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Prevention of Recurrent Hepatitis B After Liver Transplantation
This study has been completed.
Study NCT00059267   Information provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First Received: April 22, 2003   Last Updated: June 1, 2007   History of Changes

April 22, 2003
June 1, 2007
June 2001
 
 
Complete list of historical versions of study NCT00059267 on ClinicalTrials.gov Archive Site
 
 
 
Prevention of Recurrent Hepatitis B After Liver Transplantation
Prevention of Recurrent Hepatitis B After Liver Transplantation

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.

 
 
Observational
Natural History, Longitudinal, Defined Population, Retrospective/Prospective Study
  • Hepatitis B
  • Cirrhosis
  • Acute Liver Failure
  • Hepatocellular Carcinoma
Drug: HBIG, Epivir, Hepsera
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
500
 
 
  • 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.
Both
13 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00059267
 
NIH HBV-OLT
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
 
 
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
June 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP