Continuing Lamivudine vs Switching to Entecavir in Patients With Detectable HBV DNA

• Status: Completed
• Trial end date: 2010-11-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a randomized, open-labelled, prospective 96-week study comparing the antiviral efficacy and safety of switching to entecavir 1 mg QD from lamivudine versus maintaining lamivudine 100 mg QD treatment in HBV-infected subjects currently receiving lamivudine monotherapy.

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

Details

• Lead Sponsor: Yonsei University
• Collaborator: Pusan National University Hospital
• Treatments: Entecavir; Lamivudine

Criteria

Inclusion Criteria:

• Adult subjects (18-70 years of age) currently taking lamivudine monotherapy for chronic HBV infection for at least 6 months with ≥ HBV DNA 60 IU/mL level and HBeAg positive at baseline.

Exclusion Criteria:

• All subjects will be tested for presence of M204V/I mutations in the YMDD motif at baseline. Subjects with M204V/I mutations in the YMDD motif at baseline are not eligible for the study.

• Subjects treated with other antiviral drugs (e.g. adefovir) in combination with lamivudine are not eligible for this study.

• Subjects should have ALT < 10 x ULN, and no evidence of hepatocellular carcinoma.

• Subjects should be without serological evidence of co-infection with HCV, HIV, or HDV.

• Subjects with decompensated liver disease, as well as pregnant or breast-feeding women, will not be eligible for the study.