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

Más betegség

• 1. Contraindications of Peginterferon such as depressive disorder, epilepsy, autoimmune diseases, uncontrolled thyroid dysfunction, etc
  • 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.
  • Decompensated liver disease
  • Child-Pugh score of B-C or over 6 points.
  • 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.

Laborértékek

• with history of alcohol or drug abuse
  • Creatinine clearance <60 mL/min.
  • HAV, HCV, HDV, HEV or HIV co-infection
  • Subjects who must be treated with Nucleosides (acids) other than TAF during treatment period
  • Subjects who used interferon in the 6 months prior to the screening period
  • Positive for anti-HBV Pre-S1 antibody.
  • Hemocytopenia: White blood cells < 3 × 10\^9 / L, neutrophil < 1.5 × 10\^9 / L, platelet < 60 × 10\^9 / L,
  • Female subjects pregnancy test positive
  • known to be allergic to the investigational drug or the underlying treatment drug
  • Other laboratories or auxiliary examinations are obviously abnormal

• 1. HBsAg or/and HBV DNA Positive for at least 6 months
  • HBeAg negative
  • Received NAs stabilization therapy for at least 2 years
  • ALT≤ 2×ULN
  • HBV DNA< LLQD(lower limit of quantitative detection) in Screening
  • Serum total bilirubin<2×ULN
  • 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.
  • have not participant in another clinical trial within 3 months before screening
  • Subjects have good compliance with the protocol
  • Subjects understood and agreed to sign the informed consent form.