Overview

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

Status:
Completed
Trial end date:
2011-03-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this clinical research study is to learn if the study drug entecavir will prevent the recurrence of hepatitis B virus (HBV) in participants who receive an orthotopic liver transplant (OLT) due to HBV infection.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Bristol-Myers Squibb
Treatments:
Antiviral Agents
Entecavir
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)