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

• Status: Completed
• Trial end date: 2011-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to investigate the safety and the antiviral activity of two doses of LB80380 for 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:

• Female or male, 18 to 65 years of age, inclusive

• Chronic hepatitis B

• Not treated with anti-viral therapeutics including interferon or pegylated interferons for more than 12 weeks before Screening

• Not treated with anti-viral therapeutics including interferon or pegylated interferons 6 months within Screening

• Compensated chronic hepatitis B

• HBeAg positive or HBeAg negative

• Elevated serum ALT level (1.2-10 X ULN, inclusive)

Exclusion Criteria:

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

• Decompensated liver disease

• Creatinine clearance (calculated by Cockroft-Gault formula) less than 50 ml/min

• Screening 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

• A history of organ transplantation

Presence of anti-HBs at screening