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 |
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Recruitment Status
:
Terminated
First Posted
: September 29, 2005
Last Update Posted
: February 13, 2007
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Sponsor:
Cubist Pharmaceuticals LLC
Information provided by:
Cubist Pharmaceuticals LLC
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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 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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| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| 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.
Information from the National Library of Medicine
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
| 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
| Principal Investigator: | Vinod Rustgi, MD | Metropolitan Liver Diseases/ Gastroenterology Center |
| 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 Hepatitis A Hepatitis B 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 |