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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 3

Conditions: Chronic Hepatitis B

Treatments: Drug: Entecavir

Study type: Interventional

Funder types: Industry

Identifiers

NCT00035633

AI463-022

Details and patient eligibility

About

The purpose of this clinical research study is to assess the safety effectiveness of entecavir, as compared to lamivudine, in the treatment of adults with chronic hepatitis B infection who are hepatitis B e antigen positive.

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

• Male and female subjects =/> 16 years of age (or minimum age required in a given country) with history of chronic hepatitis B infection;
• Documentation of positive Hepatitis B e antigen (HBeAg) status.;
• The absence of coinfection with immunodeficiency virus (HIV), hepatitis C virus (HCV) or hepatitis D virus (HDV);
• The 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)