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

Sponsor
CSL Behring (Industry)
Overall Status
Completed
CT.gov ID
NCT03033745
Collaborator
(none)
49
Enrollment
12
Locations
3
Arms
22.4
Actual Duration (Months)
4.1
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This multicenter, open-label, parallel-arm, non-randomized study is designed to evaluate safety and tolerability of higher infusion parameters of IgPro20 in subjects with primary immunodeficiency (PID). A total of 45 subjects (including at least 14 [30%] pediatric subjects ≤ 17 years of age and at least 9 [20%] obese subjects with body mass index [BMI] of ≥30 kg/m2) with confirmed PID will be evaluated in the study. The study will include three cohorts of 15 subjects each as follows: i) Pump-Assisted Volume Cohort (weekly infusions), volume per injection site of 25 mL up to 50 mL, ii) Pump Assisted Flow Rate Cohort (weekly infusions), flow rate per injection site of 25 mL/hour up to 100 mL/hour, iii) Manual Push Flow Rate Cohort (2 to 7 infusions per week), flow rate per injection site of 25 to 30 mL/hour up to 120 mL/hour (equivalent of approximately 0.5 mL/minute up to 2 mL/minute). Each cohort will test 3 infusion parameter levels (4 for the pump-assisted flow rate cohort), repeated at least 4 times over a duration of 12 weeks (16 weeks for the flow rate cohort). After 4 infusion weeks at each level, qualifying subjects (responders) will switch to the next infusion parameter level (eg, from 25 to 50 mL/h). During the study, the weekly dose will remain unchanged (as prescribed by treating physician, usually within 100-200 mg/kg per week range); only the respective infusion parameter under evaluation will change.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
49 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open-label Multicenter Study to Evaluate the Safety and Tolerability of Higher Infusion Parameters of Immune Globulin Subcutaneous (Human), 20% Liquid (Hizentra®) in Subjects With Primary Immunodeficiency
Actual Study Start Date :
Feb 1, 2017
Actual Primary Completion Date :
Dec 14, 2018
Actual Study Completion Date :
Dec 14, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: IgPro20 (Pump-Assisted Volume Cohort)

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

Drug: 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.
Other Names:
  • Hizentra

    		•
    Experimental: IgPro20 (Pump Assisted Flow Rate Cohort)

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

    Drug: 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.
    Other Names:
  • Hizentra

    		•
    Experimental: IgPro20 (Manual Push Flow Rate Cohort)

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

    Drug: 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.
    Other Names:
  • Hizentra

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of Responders [At the end of 4 weeks for each planned infusion parameter]

      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.

    Secondary Outcome Measures

    1. Rate of Treatment-emergent Adverse Events (TEAEs) Per Infusion [At the end of 4 weeks for each planned infusion parameter]

      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.

    2. Rate of Local TEAEs Per Infusion [At the end of 4 weeks for each planned infusion parameter]

      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.

    3. Time to Onset of Local TEAEs [At the end of 4 weeks for each planned infusion parameter]

      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.

    4. Intensity of Local TEAEs [At the end of 4 weeks for each planned infusion parameter]

      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.

    5. Duration of Local TEAEs [At the end of 4 weeks for each planned infusion parameter]

      Local Adverse Events: comprises all events reported within the MedDRA high level terms "administration site reactions NEC", "infusion site reactions", and "injection site reactions".

    6. Tolerability of Infusions [At the end of 4 weeks for each planned infusion parameter]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    2 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Male or female on stable dose of IgPro20 (Hizentra) therapy.

    • Women of childbearing potential must be using and agree to continue using medically approved contraception (which must be discussed with the study doctor) and must have a negative pregnancy test at screening.

    • Subjects with PID, eg, with a diagnosis of common variable immunodeficiency or X-linked agammaglobulinemia, as defined by the Pan American Group for Immune Deficiency and the European Society of Immune Deficiencies.

    • With infusion parameters as specified below:

    Pump-Assisted Flow Rate Cohort subjects only

    • Experience with pump-assisted infusions of IgPro20 at the tolerated flow rate of 25 mL/h per injection site for at least 1 month prior to Day 1.

    Pump-Assisted Volume Cohort subjects only

    • Total weekly IgPro20 dose of ≥ 50 mL (≥ 10 g).

    • Experience with pump-assisted infusions of IgPro20 at tolerated volumes of 25 mL/injection site for at least 1 month prior to Day 1.

