Back to resultsStudy of Immune Globulin Intravenous (Human) GC5107 in Pediatric Subjects With Primary Humoral Immunodeficiency
Primary Purpose
Primary Immune Deficiency
Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
GC5107
Sponsored by
About this trial
This is an interventional treatment trial for Primary Immune Deficiency
Eligibility Criteria
Inclusion Criteria:
- Subject must be ≥ 2 to < 17 years of age, at the time of signing the informed consent
- Pediatric subject has a confirmed and documented clinical diagnosis of Primary Humoral Immunodeficiency, including hypogammaglobulinemia or agammaglobulinemia
- Subject who has received 300 - 900 mg/kg of IGIV therapy at 21 or 28 day intervals for at least 3 months prior to this study
- Subject who has at least 2 documented plasma IgG trough level of ≥ 500 mg/dL at two infusion cycles (21 or 28 days) within 12 months prior to enrollment
- Subject who is willing to comply with all requirements of the protocol
Exclusion Criteria:
- Subject who has a history of clinically significant reactions or hypersensitivity to IGIV or other injectable forms of IgG
- Subject who has IgA deficiency and is known to have antibodies to IgA
- Subject who has secondary immunodeficiency
- Subject who has participated in another clinical study (other than an IGIV study) within 3 weeks prior to screening
- Subject who has been diagnosed with dysgammaglobulinemia or isolated IgG subclass deficiency or isolated IgA deficiency, or who has clinically significant impairment of cellular or innate immunity at the discretion of the Investigator
- Subject who has received blood products other than human albumin or human immune globulin within 6 months prior to enrollment
Sites / Locations
- Oklahoma Institute of Allergy & Asthma Clinical Research, LLC
- Allergy Partners of North Texas ResearchRecruiting
- Lysosomal and Rare Disorders Research and Treatment Center, Inc.Recruiting
- Children's Hospital of Richmond at VCURecruiting
- University of Wisconsin
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
GC5107
Arm Description
Immune Globulin Intravenous (Human), 10% Liquid
Outcomes
Primary Outcome Measures
The Pharmacokinetic (PK) Plasma concentration-time curve of total IgG
The Pharmacokinetic (PK) Half-life of total IgG
The Pharmacokinetic (PK) Area under the curve of total IgG
The Pharmacokinetic (PK) Volume of distribution of total IgG
The Pharmacokinetic (PK) Maximum concentration of total IgG
The Pharmacokinetic (PK) Minimum concentration of total IgG
The Pharmacokinetic (PK) Time of maximum concentration of total IgG
The Pharmacokinetic (PK) Clearance of total IgG
Trough serum total IgG levels before each infusion of GC5107 in all subjects and the interval between infusions
The proportion of infusions with temporally associated adverse events (AEs) that occur during or within 1 hour, 24 hours, and 72 hours following an infusion of investigational product
AEs that occur during or within 1 hour, 24 hours, and 72 hours following each infusion during 12 months of the study period
Secondary Outcome Measures
The Pharmacokinetic (PK) Maximum concentration of IgG subclasses
The Pharmacokinetic (PK) Minimum concentration of IgG subclasses
The Pharmacokinetic (PK) Half-life of IgG subclasses
Trough serum level of IgG subclasses and specific IgG antibodies before Infusion 1 and 13 (for subjects on 28-day infusion schedule) or Infusion 1 and 17 (for subjects on 21-day infusion schedule)
Number and proportion of subjects who failed to meet the target IgG trough level (500 mg/dL) at any time point equal to or subsequent to 5th infusion (estimated 5 half-lives)
The overall incidence of all AEs that occur during or within 1 hour, 24 hours, and 72 hours following an infusion of investigational product
AEs that occur during or within 1 hour, 24 hours, and 72 hours following each infusion during 12 months of the study period
The frequency of all AEs that occur during the study regardless of the investigator's assessment of their relationship to investigational product
The frequency of suspected adverse reactions as defined by all AEs either classified as at least possibly related to GC5107
The number and proportion of GC5107 infusions for which the infusion rate was decreased due to AEs
The proportion of AEs considered by the investigator to be investigational product related
Viral safety (freedom from transmission of blood-borne viral diseases): the human immunodeficiency virus (HIV) type 1 & 2, hepatitis A virus (HAV), hepatitis B virus (HBV), hepatitis C virus (HCV), and parvovirus B19
Full Information
NCT ID
NCT04565015
First Posted
September 7, 2020
Last Updated
May 15, 2023
Sponsor
Green Cross Corporation
Collaborators
Atlantic Research Group
1. Study Identification
Unique Protocol Identification Number
NCT04565015
Brief Title
Study of Immune Globulin Intravenous (Human) GC5107 in Pediatric Subjects With Primary Humoral Immunodeficiency
Official Title
An Open-Label, Single-Arm, Historically Controlled, Prospective, Multi-Center Phase III Study to Evaluate the Pharmacokinetics and Safety of Immune Globulin Intravenous (Human) GC5107 in Pediatric Subjects With Primary Humoral Immunodeficiency
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 21, 2020 (Actual)
Primary Completion Date
May 2023 (Anticipated)
Study Completion Date
November 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Green Cross Corporation
Collaborators
Atlantic Research Group
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to evaluate the pharmacokinetics and safety of Immune Globulin Intravenous (Human) GC5107 in pediatric subjects with Primary Humoral Immunodeficiency (PHID).
