Study of Immune Globulin Intravenous (Human) GC5107 in Subjects With Primary Humoral Immunodeficiency
NCT ID: NCT02783482
Last Updated: 2022-12-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
49 participants
INTERVENTIONAL
2016-10-31
2019-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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GC5107
GC5107 Immune globulin intravenous (human) solution, 10% liquid
GC5107
GC5107 20g/200mL, intravenously, dose of 300 - 900 mg/kg (of body weight) every 21 or 28 days for 12 months, a follow-up (3 or 4 weeks)
Interventions
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GC5107
GC5107 20g/200mL, intravenously, dose of 300 - 900 mg/kg (of body weight) every 21 or 28 days for 12 months, a follow-up (3 or 4 weeks)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
2 Years
70 Years
ALL
No
Sponsors
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Parexel
INDUSTRY
Atlantic Research Group
OTHER
Green Cross Corporation
INDUSTRY
Responsible Party
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Locations
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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
Countries
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References
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Perez EE, Hebert J, Ellis AK, Alpan O, Lumry WR, Shapiro R, Suez D, Mandujano JF, Wasserman RL. Efficacy, Safety and Tolerability of a New 10% Intravenous Immunoglobulin for the Treatment of Primary Immunodeficiencies. Front Immunol. 2021 Jul 8;12:707463. doi: 10.3389/fimmu.2021.707463. eCollection 2021.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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GC5107B_P3
Identifier Type: -
Identifier Source: org_study_id