Overview

This trial is active, not recruiting.

Condition chronic hepatitis b
Treatments lb80380, entecavir 0.5 mg
Phase phase 2
Sponsor LG Life Sciences
Start date August 2010
End date September 2012
Trial size 115 participants
Trial identifier NCT01242787, BVCL008

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Entecavir 0.5 mg
entecavir 0.5 mg
Entecavir 0.5 mg, by oral for 48 weeks
(Experimental)
Optimal dose of LB80380 (optimal dose will be chosen early 2011 based on the results of LG-BVCL007 study)
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)

Primary Outcomes

Measure
Percentage of patients showing HBV DNA mutation
time frame: at Week 48

Secondary Outcomes

Measure
Change of HBV DNA from Baseline of LG-BVCL007 study
time frame: at Week 48

Eligibility Criteria

Male or female participants from 18 years up to 66 years old.

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

Additional Information

Official title 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
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
Trial information was received from ClinicalTrials.gov and was last updated in April 2012.
Information provided to ClinicalTrials.gov by LG Life Sciences.