    Manual Push Flow Rate Cohort subjects only

    • Experience with frequent (2-7 times per week) infusions of IgPro20 at the tolerated flow rate of approximately 0.5 mL/min (equivalent of 25-30 mL/h) per injection site for at least 1 month prior to Day 1. The dose (volume) per injection site should not exceed 25 mL.
    Exclusion Criteria:

    • Ongoing serious bacterial infections at the time of screening.

    • Other significant medical conditions that could increase the risk to the subject.

    • Females who are pregnant, breast feeding, or planning a pregnancy during the course study.

    • Participation in a study with an Investigational Medicinal Product (IMP) other than IgPro20 within three months prior to enrollment.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Clinical Research Center of Alabama Birmingham Alabama United States 35209
    2 Research Solutions of Arizona Litchfield Park Arizona United States 85340
    3 University of Southern Florida Saint Petersburg Florida United States 33701
    4 Georgia Pollens Clinical Research Centers Albany Georgia United States 31707
    5 Long Island Jewish Medical Center Great Neck New York United States 11021
    6 Icahn Medical Institute New York New York United States 10029
    7 Center for Clinical Research Rochester General Hospital Rochester New York United States 14607
    8 Levine Children's Hospital Charlotte North Carolina United States 28203
    9 Duke University School of Medicine Durham North Carolina United States 27705
    10 Medical College of Wisconsin Milwaukee Wisconsin United States 53226
    11 The Ottawa Hospital Ottawa Ontario Canada K1H 8L6
    12 McGill University Montréal Quebec Canada H4A3J1

    Sponsors and Collaborators

    • CSL Behring

    Investigators

    • Study Director: Study Physician, CSL Behring

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    CSL Behring
    ClinicalTrials.gov Identifier:
    NCT03033745
    Other Study ID Numbers:
    • IgPro20_4004
    • 2016-003799-33
    First Posted:
    Jan 27, 2017
    Last Update Posted:
    Mar 25, 2020
    Last Verified:
    Mar 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Primary Immunodeficiency Diseases
    Immunologic Deficiency Syndromes

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title IgPro20 (Pump-Assisted Volume Cohort) IgPro20 (Pump Assisted Flow Rate Cohort) IgPro20 (Manual Push Flow Rate Cohort)
    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

    Baseline Characteristics

    Arm/Group Title IgPro20 (Pump-Assisted Volume Cohort) IgPro20 (Pump Assisted Flow Rate Cohort) IgPro20 (Manual Push Flow Rate Cohort) Total
    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 Participants 15 18 16 49
    Age (Count of Participants)
    <=18 years
    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 (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    49.1
    (14.18)
    26.7
    (24.52)
    47.9
    (13.28)
    40.5
    (20.97)
    Sex: Female, Male (Count of Participants)
    Female
    9
    60%
    10
    55.6%
    10
    62.5%
    29
    59.2%
    Male
    6
    40%
    8
    44.4%
    6
    37.5%
    20
    40.8%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    1
    5.6%
    0
    0%
    1
    2%
    Asian
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Black or African American
    0
    0%
    1
    5.6%
    1
    6.3%
    2
    4.1%
    White
    14
    93.3%
    16
    88.9%
    12
    75%
    42
    85.7%
    More than one race
    1
    6.7%
    0
    0%
    2
    12.5%
    3
    6.1%
    Unknown or Not Reported
    0
    0%
    0
    0%
    1
    6.3%
    1
    2%
    Region of Enrollment (participants) [Number]
    Canada
    3
    20%
    0
    0%
    6
    37.5%
    9
    18.4%
    United States
    12
    80%
    18
    100%
    10
    62.5%
    40
    81.6%

    Outcome Measures

    1. Primary Outcome
    Title Percentage of Responders
    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

    Outcome Measure Data

    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)
    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.
    Measure Participants 15 18 16
    25 ml
    86.7
    40 ml
    73.3
    50 ml
    73.3
    25 ml/h
    77.8
    50 ml/h
    77.8
    75 ml/h
    66.7
    100 ml/h
    61.1
    30 ml/h
    100.0
    60 ml/h
    100.0
    120 ml/h
    87.5
    2. Secondary Outcome
    Title Rate of Treatment-emergent Adverse Events (TEAEs) Per Infusion
    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

