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Sponsored by: |
Talecris Biotherapeutics |
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Information provided by: | Talecris Biotherapeutics |
ClinicalTrials.gov Identifier: | NCT00389324 |
This study will compare the blood level of Gamunex in patients. Patients will take it as an injection under the skin or in a vein. The study will compare how safe and tolerable the two methods are in the patients. The patients in this study have a defect in their immune system from a genetic cause.
Condition | Intervention | Phase |
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Immunologic Deficiency Syndrome |
Drug: Immune Globulin Intravenous (Human), 10%, Caprylate/Chromatography Purified |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Crossover Assignment, Pharmacokinetics Study |
Official Title: | An Open-Label Single-Sequence, Crossover Trial to Evaluate the Pharmacokinetics, Safety, and Tolerability, of Subcutaneous Gamunex® 10% in Subjects With Primary Immunodeficiency |
Enrollment: | 35 |
Study Start Date: | November 2006 |
Study Completion Date: | August 2008 |
Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Entered study: Experimental |
Drug: Immune Globulin Intravenous (Human), 10%, Caprylate/Chromatography Purified
Subjects will be on IGIV (intravenous) until until a steady state is reached at which time PK profiling during the IV phase will occur. Subjects will begin SC administration 1 week following last IV dose and followed for a period of six months.
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This is an open-label, single-sequence, multi-center trial with subjects previously diagnosed with primary immune deficiency. Subjects will be on IGIV until until a steady state is reached at which time PK profiling during the IV phase will occur. Subjects will begin SC administration 1 week following last IV dose and followed for a period of six months. PK profiling in SC phase will occur when subject reaches approximate steady-state on SC administration.
Ages Eligible for Study: | 13 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
UCLA School of Medicine | |
Los Angeles, California, United States, 90095 | |
University of California, Irvine | |
Irvine, California, United States, 92697 | |
United States, Georgia | |
Family Allergy & Asthma Center, PC | |
Atlanta, Georgia, United States, 30342 | |
United States, Nebraska | |
Allergy, Asthma & Immunology Associates, PC | |
Omaha, Nebraska, United States, 68124 | |
United States, Texas | |
Pediatric Allergy / Immunology Associates, PA | |
Dallas, Texas, United States, 75230 | |
United States, Virginia | |
Virginia Commonwealth University | |
Richmond, Virginia, United States, 23219 | |
Canada, British Columbia | |
Dr. Donald F. Stark, Inc | |
Vancouver, British Columbia, Canada, V6H3K2 | |
Canada, Quebec | |
McGill University - Montreal General Hospital | |
Montreal, Quebec, Canada, H3G1A4 |
Study Director: | Susan Sorrells | Talecris Biotherapeutics |
Responsible Party: | Talecris Biotherapeutics, Inc. ( Gerald Klein, MD, Chief Medical Officer, Vice President of Medical and Clinical Affairs ) |
Study ID Numbers: | 060001 |
Study First Received: | October 17, 2006 |
Last Updated: | September 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00389324 |
Health Authority: | United States: Food and Drug Administration; Canada: Health Canada |
Primary immune deficiency |
Antibodies Immunoglobulins, Intravenous Rho(D) Immune Globulin Immunologic Deficiency Syndromes Immunoglobulins |
Pathologic Processes Disease Immunologic Factors Immune System Diseases |
Syndrome Physiological Effects of Drugs Pharmacologic Actions |