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