Status:
COMPLETED
Aspirin for the Treatment of Nonalcoholic Fatty Liver Disease
Lead Sponsor:
Massachusetts General Hospital
Conditions:
Nonalcoholic Fatty Liver
Nonalcoholic Steatohepatitis
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
PHASE2
Brief Summary
Nonalcoholic fatty liver disease (NAFLD), defined by fatty infiltration of the liver in the absence of excess alcohol consumption, affects an estimated 30% of adults in the United States. A proportion...
Eligibility Criteria
Inclusion
- Ages 18 to 70 years
- NAFLD, defined by confirmed hepatic steatosis by imaging or by liver biopsy, in the absence of other causes of hepatic steatosis or significant alcohol consumption. If liver imaging or biopsy has not been performed clinically, liver ultrasound assessment will be performed as part of the screening visit.
- Early-stage liver fibrosis, defined as fibrosis less than or equal to Fibrosis Stage 3 (F3), confirmed by either (1) a recent liver biopsy or (2) a recent elastography / Fibroscan study. If no recent biopsy or elastography/Fibroscan have been performed, a Fibroscan will be performed as part of the screening visit.
Exclusion
- Liver fibrosis stage \> 3
- Current aspirin use
- Contraindications to aspirin use
- Contraindications to magnetic resonance imaging (MRI)
- Pregnancy or desire to become pregnant
- Breastfeeding
Key Trial Info
Start Date :
September 12 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 23 2023
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04031729
Start Date
September 12 2019
End Date
February 23 2023
Last Update
May 24 2024
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114