Detailed Description
This is a prospective, open-label, single-arm, historically controlled, multi-center Phase III study to assess the pharmacokinetics and safety of Immune Globulin Intravenous (Human) GC5107 in pediatric subjects aged ≥ 2 years and < 17 years with PHID.
Subjects will receive intravenous infusions of the investigational product at the same dose and interval as used for their previous Immunoglobulin intravenous (IGIV) maintenance therapy. GC5107 will be infused every 21 or 28 days for a period of 12 months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Immune Deficiency
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
GC5107
Arm Type
Experimental
Arm Description
Immune Globulin Intravenous (Human), 10% Liquid
Intervention Type
Biological
Intervention Name(s)
GC5107
Other Intervention Name(s)
GCC 10% IGIV, Immune Globulin Intravenous (Human), 10% Liquid
Intervention Description
Intravenously infused at a dose of 300 - 900 mg per kg (of body weight) every 21 or 28 days for 12 months
Primary Outcome Measure Information:
Title
The Pharmacokinetic (PK) Plasma concentration-time curve of total IgG
Time Frame
before and after 5th infusion (12 or 16 weeks)
Title
The Pharmacokinetic (PK) Half-life of total IgG
Time Frame
before and after 5th infusion (12 or 16 weeks)
Title
The Pharmacokinetic (PK) Area under the curve of total IgG
Time Frame
before and after 5th infusion (12 or 16 weeks)
Title
The Pharmacokinetic (PK) Volume of distribution of total IgG
Time Frame
before and after 5th infusion (12 or 16 weeks)
Title
The Pharmacokinetic (PK) Maximum concentration of total IgG
Time Frame
before and after 5th infusion (12 or 16 weeks)
Title
The Pharmacokinetic (PK) Minimum concentration of total IgG
Time Frame
before and after 5th infusion (12 or 16 weeks)
Title
The Pharmacokinetic (PK) Time of maximum concentration of total IgG
Time Frame
before and after 5th infusion (12 or 16 weeks)
Title
The Pharmacokinetic (PK) Clearance of total IgG
Time Frame
before and after 5th infusion (12 or 16 weeks)
Title
Trough serum total IgG levels before each infusion of GC5107 in all subjects and the interval between infusions
Time Frame
12 months
Title
The proportion of infusions with temporally associated adverse events (AEs) that occur during or within 1 hour, 24 hours, and 72 hours following an infusion of investigational product
Description
AEs that occur during or within 1 hour, 24 hours, and 72 hours following each infusion during 12 months of the study period
Time Frame
12 months
Secondary Outcome Measure Information:
Title
The Pharmacokinetic (PK) Maximum concentration of IgG subclasses
Time Frame
before and after 5th infusion (12 or 16 weeks)
Title
The Pharmacokinetic (PK) Minimum concentration of IgG subclasses
Time Frame
before and after 5th infusion (12 or 16 weeks)
Title
The Pharmacokinetic (PK) Half-life of IgG subclasses
Time Frame
before and after 5th infusion (12 or 16 weeks)
Title
Trough serum level of IgG subclasses and specific IgG antibodies before Infusion 1 and 13 (for subjects on 28-day infusion schedule) or Infusion 1 and 17 (for subjects on 21-day infusion schedule)
Time Frame
12 months
Title
Number and proportion of subjects who failed to meet the target IgG trough level (500 mg/dL) at any time point equal to or subsequent to 5th infusion (estimated 5 half-lives)
Time Frame
12 months
Title
The overall incidence of all AEs that occur during or within 1 hour, 24 hours, and 72 hours following an infusion of investigational product
Description
AEs that occur during or within 1 hour, 24 hours, and 72 hours following each infusion during 12 months of the study period
Time Frame
12 months
Title
The frequency of all AEs that occur during the study regardless of the investigator's assessment of their relationship to investigational product
Time Frame
13 months (12 months of treatment + 1 month of follow-up)
Title
The frequency of suspected adverse reactions as defined by all AEs either classified as at least possibly related to GC5107
Time Frame
13 months (12 months of treatment + 1 month of follow-up)
Title
The number and proportion of GC5107 infusions for which the infusion rate was decreased due to AEs
Time Frame
12 months
Title
The proportion of AEs considered by the investigator to be investigational product related
Time Frame
13 months (12 months of treatment + 1 month of follow-up)
Title
