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

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

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.

Study Overview

• Status: Terminated
• Conditions: Liver Transplantation; Hepatitis B
• Intervention / Treatment: Drug: HepeX-B; Drug: Hepatitis B Immune Globulin (HBIg)

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Collaborators and Investigators

• Sponsor: Cubist Pharmaceuticals LLC
• Investigators: Principal Investigator: Vinod Rustgi, MD, Metropolitan Liver Diseases/ Gastroenterology Center

Study record dates

Study Major Dates

• Study Completion: August 1, 2005

Study Registration Dates

• First Submitted: September 27, 2005
• First Submitted That Met QC Criteria: September 27, 2005
• First Posted (Estimate): September 29, 2005

Study Record Updates

• Last Update Posted (Estimate): February 13, 2007
• Last Update Submitted That Met QC Criteria: February 12, 2007
• Last Verified: February 1, 2007

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Failure; Hepatic Insufficiency; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Hepatitis, Viral, Human; Hepadnaviridae Infections; DNA Virus Infections; Enterovirus Infections; Picornaviridae Infections; Liver Diseases; End Stage Liver Disease; Hepatitis B; Hepatitis; Hepatitis A; Physiological Effects of Drugs; Immunologic Factors; Antibodies; Immunoglobulins; Immunoglobulins, Intravenous; gamma-Globulins; Rho(D) Immune Globulin
• Other Study ID Numbers: HepeX-B 2003-12