Overview

A Phase III Study of Entecavir vs Lamivudine in Adults With Chronic Hepatitis B Infection and Negative for Hepatitis B e Antigen

Status:
Completed
Trial end date:
2005-05-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this clinical research study is to assess the safety and effectiveness of entecavir, as compared to lamivudine, in the treatment of adults with chronic hepatitis B infection who are hepatitis B e antigen negative.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Bristol-Myers Squibb
Treatments:
Entecavir
Criteria
- Male and female subjects =/> 16 years of age (or minimum age required in a given
country) with history of chronic hepatitis B infection;

- HBeAg negative, anti-HBeAb positive;

- Absence of coinfection with human immunodeficiency virus (HIV), hepatitis C virus
(HCV) or hepatitis D virus (HDV);

- Absence of other forms of liver disease e.g., alcoholic, autoimmune, biliary disease;

- Less than 12 weeks prior therapy with nucleoside or nucleotide analogue antiviral
agents with activity against hepatitis B (e.g., adefovir, famciclovir and lamivudine)