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.
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
115
Optimal dose of LB80380, by oral for 48 weeks (optimal dose will be chosen early 2011 based on the results of LG-BVCL007 study)
Entecavir 0.5 mg, by oral for 48 weeks
Queen Mary Hospital
Hong Kong, China
Severance Hospital of Yonsei University and other 8 sites in Korea
Seoul, South Korea
Percentage of patients showing HBV DNA mutation
Safety assessment including adverse events, laboratory abnormalities and DNA mutation
Time frame: at Week 48
Change of HBV DNA from Baseline of LG-BVCL007 study
Efficacy assessment including normalization of ALT, HBsAg seroconversion, HBeAg seroconversion
Time frame: at Week 48
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