Long-term Safety and Efficacy Study of LB80380 in the Treatment-naive Patients of Chronic Hepatitis B

• Status: Unknown status
• Trial end date: 2012-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to investigate the long-term safety and the antiviral activity of the optimal doses of LB80380 for additional 48 weeks in treatment-naive patients with chronic hepatitis B infection compared to entecavir 0.5 mg.

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

Details

• Lead Sponsor: LG Life Sciences
• Treatments: Entecavir

Criteria

Inclusion Criteria:

• The patients who are able to participate in this expanded study without any interruption after completing 48 weeks treatment of LG-BVCL007 study

Exclusion Criteria:

• Co-infection with hepatitis C or D virus (HCV or HDV) or HIV

• Decompensated liver disease

• ALT > 10 x ULN

• Creatinine clearance (calculated by cockcroft-gault formula) less than 50 ml/min

• Alpha-fetoprotein (AFP) value greater than or equal to 50 ng/mL, and a follow-up ultrasonography performed prior to baseline shows findings indicative of HCC

• Treatment with immunomodulatory agent or corticosteroids within 6 months prior to study entry.

• Pregnancy or breast-feeding

• Patient is currently abusing alcohol or illicit drugs

• Significant systemic illnesses other than liver diseases

• Presence of other causes of liver disease

• Plan for liver transplantation