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Study of Immune Globulin Intravenous (Human) GC5107 in Subjects With Primary Humoral Immunodeficiency

Primary Purpose

Immunologic Deficiency Syndromes

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
GC5107
Sponsored by
Green Cross Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Immunologic Deficiency Syndromes

Eligibility Criteria

2 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subject 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
  • Male or Female, ages 2 to 70 years
  • The subject has received 300-900 mg/kg of a licensed IGIV therapy at 21 or 28 day intervals for at least 3 months prior to this study
  • At least 2 documented IgG trough levels of ≥ 500 mg/dL are obtained at two infusion cycles (21 or 28 days) within 12 months prior to study enrollment

Exclusion Criteria:

  • Subject has secondary immunodeficiency
  • Subject was newly diagnosed with PHID and has not yet been treated with immunoglobulin
  • Subject has been diagnosed with dysgammaglobulinemia or isolated IgG subclass deficiency or isolated IgA deficiency with known anti-IgA antibodies
  • History of severe reaction or hypersensitivity to IGIV or other injectable form of IgG
  • Subject has a lifetime history of at least one thrombotic event including deep vein thrombosis, cerebrovascular accident, pulmonary embolism, transient ischemic attacks, or myocardial infarction
  • Subject has received blood products other than human albumin or human immunoglobulin within 12 months prior to enrollment

Sites / Locations

  • Immuno International Research Centers
  • Allergy Associates of Palm Beaches PA
  • Midwest Immunology Clinic and Infusion Center
  • Optimed Infusions LLC
  • Oklahoma Institute of Allergy Ashma and Immunology
  • Allergy Partners of North Texas Research
  • Allergy and Asthma Specialists
  • Pediatric Pulmonary Associates of North Texas
  • Allergy Asthma and Immunology Clinic PA
  • Lysosomal Rare Disorder Research and Treatment Center, Inc.
  • University of Alberta Hospital
  • Hamilton Health Sciences Corporation
  • Queen's University - Kingston General Hospital (KGH)
  • The Ottawa Hospital
  • Gordon Sussman Clinical Research
  • Saint Michael's Hospital
  • CHU Ste-Justine - University of Montreal
  • McGill University Health Centre (MUHC) - The Montreal Children's Hospital
  • Hotel Dieu de Montreal
  • Clinique Spécialisée en Allergie de la Capitale

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

GC5107

Arm Description

GC5107 Immune globulin intravenous (human) solution, 10% liquid

Outcomes

Primary Outcome Measures

The Incidence of Acute Serious Bacterial Infections (SBI)
The incidence of acute serious bacterial infections (aSBIs) meeting FDA guidance criteria, which includes bacterial pneumonia, bacteremia/sepsis, bacterial meningitis, visceral abscesses, and osteomyelitis/septic arthritis. Efficacy data is evaluated by comparing the frequency of acute serious bacterial infections per subject per year according to the FDA guideline of an upper one-sided 99% confidence limit < 1.0 per subject per year.
The Proportion of Infusions With Temporally Associated Adverse Events (TAAEs) That Occur Within 72 Hours Following an Infusion of Test Product
The proportion of infusions with temporally associated adverse events occurring during or within 72 hours following infusion, whether or not they were thought to be related to GC5107

Secondary Outcome Measures

The Incidence of Infections Other Than Acute Serious Bacterial Infections
The Number of Days Missed From Work/School/Kindergarten/Daycare, or Days Unable to Perform Normal Daily Activities Due to Infections
Based on the total number of days missed from work/school/kindergarten/daycare or days unable to perform normal daily activities due to infections for each subject. Mean and SD are calculated based on weighting for the duration of data available for each subject, where duration is defined as (date of last visit - first infusion date + 1) for subjects who complete the study; and defined as (date of withdrawal - first infusion date + 1) for subjects who withdraw from the study.
The Number of Days of Unscheduled Physician Visits Due to Infections
Based on the total number of days of unscheduled physician visits due to infections for each subject. Mean and SD are calculated based on weighting for the duration of data available for each subject, where duration is defined as (date of last visit - first infusion date + 1) for subjects who complete the study; and defined as (date of withdrawal - first infusion date + 1) for subjects who withdraw from the study.
The Number of Days of Hospitalizations Due to Infections
Subject with no experience of specific event will be included in the analysis as zero incidence, zero day, or zero time duration. The mean and SD will be calculated weighting for the duration of data available for each subject.
The Number of Days of Intravenous (IV) Therapeutic Antibiotics
Based on the total number of days of IV therapeutic antibiotics for each subject. Mean and SD are calculated based on weighting for the duration of data available for each subject, where duration is defined as (date of last visit -first infusion date + 1) for subjects who complete the study; and defined as (date of withdrawal - first infusion date + 1) for subjects who withdraw from the study.
The Number of Days of Oral Therapeutic Antibiotics
Based on the total number of days of oral (PO) therapeutic antibiotics for each subject. Mean and SD are calculated based on weighting for the duration of data available for each subject, where duration is defined as (date of last visit - first infusion date + 1) for subjects who complete the study; and defined as (date of withdrawal - first infusion date + 1) for subjects who withdraw from the study.