    Outcome Measure Data

    Analysis Population Description
    SAS
    Arm/Group Title IgPro20 (Pump-Assisted Volume Cohort) IgPro20 (Pump Assisted Flow Rate Cohort) IgPro20 (Manual Push Flow Rate Cohort)
    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.
    Measure Participants 15 18 16
    Measure Infusions 152 222 626
    25 ml
    0.183
    40 ml
    0.188
    50 ml
    0.023
    25 ml/h
    0.329
    50 ml/h
    0.255
    75 ml/h
    0.140
    100 ml/h
    0.085
    30 ml/h
    0.064
    60 ml/h
    0.111
    120 ml/h
    0.081
    3. Secondary Outcome
    Title Rate of Local TEAEs Per Infusion
    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

    Outcome Measure Data

    Analysis Population Description
    SAS
    Arm/Group Title IgPro20 (Pump-Assisted Volume Cohort) IgPro20 (Pump Assisted Flow Rate Cohort) IgPro20 (Manual Push Flow Rate Cohort)
    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.
    Measure Participants 15 18 16
    Measure Infusions 152 222 626
    25 ml
    0.150
    40 ml
    0.063
    50 ml
    0.0
    25 ml/h
    0.286
    50 ml/h
    0.145
    75 ml/h
    0.040
    100 ml/h
    0.021
    30 ml/h
    0.027
    60 ml/h
    0.082
    120 ml/h
    0.025
    4. Secondary Outcome
    Title Time to Onset of Local TEAEs
    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

    Outcome Measure Data

    Analysis Population Description
    SAS
    Arm/Group Title IgPro20 (Pump-Assisted Volume Cohort) IgPro20 (Pump Assisted Flow Rate Cohort) IgPro20 (Manual Push Flow Rate Cohort)
    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.
    Measure Participants 15 18 16
    Measure Local TEAEs 12 31 28
    25 ml
    1.3
    (2.45)
    40 ml
    0
    (0.0)
    25 ml/h
    1.7
    (2.94)
    50 ml/h
    0.0
    (0.04)
    75 ml/h
    0
    (0.0)
    100 ml/h
    0
    (NA)
    30 ml/h
    0.2
    (0.41)
    60 ml/h
    0.3
    (0.59)
    120 ml/h
    0.2
    (0.45)
    5. Secondary Outcome
    Title Intensity of Local TEAEs
    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

    Outcome Measure Data

    Analysis Population Description
    SAS
    Arm/Group Title IgPro20 (Pump-Assisted Volume Cohort) IgPro20 (Pump Assisted Flow Rate Cohort) IgPro20 (Manual Push Flow Rate Cohort)
    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.
    Measure Participants 15 18 16
    25 ml (mild)
    3
    20%
    25 ml (moderate)
    0
    0%
    25 ml (severe)
    0
    0%
    40 ml (mild)
    1
    6.7%
    40 ml (moderate)
    0
    0%
    40 ml (severe)
    0
    0%
    50 ml (mild)
    0
    0%
    50 ml (moderate)
    0
    0%
    50 ml (severe)
    0
    0%
    25 ml/h (mild)
    4
    26.7%
    25 ml/h (moderate)
    2
    13.3%
    25 ml/h (severe)
    0
    0%
    50 ml/h (mild)
    3
    20%
    50 ml/h (moderate)
    0
    0%
    50 ml/h (severe)
    0
    0%
    75 ml/h (mild)
    1
    6.7%
    75 ml/h (moderate)
    0
    0%
    75 ml/h (severe)
    0
    0%
    100 ml/h (mild)
    0
    0%
    100 ml/h (moderate)
    0
    0%
    100 ml/h (severe)
    1
    6.7%
    30 ml/h (mild)
    3
    20%
    30 ml/h (moderate)
    0
    0%
    30 ml/h (severe)
    0
    0%
    60 ml/h (mild)
    4
    26.7%
    60 ml/h (moderate)
    0
    0%
    60 ml/h (severe)
    0
    0%
    120 ml/h (mild)
    2
    13.3%
    120 ml/h (moderate)
    0
    0%
    120 ml/h (severe)
    0
    0%
    6. Secondary Outcome
    Title Duration of Local TEAEs
    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

