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

Completed · Phase 3

Conditions studied: Immunologic Deficiency Syndromes

In brief

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).

Key facts

Study ID

NCT02783482

Run by

Green Cross Corporation

People needed

49

Starts

2016-10-01

Expected to finish

2019-07-01

Last updated by the study team

2022-12-09

Who can join

Age: 2 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Immuno International Research Centers — Centennial, Colorado, United States
• Allergy Associates of Palm Beaches PA — North Palm Beach, Florida, United States
• Midwest Immunology Clinic and Infusion Center — Plymouth, Minnesota, United States
• Optimed Infusions LLC — Columbus, Ohio, United States
• Oklahoma Institute of Allergy Ashma and Immunology — Oklahoma City, Oklahoma, United States
• Allergy Partners of North Texas Research — Dallas, Texas, United States
• Allergy and Asthma Specialists — Dallas, Texas, United States
• Pediatric Pulmonary Associates of North Texas — Frisco, Texas, United States
• Allergy Asthma and Immunology Clinic PA — Irving, Texas, United States
• Lysosomal Rare Disorder Research and Treatment Center, Inc. — Fairfax, Virginia, United States
• University of Alberta Hospital — Edmonton, Alberta, Canada
• Hamilton Health Sciences Corporation — Hamilton, Ontario, Canada
• Queen's University - Kingston General Hospital (KGH) — Kingston, Ontario, Canada
• The Ottawa Hospital — Ottawa, Ontario, Canada
• Gordon Sussman Clinical Research — Toronto, Ontario, Canada
• Saint Michael's Hospital — Toronto, Ontario, Canada
• Hotel Dieu de Montreal — Montreal, Quebec, Canada
• CHU Ste-Justine - University of Montreal — Montreal, Quebec, Canada
• McGill University Health Centre (MUHC) - The Montreal Children's Hospital — Montreal, Quebec, Canada
• Clinique Spécialisée en Allergie de la Capitale — Québec, Quebec, Canada

Full record on ClinicalTrials.gov

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