Evaluation of HepaGam B™ in Combination With Antiviral Treatment in Hepatitis B Liver Transplant Patients
Information source: Cangene Corporation
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hepatitis B; Liver Transplantation
Intervention: HepaGam B (Biological)
Phase: Phase 4
Status: Recruiting
Sponsored by: Cangene Corporation Overall contact:
Deepak Jain, MD, Phone: 416-675-8306, Email: djain@cangene.com
Summary
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.
Clinical Details
Official title: Evaluation of HepaGam B™ in Combination With Antiviral Treatment in Hepatitis B Liver Transplant Patients
Study design: Prevention, Open Label, Single Group Assignment
Primary outcome: Pharmacokinetic profile of HepaGam B in combination with antiviral therapy
Secondary outcome: Safety and Efficacy of HepaGam B in combination with antiviral therapy
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- HBsAg-positive candidates for HBV-related liver transplant
- One or more of the following risk factors:
1. HBV DNA positive, 2. HBeAg positive, 3. Evidence of resistance to an antiviral
medication
- Treatment with antiviral therapy before transplantation as per treating
Exclusion Criteria:
- Multi-organ transplantation recipients
- Liver re-transplantation except for primary non-function
- Presence of a hepatoma (Milan Criteria).
- Patients requiring an OLT due to fulminant hepatitis B
- OLT patients receiving a liver graft from a donor that is positive for HBsAg
- History of IgA deficiency
- History of hypersensitivity to blood products.
- HIV or HCV positive
- Use of an investigational product, or participation in another clinical trial during
the course of the study
- Pregnancy or planned pregnancy during the course of the study
Locations and Contacts
Deepak Jain, MD, Phone: 416-675-8306, Email: djain@cangene.com
Stanford University Medical Center, Palo Alto, California 94304, United States; Recruiting
University of Southern California, Los Angeles, California 90033, United States; Recruiting
Northwestern Medical Faculty Foundation, Chicago, Illinois 60611, United States; Recruiting
Lahey Clinic Med Ctr, Boston, Massachusetts 01805, United States; Recruiting
Univ Med and Dentistry of New Jersey, Newark, New Jersey 07101, United States; Recruiting
Mount Sinai Medical Center, New York, New York 10029, United States; Recruiting
Cleveland Clinic Foundation, Cleveland, Ohio 44195, United States; Recruiting
University of Pittsburgh Med Ctr, Pittsburgh, Pennsylvania 15123, United States; Recruiting
Baylor University Medical Center, Dallas, Texas 75246, United States; Recruiting
Baylor College of Medicine, Houston, Texas 77030, United States; Recruiting
Additional Information
Starting date: February 2008
Ending date: January 2011
Last updated: September 8, 2008
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