HepeX-B in Post Hepatic Allografts for Treatment of End Stage Liver Disease Due to Hepatitis B Infection
- Conditions
- Hepatitis BLiver Transplantation
- Registration Number
- NCT00228592
- Lead Sponsor
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
- Brief Summary
The purpose of this study is to compare the use of HepeX-B versus HBIg, two anti-viral drugs, in patients who have received liver transplants due to liver failure caused by Hepatitis B infection. Patients will be evaluated over a 6 month to 1.5 year period to evaluate whether or not the drugs prevent the Hepatitis B virus from infecting the new liver.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- Not specified
- Male and female patients who are 18 years of age or older,
- Patients who are at least 6 months post first orthotopic liver transplantation (living or cadaveric donor) for treatment of end-stage liver disease due to HBV infection,
- Patients who have received HBIg since transplantation and are on a stable regimen (i.e., same dose and frequency) for at least the 3 months immediately preceding study entry (Day 1),
- Patients who have received treatment with an inhibitor of HBV polymerase for at least the 3 months immediately preceding study entry (Day 1),
- Patients with undetectable HBsAg and HBV DNA concentrations on two consecutive tests at least 1 week apart during the screening period,
- Female patients who are of childbearing potential, and males whose partners are women of childbearing potential, are required to use adequate contraception, and
- Patients who are able to provide written informed consent.
- Patients who successfully complete the initial 20-week treatment in the core trial are eligible for the 52-week extension phase.
- Women who are pregnant or breastfeeding,
- Patients who have received another organ transplant that requires immunosuppression,
- Patients who are co-infected with hepatitis delta virus (HDV), hepatitis C virus (HCV) and/or human immunodeficiency virus (HIV),
- Patients with clinical conditions or diseases, which, in the judgment of the investigator, would place the patient at undue risk, interfere with study participation, or confound the results of the study, and/or
- Patients who have participated in clinical studies in the 3 months prior to study entry.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (20)
University of Virginia
🇺🇸Charlottesville, Virginia, United States
Rabin Medical Center
🇮🇱Petach Tikva, Israel
Tel-Aviv Sourasky Medical Center
🇮🇱Tel Aviv, Israel
Auckland City Hospital
🇳🇿Auckland, New Zealand
Centre Hepato-Biliaire Hospital Paul Brousse
🇫🇷Paris, France
Humbolt University Virchow Clinic Dept. Viceral and Transplant Surgery
🇩🇪Berlin, Germany
Mt. Sinai
🇺🇸New York, New York, United States
Hadassah University Hospital
🇮🇱Jerusalem, Israel
Virginia Commonwealth University Health System
🇺🇸Richmond, Virginia, United States
Royal Free Hospital
🇬🇧London, United Kingdom
Hospital La Fe Servicio de Medicina Degestiva
🇪🇸Valencia, Spain
University of Cincinnati Medical Center
🇺🇸Cincinnati, Ohio, United States
UCLA
🇺🇸Los Angeles, California, United States
California Pacific Medical Center
🇺🇸San Francisco, California, United States
UCSF
🇺🇸San Francisco, California, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Metropolitan Liver Diseases/Gastroenterology Center
🇺🇸Fairfax, Virginia, United States
University of Nebraska
🇺🇸Omaha, Nebraska, United States
University of North Carolina
🇺🇸Chapel Hill, North Carolina, United States
University of Pennsylvania Health System
🇺🇸Philadelphia, Pennsylvania, United States