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
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: September 12, 2019
• Est. completion date: February 23, 2023

Study information

• Verified date: April 2024
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• 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

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• Non-alcoholic Fatty Liver Disease
• Nonalcoholic Fatty Liver
• Nonalcoholic Steatohepatitis

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	Absolute Change in Intrahepatic Lipid Content, by 1H-MRS	Absolute percentage change in intrahepatic lipid content, quantified by 1H-MRS	6 months
Secondary	Relative Change in Intrahepatic Lipid Content	Relative percentage point change in intrahepatic lipid content	6 months