The purpose of the study is to investigate the safety and the antiviral activity of ascending multiple oral doses of LB80380 for 12 weeks in adults with lamivudine-refractory chronic hepatitis B infection.

NCT00895596

Conditions

1. Chronic Hepatitis B

Interventions

1. Drug: LB80380

MeSH:Hepatitis A Hepatitis B Hepatitis B, Chronic Hepatitis Hepatitis, Chronic

HPO:Chronic active hepatitis Chronic hepatitis Hepatitis

- Presence of HBeAg for more than 1 month with compensated liver disease - Confirmation of YMDD mutants (M552V, M552I and its related double mutant at L528M) by genotyping of the YMDD motif using line probe assay (INNO-LiPA HBV DR assay) - Screening HBV DNA value higher than or equal to 1,000,000 copies/mL (measured by the COBAS Amplicor HBV Monitor™ assay) - Screening ALT value between 1.5 and 10 x ULN Exclusion Criteria: - Co-infection with hepatitis C or D virus (HCV or HDV) or HIV - Pregnancy or breast-feeding - Previous treatment with nucleoside analogue or any other treatment for HBV except for lamivudine within 6 months prior to study entry - Treatment with immunomodulatory agent or corticosteroids within 6 months prior to study entry. --- M552V --- --- M552I --- --- L528M ---