Efficacy Optimizing Research of Lamivudine Therapy

• Status: Completed
• Trial end date: 2013-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to compare the adefovir early add-on to rescue therapy strategy, and also explore the efficacy of Lamivudine and adefovir de-novo combination therapy.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nanfang Hospital of Southern Medical University
• Collaborators: GlaxoSmithKline; Major Science and Technology Special Project of China Eleventh Five-year
• Treatments: Adefovir; Adefovir dipivoxil; Lamivudine

Criteria

Inclusion Criteria:

• Male or female aged 18-65 years;

• Capable of understanding and signing the informed consent. Willing to comply with the study requirements;

• Serum HBsAg and HBeAg positive at study screening; Documented chronic hepatitis B infection determined by the presence of serum HBsAg for at least 6 months;

Exclusion Criteria:

• History of decompensated liver function, or current signs/symptoms of decompensation e.g. ascites, variceal bleeding, encephalopathy or spontaneous peritonitis;

• other protocol defined inclusion/exclusion criteria