A Study in Korea of Entecavir Versus Lamivudine in Adults With Chronic Hepatitis B Infection

• Status: Completed
• Trial end date: 2013-09-01
• Target enrollment: 0
• Participant gender: All

Summary

Entecavir, 0.5 mg daily, will have clinical efficacy (assessed as an undetectable hepatitis B DNA, <300 copies/mL, by Roche Comprehensive Bio-Analytical System Amplicor polymerase chain reaction assay) that is comparable (noninferior) and potentially superior to lamivudine, 100 mg once daily, in adults with hepatitis B e antigen-negative chronic hepatitis B virus infection.

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

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Entecavir; Lamivudine

Criteria

Inclusion Criteria:

• Nucleoside and nucleotide-naive subjects with chronic HBV infection

• Hepatitis B Surface antigen(HBsAg)-positive ≥6 months

• Detectable HBsAg

• HBV DNA ≥ 105 copies/mL by PCR

• ALT 1.3 to 10 x the ULN

• HBeAg negative, anti-hepatitis B Virus E antigen antibody (anti-HBeAb) positive status