Status:
TERMINATED
HepeX-B in Post Hepatic Allografts for Treatment of End Stage Liver Disease Due to Hepatitis B Infection
Lead Sponsor:
Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Conditions:
Hepatitis B
Liver Transplantation
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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. Pati...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
August 1 2005
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00228592
End Date
August 1 2005
Last Update
February 13 2007
Active Locations (20)
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1
UCLA
Los Angeles, California, United States
2
California Pacific Medical Center
San Francisco, California, United States
3
UCSF
San Francisco, California, United States
4
Mayo Clinic
Rochester, Minnesota, United States