HepeX-B in Post Hepatic Allografts for Treatment of End Stage Liver Disease Due to Hepatitis B Infection

Stopped early · Phase 2

Conditions studied: Hepatitis B, Liver Transplantation

In brief

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.

Key facts

Study ID

NCT00228592

Run by

Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Expected to finish

2005-08-01

Last updated by the study team

2007-02-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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
• University of Nebraska — Omaha, Nebraska, United States
• Mt. Sinai — New York, New York, United States
• University of North Carolina — Chapel Hill, North Carolina, United States
• University of Cincinnati Medical Center — Cincinnati, Ohio, United States
• University of Pennsylvania Health System — Philadelphia, Pennsylvania, United States
• University of Virginia — Charlottesville, Virginia, United States
• Metropolitan Liver Diseases/Gastroenterology Center — Fairfax, Virginia, United States
• Virginia Commonwealth University Health System — Richmond, Virginia, United States
• Centre Hepato-Biliaire Hospital Paul Brousse — Paris, France
• Humbolt University Virchow Clinic Dept. Viceral and Transplant Surgery — Berlin, Germany
• Hadassah University Hospital — Jerusalem, Israel
• Rabin Medical Center — Petah Tikva, Israel
• Tel-Aviv Sourasky Medical Center — Tel Aviv, Israel
• Auckland City Hospital — Auckland, New Zealand
• Hospital La Fe Servicio de Medicina Degestiva — Valencia, Spain
• Royal Free Hospital — London, United Kingdom

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.