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
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Green Cross Corporation
- Enrollment
- 49
- Locations
- 20
- Primary Endpoint
- The Proportion of Infusions With Temporally Associated Adverse Events (TAAEs) That Occur Within 72 Hours Following an Infusion of Test Product
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 2 Years to 70 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
GC5107
GC5107 Immune globulin intravenous (human) solution, 10% liquid
Intervention: GC5107 (Biological)
Outcomes
Primary Outcomes
The Proportion of Infusions With Temporally Associated Adverse Events (TAAEs) That Occur Within 72 Hours Following an Infusion of Test Product
Time Frame: 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)
Time Frame: 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 Outcomes
- 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)
- The Incidence of Infections Other Than Acute Serious Bacterial Infections(One year)
- The Number of Days of Oral Therapeutic Antibiotics(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)