Phase 3
N=49
Study of Immune Globulin Intravenous (Human) GC5107 in Subjects With Primary Humoral Immunodeficiency
Immunologic Deficiency Syndromes
Bottom Line
View on ClinicalTrials.gov: NCT02783482 ↗Enrolled (actual)
49
Serious AEs
8.2%
Results posted
Oct 2022
Primary outcome: Primary: The Incidence of Acute Serious Bacterial Infections (SBI) — 0.04; 0; 0.02 Number of events per patient per year
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- GC5107 (Biological)
- Age
- Pediatric, Adult, Older Adult · 2+ yrs
- Sex
- All
- Sponsor
- Green Cross Corporation
- Primary completion
- Jul 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Incidence of Acute Serious Bacterial Infections (SBI) |
0.04; 0; 0.02 | — |
| PRIMARY The Proportion of Infusions With Temporally Associated Adverse Events (TAAEs) That Occur Within 72 Hours Following an Infusion of Test Product |
0.31; 0.16; 0.24 | — |
| SECONDARY The Incidence of Infections Other Than Acute Serious Bacterial Infections |
2.4; 3.6; 2.9 | — |
| SECONDARY The Number of Days Missed From Work/School/Kindergarten/Daycare, or Days Unable to Perform Normal Daily Activities Due to Infections |
2.9; 12.7; 7.1 | — |
| SECONDARY The Number of Days of Unscheduled Physician Visits Due to Infections |
2.3; 2.4; 2.3 | — |
| SECONDARY The Number of Days of Hospitalizations Due to Infections |
0.1; 0.1; 0.1 | — |
| SECONDARY The Number of Days of Intravenous (IV) Therapeutic Antibiotics |
0.1; 0.0; 0.1 | — |
| SECONDARY The Number of Days of Oral Therapeutic Antibiotics |
13.3; 13.1; 13.2 | — |
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).
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
Data sourced from ClinicalTrials.gov (NCT02783482). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.