HepeX-B in Post Hepatic Allografts for Treatment of End Stage Liver Disease Due to Hepatitis B Infection
Information source: Cubist Pharmaceuticals
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hepatitis B; Liver Transplantation
Intervention: HepeX-B (Drug); Hepatitis B Immune Globulin (HBIg) (Drug)
Phase: Phase 2
Status: Terminated
Sponsored by: Cubist Pharmaceuticals Official(s) and/or principal investigator(s):
Vinod Rustgi, MD, Principal Investigator, Affiliation: Metropolitan Liver Diseases/ Gastroenterology Center
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.
Clinical Details
Official title: A Phase II, Multicenter, Randomized, Open-Label, Dose-Ranging, Parallel Group Study to Compare the Anti-Viral Effects, Pharmacokinetics and Safety of HepeX-Bä, a Mixture of Two Monoclonal Antibodies, as Compared to Hepatitis B Immune Globulin in Patients Who Have Received Hepatic Allografts for Treatment of End-Stage Liver Disease Due to Hepatitis B Virus Infection
Study design: Prevention, Randomized, Open Label, Uncontrolled, Parallel Assignment
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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 Criteria:
- 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.
Locations and Contacts
Centre Hepato-Biliaire Hospital Paul Brousse, Paris, France
Humbolt University Virchow Clinic Dept. Viceral and Transplant Surgery, Berlin, Germany
Hadassah University Hospital, Jerusalem, Israel
Tel-Aviv Sourasky Medical Center, Tel Aviv, Israel
Rabin Medical Center, Petach Tikva, Israel
Auckland City Hospital, Auckland, New Zealand
Hospital La Fe Servicio de Medicina Degestiva, Valencia, Spain
Royal Free Hospital, London, United Kingdom
California Pacific Medical Center, San Francisco, California, United States
UCLA, Los Angeles, 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
Metropolitan Liver Diseases/Gastroenterology Center, Fairfax, Virginia, United States
University of Virginia, Charlottesville, Virginia, United States
Virginia Commonwealth University Health System, Richmond, Virginia, United States
Additional Information
Ending date: August 2005
Last updated: February 12, 2007
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