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Antiviral Activity of Entecavir in Patients Receiving Liver Transplant Due to Chronic Hepatitis B Virus Infection - NCT00395018-70112(Clinical Trial 154592)



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City:  New Orleans
State:  
LA
Zip Code: 70112
Conditions: Hepatitis B, Chronic
Purpose: The purpose of this clinical research study is to learn if the study drug entecavir will prevent the recurrence of hepatitis B virus in subjects who receive an orthotopic liver transplant (OLT).
Study summary:
Criteria: Inclusion Criteria: - Patients receiving orthotopic liver transplant (OLT) due to end-stage liver disease because of chronic HBV infection, with HBV-DNA < 172 IU/mL (approximately < 1000 copies/mL) prior to liver transplant - Must have detectable hepatitis B surface antigen (HBsAg) at screening and for at least 24 weeks prior to screening Exclusion Criteria: - Patients with hepatocellular carcinoma with evidence of extrahepatic spread, multiple tumors ≥ 6.5 cm in diameter or there is up to three nodules ≥ 4.5 cm in diameter and total tumor diameter is ≥ 8 cm - Co-infection with human immunodeficiency virus (HIV), cytomegalovirus (CMV), Epstein-Barr virus (EBV) or hepatitis C virus (HCV)
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Data Source: ClinicalTrials.gov
Date Processed: February 1, 2010
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