A Study of Hepalatide Combined With TAF and PEG-IFN as Finite Treatment of Chronic Hepatitis B Patients
Chronic Hepatitis B
About this trial
This is an interventional treatment trial for Chronic Hepatitis B focused on measuring hepalatide, Hepatitis B,finite treatment,
Eligibility 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
Sites / Locations
- Shanghai Tong Ren HospitalRecruiting
- Shanghai East Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Hepalatide + TAF + PEG-IFN
Placebo+ TAF + PEG-IFN
Patients will receive 4.2mg Hepalatide +25mg Tenofovir alafenamide+ 90ug Pegylated Interferon for 48 weeks with a further follow-up period of 24 weeks.
Patients will receive Placebo +25mg Tenofovir alafenamide + 90ug Pegylated Interferon for 48 weeks with a further follow-up period of 24 weeks.