Adefovir Dipivoxil In Compensated Chronic Hepatitis B Patients

Phase III Study of Adefovir Dipivoxil Tablets in Patients With Compensated Chronic Hepatitis B -Comparative Study Against Lamivudine-

This study is designed to compare the efficacy and safety of adefovir dipivoxil 10 mg with lamivudine 100 mg in Japanese patients with compensated chronic hepatitis B over 52-week periods.

Inclusion criteria:

• Have compensated chronic hepatitis B.
• Have not been treated with anti HBV agents with antiproliferative activity against. However, previous Interferon (IFN) therapy is permitted.
• Ability to read, understand, and sign the informed consent.
• Have a positive serum HBV-DNA >= 1,000,000 copies/mL and ALT level 50-500 U/L

Exclusion criteria:

• Having or suspected of having liver cancer.
• Co-infected with Hepatitis C virus (HCV) or Human Immunodeficiency virus (HIV).
• Autoimmune hepatitis.
• Received any previous transplantation or having a plan for any transplantation.
• Existence of any serious complication, except hepatitis B.