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 @ 4:11 AM
Ignite Modification Date:
2025-12-25 @ 4:11 AM
NCT ID:
NCT05451420
Eligibility Criteria:
Inclusion Criteria:
* age 18 to 65 years;
* HBsAg seropositive status for more than 6 months prior to enrollment;
* never received treatment with any form of nucleos(t)ide analogues (NAs) or interferon before enrollment;
* Serum HBsAg ≤1500 IU/mL;
* HBeAg negative with or without HBeAb positive;
* Serum HBV DNA ≤2000IU/ml IU/mL;
* normal ALT levels;
* normal white blood cell and platelet counts;
* abdominal computed tomography or B-ultrasound showed no cirrhosis, splenomegaly or ascites.
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:
NCT05451420
Study Brief:
Protocol Section:
NCT05451420