Full Information

First Posted
April 24, 2016
Last Updated
November 11, 2022
Sponsor
Green Cross Corporation
Collaborators
Parexel, Atlantic Research Group
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1. Study Identification

Unique Protocol Identification Number
NCT02783482
Brief Title
Study of Immune Globulin Intravenous (Human) GC5107 in Subjects With Primary Humoral Immunodeficiency
Official Title
An Open-Label, Single-Arm, Historically Controlled, Prospective, Multicenter Phase III Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Immune Globulin Intravenous (Human) GC5107 in Subjects With Primary Humoral Immunodeficiency
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
October 2016 (Actual)
Primary Completion Date
July 2019 (Actual)
Study Completion Date
July 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Green Cross Corporation
Collaborators
Parexel, Atlantic Research Group

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to evaluate the safety, efficacy and Pharmacokinetics of Immune Globulin Intravenous (Human) GC5107 in subjects with Primary Humoral Immunodeficiency (PHID).
Detailed Description
This was a prospective, open-label, single-arm, historically controlled, multicenter phase 3 study measuring the safety, efficacy and pharmacokinetics and tolerability of GC5107 in subjects with Primary Humoral Immunodeficiency disease (PHID). Subjects received intravenous infusions of the investigational product at the same dose and interval as used for their previous Immunoglobulin intravenous (IVIG) maintenance therapy. GC5107 was administered 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
Immunologic Deficiency Syndromes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
49 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GC5107
Arm Type
Experimental
Arm Description
GC5107 Immune globulin intravenous (human) solution, 10% liquid
Intervention Type
Biological
Intervention Name(s)
GC5107
Other Intervention Name(s)
IGIV, Immune globulin intravenous (human) solution, 10% liquid
Intervention Description
GC5107 20g/200mL, intravenously, dose of 300 - 900 mg/kg (of body weight) every 21 or 28 days for 12 months, a follow-up (3 or 4 weeks)
Primary Outcome Measure Information:
Title
The Incidence of Acute Serious Bacterial Infections (SBI)
Description
The incidence of acute serious bacterial infections (aSBIs) meeting FDA guidance criteria, which includes bacterial pneumonia, bacteremia/sepsis, bacterial meningitis, visceral abscesses, and osteomyelitis/septic arthritis. Efficacy data is evaluated by comparing the frequency of acute serious bacterial infections per subject per year according to the FDA guideline of an upper one-sided 99% confidence limit < 1.0 per subject per year.
Time Frame
One year
Title
The Proportion of Infusions With Temporally Associated Adverse Events (TAAEs) That Occur Within 72 Hours Following an Infusion of Test Product
Description
The proportion of infusions with temporally associated adverse events occurring during or within 72 hours following infusion, whether or not they were thought to be related to GC5107
Time Frame
Within 72 hours after an infusion of GC5107
Secondary Outcome Measure Information:
Title
The Incidence of Infections Other Than Acute Serious Bacterial Infections
Time Frame
One year
Title
The Number of Days Missed From Work/School/Kindergarten/Daycare, or Days Unable to Perform Normal Daily Activities Due to Infections
Description
Based on the total number of days missed from work/school/kindergarten/daycare or days unable to perform normal daily activities due to infections for each subject. Mean and SD are calculated based on weighting for the duration of data available for each subject, where duration is defined as (date of last visit - first infusion date + 1) for subjects who complete the study; and defined as (date of withdrawal - first infusion date + 1) for subjects who withdraw from the study.
Time Frame
One year
Title
The Number of Days of Unscheduled Physician Visits Due to Infections
Description
Based on the total number of days of unscheduled physician visits due to infections for each subject. Mean and SD are calculated based on weighting for the duration of data available for each subject, where duration is defined as (date of last visit - first infusion date + 1) for subjects who complete the study; and defined as (date of withdrawal - first infusion date + 1) for subjects who withdraw from the study.
Time Frame
One year
Title
The Number of Days of Hospitalizations Due to Infections
Description
Subject with no experience of specific event will be included in the analysis as zero incidence, zero day, or zero time duration. The mean and SD will be calculated weighting for the duration of data available for each subject.
Time Frame
One year
Title
The Number of Days of Intravenous (IV) Therapeutic Antibiotics
Description
