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 @ 4:35 PM
Ignite Modification Date:
2025-12-24 @ 4:35 PM
NCT ID:
NCT06900166
Eligibility Criteria:
Inclusion Criteria:
1. Aged between 18 and 65 (inclusive), regardless of gender;
2. Fibroscan ≤ 7.4kpa;
3. HBeAg-negative CHB patients: HBsAg positive, HBeAg negative, HBsAb negative and HBeAb positive before receiving NUC treatment and during screening in this study;
4. HBeAg-negative chronic hepatitis B patients without liver cirrhosis who have been viral-negative for more than 3 years after receiving NUC treatment, and they meet the 2017 EASL guideline discontinuation standard (HBV DNA is lower than the lower limit of detection, that is, \<20 IU/ml);
5. HBsAg≤1000 IU/ml;
6. Have the intention to stop taking the drug, and sign a written informed consent.
Exclusion Criteria:
1. HBsAb positive during screening;
2. Patients with hepatitis B cirrhosis in the compensatory and decompensated stage: patients with a clear history of cirrhosis (imaging or histological evidence) or Child-Pugh score ≥5 before NUC treatment, or complications of cirrhosis in the decompensated stage such as ascites, hepatic encephalopathy, esophageal variceal hemorrhage, etc.;
3. Patients who are allergic to alpha interferon and its drug ingredients, and the researchers judge that alpha interferon is not suitable for patients;
4. Received immunomodulators (including interferon, etc.) within 1 year before screening;
5. Combined with HAV, HCV, HDV, HEV, HIV infection, alcoholic liver disease, genetic metabolic liver disease, drug liver disease, non-alcoholic fatty liver disease and other chronic liver diseases;
6. Combined with autoimmune diseases, including autoimmune liver disease, psoriasis, etc.
7. Patients with primary liver cancer or screening with AFP greater than 100 ng/ml and imaging findings indicating the possibility of malignant liver occupation; Or AFP greater than 100 ng/ml for 3 months;
8. Neutrophil count \< 1.5 x 109 cells /L or platelet count \< 90 x 109 cells /L;
9. Creatinine is 1.5 times higher than the upper limit of normal;
10. Patients with other malignant tumors (excluding cured patients);
11. Patients with serious diseases of heart, lung, kidney, brain, blood and other important organs;
12. Patients with severe neurological and psychiatric disorders (such as epilepsy, depression, mania, seizures, schizophrenia, etc.);
13. Control unstable diabetes, hypertension, thyroid disease, etc.;
14. Pregnant and lactating women or patients who had pregnancy plans during the study period and did not want to use contraception;
15. Participate in other clinical investigators;
16. Patients who were not considered suitable for participation in this study by the investigators.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT06900166
Study Brief:
Protocol Section:
NCT06900166