Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2025-12-24 @ 6:51 PM
NCT ID:
NCT05244057
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT05244057
Study Brief:
Protocol Section:
NCT05244057