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

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ClinicalTrials.gov Identifier: NCT00228592
Recruitment Status : Terminated
First Posted : September 29, 2005
Last Update Posted : February 13, 2007
Sponsor:
Information provided by:
Cubist Pharmaceuticals LLC

Study Description
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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. 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.

Condition or disease Intervention/treatment Phase
Hepatitis B Liver Transplantation Drug: HepeX-B Drug: Hepatitis B Immune Globulin (HBIg) Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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 Completion Date : August 2005

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Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00228592


Locations
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United States, California
UCLA
Los Angeles, California, United States
California Pacific Medical Center
San Francisco, California, United States
UCSF
San Francisco, California, United States
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States
United States, Nebraska
University of Nebraska
Omaha, Nebraska, United States
United States, New York
Mt. Sinai
New York, New York, United States
United States, North Carolina
University of North Carolina
Chapel Hill, North Carolina, United States
United States, Ohio
University of Cincinnati Medical Center
Cincinnati, Ohio, United States
United States, Pennsylvania
University of Pennsylvania Health System
Philadelphia, Pennsylvania, United States
United States, Virginia
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
France
Centre Hepato-Biliaire Hospital Paul Brousse
Paris, France
Germany
Humbolt University Virchow Clinic Dept. Viceral and Transplant Surgery
Berlin, Germany
Israel
Hadassah University Hospital
Jerusalem, Israel
Rabin Medical Center
Petach Tikva, Israel
Tel-Aviv Sourasky Medical Center
Tel Aviv, Israel
New Zealand
Auckland City Hospital
Auckland, New Zealand
Spain
Hospital La Fe Servicio de Medicina Degestiva
Valencia, Spain
United Kingdom
Royal Free Hospital
London, United Kingdom
Sponsors and Collaborators
Cubist Pharmaceuticals LLC
Investigators
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Principal Investigator: Vinod Rustgi, MD Metropolitan Liver Diseases/ Gastroenterology Center
More Information
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ClinicalTrials.gov Identifier: NCT00228592     History of Changes
Other Study ID Numbers: HepeX-B 2003-12
First Posted: September 29, 2005    Key Record Dates
Last Update Posted: February 13, 2007
Last Verified: February 2007
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis B
Hepatitis
Liver Diseases
End Stage Liver Disease
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
 Hepadnaviridae Infections
DNA Virus Infections
Liver Failure
Hepatic Insufficiency
Immunoglobulins
Antibodies
gamma-Globulins
Immunoglobulins, Intravenous
Rho(D) Immune Globulin
Immunologic Factors
Physiological Effects of Drugs