    Outcome Measure Data

    Analysis Population Description
    SAS
    Arm/Group Title IgPro20 (Pump-Assisted Volume Cohort) IgPro20 (Pump Assisted Flow Rate Cohort) IgPro20 (Manual Push Flow Rate Cohort)
    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.
    Measure Participants 15 18 16
    Measure Local TEAEs 12 31 28
    25 ml
    2.2
    (1.30)
    40 ml
    2.7
    (2.08)
    25 ml/h
    1.2
    (0.37)
    50 ml/h
    1.6
    (0.92)
    75 ml/h
    1.0
    (0.00)
    100 ml/h
    1.0
    (NA)
    30 ml/h
    2.2
    (2.86)
    60 ml/h
    5.6
    (12.91)
    120 ml/h
    3.0
    (2.12)
    7. Secondary Outcome
    Title Tolerability of Infusions
    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

    Outcome Measure Data

    Analysis Population Description
    SAS
    Arm/Group Title IgPro20 (Pump-Assisted Volume Cohort) IgPro20 (Pump Assisted Flow Rate Cohort) IgPro20 (Manual Push Flow Rate Cohort)
    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.
    Measure Participants 15 18 16
    Measure Infusions 152 222 626
    25 ml
    1.00
    40 ml
    1.00
    50 ml
    1.00
    25 ml/h
    1.00
    50 ml/h
    1.00
    75 ml/h
    1.00
    100 ml/h
    0.98
    30 ml/h
    1.00
    60 ml/h
    1.00
    120 ml/h
    1.00

