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 @ 1:47 AM
Ignite Modification Date:
2025-12-25 @ 1:47 AM
NCT ID:
NCT06935994
Eligibility Criteria:
Inclusion Criteria:
1. 18 years of age or older
2. Diagnosed with MASLD, which is defined by the Delphi consensus, with at least one out of five cardiometabolic criteria
Exclusion Criteria:
1. Increased alcohol intake (average ≥ 20 g/day for women and ≥ 30 g/day for men)
2. Glycated hemoglobin (HbA1c) level ≥ 9.0%
3. Other causes of chronic liver disease, such as HBV, HCV, autoimmune hepatitis, Wilson's disease, etc.
4. Liver decompensation (Child-Pugh class B or C)
5. Liver cirrhosis with significant portal hypertension (platelet count \< 100,000/mm3, splenomegaly, and/or the presence of esophageal/gastric varices)
6. High-risk EGV, defined as F2, F3, or with red-color signs, diagnosed by endoscopy within 6 months before screening
7. Active peptic ulcer disease diagnosed by endoscopy within 6 months be- fore screening
8. FIB-4 index \< 1.3 at screening
9. Indicated for any anti-platelet therapy, such as history of cardiovascular events
10. History of aspirin allergy
11. History of bleeding disorders, such as hemophilia
12. Pregnancy or breast feeding
13. Severe renal impairment, which is defined as eGFR \< 30 mL/min/1.73 m²
14. Any malignancies
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06935994
Study Brief:
Protocol Section:
NCT06935994