Phase
Condition
Primary Biliary Cholangitis
Treatment
Aspirin 81 mg Enteric Coated Tab - 1 tablet
Placebo
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
18 years of age or older
Diagnosed with MASLD, which is defined by the Delphi consensus, with at least oneout of five cardiometabolic criteria
Exclusion
Exclusion Criteria:
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 endoscopywithin 6 months before screening
Active peptic ulcer disease diagnosed by endoscopy within 6 months be- forescreening
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
Study Design
Study Description
Connect with a study center
Taichung Veterans General Hospital
Taichung, 40705
TaiwanActive - Recruiting
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