Safety and Tolerability of Higher Infusion Parameters of... | NCT03033745 | Trialant
NCT03033745
Sponsor
CSL Behring
Status
Completed
Last Update Posted
Mar 25, 2020Actual
Enrollment
49Actual
Phase
Phase 4
Conditions
Primary Immunodeficiency
Interventions
IgPro20
Countries
United States
Canada
Protocol Section
Identification Module
NCT ID
NCT03033745
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
IgPro20_4004
Secondary IDs
ID
Type
Description
Link
2016-003799-33
EudraCT Number
Brief Title
Safety and Tolerability of Higher Infusion Parameters of IgPro20 (Hizentra) in Subjects With Primary Immunodeficiency (PID)
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
Acronym
Not provided
Organization
CSL BehringINDUSTRY
Status Module
Record Verification Date
Mar 2020
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Feb 1, 2017Actual
Primary Completion Date
Dec 14, 2018Actual
Completion Date
Dec 14, 2018Actual
First Submitted Date
Jan 23, 2017
First Submission Date that Met QC Criteria
Jan 24, 2017
First Posted Date
Jan 27, 2017Estimated
Results Waived
Not provided
Results First Submitted Date
Dec 4, 2019
Results First Submitted that Met QC Criteria
Dec 30, 2019
Results First Posted Date
Jan 13, 2020Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Mar 16, 2020
Last Update Posted Date
Mar 25, 2020Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
CSL BehringINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
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.
Detailed Description
Not provided
Conditions Module
Conditions
Primary Immunodeficiency
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 4
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
49Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
IgPro20 (Pump-Assisted Volume Cohort)
Experimental
Weekly volumes per injection site of 25 mL up to 50 mL administered subcutaneously.
Drug: IgPro20
IgPro20 (Pump Assisted Flow Rate Cohort)
Experimental
Weekly flow rates per injection site of 25 mL/hour up to 100 mL/hour administered subcutaneously.
Drug: IgPro20
IgPro20 (Manual Push Flow Rate Cohort)
Experimental
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
Interventions
Name
Type
Description
Arm Group Labels
Other Names
IgPro20
Drug
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.
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage of Responders
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.
At the end of 4 weeks for each planned infusion parameter
Secondary Outcomes
Measure
Description
Time Frame
Rate of Treatment-emergent Adverse Events (TEAEs) Per Infusion
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.
At the end of 4 weeks for each planned infusion parameter
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
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.
Anderson JT, Bonagura VR, Cowan J, Hsu C, Mustafa SS, Patel NC, Routes JM, Sriaroon P, Vinh DC, Hofmann JH, Praus M, Rojavin MA. Safety and Tolerability of Subcutaneous IgPro20 at High Infusion Parameters in Patients with Primary Immunodeficiency: Findings from the Pump-Assisted Administration Cohorts of the HILO Study. J Clin Immunol. 2021 Feb;41(2):458-469. doi: 10.1007/s10875-020-00912-5. Epub 2021 Jan 6.
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.
FG001
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Dec 2, 2017
Dec 4, 2019
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Non-Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
IgPro20 (Manual Push Flow Rate Cohort)
IgPro20 (Pump Assisted Flow Rate Cohort)
IgPro20 (Pump-Assisted Volume Cohort)
Hizentra
Rate of Local TEAEs Per Infusion
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.
At the end of 4 weeks for each planned infusion parameter
Time to Onset of Local TEAEs
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.
At the end of 4 weeks for each planned infusion parameter
Intensity of Local TEAEs
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.
At the end of 4 weeks for each planned infusion parameter
Duration of Local TEAEs
Local Adverse Events: comprises all events reported within the MedDRA high level terms "administration site reactions NEC", "infusion site reactions", and "injection site reactions".
At the end of 4 weeks for each planned infusion parameter
Tolerability of Infusions
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.
At the end of 4 weeks for each planned infusion parameter
Litchfield Park
Arizona
85340
United States
University of Southern Florida
St. Petersburg
Florida
33701
United States
Georgia Pollens Clinical Research Centers
Albany
Georgia
31707
United States
Long Island Jewish Medical Center
Great Neck
New York
11021
United States
Icahn Medical Institute
New York
New York
10029
United States
Center for Clinical Research Rochester General Hospital
Rochester
New York
14607
United States
Levine Children's Hospital
Charlotte
North Carolina
28203
United States
Duke University School of Medicine
Durham
North Carolina
27705
United States
Medical College of Wisconsin
Milwaukee
Wisconsin
53226
United States
The Ottawa Hospital
Ottawa
Ontario
K1H 8L6
Canada
McGill University
Montreal
Quebec
H4A3J1
Canada
Derived
Cowan J, Bonagura VR, Lugar PL, Maglione PJ, Patel NC, Vinh DC, Hofmann JH, Praus M, Rojavin MA. Safety and Tolerability of Manual Push Administration of Subcutaneous IgPro20 at High Infusion Rates in Patients with Primary Immunodeficiency: Findings from the Manual Push Administration Cohort of the HILO Study. J Clin Immunol. 2021 Jan;41(1):66-75. doi: 10.1007/s10875-020-00876-6. Epub 2020 Oct 6.
IgPro20 (Pump Assisted Flow Rate Cohort)
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.
FG002
IgPro20 (Manual Push Flow Rate Cohort)
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.
FG00015 subjects
FG00118 subjects
FG00216 subjects
COMPLETED
FG00014 subjects
FG00117 subjects
FG00214 subjects
NOT COMPLETED
FG0001 subjects
FG0011 subjects
FG0022 subjects
Type
Comment
Reasons
Protocol Violation
FG0000 subjects
FG0010 subjects
FG0021 subjects
Adverse Event
FG0001 subjects
FG0010 subjects
FG0021 subjects
Withdrawal by Subject
FG0000 subjects
FG0011 subjects
FG0020 subjects
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
IgPro20 (Pump-Assisted Volume Cohort)
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.
BG001
IgPro20 (Pump Assisted Flow Rate Cohort)
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.
BG002
IgPro20 (Manual Push Flow Rate Cohort)
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.
BG003
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00015
BG00118
BG00216
BG00349
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Categorical
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
<=18 years
BG0000
BG00111
BG0021
BG003
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00049.1± 14.18
BG00126.7± 24.52
BG002
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0009
BG00110
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0011
BG002
Region of Enrollment
Number
participants
Title
Denominators
Categories
Canada
Title
Measurements
BG0003
BG0010
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Percentage of Responders
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.
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.
Posted
Number
percentage of responders
At the end of 4 weeks for each planned infusion parameter
ID
Title
Description
OG000
IgPro20 (Pump-Assisted Volume Cohort)
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.
OG001
IgPro20 (Pump Assisted Flow Rate Cohort)
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.
OG002
IgPro20 (Manual Push Flow Rate Cohort)
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.
Units
Counts
Participants
OG00015
OG00118
OG00216
Title
Denominators
Categories
25 ml
ParticipantsOG00015
ParticipantsOG0010
ParticipantsOG0020
Title
Measurements
Secondary
Rate of Treatment-emergent Adverse Events (TEAEs) Per Infusion
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.
SAS
Posted
Number
Number of TEAEs/infusion
At the end of 4 weeks for each planned infusion parameter
Infusions
Infusions
ID
Title
Description
OG000
IgPro20 (Pump-Assisted Volume Cohort)
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.
OG001
IgPro20 (Pump Assisted Flow Rate Cohort)
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.
OG002
IgPro20 (Manual Push Flow Rate Cohort)
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.
Secondary
Rate of Local TEAEs Per Infusion
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.
SAS
Posted
Number
Number of local TEAEs/infusion
At the end of 4 weeks for each planned infusion parameter
Infusions
Infusions
ID
Title
Description
OG000
IgPro20 (Pump-Assisted Volume Cohort)
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.
OG001
IgPro20 (Pump Assisted Flow Rate Cohort)
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.
OG002
IgPro20 (Manual Push Flow Rate Cohort)
Secondary
Time to Onset of Local TEAEs
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.
SAS
Posted
Mean
Standard Deviation
Days
At the end of 4 weeks for each planned infusion parameter
Local TEAEs
Local TEAEs
ID
Title
Description
OG000
IgPro20 (Pump-Assisted Volume Cohort)
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.
OG001
IgPro20 (Pump Assisted Flow Rate Cohort)
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.
OG002
IgPro20 (Manual Push Flow Rate Cohort)
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.
Secondary
Intensity of Local TEAEs
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.
SAS
Posted
Count of Participants
Participants
At the end of 4 weeks for each planned infusion parameter
ID
Title
Description
OG000
IgPro20 (Pump-Assisted Volume Cohort)
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.
OG001
IgPro20 (Pump Assisted Flow Rate Cohort)
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.
Secondary
Duration of Local TEAEs
Local Adverse Events: comprises all events reported within the MedDRA high level terms "administration site reactions NEC", "infusion site reactions", and "injection site reactions".
SAS
Posted
Mean
Standard Deviation
Days
At the end of 4 weeks for each planned infusion parameter
Local TEAEs
Local TEAEs
ID
Title
Description
OG000
IgPro20 (Pump-Assisted Volume Cohort)
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.
OG001
IgPro20 (Pump Assisted Flow Rate Cohort)
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.
OG002
IgPro20 (Manual Push Flow Rate Cohort)
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.
Secondary
Tolerability of Infusions
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.
SAS
Posted
Number
Ratio
At the end of 4 weeks for each planned infusion parameter
Infusions
Infusions
ID
Title
Description
OG000
IgPro20 (Pump-Assisted Volume Cohort)
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.
OG001
IgPro20 (Pump Assisted Flow Rate Cohort)
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.
OG002
IgPro20 (Manual Push Flow Rate Cohort)
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.
Time Frame
Up to 17 weeks per participant
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
IgPro20 (Pump-assisted Volume) 25 mL
Volumes per injection site of 25 mL administered subcutaneously.
0
15
0
15
4
15
EG001
IgPro20 (Pump-assisted Volume) 40 mL
Volumes per injection site of 40 mL administered subcutaneously.
0
12
0
12
4
12
EG002
IgPro20 (Pump-assisted Volume) 50 mL
Volumes per injection site of 50 mL administered subcutaneously.
0
11
0
11
1
11
EG003
IgPro20 (Pump-assisted Flow Rate) 25 mL/h
Flow rates per injection site of 25 mL/hour administered subcutaneously.
0
18
0
18
7
18
EG004
IgPro20 (Pump-assisted Flow Rate) 50 mL/h
Flow rates per injection site of 50 mL/hour administered subcutaneously.
0
14
0
14
4
14
EG005
IgPro20 (Pump-assisted Flow Rate) 75 mL/h
Flow rates per injection site of 75 mL/hour administered subcutaneously.
0
13
0
13
3
13
EG006
IgPro20 (Pump-assisted Flow Rate) 100 mL/h
Flow rates per injection site of 100 mL/hour administered subcutaneously.
0
12
0
12
3
12
EG007
IgPro20 (Manual Push Flow Rate) 30 mL/h
Flow rates per injection site of approximately 30 mL/hour administered subcutaneously.
0
16
0
16
5
16
EG008
IgPro20 (Manual Push Flow Rate) 60 mL/h
Flow rates per injection site of approximately 60 mL/hour administered subcutaneously.
0
16
1
16
8
16
EG009
IgPro20 (Manual Push Flow Rate) 120 mL/h
Flow rates per injection site of approximately 120 mL/hour administered subcutaneously.
0
14
0
14
7
14
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
suicide attempt
Psychiatric disorders
MedDRA (18.1)
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected18 at risk
EG0040 events0 affected14 at risk
EG0050 events0 affected13 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected16 at risk
EG0081 events1 affected16 at risk
EG0090 events0 affected14 at risk
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Hot flush
Vascular disorders
MedDRA (18.1)
Systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected11 at risk
EG0030 events0 affected18 at risk
EG0040 events0 affected14 at risk
EG0050 events0 affected13 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected16 at risk
EG0080 events0 affected16 at risk
EG0090 events0 affected14 at risk
Hypertension
Vascular disorders
MedDRA (18.1)
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected11 at risk
EG003
Hypotension
Vascular disorders
MedDRA (18.1)
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected11 at risk
EG003
Allergy to arthropod bite
Immune system disorders
MedDRA (18.1)
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected11 at risk
EG003
Injection site swelling
General disorders
MedDRA (18.1)
Systematic Assessment
EG0004 events1 affected15 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected11 at risk
EG003
Injection site erythema
General disorders
MedDRA (18.1)
Systematic Assessment
EG0001 events1 affected15 at risk
EG0012 events1 affected12 at risk
EG0020 events0 affected11 at risk
EG003
Injection site pain
General disorders
MedDRA (18.1)
Systematic Assessment
EG0002 events1 affected15 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected11 at risk
EG003
Injection site extravasation
General disorders
MedDRA (18.1)
Systematic Assessment
EG0001 events1 affected15 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected11 at risk
EG003
Injection site hemorrhage
General disorders
MedDRA (18.1)
Systematic Assessment
EG0001 events1 affected15 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected11 at risk
EG003
Injection site mass
General disorders
MedDRA (18.1)
Systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected11 at risk
EG003
Injection site pruritus
