NCT01242787

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

A Multinational, Multi-center, Open, Comparative, Paralleled, Roll-over Study to Assess the Safety and Antiviral Activity of LB80380 Tablet Compared to Entecavir 0.5 mg After Additional 48 Weeks of Treatment in Chronic Hepatitis B Patients Who Have Completed LG-BVCL007 Study

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 115 (estimated)
• Sponsor: LG Life Sciences · Industry
• Sex: All
• Age: 18 Years – 66 Years
• Healthy volunteers: Not accepted

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.

Detailed description

LB80380, an oral prodrug, is a promising candidate nucleotide analogue with antiviral activity against wild-type hepatitis B virus (HBV). LB80380 is undergoing clinical development by LG Life Sciences for use in the treatment of chronic HBV infection. This study is an extension study of the Phase IIb (Protocol No. LG-BVCL007), the treatment period of this study is 48-week with 24-week of follow-up period

Conditions

• Chronic Hepatitis B

Interventions

Type	Name	Description
DRUG	LB80380	Optimal dose of LB80380, by oral for 48 weeks (optimal dose will be chosen early 2011 based on the results of LG-BVCL007 study)
DRUG	Entecavir 0.5 mg	Entecavir 0.5 mg, by oral for 48 weeks

Timeline

• Start date: 2010-08-01
• Primary completion: 2012-09-01
• Completion: 2012-09-01
• First posted: 2010-11-17
• Last updated: 2012-04-16

Locations

2 sites across 2 countries: China, South Korea