Antiviral Activity of Entecavir in Patients Receiving Liver Transplant Due to Chronic Hepatitis B Virus Infection
NCT00395018 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 109
Last updated 2012-05-31
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.
Conditions
- Hepatitis B, Chronic
Interventions
- DRUG
-
entecavir
Tablets, Oral, 1 mg, once daily, up to 72 weeks
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Bristol-Myers Squibb · Bristol-Myers Squibb
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 16 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2007-04-30
- Primary Completion
- 2011-03-31
- Completion
- 2011-03-31
Countries
- United States
- Argentina
- Australia
- Brazil
- France
- Italy
- South Korea
- Spain
- Taiwan
Study Locations
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