Overview

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.