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NCT04031729 Clinical Trial

Aspirin for the Treatment of Nonalcoholic Fatty Liver Disease

Nonalcoholic Steatohepatitis Clinical Trial

Official title:
Aspirin in Adults With Nonalcoholic Fatty Liver Disease

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04031729
Other study ID # 2019P001809
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received
Last updated
Start date September 12, 2019
Est. completion date February 23, 2023

Study information
Verified date August 2023
Source Massachusetts General Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 of people with NAFLD will develop progressive, inflammatory nonalcoholic steatohepatitis (NASH), which can progress to liver cirrhosis and liver failure. NAFLD is expected to be the most common indication for liver transplantation by the year 2020. We hypothesize that among adults with NAFLD, aspirin will reduce intrahepatic lipid content, as quantified by 1H magnetic resonance spectroscopy (1H-MRS).

Recruitment information / eligibility
Status Completed
Enrollment 80
Est. completion date February 23, 2023
Est. primary completion date February 23, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: - 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 Criteria: - Liver fibrosis stage > 3 - Current aspirin use - Contraindications to aspirin use - Contraindications to magnetic resonance imaging (MRI) - Pregnancy or desire to become pregnant - Breastfeeding

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Aspirin 81 mg
Aspirin 81mg tablets will be given once daily, for the duration of the clinical trial.
• Placebo oral tablet
Identical, blinded placebo tablets will be given once daily, for the duration of the clinical trial.

Locations
Country Name City State
United States Massachusetts General Hospital Boston Massachusetts

Sponsors (1)
Lead Sponsor Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Percent intrahepatic lipid content, quantified by 1H-MRS 6 months
Secondary Concentrations of circulating bioactive lipid mediators 6 months
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