A Phase 2 interventional study of Hepalatide and Placebo of Hepalatide in Chronic Hepatitis B, sponsored by Shanghai HEP Pharmaceutical Co., Ltd.. Completed at 1 site in China. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2024-07-15.
Sponsored by Shanghai HEP Pharmaceutical Co., Ltd. · Phase 2, Interventional, and Treatment
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).
HBsAg or/and HBV DNA Positive for at least 6 months
Exclusion Criteria:
Contraindications of Peginterferon such as depressive disorder, epilepsy, autoimmune diseases, uncontrolled thyroid dysfunction, etc
with history of alcohol or drug abuse
Patients will receive 6.3mg Hepalatide +25mg Tenofovir alafenamide+ 90ug Pegylated Interferon for 48 weeks with a further follow-up period of 24 weeks.
Drug: Hepalatide · Drug: Tenofovir Alafenamide Tablets · Drug: Pegylated Interferon alfa 2a
Patients will receive Placebo +25mg Tenofovir alafenamide + 90ug Pegylated Interferon for 48 weeks with a further follow-up period of 24 weeks.
Drug: Placebo of Hepalatide · Drug: Tenofovir Alafenamide Tablets · Drug: Pegylated Interferon alfa 2a
6.3mg, s.c., qd for 48 weeks
Also known as: L47
s.c., qd for 48 weeks
Also known as: Placebo
25mg, p.o., qd for 48 weeks
Also known as: Vemlidy
90ug, s.c., qw for 48 weeks
Also known as: Pegasys
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
Plan to share: No
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This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
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Shanghai HEP Pharmaceutical Co., Ltd.