This is a multicenter, randomized, controlled, open-label, Phase IIb study of HH-003 injection, HH-003 injection is a monoclonal antibody targeting Hepatitis B virus. This study aims to assess efficacy and safety in subjects with chronic hepatitis delta virus infection.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
101
20 mg/kg Q2W intravenously for 48 weeks
10 mg/kg Q2W intravenously for 48 weeks
TAF 25 mg QD orally during 48-week treatment period and 24-week follow-up period
Beijing Ditan Hospital Captial Medical University
Beijing, Beijing Municipality, China
Proportion of subjects with serum HDV RNA below the lower limit of detection or a decrease of ≥2 log10 IU/mL from baseline and ALT normalization
Time frame: At Week 24 of the treatment period
Proportion of subjects with serum HDV RNA below the lower limit of detection or a decrease of ≥2 log10 IU/mL from baseline
Time frame: At Week 24 of the treatment period
Proportion of subjects with ALT normalization
Time frame: At Week 24 of the treatment period
Change from baseline in liver stiffness measurement (LSM)
Time frame: At Week 24 of the treatment period
Proportion of subjects with serum HDV RNA below the lower limit of detection or a decrease of ≥2 log10 IU/mL from baseline and ALT normalization
Time frame: At Week 48 of the treatment period
Proportion of subjects with serum HDV RNA below the lower limit of detection or a decrease of ≥2 log10 IU/mL from baseline
Time frame: At Week 48 of the treatment period
Proportion of subjects with ALT normalization
Time frame: At Week 48 of the treatment period
Change from baseline in liver stiffness measurement (LSM)
Time frame: At Week 48 of the treatment period
Proportion of subjects with serum HDV RNA below the lower limit of detection or a decrease of ≥2 log10 IU/mL from baseline
Time frame: At Week 24 of the follow-up period
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Proportion of subjects with ALT normalization
Time frame: At Week 24 of the follow-up period
Change from baseline in liver stiffness measurement (LSM)
Time frame: At Week 24 of the follow-up period
Change from baseline in serum HDV RNA levels at different time points
Time frame: Up to Week 72
Change from baseline in serum ALT levels at different time points
Time frame: Up to Week 72