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| Sponsor: | Talecris Biotherapeutics |
|---|---|
| Information provided by: | Talecris Biotherapeutics |
| ClinicalTrials.gov Identifier: | NCT00389324 |
Purpose
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 |
|---|---|---|
|
Immunologic Deficiency Syndrome |
Drug: Immune Globulin Intravenous (Human), 10%, Caprylate/Chromatography Purified |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
|---|---|
| Experimental: Entered study |
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.
Other Names:
|
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.
Eligibility| Ages Eligible for Study: | 13 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, California | |
| University of California, Irvine | |
| Irvine, California, United States, 92697 | |
| UCLA School of Medicine | |
| Los Angeles, California, United States, 90095 | |
| 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 |
More Information
| Responsible Party: | Gerald Klein, MD, Chief Medical Officer, Vice President of Medical and Clinical Affairs, Talecris Biotherapeutics, Inc. |
| ClinicalTrials.gov Identifier: | NCT00389324 History of Changes |
| Other Study ID Numbers: | 060001 |
| Study First Received: | October 17, 2006 |
| Last Updated: | September 12, 2008 |
| Health Authority: | United States: Food and Drug Administration; Canada: Health Canada |
|
Primary immune deficiency |
|
Immunologic Deficiency Syndromes Immune System Diseases Antibodies Immunoglobulins Immunoglobulins, Intravenous |
Rho(D) Immune Globulin Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |