NCT01026610

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

A Phase IIb, Open, Multinational, Multi-center, Randomised, Comparative, Parallel Study to Assess the Safety and Antiviral Activity of LB80380 Compared to Entecavir 0.5 mg in Chronic Hepatitis B Patients for 48 Weeks With a Planned Analysis of Efficacy and Safety at Week 24 of the Treatment for Selecting Optimal Dose

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 115 (actual)
• Sponsor: LG Life Sciences · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

LB80380, an oral prodrug, is a promising candidate nucleotide analogue with antiviral activity against wild-type HBV. LB80380 is undergoing clinical development by LG Life Sciences for use in the treatment of chronic HBV infection. In this study, the treatment period is 48-week with 24-week of follow-up period.

Conditions

• Chronic Hepatitis B

Interventions

Type	Name	Description
DRUG	LB80380 90 mg	LB80380 90 mg + placebo tablets, once daily, for 48 weeks
DRUG	LB80380 150 mg	LB80380 60 mg + 90 mg tablets, once daily, for 48 weeks
DRUG	entecavir 0.5 mg	entecavir 0.5 mg tablet, once daily, for 48 weeks

Timeline

• Start date: 2009-08-01
• Primary completion: 2010-11-01
• Completion: 2011-05-01
• First posted: 2009-12-04
• Last updated: 2012-10-05

Locations

10 sites across 2 countries: China, South Korea