Safety and Efficacy Study of LB80380 in the Patients With Lamivudine-Refractory Chronic Hepatitis B

• Status: Completed
• Trial end date: 2007-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: LG Life Sciences
• Treatments: Lamivudine

Criteria

Inclusion Criteria:

• Compensated chronic hepatitis B patient

• Presence of serum HBsAg for more than 6 months.

• 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.

• De-compensated liver disease

• Screening alpha-fetoprotein (AFP) value > 20 ng/mL, and a follow-up ultrasonography performed prior to baseline shows findings indicative of HCC.

• Presence of anti-HBs at screening