Chronic Hepatitis B
Conditions
Brief summary
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.
Interventions
DRUGEntecavir
Sponsors
Bristol-Myers Squibb
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion 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)
Countries
United States
Outcome results
None listed