This is a phase2, randomized, single-blind, placebo controlled and multi-center study in adults with chronic hepatitis B virus. The study is aimed at evaluating efficacy and safety of ASC42 in combination with entecavir and pegylated interferon α-2a in subjects with chronic hepatitis B virus.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
43
ASC42 10mg orally once daily;
ASC42 15mg orally once daily.
ih PEG-IFN α-2a 180μg subcutaneous injection once a week.
NanFang Hospital of Southern Medical University
Guangzhou, Guangdong, China
Serum HBsAg change compared with baseline
Time frame: Week 12 of intervention\Week 24 of follow-up
Serum HBV pgRNA change compared with baseline
Time frame: Week 12 of intervention\Week 24 of follow-up
Serum HBsAg change compared with baseline
Time frame: Week 2, 4 ,8 of intervention\Week 4,12 of follow-up
Serum HBV pgRNA change compared with baseline
Time frame: Week 2, 4 ,8 of intervention\Week 4,12 of follow-up
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Entecavir 0.5 mg orally once daily.
Placebo orally once daily.