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

This is an interventional treatment trial for Chronic Hepatitis B focused on measuring hepalatide, Hepatitis B，finite treatment, Read More

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