A multicenter, randomized, open, parallel-designed Phase II study to evaluate the efficacy and safety of HRS-5635 injection alone or in combination with other agents in patients treated for chronic hepatitis B.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
369
HRS-5635 Injection low dose administered by subcutaneous injection
HRS-5635 Injection medium dose administered by subcutaneous injection
HRS-5635 Injection high dose administered by subcutaneous injection
Nanfang Hospital
Guangzhou, Guangdong, China
RECRUITINGPartA:Change in mean log10 serum hepatitis B surface antigen levels from baseline at week 12
Time frame: Week 12
PartB:Proportion of subjects whose serum hepatitis B surface antigen (HBsAg) had turned negative at week 48
Time frame: Week 48
PartC:Proportion of subjects whose serum hepatitis B surface antigen (HBsAg) had turned negative at week 48
Time frame: Week 48
PartD:Proportion of subjects whose serum hepatitis B surface antigen (HBsAg) had turned negative at week 48
Time frame: Week 48
Changes from baseline in mean log10 serum hepatitis B surface antigen levels
Time frame: Pre-specified time points up to 72 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 72 weeks
Proportion of subjects with serum hepatitis B surface antigen loss
Time frame: Pre-specified time points up to 72 weeks
Proportion of subjects with serum hepatitis B surface antigen seroconversion
Time frame: Pre-specified time points up to 72 weeks
Proportion of subjects with hepatitis B e-antigen loss
Time frame: Pre-specified time points up to 72 weeks
Proportion of subjects with serum hepatitis B e-antigen seroconversion
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
HRS-5635 Injection lowest dose administered by subcutaneous injection
HRS-5635 Injection (low dose) and Peg-IFN-α, administered by subcutaneous injection
HRS-5635 Injection (high dose) and Peg-IFN-α, administered by subcutaneous injection
Peg-IFN-α, administered by subcutaneous injection
HRS-5635 Injection and Peg-IFN-α, administered by subcutaneous injection
HRS-5635 Injection, administered by subcutaneous injection
Time frame: Pre-specified time points up to 72 weeks
Proportion of subjects with virologic breakthrough
Time frame: Pre-specified time points up to 72 weeks
Proportion of subjects with drug resistance
Time frame: Pre-specified time points up to 72 weeks
Proportion of subjects who meet the criteria for stopping NA therapy
Time frame: From 48 weeks to 72 weeks
Proportion of subjects with serum hepatitis B surface antigen loss and HBV DNA loss
Time frame: Week 48