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

Green Cross Corporation

Status and phase

Enrolling

Phase 3

Conditions

Primary Immune Deficiency

Treatments

Biological: GC5107

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT04565015

GC5107D

Details and patient eligibility

About

The purpose of this study is to evaluate the pharmacokinetics and safety of Immune Globulin Intravenous (Human) GC5107 in pediatric subjects with Primary Humoral Immunodeficiency (PHID).

Full description

This is a prospective, open-label, single-arm, historically controlled, multi-center Phase III study to assess the pharmacokinetics and safety of Immune Globulin Intravenous (Human) GC5107 in pediatric subjects aged ≥ 2 years and < 17 years with PHID.

Subjects will receive intravenous infusions of the investigational product at the same dose and interval as used for their previous Immunoglobulin intravenous (IGIV) maintenance therapy. GC5107 will be infused every 21 or 28 days for a period of 12 months.

Enrollment

24 estimated patients

Sex

All

Ages

2 to 16 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Subject must be ≥ 2 to < 17 years of age, at the time of signing the informed consent
Pediatric subject has a confirmed and documented clinical diagnosis of Primary Humoral Immunodeficiency, including hypogammaglobulinemia or agammaglobulinemia
Subject who has received 300 - 900 mg/kg of IGIV therapy at 21 or 28 day intervals for at least 3 months prior to this study
Subject who has at least 2 documented plasma IgG trough level of ≥ 500 mg/dL at two infusion cycles (21 or 28 days) within 12 months prior to enrollment
Subject who is willing to comply with all requirements of the protocol

Exclusion criteria

Subject who has a history of clinically significant reactions or hypersensitivity to IGIV or other injectable forms of IgG
Subject who has IgA deficiency and is known to have antibodies to IgA
Subject who has secondary immunodeficiency
Subject who has participated in another clinical study (other than an IGIV study) within 3 weeks prior to screening
Subject who has been diagnosed with dysgammaglobulinemia or isolated IgG subclass deficiency or isolated IgA deficiency, or who has clinically significant impairment of cellular or innate immunity at the discretion of the Investigator
Subject who has received blood products other than human albumin or human immune globulin within 6 months prior to enrollment