Status:
COMPLETED
A Study of Hepalatide Combined With TAF and PEG-IFN as Finite Treatment of Chronic Hepatitis B Patients
Lead Sponsor:
Shanghai HEP Pharmaceutical Co., Ltd.
Collaborating Sponsors:
Shanghai Tong Ren Hospital
Shanghai East Hospital
Conditions:
Chronic Hepatitis B
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
Brief 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 Pegylate...
Detailed Description
Hepalatide is a liver-targeted antiviral therapeutic for subcutaneous injection designed to treat chronic hepatitis B virus (HBV) infection. The aim of this study is to assess efficacy of a finitie tr...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 23 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 24 2024
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT05244057
Start Date
August 23 2022
End Date
June 24 2024
Last Update
July 15 2024
Active Locations (1)
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1
Shanghai Tong Ren Hospital
Shanghai, Shanghai Municipality, China, 200050