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