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Sponsored by: |
Cangene Corporation |
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 |
MedlinePlus related topics: | Hepatitis Hepatitis B Liver Transplantation |
Drug Information available for: | Hepatitis B Vaccines Immunoglobulins Globulin, Immune Hepatitis B hyperimmune globulin |
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 |
Cangene Corporation |
Responsible Party: | Cangene Corporation ( Deepak Jain, MD Manager, Medical Affairs ) |
Study ID Numbers: | HB-009 |
First Received: | July 23, 2008 |
Last Updated: | September 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00722332 |
Health Authority: | United States: Food and Drug Administration |
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