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 @ 11:57 PM
Ignite Modification Date:
2025-12-24 @ 11:57 PM
NCT ID:
NCT05382351
Eligibility Criteria:
Inclusion Criteria:
1. Age between 18-65 years old;
2. HBsAg positive \>6 months, HBsAg\>1\*10e4IU/ml;
3. HBV-DNA\> 2 \* 10e7IU / ml;
4. HBeAg positive;
5. ALT / AST remained normal which were followed up twice within 1 year with at least a 6-month interval each time.
6. No antiviral treatment with interferon or nucleoside (acid) analogues in the previous year
Exclusion Criteria:
1. infection with hepatitis A, C, D, E viruses or HIV infection ;
2. Combined with diabetes, hypertension, renal insufficiency, autoimmune diseases and other organ dysfunction And malignant tumors;
3. Patients using Immunosuppressive therapy or radiotherapy / chemotherapy for other diseases;
4. Patients with liver fibrosis, cirrhosis (FibroScan \> = 9.4kpa) and liver cancer were identified;
5. Extrahepatic manifestations related to HBV (glomerulonephritis, vasculitis, nodular polyarteritis, peripheral neuropathy, etc.);
6. Allergic to nucleoside drugs
7. Pregnancy or having pregnancy plan within 2 years and Lactating patients;
8. Patients who are unable to comply with the arrange ment of this study or sign the informed consent.
9. Failed to return to hospital regularly for follow-up ac- cording to the study plan.
10. Researchers determine other condition that does not fit into the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT05382351
Study Brief:
Protocol Section:
NCT05382351