A Study of Hepalatide Combined With TAF and PEG-IFN as Finite Treatment of Chronic Hepatitis B Patients

• Status: Not yet recruiting
• Trial end date: 2024-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai HEP Pharmaceutical Co., Ltd.
• Collaborators: Shanghai East Hospital; Shanghai Tong Ren Hospital
• Treatments: Interferon alpha-2; Interferon-alpha; Interferons; Peginterferon alfa-2a; Tenofovir

Criteria

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