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
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