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).

Official Title

Study of the Antiviral Activity of Entecavir in Patients Receiving Liver Transplant Due to Chronic Hepatitis B Virus Infection

Conditions

Hepatitis B, Chronic

Study Type

Interventional

Study Design

Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Further Details

  • Primary Outcome Measures:Recurrence of hepatitis B virus (HBV) as measured by HBV DNA by PCR > 50 IU/mL (approximately > 300 copies/mL) [Time Frame: at 72 weeks post liver transplant]
  • Secondary Outcome Measures: Serological endpoints will be assessed as counts and proportions. [Time Frame: at 72 weeks post liver transplant]

Study Start

April 2007

Eligibility & Criteria

  • Ages Eligible for Study: 16 Years and above
  • Genders Eligible for Study: Both

Inclusion Criteria:

  • 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)

Total Enrolment

70

Contact Details

  • Woolloongabba, Queensland, 4102, Australia; Recruiting
  • Heidelberg, Victoria, 3084, Australia; Recruiting