Viral safety (freedom from transmission of blood-borne viral diseases): the human immunodeficiency virus (HIV) type 1 & 2, hepatitis A virus (HAV), hepatitis B virus (HBV), hepatitis C virus (HCV), and parvovirus B19
Time Frame
13 months (12 months of treatment + 1 month of follow-up)
Other Pre-specified Outcome Measures:
Title
The incidence of acute serious bacterial infections (aSBIs) defined at United States Food and Drug Administration (FDA) guidance criteria (bacterial pneumonia, bacteremia/sepsis, bacterial meningitis, visceral abscess, osteomyelitis/septic arthritis)
Time Frame
13 months (12 months of treatment + 1 month of follow-up)
Title
The incidence of infections other than acute serious bacterial infections
Time Frame
13 months (12 months of treatment + 1 month of follow-up)
Title
The number of days missed from work, school, kindergarten, day care or days unable to perform normal daily activities due to infections
Time Frame
13 months (12 months of treatment + 1 month of follow-up)
Title
The number of days that the care provider of the pediatric subject had to miss work in order to care for the child due to infections
Time Frame
13 months (12 months of treatment + 1 month of follow-up)
Title
The number of days of unscheduled physician visits due to infection
Time Frame
13 months (12 months of treatment + 1 month of follow-up)
Title
The number of days of hospitalizations due to infection
Time Frame
13 months (12 months of treatment + 1 month of follow-up)
Title
The number of days of intravenous (IV) therapeutic antibiotics
Time Frame
13 months (12 months of treatment + 1 month of follow-up)
Title
The number of days of oral (PO) therapeutic antibiotics
Time Frame
13 months (12 months of treatment + 1 month of follow-up)
Title
Time to resolution of infections
Time Frame
13 months (12 months of treatment + 1 month of follow-up)
Title
The incidence of infections by trough IgG levels
Time Frame
13 months (12 months of treatment + 1 month of follow-up)
Title
Episodes of fever (annual rate of fever episodes per subject)
Time Frame
13 months (12 months of treatment + 1 month of follow-up)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subject must be ≥ 2 to < 17 years of age, at the time of signing the informed consent
Pediatric subject has a confirmed and documented clinical diagnosis of Primary Humoral Immunodeficiency, including hypogammaglobulinemia or agammaglobulinemia
Subject who has received 300 - 900 mg/kg of IGIV therapy at 21 or 28 day intervals for at least 3 months prior to this study
Subject who has at least 2 documented plasma IgG trough level of ≥ 500 mg/dL at two infusion cycles (21 or 28 days) within 12 months prior to enrollment
Subject who is willing to comply with all requirements of the protocol
Exclusion Criteria:
Subject who has a history of clinically significant reactions or hypersensitivity to IGIV or other injectable forms of IgG
Subject who has IgA deficiency and is known to have antibodies to IgA
Subject who has secondary immunodeficiency
Subject who has participated in another clinical study (other than an IGIV study) within 3 weeks prior to screening
Subject who has been diagnosed with dysgammaglobulinemia or isolated IgG subclass deficiency or isolated IgA deficiency, or who has clinically significant impairment of cellular or innate immunity at the discretion of the Investigator
Subject who has received blood products other than human albumin or human immune globulin within 6 months prior to enrollment
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hyejoo Kim
Phone
+82-31-260-9192
Email
hyejoo.kim@gccorp.com
Facility Information:
Facility Name
Oklahoma Institute of Allergy & Asthma Clinical Research, LLC
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73131
Country
United States
Individual Site Status
Withdrawn
Facility Name
Allergy Partners of North Texas Research
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Individual Site Status
Recruiting
Facility Name
Lysosomal and Rare Disorders Research and Treatment Center, Inc.
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22030
Country
United States
Individual Site Status
Recruiting
Facility Name
Children's Hospital of Richmond at VCU
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23219
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Individual Site Status
Withdrawn
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Study of Immune Globulin Intravenous (Human) GC5107 in Pediatric Subjects With Primary Humoral Immunodeficiency
We'll reach out to this number within 24 hrs