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:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2025-12-25 @ 4:07 AM
NCT ID:
NCT05457920
Eligibility Criteria:
Inclusion Criteria:
* age 18 to 65 years, both male and female (including 18 and 65 years old);
* HBV DNA≤2000 IU/ml and HBeAg negative;
* HBsAg positive for more than 6 months, and HBsAg≤1000 IU/ml;
* ALT≤ULN at screening (discontinue liver-protecting enzyme-lowering drugs for at least 2 weeks);
* A negative urine or serum pregnancy test (for women of childbearing age) within 24 hours before the first dose;
* B-ultrasound or fibroscan suggest no liver cirrhosis;
* Willing to accept treatment and sign informed consent.
Exclusion Criteria:
* Participants with other hepatotropic viruses or human immunodeficiency virus co-infection;
* other chronic non-viral liver diseases or decompensated liver diseases;
* tumours;
* drug abuse;
* severe psychiatric disease;
* uncontrolled thyroid disease or diabetes;
* pregnancy or lactation.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT05457920
Study Brief:
Protocol Section:
NCT05457920