Adefovir Dipivoxil In Compensated Chronic Hepatitis B Patients

• Status: Completed
• Trial end date: 2008-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Adefovir; Adefovir dipivoxil; Lamivudine

Criteria

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.