    Adverse Events

    Time Frame Up to 17 weeks per participant
    Adverse Event Reporting Description
    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
    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 (%) # 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%) 0/12 (0%) 0/11 (0%) 0/18 (0%) 0/14 (0%) 0/13 (0%) 0/12 (0%) 0/16 (0%) 0/16 (0%) 0/14 (0%)
    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%) 0/12 (0%) 0/11 (0%) 0/18 (0%) 0/14 (0%) 0/13 (0%) 0/12 (0%) 0/16 (0%) 1/16 (6.3%) 0/14 (0%)
    Psychiatric disorders
    suicide attempt 0/15 (0%) 0 0/12 (0%) 0 0/11 (0%) 0 0/18 (0%) 0 0/14 (0%) 0 0/13 (0%) 0 0/12 (0%) 0 0/16 (0%) 0 1/16 (6.3%) 1 0/14 (0%) 0
    Other (Not Including 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 4/15 (26.7%) 4/12 (33.3%) 1/11 (9.1%) 7/18 (38.9%) 4/14 (28.6%) 3/13 (23.1%) 3/12 (25%) 5/16 (31.3%) 8/16 (50%) 7/14 (50%)
    Blood and lymphatic system disorders
    Leukopenia 0/15 (0%) 0 0/12 (0%) 0 0/11 (0%) 0 0/18 (0%) 0 0/14 (0%) 0 0/13 (0%) 0 0/12 (0%) 0 0/16 (0%) 0 0/16 (0%) 0 1/14 (7.1%) 1
    Endocrine disorders
    Adrenal insufficiency 0/15 (0%) 0 0/12 (0%) 0 0/11 (0%) 0 0/18 (0%) 0 0/14 (0%) 0 0/13 (0%) 0 0/12 (0%) 0 0/16 (0%) 0 1/16 (6.3%) 1 0/14 (0%) 0
    Gastrointestinal disorders
    Gastrooesophageal reflux disease 0/15 (0%) 0 1/12 (8.3%) 1 0/11 (0%) 0 0/18 (0%) 0 0/14 (0%) 0 0/13 (0%) 0 0/12 (0%) 0 0/16 (0%) 0 0/16 (0%) 0 0/14 (0%) 0
    Diarrhoea 0/15 (0%) 0 0/12 (0%) 0 0/11 (0%) 0 0/18 (0%) 0 0/14 (0%) 0 0/13 (0%) 0 0/12 (0%) 0 2/16 (12.5%) 3 1/16 (6.3%) 1 0/14 (0%) 0
    Nausea 0/15 (0%) 0 0/12 (0%) 0 0/11 (0%) 0 0/18 (0%) 0 0/14 (0%) 0 0/13 (0%) 0 0/12 (0%) 0 2/16 (12.5%) 3 0/16 (0%) 0 0/14 (0%) 0
    General disorders
    Injection site swelling 1/15 (6.7%) 4 0/12 (0%) 0 0/11 (0%) 0 2/18 (11.1%) 3 0/14 (0%) 0 0/13 (0%) 0 0/12 (0%) 0 1/16 (6.3%) 1 1/16 (6.3%) 3 1/14 (7.1%) 1
    Injection site erythema 1/15 (6.7%) 1 1/12 (8.3%) 2 0/11 (0%) 0 3/18 (16.7%) 8 0/14 (0%) 0 0/13 (0%) 0 0/12 (0%) 0 0/16 (0%) 0 1/16 (6.3%) 3 0/14 (0%) 0
    Injection site pain 1/15 (6.7%) 2 0/12 (0%) 0 0/11 (0%) 0 2/18 (11.1%) 7 2/14 (14.3%) 5 0/13 (0%) 0 1/12 (8.3%) 1 1/16 (6.3%) 4 2/16 (12.5%) 4 1/14 (7.1%) 1
    Injection site extravasation 1/15 (6.7%) 1 0/12 (0%) 0 0/11 (0%) 0 0/18 (0%) 0 0/14 (0%) 0 0/13 (0%) 0 0/12 (0%) 0 0/16 (0%) 0 0/16 (0%) 0 0/14 (0%) 0
    Injection site hemorrhage 1/15 (6.7%) 1 0/12 (0%) 0 0/11 (0%) 0 0/18 (0%) 0 0/14 (0%) 0 1/13 (7.7%) 2 0/12 (0%) 0 1/16 (6.3%) 1 0/16 (0%) 0 0/14 (0%) 0
    Injection site mass 0/15 (0%) 0 1/12 (8.3%) 1 0/11 (0%) 0 0/18 (0%) 0 0/14 (0%) 0 0/13 (0%) 0 0/12 (0%) 0 0/16 (0%) 0 0/16 (0%) 0 0/14 (0%) 0
    Injection site pruritus 0/15 (0%) 0 0/12 (0%) 0 0/11 (0%) 0 2/18 (11.1%) 2 1/14 (7.1%) 2 0/13 (0%) 0 0/12 (0%) 0 0/16 (0%) 0 1/16 (6.3%) 2 0/14 (0%) 0
