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Prevention of Recurrent Hepatitis B After Liver Transplantation
This study has been completed.
Sponsored by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier: NCT00059267
  Purpose

Hepatitis B accounts for approximately 5000 deaths per year in the United States. Liver transplantation offers the only hope for patients who develop end-stage liver disease. Early results of liver transplantation for hepatitis B were poor with recurrence rate of 80% and 1-year survival of only 50%. Recent studies found that preventive therapy using hepatitis B immune globulin (HBIG) or antiviral medications such as lamivudine can reduce the recurrence rate to roughly 30% with accompanying improvement in survival. However, HBIG when given as intravenous infusion in high doses is very expensive, while long-term use of lamivudine is associated with drug resistance. Some studies found that preventive therapy using both HBIG and lamivudine may decrease recurrence rate to less than 10% but the dose and duration of HBIG needed when used in combination with lamivudine is not clear. Adefovir, a new antiviral medication, is effective against lamivudine resistant hepatitis B but its role in liver transplantation is uncertain because of the risk of kidney damage. Many studies showed that the risk of recurrent hepatitis B is related to the viral load before transplant. Thus, it may be possible to tailor the preventive therapy according to the risk. The aim of this study is to establish the most cost-effective preventive therapy for recurrent hepatitis B after liver transplantation.


Condition Intervention
Hepatitis B
Cirrhosis
Acute Liver Failure
Hepatocellular Carcinoma
Drug: HBIG, Epivir, Hepsera

MedlinePlus related topics: Hepatitis Hepatitis B Liver Transplantation
Drug Information available for: Lamivudine Hepatitis B Vaccines Adefovir dipivoxil Adefovir
U.S. FDA Resources
Study Type: Observational
Study Design: Natural History, Longitudinal, Defined Population, Retrospective/Prospective Study
Official Title: Prevention of Recurrent Hepatitis B After Liver Transplantation

Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Estimated Enrollment: 500
Study Start Date: June 2001
  Eligibility

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • Patients awaiting or had received liver or combined liver-kidney transplantation for hepatitis B including hepatitis B cirrhosis, hepatitis B liver cancer and fulminant hepatitis B.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00059267

Locations
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
  More Information

Study ID Numbers: NIH HBV-OLT
Study First Received: April 22, 2003
Last Updated: June 1, 2007
ClinicalTrials.gov Identifier: NCT00059267  
Health Authority: United States: Federal Government

Study placed in the following topic categories:
Liver Diseases
Hepatitis, Chronic
Fibrosis
Carcinoma, Hepatocellular
Liver neoplasms
Hepatitis, Viral, Human
Lamivudine
Liver Cirrhosis
Liver Neoplasms
Liver Failure, Acute
Hepatitis B
Hepatic Insufficiency
Hepatocellular carcinoma
Liver Failure
Digestive System Neoplasms
Recurrence
Carcinoma
Hepatitis
Virus Diseases
Digestive System Diseases
Gastrointestinal Neoplasms
DNA Virus Infections
Adefovir dipivoxil
Adenocarcinoma
Adefovir
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Neoplasms
Pathologic Processes
Neoplasms by Site
Neoplasms by Histologic Type
Hepadnaviridae Infections

ClinicalTrials.gov processed this record on January 16, 2009