Status:
RECRUITING
Aspirin for Patients With Metabolic Dysfunction-Associated Steatotic Liver Disease
Lead Sponsor:
Taichung Veterans General Hospital
Conditions:
Metabolic Dysfunction Associated Steatotic Liver Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Metabolic dysfunction-associated steatotic liver disease (MASLD) is a leading cause of chronic liver disease worldwide and a significant public health issue. MASLD may progress to liver cirrhosis and/...
Detailed Description
Metabolic dysfunction-associated steatotic liver disease (MASLD) has become one of the most common chronic liver diseases, with an estimated prevalence exceeding 30% globally. MASLD can result in live...
Eligibility Criteria
Inclusion
- 18 years of age or older
- Diagnosed with MASLD, which is defined by the Delphi consensus, with at least one out of five cardiometabolic criteria
Exclusion
- Increased alcohol intake (average ≥ 20 g/day for women and ≥ 30 g/day for men)
- Glycated hemoglobin (HbA1c) level ≥ 9.0%
- Other causes of chronic liver disease, such as HBV, HCV, autoimmune hepatitis, Wilson's disease, etc.
- Liver decompensation (Child-Pugh class B or C)
- Liver cirrhosis with significant portal hypertension (platelet count \< 100,000/mm3, splenomegaly, and/or the presence of esophageal/gastric varices)
- High-risk EGV, defined as F2, F3, or with red-color signs, diagnosed by endoscopy within 6 months before screening
- Active peptic ulcer disease diagnosed by endoscopy within 6 months be- fore screening
- FIB-4 index \< 1.3 at screening
- Indicated for any anti-platelet therapy, such as history of cardiovascular events
- History of aspirin allergy
- History of bleeding disorders, such as hemophilia
- Pregnancy or breast feeding
- Severe renal impairment, which is defined as eGFR \< 30 mL/min/1.73 m²
- Any malignancies
Key Trial Info
Start Date :
May 5 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2032
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06935994
Start Date
May 5 2025
End Date
December 31 2032
Last Update
May 11 2025
Active Locations (1)
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1
Taichung Veterans General Hospital
Taichung, Taiwan, Taiwan, 40705