    Injection site bruising 0/15 (0%) 0 0/12 (0%) 0 0/11 (0%) 0 0/18 (0%) 0 1/14 (7.1%) 1 0/13 (0%) 0 0/12 (0%) 0 0/16 (0%) 0 1/16 (6.3%) 2 1/14 (7.1%) 3
    Injection site discoloration 0/15 (0%) 0 0/12 (0%) 0 0/11 (0%) 0 0/18 (0%) 0 0/14 (0%) 0 0/13 (0%) 0 0/12 (0%) 0 0/16 (0%) 0 1/16 (6.3%) 2 0/14 (0%) 0
    Injection site reaction 0/15 (0%) 0 0/12 (0%) 0 0/11 (0%) 0 0/18 (0%) 0 0/14 (0%) 0 0/13 (0%) 0 0/12 (0%) 0 0/16 (0%) 0 1/16 (6.3%) 1 0/14 (0%) 0
    Gait inability 0/15 (0%) 0 0/12 (0%) 0 0/11 (0%) 0 0/18 (0%) 0 0/14 (0%) 0 0/13 (0%) 0 1/12 (8.3%) 1 0/16 (0%) 0 0/16 (0%) 0 0/14 (0%) 0
    Fatigue 0/15 (0%) 0 0/12 (0%) 0 0/11 (0%) 0 0/18 (0%) 0 0/14 (0%) 0 0/13 (0%) 0 0/12 (0%) 0 0/16 (0%) 0 0/16 (0%) 0 1/14 (7.1%) 1
    Immune system disorders
    Allergy to arthropod bite 0/15 (0%) 0 0/12 (0%) 0 0/11 (0%) 0 0/18 (0%) 0 1/14 (7.1%) 1 0/13 (0%) 0 0/12 (0%) 0 0/16 (0%) 0 0/16 (0%) 0 0/14 (0%) 0
    Infections and infestations
    Bronchitis viral 0/15 (0%) 0 1/12 (8.3%) 1 0/11 (0%) 0 0/18 (0%) 0 0/14 (0%) 0 0/13 (0%) 0 0/12 (0%) 0 0/16 (0%) 0 0/16 (0%) 0 0/14 (0%) 0
    Bronchitis 0/15 (0%) 0 0/12 (0%) 0 0/11 (0%) 0 0/18 (0%) 0 1/14 (7.1%) 1 0/13 (0%) 0 0/12 (0%) 0 0/16 (0%) 0 0/16 (0%) 0 0/14 (0%) 0
    Influenza 0/15 (0%) 0 1/12 (8.3%) 1 0/11 (0%) 0 1/18 (5.6%) 1 0/14 (0%) 0 1/13 (7.7%) 1 0/12 (0%) 0 0/16 (0%) 0 0/16 (0%) 0 0/14 (0%) 0
    Respiratory tract infection viral 0/15 (0%) 0 0/12 (0%) 0 1/11 (9.1%) 1 0/18 (0%) 0 0/14 (0%) 0 0/13 (0%) 0 0/12 (0%) 0 0/16 (0%) 0 0/16 (0%) 0 0/14 (0%) 0
    Tinea infection 1/15 (6.7%) 1 0/12 (0%) 0 0/11 (0%) 0 0/18 (0%) 0 0/14 (0%) 0 0/13 (0%) 0 0/12 (0%) 0 0/16 (0%) 0 0/16 (0%) 0 0/14 (0%) 0
    Urinary tract infection 0/15 (0%) 0 1/12 (8.3%) 1 0/11 (0%) 0 0/18 (0%) 0 0/14 (0%) 0 0/13 (0%) 0 0/12 (0%) 0 0/16 (0%) 0 0/16 (0%) 0 0/14 (0%) 0
    Herpes zoster 0/15 (0%) 0 0/12 (0%) 0 0/11 (0%) 0 0/18 (0%) 0 0/14 (0%) 0 0/13 (0%) 0 1/12 (8.3%) 1 0/16 (0%) 0 0/16 (0%) 0 0/14 (0%) 0
    Oral candidiasis 0/15 (0%) 0 0/12 (0%) 0 0/11 (0%) 0 1/18 (5.6%) 1 0/14 (0%) 0 0/13 (0%) 0 0/12 (0%) 0 0/16 (0%) 0 0/16 (0%) 0 0/14 (0%) 0
    Upper respiratory tract infection 0/15 (0%) 0 0/12 (0%) 0 0/11 (0%) 0 0/18 (0%) 0 0/14 (0%) 0 0/13 (0%) 0 0/12 (0%) 0 0/16 (0%) 0 0/16 (0%) 0 2/14 (14.3%) 2
    Viral upper respiratory tract infection 0/15 (0%) 0 0/12 (0%) 0 0/11 (0%) 0 0/18 (0%) 0 0/14 (0%) 0 0/13 (0%) 0 0/12 (0%) 0 1/16 (6.3%) 1 1/16 (6.3%) 1 0/14 (0%) 0
    Nasopharyngitis 0/15 (0%) 0 0/12 (0%) 0 0/11 (0%) 0 0/18 (0%) 0 0/14 (0%) 0 0/13 (0%) 0 0/12 (0%) 0 0/16 (0%) 0 0/16 (0%) 0 1/14 (7.1%) 1
    Sinusitis 0/15 (0%) 0 0/12 (0%) 0 0/11 (0%) 0 0/18 (0%) 0 0/14 (0%) 0 0/13 (0%) 0 0/12 (0%) 0 0/16 (0%) 0 1/16 (6.3%) 1 0/14 (0%) 0
    Tooth abscess 0/15 (0%) 0 0/12 (0%) 0 0/11 (0%) 0 0/18 (0%) 0 0/14 (0%) 0 0/13 (0%) 0 0/12 (0%) 0 0/16 (0%) 0 0/16 (0%) 0 1/14 (7.1%) 1
    Injury, poisoning and procedural complications
