This is a multicenter, randomized, controlled Phase IIa study of HH-003 injection, HH-003 injection is a monoclonal antibody targeting Hepatitis B virus. This study aims to evaluate the antiviral activity and safety in subjects with with HBeAg-negative Chronic Hepatitis B treated with nucleos(t)ide reverse transcriptase inhibitors.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
73
Subjects will receive NrtIs therapy for 24 weeks.
Subjects will receive HH-003 20 mg/kg intravenously Q2W for 24 weeks.
Subjects will receive HH-003 20 mg/kg intravenously Q2W for 24 weeks. Subjects will receive NrtIs therapy for 24 weeks.
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China
Proportion of participants achieving sustained viral response
Time frame: From baseline to Week 24
Changes from baseline in serum HBsAg levels
Time frame: From treatment start to Week 24
Proportion of participants with undetectable HBV DNA in those with positive HBV DNA at baseline
Time frame: From treatment start to Week 24
Proportion of participants achieving sustained viral response
Time frame: From baseline to Week 48
Duration of sustained viral response
Time frame: From treatment start to Week 48
Changes from baseline in serum HBsAg levels
Time frame: From treatment start up to Week 48
Proportion of participants with HBV pgRNA negativation in those with positive HBV pgRNA at baseline
Time frame: From baseline to Week 24
Proportion of participants with normal ALT levels
Time frame: From treatment start to Week 48
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