Study of Immune Globulin Intravenous (Human) GC5107 in Subjects With Primary Humoral Immunodeficiency
- Conditions
- Immunologic Deficiency Syndromes
- Interventions
- Biological: GC5107
- Registration Number
- NCT02783482
- Lead Sponsor
- Green Cross Corporation
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 49
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description GC5107 GC5107 GC5107 Immune globulin intravenous (human) solution, 10% liquid
- Primary Outcome Measures
Name Time Method The Proportion of Infusions With Temporally Associated Adverse Events (TAAEs) That Occur Within 72 Hours Following an Infusion of Test Product Within 72 hours after an infusion of GC5107 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
The Incidence of Acute Serious Bacterial Infections (SBI) One year 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.
- Secondary Outcome Measures
Name Time Method The Incidence of Infections Other Than Acute Serious Bacterial Infections One year The Number of Days of Oral Therapeutic Antibiotics One year 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.
The Number of Days of Unscheduled Physician Visits Due to Infections One year 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 One year 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 One year 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 Missed From Work/School/Kindergarten/Daycare, or Days Unable to Perform Normal Daily Activities Due to Infections One year 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.
Trial Locations
- Locations (20)
Hotel Dieu de Montreal
🇨🇦Montréal, Quebec, Canada
Immuno International Research Centers
🇺🇸Centennial, Colorado, United States
CHU Ste-Justine - University of Montreal
🇨🇦Montreal, Quebec, Canada
University of Alberta Hospital
🇨🇦Edmonton, Alberta, Canada
Allergy Associates of Palm Beaches PA
🇺🇸North Palm Beach, Florida, United States
Pediatric Pulmonary Associates of North Texas
🇺🇸Frisco, Texas, United States
Hamilton Health Sciences Corporation
🇨🇦Hamilton, Ontario, Canada
Optimed Infusions LLC
🇺🇸Columbus, Ohio, United States
Lysosomal Rare Disorder Research and Treatment Center, Inc.
🇺🇸Fairfax, Virginia, United States
Allergy and Asthma Specialists
🇺🇸Dallas, Texas, United States
Saint Michael's Hospital
🇨🇦Toronto, Ontario, Canada
Midwest Immunology Clinic and Infusion Center
🇺🇸Plymouth, Minnesota, United States
Allergy Partners of North Texas Research
🇺🇸Dallas, Texas, United States
Allergy Asthma and Immunology Clinic PA
🇺🇸Irving, Texas, United States
Queen's University - Kingston General Hospital (KGH)
🇨🇦Kingston, Ontario, Canada
The Ottawa Hospital
🇨🇦Ottawa, Ontario, Canada
Clinique Spécialisée en Allergie de la Capitale
🇨🇦Québec City, Quebec, Canada
Gordon Sussman Clinical Research
🇨🇦Toronto, Ontario, Canada
McGill University Health Centre (MUHC) - The Montreal Children's Hospital
🇨🇦Montreal, Quebec, Canada
Oklahoma Institute of Allergy Ashma and Immunology
🇺🇸Oklahoma City, Oklahoma, United States