    Foot fracture 0/15 (0%) 0 0/12 (0%) 0 0/11 (0%) 0 0/18 (0%) 0 0/14 (0%) 0 1/13 (7.7%) 1 0/12 (0%) 0 0/16 (0%) 0 0/16 (0%) 0 0/14 (0%) 0
    Investigations
    Hepatic enzyme increased 0/15 (0%) 0 0/12 (0%) 0 0/11 (0%) 0 0/18 (0%) 0 0/14 (0%) 0 0/13 (0%) 0 0/12 (0%) 0 0/16 (0%) 0 0/16 (0%) 0 1/14 (7.1%) 1
    Metabolism and nutrition disorders
    Vitamin D deficiency 0/15 (0%) 0 0/12 (0%) 0 0/11 (0%) 0 0/18 (0%) 0 0/14 (0%) 0 0/13 (0%) 0 0/12 (0%) 0 0/16 (0%) 0 0/16 (0%) 0 1/14 (7.1%) 1
    Nervous system disorders
    Headache 0/15 (0%) 0 0/12 (0%) 0 0/11 (0%) 0 0/18 (0%) 0 2/14 (14.3%) 2 1/13 (7.7%) 1 1/12 (8.3%) 1 0/16 (0%) 0 0/16 (0%) 0 0/14 (0%) 0
    Trigeminal neuralgia 0/15 (0%) 0 0/12 (0%) 0 0/11 (0%) 0 0/18 (0%) 0 0/14 (0%) 0 0/13 (0%) 0 0/12 (0%) 0 0/16 (0%) 0 0/16 (0%) 0 1/14 (7.1%) 1
    Renal and urinary disorders
    Hypertonic bladder 0/15 (0%) 0 1/12 (8.3%) 1 0/11 (0%) 0 0/18 (0%) 0 0/14 (0%) 0 0/13 (0%) 0 0/12 (0%) 0 0/16 (0%) 0 0/16 (0%) 0 0/14 (0%) 0
    Respiratory, thoracic and mediastinal disorders
    Cough 1/15 (6.7%) 1 0/12 (0%) 0 0/11 (0%) 0 0/18 (0%) 0 1/14 (7.1%) 1 0/13 (0%) 0 0/12 (0%) 0 0/16 (0%) 0 0/16 (0%) 0 0/14 (0%) 0
    Rhinorrhoea 0/15 (0%) 0 0/12 (0%) 0 0/11 (0%) 0 0/18 (0%) 0 1/14 (7.1%) 1 0/13 (0%) 0 0/12 (0%) 0 0/16 (0%) 0 0/16 (0%) 0 0/14 (0%) 0
    Dyspnoea 0/15 (0%) 0 0/12 (0%) 0 0/11 (0%) 0 0/18 (0%) 0 0/14 (0%) 0 0/13 (0%) 0 0/12 (0%) 0 1/16 (6.3%) 1 0/16 (0%) 0 0/14 (0%) 0
    Skin and subcutaneous tissue disorders
    Erythema 0/15 (0%) 0 0/12 (0%) 0 0/11 (0%) 0 1/18 (5.6%) 1 0/14 (0%) 0 0/13 (0%) 0 0/12 (0%) 0 0/16 (0%) 0 0/16 (0%) 0 0/14 (0%) 0
    Pruritus 0/15 (0%) 0 0/12 (0%) 0 0/11 (0%) 0 0/18 (0%) 0 0/14 (0%) 0 1/13 (7.7%) 1 0/12 (0%) 0 0/16 (0%) 0 0/16 (0%) 0 0/14 (0%) 0
    Rash 0/15 (0%) 0 0/12 (0%) 0 0/11 (0%) 0 0/18 (0%) 0 0/14 (0%) 0 1/13 (7.7%) 1 0/12 (0%) 0 0/16 (0%) 0 0/16 (0%) 0 1/14 (7.1%) 1
    Vascular disorders
    Hot flush 0/15 (0%) 0 1/12 (8.3%) 1 0/11 (0%) 0 0/18 (0%) 0 0/14 (0%) 0 0/13 (0%) 0 0/12 (0%) 0 0/16 (0%) 0 0/16 (0%) 0 0/14 (0%) 0
    Hypertension 0/15 (0%) 0 0/12 (0%) 0 0/11 (0%) 0 0/18 (0%) 0 0/14 (0%) 0 0/13 (0%) 0 0/12 (0%) 0 0/16 (0%) 0 1/16 (6.3%) 1 0/14 (0%) 0
    Hypotension 0/15 (0%) 0 0/12 (0%) 0 0/11 (0%) 0 0/18 (0%) 0 0/14 (0%) 0 0/13 (0%) 0 0/12 (0%) 0 0/16 (0%) 0 0/16 (0%) 0 1/14 (7.1%) 1

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    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

    Name/Title Trial Registration Coordinator
    Organization CSL Behring
    Phone 610 878-4000
    Email clinicaltrials@cslbehring.com
    Responsible Party:
    CSL Behring
    ClinicalTrials.gov Identifier:
    NCT03033745
    Other Study ID Numbers:
    • IgPro20_4004
    • 2016-003799-33
    First Posted:
    Jan 27, 2017
    Last Update Posted:
    Mar 25, 2020
    Last Verified:
    Mar 1, 2020