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Tracking Information | |
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First Received Date ICMJE | April 22, 2003 |
Last Updated Date | June 1, 2007 |
Start Date ICMJE | June 2001 |
Current Primary Outcome Measures ICMJE | |
Original Primary Outcome Measures ICMJE | |
Change History | Complete list of historical versions of study NCT00059267 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures ICMJE | |
Original Secondary Outcome Measures ICMJE | |
Descriptive Information | |
Brief Title ICMJE | Prevention of Recurrent Hepatitis B After Liver Transplantation |
Official Title ICMJE | Prevention of Recurrent Hepatitis B After Liver Transplantation |
Brief Summary | 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. |
Detailed Description | |
Study Phase | |
Study Type ICMJE | Observational |
Study Design ICMJE | Natural History, Longitudinal, Defined Population, Retrospective/Prospective Study |
Condition ICMJE |
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Intervention ICMJE | Drug: HBIG, Epivir, Hepsera |
Study Arms / Comparison Groups | |
Publications * | |
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |
Recruitment Status ICMJE | Completed |
Enrollment ICMJE | 500 |
Completion Date | |
Primary Completion Date | |
Eligibility Criteria ICMJE |
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Gender | Both |
Ages | 13 Years and older |
Accepts Healthy Volunteers | No |
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
Location Countries ICMJE | United States |
Expanded Access Status | |
Administrative Information | |
NCT ID ICMJE | NCT00059267 |
Responsible Party | |
Study ID Numbers ICMJE | NIH HBV-OLT |
Study Sponsor ICMJE | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
Collaborators ICMJE | |
Investigators ICMJE | |
Information Provided By | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
Verification Date | June 2007 |
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |