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



Status:Recruiting
Conditions:Infectious Disease, HIV / AIDS
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:2 - 70
Updated:11/24/2017
Start Date:June 2016
Contact:Ahmi Woo
Email:ahmi.woo@greencross.com
Phone:82 31 260 9467

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An Open-Label, Single-Arm, Historically Controlled, Prospective, Multicenter Phase III Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Immune Globulin Intravenous (Human) GC5107 in Subjects With Primary Humoral Immunodeficiency

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).

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.

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
We found this trial at
11
sites
1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Principal Investigator: James Moy, M.D
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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Centennial, Colorado 80112
Principal Investigator: Issac Melamed, M.D
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8080 Ravines Edge Court
Columbus, Ohio 43235
Principal Investigator: Donald McNeil, M.D
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Dallas, Texas 75230
Principal Investigator: Richard Wasserman, M.D
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Dallas, Texas 75231
Principal Investigator: William Lumry, M.D
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Edmonton, Alberta
Principal Investigator: Bruce Ritchie, M.D
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Fairfax, Virginia 22030
Principal Investigator: Oral Alpan, M.D
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Irving, Texas 75063
Principal Investigator: Daniel Suez, M.D
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North Palm Beach, Florida 33408
Principal Investigator: Mark Stein, M.D
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1810 East Memorial Road
Oklahoma City, Oklahoma 73131
Principal Investigator: Amy Darter, M.D
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Plymouth, Minnesota 55446
Principal Investigator: Ralph Shapiro, M.D
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Plymouth, MN
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