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Sponsored by: |
Biotest Pharmaceuticals Corporation |
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Information provided by: | Biotest Pharmaceuticals Corporation |
ClinicalTrials.gov Identifier: | NCT00800787 |
A phase 3, multicenter, open label study to assess the safety and efficacy of Nabi-HB, administered subcutaneously in patients with Hepatitis B Virus Associated Liver Disease who underwent liver transplantation.
Condition | Intervention | Phase |
---|---|---|
Chronic Hepatitis B Liver Disease Orthostotic Liver Transplant |
Biological: Hepatitis B immune globulin (Human) |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase 3, Multicenter, Open Label Study to Assess the Safety and Efficacy of Nabi-HB Administered Subcutaneously in Patients With Hepatitis B Virus Associated Liver Disease Who Underwent Liver Transplantation |
Estimated Enrollment: | 25 |
Study Start Date: | April 2009 |
Estimated Study Completion Date: | September 2009 |
Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arm One: Nabi-HB: Experimental
All subjects will be administered Nabi HB Subcutaneously
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Biological: Hepatitis B immune globulin (Human)
Hepatitis b Immune Globulin (Human)(Nabi-HB) 312 IU/L per dose administered subcutaneously. Dosage will be according to each patients body weight, as follow: < 75 kg: 500 IU weekly ( may be increase to 1,000 IU weekly if anti-HBs levels are <150 IU/ML > 75 Kg: 1,000 IU weekly |
This is a phase 3 prospective, single arm open label study to be conducted t approximately 4 study sited located in th e USA. Approximately 25 HBV DNA negative patients who underwent liver transplant at least one year prior, due to chronic hepatitis B infection will bwe eligible for study participation. The study consist of a total of 16 study visit and the duration of participation will be 20 weeks for each patients. Patients will be converted from the intravenous standard HBIG to Nabi-HB subcutaneous administration according to the individual scheduled dosing interval.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria
Contact: Sabine Teske, Ph.D. | 561-989-5506 | steske@biotestpharma.com |
Responsible Party: | Biotest Pharmaceuticals Corporation ( George L. Herrera, MD ) |
Study ID Numbers: | 4210 |
Study First Received: | November 26, 2008 |
Last Updated: | December 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00800787 |
Health Authority: | United States: Food and Drug Administration |
Chronic hepatitis B liver disease |
Virus Diseases Hepatitis Antibodies Liver Diseases Digestive System Diseases Hepatitis, Chronic |
Hepatitis B, Chronic Hepatitis B Hepatitis, Viral, Human DNA Virus Infections Immunoglobulins |
Immunologic Factors Physiological Effects of Drugs Hepadnaviridae Infections Pharmacologic Actions |