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Sponsored by: |
Cangene Corporation |
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Information provided by: | Cangene Corporation |
ClinicalTrials.gov Identifier: | NCT00722332 |
The purpose of the study is to assess the pharmacokinetics, safety and efficacy of HepaGam B in combination with antiviral therapy for the prevention of hepatitis B virus (HBV) recurrence following HBV-related orthotopic liver transplant.
Condition | Intervention | Phase |
---|---|---|
Hepatitis B Liver Transplantation |
Biological: HepaGam B |
Phase IV |
Study Type: | Interventional |
Study Design: | Prevention, Open Label, Single Group Assignment |
Official Title: | Evaluation of HepaGam B™ in Combination With Antiviral Treatment in Hepatitis B Liver Transplant Patients |
Estimated Enrollment: | 30 |
Study Start Date: | February 2008 |
Estimated Study Completion Date: | January 2011 |
Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
HBV-related liver transplant patients
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Biological: HepaGam B
Hepatitis B Immunoglobulin
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Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
One or more of the following risk factors:
1. HBV DNA positive, 2. HBeAg positive, 3. Evidence of resistance to an antiviral medication
Exclusion Criteria:
Contact: Deepak Jain, MD | 416-675-8306 | djain@cangene.com |
United States, California | |
Stanford University Medical Center | Recruiting |
Palo Alto, California, United States, 94304 | |
University of Southern California | Recruiting |
Los Angeles, California, United States, 90033 | |
United States, Illinois | |
Northwestern Medical Faculty Foundation | Recruiting |
Chicago, Illinois, United States, 60611 | |
United States, Massachusetts | |
Lahey Clinic Med Ctr | Recruiting |
Boston, Massachusetts, United States, 01805 | |
United States, New Jersey | |
Univ Med and Dentistry of New Jersey | Recruiting |
Newark, New Jersey, United States, 07101 | |
United States, New York | |
Mount Sinai Medical Center | Recruiting |
New York, New York, United States, 10029 | |
United States, Ohio | |
Cleveland Clinic Foundation | Recruiting |
Cleveland, Ohio, United States, 44195 | |
United States, Pennsylvania | |
University of Pittsburgh Med Ctr | Recruiting |
Pittsburgh, Pennsylvania, United States, 15123 | |
United States, Texas | |
Baylor University Medical Center | Recruiting |
Dallas, Texas, United States, 75246 | |
Baylor College of Medicine | Recruiting |
Houston, Texas, United States, 77030 |
Responsible Party: | Cangene Corporation ( Deepak Jain, MD Manager, Medical Affairs ) |
Study ID Numbers: | HB-009 |
Study First Received: | July 23, 2008 |
Last Updated: | September 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00722332 History of Changes |
Health Authority: | United States: Food and Drug Administration |
HBIG Chronic Hepatitis B Recurrence Liver Transplant |
Liver Diseases Hepatitis, Chronic Hepatitis, Viral, Human Antiviral Agents Recurrence Hepatitis Virus Diseases |
Antibodies Digestive System Diseases Hepatitis B, Chronic Hepatitis B DNA Virus Infections Immunoglobulins |
Virus Diseases Hepatitis Anti-Infective Agents Liver Diseases Digestive System Diseases Therapeutic Uses |
Hepatitis B Hepatitis, Viral, Human DNA Virus Infections Antiviral Agents Hepadnaviridae Infections Pharmacologic Actions |