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Prevention of Recurrent Hepatitis B after Liver Transplantation



Prevention of Recurrent Hepatitis B after Liver Transplantation

For Condition: Hepatitis B,Acute Liver Failure,Cirrhosis,Hepatocellular Carcinoma
Status: Recruiting
Sponsor(s): National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) ,
Synopsis: 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.
Details:
Eligibility:
Study Type:  Observational, Natural History, Longitudinal, Defined Population, Retrospective/Prospective Study
Minimum Age/Maximum Age: 13 Years/
Genders: Both
Protocol Entry 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.
Total Enrollment: 500

Location and Contact Information:

University of Michigan *Recruiting*
Ann Arbor,  Michigan,  48109
United States
Recruiting Anna  Lok 734-615-4628


Additional Information:
Study ID Numbers:  NIH HBV-OLT; 
Study Start Date: June 2001
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00059267

Other Hepatocellular Carcinoma Studies:
1. Adefovir Dipivoxil to Treat Hepatitis B in HIV-Infected Patients

2. A Phase II Study of the Safety and Efficacy of Adding Entecavir to Current Lamivudine Therapy in HIV and HBV Co-Infected Patients Who Have Hepatitis B Viremia While Being Treated with Lamivudine

3. The Tolerance of HIV-Infected Patients with Herpes Group Virus Infections to Oral Doses of FIAU

4. Lamivudine and Adefovir to Treat Chronic Hepatitis B

5. Pneumococcal Vaccine and Routine Pediatric Immunizations in HIV-Infected Children Receiving Anti-HIV Drugs

Related Studies:

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Prevention of Recurrent Hepatitis B after Liver Transplantation
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