Study of Immune Globulin Intravenous (Human) GC5101F in Subjects With Primary Humoral Immunodeficiency
Primary Purpose
Primary Immune Deficiency Disorder
Status
Withdrawn
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Immunoglobulin
Sponsored by
About this trial
This is an interventional treatment trial for Primary Immune Deficiency Disorder
Eligibility Criteria
Inclusion Criteria:
- Pediatric subjects with a confirmed clinical diagnosis of a Primary Humoral Immunodeficiency Disease as defined by IUIS (International Union of Immunological Societies) and require treatment with IGIV. Documented agammaglobulinemia or hypogammaglobulinemia
- Subject is willing to comply with all requirements of protocol
- Authorization to access personal health information
Exclusion Criteria:
- Subject has secondary immunodeficiency
- Subject has a history of repeated reactions or hypersensitivity to IGIV or other injectable forms of IgG
- Subject has significant protein loss from enteropathy, nephrotic syndrome or lymphangiectasia
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
IGIV-SN
Arm Description
Immunoglobulin, Supplied in 5g (100mL) and/or 10g (200mL)
Outcomes
Primary Outcome Measures
Efficacy: Incidence of Acute SBIs (Serious Bacterial Infections)
The incidence of acute serious bacterial infections, i.e. bacterial pneumonia, bacteremia/sepsis, bacterial meningitis, osteomyelitis/ septic arthritis, visceral abscess
Safety: Overall Incidence of AEs that occur during 72 hours of following an infusion of test drug
The overall incidence of adverse events (AEs) that occur during or within 1 hours, 24 hours, and 72 hours following an infusion of test product, regardless of whether or not the AE is determined to be product related
Secondary Outcome Measures
Efficacy: Incidence of Infections other than acute serious bacterial infections
Safety: The frequency of all AEs that occuring during the study
(regardless of the casual relationship)
Full Information
NCT ID
NCT03492710
First Posted
February 19, 2018
Last Updated
July 1, 2020
Sponsor
Green Cross Corporation
1. Study Identification
Unique Protocol Identification Number
NCT03492710
Brief Title
Study of Immune Globulin Intravenous (Human) GC5101F in Subjects With Primary Humoral Immunodeficiency
Official Title
Phase III Study of Immune Globulin Intravenous (Human) IGIV-SN in Pediatric Subjects With Primary Humoral Immunodeficiency
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Withdrawn
Why Stopped
A change in sponsor's developmental strategy
Study Start Date
April 30, 2019 (Actual)
Primary Completion Date
April 30, 2019 (Actual)
Study Completion Date
April 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Green Cross Corporation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
To assess the safety, efficacy, and pharmacokinetics of IGIV-SN in pediatric subjects with primary immunodeficiency humoral diseases (PHID)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Immune Deficiency Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Model Description
Open-Label, Single-Arm, Historically Controlled, Prospective, Multicenter
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IGIV-SN
Arm Type
Experimental
Arm Description
Immunoglobulin, Supplied in 5g (100mL) and/or 10g (200mL)
Intervention Type
Biological
Intervention Name(s)
Immunoglobulin
Other Intervention Name(s)
IGIV-SN
Intervention Description
Administer volume of IGIV-SN to maintain a trough level of of 5g/L or more
Primary Outcome Measure Information:
Title
Efficacy: Incidence of Acute SBIs (Serious Bacterial Infections)
Description
The incidence of acute serious bacterial infections, i.e. bacterial pneumonia, bacteremia/sepsis, bacterial meningitis, osteomyelitis/ septic arthritis, visceral abscess
Time Frame
13 months (12 months of treatment + 1 month of Follow-Up)
Title
Safety: Overall Incidence of AEs that occur during 72 hours of following an infusion of test drug
Description
The overall incidence of adverse events (AEs) that occur during or within 1 hours, 24 hours, and 72 hours following an infusion of test product, regardless of whether or not the AE is determined to be product related
Time Frame
13 months (12 months of treatment + 1 month of Follow-Up)
Secondary Outcome Measure Information:
Title
Efficacy: Incidence of Infections other than acute serious bacterial infections
Time Frame
13 months (12 months of treatment + 1 month of Follow-Up)
Title
Safety: The frequency of all AEs that occuring during the study
Description
(regardless of the casual relationship)
Time Frame
13 months (12 months of treatment + 1 month of Follow-Up)
Other Pre-specified Outcome Measures:
Title
PK Endpoint (1)
Description
Plasma Concentration-Time Curve (PK Parameters of Total IgG)
Time Frame
13 months (12 months of treatment + 1 month of Follow-Up)
Title
PK Endpoint (2)
Description
Area Under the Curve (PK Parameters of Total IgG)
Time Frame
13 months (12 months of treatment + 1 month of Follow-Up)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
24 Months
Maximum Age & Unit of Time
203 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Pediatric subjects with a confirmed clinical diagnosis of a Primary Humoral Immunodeficiency Disease as defined by IUIS (International Union of Immunological Societies) and require treatment with IGIV. Documented agammaglobulinemia or hypogammaglobulinemia
Subject is willing to comply with all requirements of protocol
Authorization to access personal health information
Exclusion Criteria:
Subject has secondary immunodeficiency
Subject has a history of repeated reactions or hypersensitivity to IGIV or other injectable forms of IgG
Subject has significant protein loss from enteropathy, nephrotic syndrome or lymphangiectasia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chaim Roifman
Organizational Affiliation
The Hospital for Sick Children
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Study of Immune Globulin Intravenous (Human) GC5101F in Subjects With Primary Humoral Immunodeficiency
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