Last updated on February 2018

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


Brief description of study

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).

Detailed Study Description

This will be 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 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 administered every 21 or 28 days for a period of 12 months.

Clinical Study Identifier: NCT02783482

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Allergy Associates of Palm Beaches PA

North Palm Beach, FL United States
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Optimed Infusions LLC

Columbus, OH United States
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