ClinicalTrials.Veeva

Menu

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

G

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

49 participants in 1 patient group

GC5107
Experimental group
Description:
GC5107 Immune globulin intravenous (human) solution, 10% liquid
Treatment:
Biological: GC5107

Trial documents
2

Trial contacts and locations

20

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems