (0.00%)  0 0/14 (0.00%)  0 0/13 (0.00%)  0 0/12 (0.00%)  0 0/16 (0.00%)  0 1/16 (6.25%)  1 0/14 (0.00%)  0
Tooth abscess  1  0/15 (0.00%)  0 0/12 (0.00%)  0 0/11 (0.00%)  0 0/18 (0.00%)  0 0/14 (0.00%)  0 0/13 (0.00%)  0 0/12 (0.00%)  0 0/16 (0.00%)  0 0/16 (0.00%)  0 1/14 (7.14%)  1
Injury, poisoning and procedural complications                     
Foot fracture  1  0/15 (0.00%)  0 0/12 (0.00%)  0 0/11 (0.00%)  0 0/18 (0.00%)  0 0/14 (0.00%)  0 1/13 (7.69%)  1 0/12 (0.00%)  0 0/16 (0.00%)  0 0/16 (0.00%)  0 0/14 (0.00%)  0
Investigations                     
Hepatic enzyme increased  1  0/15 (0.00%)  0 0/12 (0.00%)  0 0/11 (0.00%)  0 0/18 (0.00%)  0 0/14 (0.00%)  0 0/13 (0.00%)  0 0/12 (0.00%)  0 0/16 (0.00%)  0 0/16 (0.00%)  0 1/14 (7.14%)  1
Metabolism and nutrition disorders                     
Vitamin D deficiency  1  0/15 (0.00%)  0 0/12 (0.00%)  0 0/11 (0.00%)  0 0/18 (0.00%)  0 0/14 (0.00%)  0 0/13 (0.00%)  0 0/12 (0.00%)  0 0/16 (0.00%)  0 0/16 (0.00%)  0 1/14 (7.14%)  1
Nervous system disorders                     
Headache  1  0/15 (0.00%)  0 0/12 (0.00%)  0 0/11 (0.00%)  0 0/18 (0.00%)  0 2/14 (14.29%)  2 1/13 (7.69%)  1 1/12 (8.33%)  1 0/16 (0.00%)  0 0/16 (0.00%)  0 0/14 (0.00%)  0
Trigeminal neuralgia  1  0/15 (0.00%)  0 0/12 (0.00%)  0 0/11 (0.00%)  0 0/18 (0.00%)  0 0/14 (0.00%)  0 0/13 (0.00%)  0 0/12 (0.00%)  0 0/16 (0.00%)  0 0/16 (0.00%)  0 1/14 (7.14%)  1
Renal and urinary disorders                     
Hypertonic bladder  1  0/15 (0.00%)  0 1/12 (8.33%)  1 0/11 (0.00%)  0 0/18 (0.00%)  0 0/14 (0.00%)  0 0/13 (0.00%)  0 0/12 (0.00%)  0 0/16 (0.00%)  0 0/16 (0.00%)  0 0/14 (0.00%)  0
Respiratory, thoracic and mediastinal disorders                     
Cough  1  1/15 (6.67%)  1 0/12 (0.00%)  0 0/11 (0.00%)  0 0/18 (0.00%)  0 1/14 (7.14%)  1 0/13 (0.00%)  0 0/12 (0.00%)  0 0/16 (0.00%)  0 0/16 (0.00%)  0 0/14 (0.00%)  0
Rhinorrhoea  1  0/15 (0.00%)  0 0/12 (0.00%)  0 0/11 (0.00%)  0 0/18 (0.00%)  0 1/14 (7.14%)  1 0/13 (0.00%)  0 0/12 (0.00%)  0 0/16 (0.00%)  0 0/16 (0.00%)  0 0/14 (0.00%)  0
Dyspnoea  1  0/15 (0.00%)  0 0/12 (0.00%)  0 0/11 (0.00%)  0 0/18 (0.00%)  0 0/14 (0.00%)  0 0/13 (0.00%)  0 0/12 (0.00%)  0 1/16 (6.25%)  1 0/16 (0.00%)  0 0/14 (0.00%)  0
Skin and subcutaneous tissue disorders                     
Erythema  1  0/15 (0.00%)  0 0/12 (0.00%)  0 0/11 (0.00%)  0 1/18 (5.56%)  1 0/14 (0.00%)  0 0/13 (0.00%)  0 0/12 (0.00%)  0 0/16 (0.00%)  0 0/16 (0.00%)  0 0/14 (0.00%)  0
Pruritus  1  0/15 (0.00%)  0 0/12 (0.00%)  0 0/11 (0.00%)  0 0/18 (0.00%)  0 0/14 (0.00%)  0 1/13 (7.69%)  1 0/12 (0.00%)  0 0/16 (0.00%)  0 0/16 (0.00%)  0 0/14 (0.00%)  0
Rash  1  0/15 (0.00%)  0 0/12 (0.00%)  0 0/11 (0.00%)  0 0/18 (0.00%)  0 0/14 (0.00%)  0 1/13 (7.69%)  1 0/12 (0.00%)  0 0/16 (0.00%)  0 0/16 (0.00%)  0 1/14 (7.14%)  1
Vascular disorders                     
Hot flush  1  0/15 (0.00%)  0 1/12 (8.33%)  1 0/11 (0.00%)  0 0/18 (0.00%)  0 0/14 (0.00%)  0 0/13 (0.00%)  0 0/12 (0.00%)  0 0/16 (0.00%)  0 0/16 (0.00%)  0 0/14 (0.00%)  0
Hypertension  1  0/15 (0.00%)  0 0/12 (0.00%)  0 0/11 (0.00%)  0 0/18 (0.00%)  0 0/14 (0.00%)  0 0/13 (0.00%)  0 0/12 (0.00%)  0 0/16 (0.00%)  0 1/16 (6.25%)  1 0/14 (0.00%)  0
Hypotension  1  0/15 (0.00%)  0 0/12 (0.00%)  0 0/11 (0.00%)  0 0/18 (0.00%)  0 0/14 (0.00%)  0 0/13 (0.00%)  0 0/12 (0.00%)  0 0/16 (0.00%)  0 0/16 (0.00%)  0 1/14 (7.14%)  1
1
Term from vocabulary, MedDRA (18.1)
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 and restrictions on publishing 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 generally requires that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Trial Registration Coordinator
Organization: CSL Behring
Phone: 610 878-4000
EMail: clinicaltrials@cslbehring.com
Layout table for additonal information
Responsible Party: CSL Behring
ClinicalTrials.gov Identifier: NCT03033745    
Other Study ID Numbers: IgPro20_4004
2016-003799-33 ( EudraCT Number )
First Submitted: January 23, 2017
First Posted: January 27, 2017
Results First Submitted: December 4, 2019
Results First Posted: January 13, 2020
Last Update Posted: March 25, 2020