To evaluate the efficacy and safety of HRS9950 tablets in chronic hepatitis B patients who are virologically suppressed on nucleoside or nucleotide analogues (NAs).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
54
HRS9950 tablets, oral, once a week, low dose
HRS9950 tablets, oral, once a week, high dose
HRS9950 placebo tablets, oral, once a week.
Nanfang Hospital
Guangzhou, Guangdong, China
Change in mean log10 serum hepatitis B surface antigen levels from baseline to week 24
Time frame: Week 24
Changes from baseline in mean log10 serum hepatitis B surface antigen levels
Time frame: Pre-specified time points up to 48 weeks
Proportion of subjects with at least one log10 decline from baseline in serum hepatitis B surface antigen
Time frame: Pre-specified time points up to 48 weeks
Proportion of subjects with serum hepatitis B surface antigen loss
Time frame: Pre-specified time points up to 48 weeks
Proportion of subjects with serum hepatitis B surface antigen seroconversion
Time frame: Pre-specified time points up to 48 weeks
Proportion of subjects with hepatitis B e-antigen loss
Time frame: Pre-specified time points up to 48 weeks
Proportion of subjects with serum hepatitis B e-antigen seroconversion
Time frame: Pre-specified time points up to 48 weeks
Proportion of subjects with virologic breakthrough
Time frame: Pre-specified time points up to 48 weeks
Proportion of subjects with drug resistance
Time frame: Pre-specified time points up to 48 weeks
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