Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Aspirin for the Treatment of Nonalcoholic Fatty Liver Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04031729
Recruitment Status : Recruiting
First Posted : July 24, 2019
Last Update Posted : September 10, 2019
Sponsor:
Information provided by (Responsible Party):
Tracey G. Simon, MD, Massachusetts General Hospital

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 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).

Condition or disease Intervention/treatment Phase
Nonalcoholic Fatty Liver Nonalcoholic Steatohepatitis Drug: Aspirin 81 mg Drug: Placebo oral tablet Phase 1 Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Aspirin in Adults With Nonalcoholic Fatty Liver Disease
Estimated Study Start Date : September 12, 2019
Estimated Primary Completion Date : January 2024
Estimated Study Completion Date : September 2024


Arm Intervention/treatment
Experimental: Aspirin
Low-dose (81mg) aspirin tablets
Drug: Aspirin 81 mg
Aspirin 81mg tablets will be given once daily, for the duration of the clinical trial.

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




Primary Outcome Measures :
  1. Percent intrahepatic lipid content, quantified by 1H-MRS [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Concentrations of circulating bioactive lipid mediators [ Time Frame: 6 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ages 18 to 65 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 2 (F2), 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 > 2
  • Current aspirin use
  • Contraindications to aspirin use
  • Contraindications to magnetic resonance imaging (MRI)
  • Pregnancy or desire to become pregnant
  • Breastfeeding

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04031729


Contacts
Layout table for location contacts
Contact: Tracey G Simon, MD, MPH 617-724-2401 tgsimon@mgh.harvard.edu

Locations
Layout table for location information
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Tracey G Simon, MD, MPH    617-724-3416    tgsimon@mgh.harvard.edu   
Contact: Rasheeda Mohammed    6177243416    rmohammed3@mgh.harvard.edu   
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Layout table for investigator information
Principal Investigator: Tracey G Simon, MD, MPH Massachusetts General Hospital

Layout table for additonal information
Responsible Party: Tracey G. Simon, MD, Instructor in Medicine and Gastroenterology, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT04031729     History of Changes
Other Study ID Numbers: 2019P001809
First Posted: July 24, 2019    Key Record Dates
Last Update Posted: September 10, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Tracey G. Simon, MD, Massachusetts General Hospital:
Aspirin
Liver Disease
Anti-inflammatory
Additional relevant MeSH terms:
Layout table for MeSH terms
Fatty Liver
Non-alcoholic Fatty Liver Disease
Liver Diseases
Digestive System Diseases
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics