A Phase II of Randomized, Double-blind, Placebo-controlled, Multi-center Study of Hepalatide for Injection Combined With Pegylated Interferon and TAF as Finite Treatment in Chronic Hepatitis B Patients

L47-HB-FIN-1(New Finite)

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 all treatments and followed with further 24 weeks follow-up.

2022-08-23

2024-08-01

2024-08-01

Recruiting

Early phase I

30

Inclusion Criteria: * 1. HBsAg or/and HBV DNA Positive for at least 6 months 2. HBeAg negative 3. Received NAs stabilization therapy for at least 2 years 4. ALT≤ 2×ULN 5. HBV DNA\< LLQD(lower limit of quantitative detection) in Screening 6. Serum total bilirubin\<2×ULN 7. no childbirth plan within 2 years and agree to take effective contraceptive measures throughout the treatment period and within 3 months after the last dose, and that the woman is not pregnant or breastfeeding. 8. have not participant in another clinical trial within 3 months before screening 9. Subjects have good compliance with the protocol 10. Subjects understood and agreed to sign the informed consent form. Exclusion Criteria: * 1. Contraindications of Peginterferon such as depressive disorder, epilepsy, autoimmune diseases, uncontrolled thyroid dysfunction, etc 2. Subjects with cirrhosis, e.g., definite cirrhosis on imaging such as abdominal ultrasound and CT; liver biopsy with Metavir fibrosis score = 4; clinical diagnosis of cirrhosis by the investigator. 3. Decompensated liver disease 4. Child-Pugh score of B-C or over 6 points. 5. Subjects with any of the following circumstances * History of decompensated liver disease * History of serious heart disease (including unstable or uncontrolled heart disease within 6 months) * Uncontrolled seizures, severe psychiatric disorders, or a history of psychiatric disorders * with history of organ transplantation * with poorly controlled diabetes and hypertension * with autoimmune diseases, immune-related extrahepatic manifestations, thyroid disease, malignant tumors, or in immunosuppressive therapy * underlying diseases such as malignant tumor, severe infection, heart failure and chronic obstructive pulmonary disease and other serious diseases. * with history of alcohol or drug abuse 6. Creatinine clearance \<60 mL/min. 7. HAV, HCV, HDV, HEV or HIV co-infection 8. Subjects who must be treated with Nucleosides (acids) other than TAF during treatment period 9. Subjects who used interferon in the 6 months prior to the screening period 10. Positive for anti-HBV Pre-S1 antibody. 11. Hemocytopenia: White blood cells \< 3 × 10\^9 / L, neutrophil \< 1.5 × 10\^9 / L, platelet \< 60 × 10\^9 / L, 12. Female subjects pregnancy test positive 13. known to be allergic to the investigational drug or the underlying treatment drug 14. Other laboratories or auxiliary examinations are obviously abnormal

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 30, 'type': 'ESTIMATED'}}

2023-12-05