Based on the total number of days of IV therapeutic antibiotics for each subject. Mean and SD are calculated based on weighting for the duration of data available for each subject, where duration is defined as (date of last visit -first infusion date + 1) for subjects who complete the study; and defined as (date of withdrawal - first infusion date + 1) for subjects who withdraw from the study.
Time Frame
One year
Title
The Number of Days of Oral Therapeutic Antibiotics
Description
Based on the total number of days of oral (PO) therapeutic antibiotics for each subject. Mean and SD are calculated based on weighting for the duration of data available for each subject, where duration is defined as (date of last visit - first infusion date + 1) for subjects who complete the study; and defined as (date of withdrawal - first infusion date + 1) for subjects who withdraw from the study.
Time Frame
One year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject 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 Male or Female, ages 2 to 70 years The subject has received 300-900 mg/kg of a licensed IGIV therapy at 21 or 28 day intervals for at least 3 months prior to this study At least 2 documented IgG trough levels of ≥ 500 mg/dL are obtained at two infusion cycles (21 or 28 days) within 12 months prior to study enrollment Exclusion Criteria: Subject has secondary immunodeficiency Subject was newly diagnosed with PHID and has not yet been treated with immunoglobulin Subject has been diagnosed with dysgammaglobulinemia or isolated IgG subclass deficiency or isolated IgA deficiency with known anti-IgA antibodies History of severe reaction or hypersensitivity to IGIV or other injectable form of IgG Subject has a lifetime history of at least one thrombotic event including deep vein thrombosis, cerebrovascular accident, pulmonary embolism, transient ischemic attacks, or myocardial infarction Subject has received blood products other than human albumin or human immunoglobulin within 12 months prior to enrollment
Facility Information:
Facility Name
Immuno International Research Centers
City
Centennial
State/Province
Colorado
ZIP/Postal Code
80112
Country
United States
Facility Name
Allergy Associates of Palm Beaches PA
City
North Palm Beach
State/Province
Florida
ZIP/Postal Code
33408
Country
United States
Facility Name
Midwest Immunology Clinic and Infusion Center
City
Plymouth
State/Province
Minnesota
ZIP/Postal Code
55446
Country
United States
Facility Name
Optimed Infusions LLC
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43235
Country
United States
Facility Name
Oklahoma Institute of Allergy Ashma and Immunology
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73131
Country
United States
Facility Name
Allergy Partners of North Texas Research
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Allergy and Asthma Specialists
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Pediatric Pulmonary Associates of North Texas
City
Frisco
State/Province
Texas
ZIP/Postal Code
75034
Country
United States
Facility Name
Allergy Asthma and Immunology Clinic PA
City
Irving
State/Province
Texas
ZIP/Postal Code
75063
Country
United States
Facility Name
Lysosomal Rare Disorder Research and Treatment Center, Inc.
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22030
Country
United States
Facility Name
University of Alberta Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2V2
Country
Canada
Facility Name
Hamilton Health Sciences Corporation
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8S4K1
Country
Canada
Facility Name
Queen's University - Kingston General Hospital (KGH)
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 2V7
Country
Canada
Facility Name
The Ottawa Hospital
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
Gordon Sussman Clinical Research
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4V 1R2
Country
Canada
Facility Name
Saint Michael's Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1W8
Country
Canada
Facility Name
CHU Ste-Justine - University of Montreal
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1C5
Country
Canada
Facility Name
McGill University Health Centre (MUHC) - The Montreal Children's Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada
Facility Name
Hotel Dieu de Montreal
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H2W 1T8
Country
Canada
Facility Name
Clinique Spécialisée en Allergie de la Capitale
City
Québec City
State/Province
Quebec
ZIP/Postal Code
G1V 4W2
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34305948
Citation
Perez EE, Hebert J, Ellis AK, Alpan O, Lumry WR, Shapiro R, Suez D, Mandujano JF, Wasserman RL. Efficacy, Safety and Tolerability of a New 10% Intravenous Immunoglobulin for the Treatment of Primary Immunodeficiencies. Front Immunol. 2021 Jul 8;12:707463. doi: 10.3389/fimmu.2021.707463. eCollection 2021.
Results Reference
derived

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Study of Immune Globulin Intravenous (Human) GC5107 in Subjects With Primary Humoral Immunodeficiency

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