General disorders
MedDRA (18.1)
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected11 at risk
EG003
Injection site bruising
General disorders
MedDRA (18.1)
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected11 at risk
EG003
Injection site discoloration
General disorders
MedDRA (18.1)
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected11 at risk
EG003
Injection site reaction
General disorders
MedDRA (18.1)
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected11 at risk
EG003
Gait inability
General disorders
MedDRA (18.1)
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected11 at risk
EG003
Fatigue
General disorders
MedDRA (18.1)
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected11 at risk
EG003
Foot fracture
Injury, poisoning and procedural complications
MedDRA (18.1)
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected11 at risk
EG003
Hepatic enzyme increased
Investigations
MedDRA (18.1)
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected11 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA (18.1)
Systematic Assessment
EG0001 events1 affected15 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected11 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA (18.1)
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected11 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA (18.1)
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected11 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
MedDRA (18.1)
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected11 at risk
EG003
Headache
Nervous system disorders
MedDRA (18.1)
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected11 at risk
EG003
Trigeminal neuralgia
Nervous system disorders
MedDRA (18.1)
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected11 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA (18.1)
Systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected11 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA (18.1)
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected11 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA (18.1)
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected11 at risk
EG003
Hypertonic bladder
Renal and urinary disorders
MedDRA (18.1)
Systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected11 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA (18.1)
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected11 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA (18.1)
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected11 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA (18.1)
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected11 at risk
EG003
Adrenal insufficiency
Endocrine disorders
MedDRA (18.1)
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected11 at risk
EG003
Vitamin D deficiency
Metabolism and nutrition disorders
MedDRA (18.1)
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected11 at risk
EG003
Bronchitis viral
Infections and infestations
MedDRA (18.1)
Systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected11 at risk
EG003
Bronchitis
Infections and infestations
MedDRA (18.1)
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected11 at risk
EG003
Influenza
Infections and infestations
MedDRA (18.1)
Systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected11 at risk
EG003
Respiratory tract infection viral
Infections and infestations
MedDRA (18.1)
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected12 at risk
EG0021 events1 affected11 at risk
EG003
Tinea infection
Infections and infestations
MedDRA (18.1)
Systematic Assessment
EG0001 events1 affected15 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected11 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA (18.1)
Systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected11 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA (18.1)
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected11 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA (18.1)
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected11 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA (18.1)
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected11 at risk
EG003
Viral upper respiratory tract infection
Infections and infestations
MedDRA (18.1)
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected11 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA (18.1)
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected11 at risk
EG003
Sinusitis
Infections and infestations
MedDRA (18.1)
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected11 at risk
EG003
Tooth abscess
Infections and infestations
MedDRA (18.1)
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected11 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
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.
Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D007153
Immunologic Deficiency Syndromes
D007154
Immune System Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C558471
Hizentra
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
12
Between 18 and 65 years
BG00014
BG0015
BG00214
BG00333
>=65 years
BG0001
BG0012
BG0021
BG0034
47.9
± 13.28
BG00340.5± 20.97
10
BG00329
Male
BG0006
BG0018
BG0026
BG00320
0
BG0031
Asian
BG0000
BG0010
BG0020
BG0030
Native Hawaiian or Other Pacific Islander
BG0000
BG0010
BG0020
BG0030
Black or African American
BG0000
BG0011
BG0021
BG0032
White
BG00014
BG00116
BG00212
BG00342
More than one race
BG0001
BG0010
BG0022
BG0033
Unknown or Not Reported
BG0000
BG0010
BG0021
BG0031
6
BG0039
United States
Title
Measurements
BG00012
BG00118
BG00210
BG00340
OG00086.7
40 ml
ParticipantsOG00015
ParticipantsOG0010
ParticipantsOG0020
Title
Measurements
OG00073.3
50 ml
ParticipantsOG00015
ParticipantsOG0010
ParticipantsOG0020
Title
Measurements
OG00073.3
25 ml/h
ParticipantsOG0000
ParticipantsOG00118
ParticipantsOG0020
Title
Measurements
OG00177.8
50 ml/h
ParticipantsOG0000
ParticipantsOG00118
ParticipantsOG0020
Title
Measurements
OG00177.8
75 ml/h
ParticipantsOG0000
ParticipantsOG00118
ParticipantsOG0020
Title
Measurements
OG00166.7
100 ml/h
ParticipantsOG0000
ParticipantsOG00118
ParticipantsOG0020
Title
Measurements
OG00161.1
30 ml/h
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG00216
Title
Measurements
OG002100.0
60 ml/h
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG00216
Title
Measurements
OG002100.0
120 ml/h
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG00216
Title
Measurements
OG00287.5
Units
Counts
Participants
OG00015
OG00118
OG00216
Infusions
OG000152
OG001222
OG002626
Title
Denominators
Categories
25 ml
ParticipantsOG00015
ParticipantsOG0010
ParticipantsOG0020
InfusionsOG00060
InfusionsOG0010
InfusionsOG0020
Title
Measurements
OG0000.183
40 ml
ParticipantsOG00012
ParticipantsOG0010
ParticipantsOG0020
InfusionsOG000
50 ml
ParticipantsOG00011
ParticipantsOG0010
ParticipantsOG0020
InfusionsOG000
25 ml/h
ParticipantsOG0000
ParticipantsOG00118
ParticipantsOG0020
InfusionsOG000
50 ml/h
ParticipantsOG0000
ParticipantsOG00114
ParticipantsOG0020
InfusionsOG000
75 ml/h
ParticipantsOG0000
ParticipantsOG00113
ParticipantsOG0020
InfusionsOG000
100 ml/h
ParticipantsOG0000
ParticipantsOG00112
ParticipantsOG0020
InfusionsOG000
30 ml/h
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG00216
InfusionsOG000
60 ml/h
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG00216
InfusionsOG000
120 ml/h
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG00214
InfusionsOG000
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.
Units
Counts
Participants
OG00015
OG00118
OG00216
Infusions
OG000152
OG001222
OG002626
Title
Denominators
Categories
25 ml
ParticipantsOG00015
ParticipantsOG0010
ParticipantsOG0020
InfusionsOG00060
InfusionsOG0010
InfusionsOG0020
Title
Measurements
OG0000.150
40 ml
ParticipantsOG00012
ParticipantsOG0010
ParticipantsOG0020
InfusionsOG000
50 ml
ParticipantsOG00011
ParticipantsOG0010
ParticipantsOG0020
InfusionsOG000
25 ml/h
ParticipantsOG0000
ParticipantsOG00118
ParticipantsOG0020
InfusionsOG000
50 ml/h
ParticipantsOG0000
ParticipantsOG00114
ParticipantsOG0020
InfusionsOG000
75 ml/h
ParticipantsOG0000
ParticipantsOG00113
ParticipantsOG0020
InfusionsOG000
100 ml/h
ParticipantsOG0000
ParticipantsOG00112
ParticipantsOG0020
InfusionsOG000
30 ml/h
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG00216
InfusionsOG000
60 ml/h
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG00216
InfusionsOG000
120 ml/h
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG00214
InfusionsOG000
Units
Counts
Participants
OG00015
OG00118
OG00216
Local TEAEs
OG00012
OG00131
OG00228
Title
Denominators
Categories
25 ml
ParticipantsOG00015
ParticipantsOG0010
ParticipantsOG0020
Local TEAEsOG0009
Local TEAEsOG0010
Local TEAEsOG0020
Title
Measurements
OG0001.3± 2.45
40 ml
ParticipantsOG00012
ParticipantsOG0010
ParticipantsOG0020
Local TEAEsOG000
50 ml
ParticipantsOG00011
ParticipantsOG0010
ParticipantsOG0020
Local TEAEsOG000
25 ml/h
ParticipantsOG0000
ParticipantsOG00118
ParticipantsOG0020
Local TEAEsOG000
50 ml/h
ParticipantsOG0000
ParticipantsOG00114
ParticipantsOG0020
Local TEAEsOG000
75 ml/h
ParticipantsOG0000
ParticipantsOG00113
ParticipantsOG0020
Local TEAEsOG000
100 ml/h
ParticipantsOG0000
ParticipantsOG00112
ParticipantsOG0020
Local TEAEsOG000
30 ml/h
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG00216
Local TEAEsOG000
60 ml/h
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG00216
Local TEAEsOG000
120 ml/h
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG00214
Local TEAEsOG000
OG002
IgPro20 (Manual Push Flow Rate Cohort)
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.