Study of Immune Globulin Intravenous (Human) GC5107 in Subjects With Primary Humoral Immunodeficiency
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
1 other identifier
interventional
49
2 countries
20
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Oct 2016
Typical duration for phase_3
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 24, 2016
CompletedFirst Posted
Study publicly available on registry
May 26, 2016
CompletedStudy Start
First participant enrolled
October 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2019
CompletedResults Posted
Study results publicly available
October 28, 2022
CompletedDecember 9, 2022
September 1, 2022
2.7 years
April 24, 2016
October 28, 2021
November 11, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
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.
One 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
Within 72 hours after an infusion of GC5107
Secondary Outcomes (6)
The Incidence of Infections Other Than Acute Serious Bacterial Infections
One year
The Number of Days Missed From Work/School/Kindergarten/Daycare, or Days Unable to Perform Normal Daily Activities Due to Infections
One year
The Number of Days of Unscheduled Physician Visits Due to Infections
One year
The Number of Days of Hospitalizations Due to Infections
One year
The Number of Days of Intravenous (IV) Therapeutic Antibiotics
One year
- +1 more secondary outcomes
Study Arms (1)
GC5107
EXPERIMENTALGC5107 Immune globulin intravenous (human) solution, 10% liquid
Interventions
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)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Green Cross Corporationlead
- Parexelcollaborator
- Atlantic Research Groupcollaborator
Study Sites (20)
Immuno International Research Centers
Centennial, Colorado, 80112, United States
Allergy Associates of Palm Beaches PA
North Palm Beach, Florida, 33408, United States
Midwest Immunology Clinic and Infusion Center
Plymouth, Minnesota, 55446, United States
Optimed Infusions LLC
Columbus, Ohio, 43235, United States
Oklahoma Institute of Allergy Ashma and Immunology
Oklahoma City, Oklahoma, 73131, United States
Allergy Partners of North Texas Research
Dallas, Texas, 75230, United States
Allergy and Asthma Specialists
Dallas, Texas, 75231, United States
Pediatric Pulmonary Associates of North Texas
Frisco, Texas, 75034, United States
Allergy Asthma and Immunology Clinic PA
Irving, Texas, 75063, United States
Lysosomal Rare Disorder Research and Treatment Center, Inc.
Fairfax, Virginia, 22030, United States
University of Alberta Hospital
Edmonton, Alberta, T6G 2V2, Canada
Hamilton Health Sciences Corporation
Hamilton, Ontario, L8S4K1, Canada
Queen's University - Kingston General Hospital (KGH)
Kingston, Ontario, K7L 2V7, Canada
The Ottawa Hospital
Ottawa, Ontario, K1H 8L6, Canada
Gordon Sussman Clinical Research
Toronto, Ontario, M4V 1R2, Canada
Saint Michael's Hospital
Toronto, Ontario, M5B 1W8, Canada
Hotel Dieu de Montreal
Montreal, Quebec, H2W 1T8, Canada
CHU Ste-Justine - University of Montreal
Montreal, Quebec, H3T 1C5, Canada
McGill University Health Centre (MUHC) - The Montreal Children's Hospital
Montreal, Quebec, H4A 3J1, Canada
Clinique Spécialisée en Allergie de la Capitale
Québec, Quebec, G1V 4W2, Canada
Related Publications (1)
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.
PMID: 34305948DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Project Manager
- Organization
- Green Cross Corporation
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 24, 2016
First Posted
May 26, 2016
Study Start
October 1, 2016
Primary Completion
July 1, 2019
Study Completion
July 1, 2019
Last Updated
December 9, 2022
Results First Posted
October 28, 2022
Record last verified: 2022-09
Data Sharing
- IPD Sharing
- Will not share