The study is designed to assess efficacy of a finitie treatment in Chronic Hepatitis B patients who had stable treatment of NAs for ≧ 2 years, which is compared hepalatide in combination with Pegylated Interferon + TAF with Pegylated Interferon +TAF. Subjects will be randomly assigned to the hepalatide or placebo groups , 15 subjects in each group . Subjects will receive hepalatide+Pegylated Interferon +TAF treatment for 48 weeks or placebo +PegylatedInterferon +TAF treatment for 48 weeks , Then, stopping hepalatide and Pegylate Interferon treatments and followed with further 8 weeks follow-up.
Hepalatide is a liver-targeted antiviral therapeutic for subcutaneous injection designed to treat chronic hepatitis B virus (HBV) infection. The aim of this study is to assess efficacy of a finitie treantment , that combination regimen of hepalatide+half dose Pegylated interferon + TAF , as measured by the primary efficacy endpoint. This study will be conducted in 3 periods: Screening Period (4weeks), Treatment Period (48 weeks) and Follow-up (FU) Period (8 weeks). Safety assessments will include adverse events (AEs), serious AEs, clinical safety laboratory tests, electrocardiograms (ECGs), vital signs, ophthalmologic examinations and physical examinations. Total duration of individual participation will be up to 60 weeks (including screening period).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
8
6.3mg, s.c., qd for 48 weeks
s.c., qd for 48 weeks
25mg, p.o., qd for 48 weeks
90ug, s.c., qw for 48 weeks
Shanghai Tong Ren Hospital
Shanghai, Shanghai Municipality, China
Proportion of subjects with negative conversion of HBsAg
Proportion of subjects with negative conversion of HBsAg treatment at 8 weeks off treatment
Time frame: 56 Weeks
Number of subjects with virological relapse(VR) at 8 weeks off treatment
VR: reappearance of HBV DNA \> 2000 IU/ml from undetectable status
Time frame: 56 Weeks
Number of subjects with clinical relapse(CR) at 8 weeks off treatment
CR: the presence of VR with the elevation of alanine transaminase (ALT) more than two times upper limit of normal (ULN)
Time frame: 56 Weeks
HBsAg is down from baseline at 8 weeks off treatment
HBsAg is down from baseline log10
Time frame: 56 Weeks
Number of subjects with Serological conversion of HBsAg
Number of subjects with Serological conversion of HBsAg at 8 weeks off treatment
Time frame: 56 Weeks
Change in liver stiffness at 8 weeks off treatment
The findings of Liver stiffness measurement(LSM) of Fibroscan/FibroTouch at week 8 off treatment compared to baseline
Time frame: 56 Weeks
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