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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
115
LB80380 90 mg + placebo tablets, once daily, for 48 weeks
LB80380 60 mg + 90 mg tablets, once daily, for 48 weeks
entecavir 0.5 mg tablet, once daily, for 48 weeks
Queen Mary Hospital
Hong Kong, China
Hanyang University Guri Hospital
Guri-si, Gyeonggi-do, South Korea
Inha University Hospital
Incheon, Inchen, South Korea
Kyungpook National University Hospital
Changes in HBV DNA level (log10) from baseline
Time frame: At Week 24
Proportion of patients with undetectable serum HBV DNA
Time frame: At Week 24 or Week 48
Proportion of patients with HBeAg seroconversion
Time frame: At Week 24 or Week 48
Proportion of patients with ALT normalization
Time frame: At Week 24 or Week 48
Safety assessment during the whole study period
Time frame: At Week 24 or Week 48
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