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

Green Cross Corporation

Status and phase

Completed

Phase 3

Conditions

Immunologic Deficiency Syndromes

Treatments

Biological: GC5107

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT02783482

GC5107B_P3

Details and patient eligibility

About

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).

Full 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.

Enrollment

49 patients

Sex

All

Ages

2 to 70 years old

Volunteers

No 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