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

Hepatitis B Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00228592
• Other study ID #: HepeX-B 2003-12
• Status: Terminated
• Phase: Phase 2
• First received: September 27, 2005
• Last updated: February 12, 2007
• Est. completion date: August 2005

Study information

• Verified date: February 2007
• Source: Cubist Pharmaceuticals LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 0
• Est. completion date: August 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• End Stage Liver Disease
• Hepatitis
• Hepatitis A
• Hepatitis B
• Liver Diseases
• Liver Transplantation

Intervention

Drug:
• HepeX-B

• Hepatitis B Immune Globulin (HBIg)

Locations

Country	Name	City	State
France	Centre Hepato-Biliaire Hospital Paul Brousse	Paris
Germany	Humbolt University Virchow Clinic Dept. Viceral and Transplant Surgery	Berlin
Israel	Hadassah University Hospital	Jerusalem
Israel	Rabin Medical Center	Petach Tikva
Israel	Tel-Aviv Sourasky Medical Center	Tel Aviv
New Zealand	Auckland City Hospital	Auckland
Spain	Hospital La Fe Servicio de Medicina Degestiva	Valencia
United Kingdom	Royal Free Hospital	London
United States	University of North Carolina	Chapel Hill	North Carolina
United States	University of Virginia	Charlottesville	Virginia
United States	University of Cincinnati Medical Center	Cincinnati	Ohio
United States	Metropolitan Liver Diseases/Gastroenterology Center	Fairfax	Virginia
United States	UCLA	Los Angeles	California
United States	Mt. Sinai	New York	New York
United States	University of Nebraska	Omaha	Nebraska
United States	University of Pennsylvania Health System	Philadelphia	Pennsylvania
United States	Virginia Commonwealth University Health System	Richmond	Virginia
United States	Mayo Clinic	Rochester	Minnesota
United States	California Pacific Medical Center	San Francisco	California
United States	UCSF	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Cubist Pharmaceuticals LLC

Countries where clinical trial is conducted

United States,  France,  Germany,  Israel,  New Zealand,  Spain,  United Kingdom,