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Note: This study is currently only recruiting patients in the hospital.

If you are interested in being notified if this study begins recruiting from the general population, please use the 'I Am Interested' button below.

Treatment Trial for Fatty Liver Disease

The MGH liver center is conducting a global clinical trial, referred to as the 747-304 study, for patients with cirrhosis due to non-alcoholic steatohepatitis (NASH), an advanced form of non-alcoholic fatty liver disease (NAFLD).

19 visits over 27 months
Estimated Time Commitment
Gender-expansive, 18-years or older
May Be Eligible
Payment up to $5,000
May Be Offered
Survey, Blood draw, Endoscopy, Medication, Ultrasound, Office visit, Biopsy
May Be Required
 
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This project is not recruiting.

What we are studying

The 747-304 study involves the investigational drug, Obeticholic Acid (OCA), which is currently being studied in patients who have cirrhosis due to NASH. OCA is a modified version of a bile acid. Bile acids, a natural compound found in the liver, are used by the body to help with digestion and play an important role in the healthy functioning of the liver.


Why it is important

There are currently no medications approved to treat NASH. The current standard of care involves lifestyle counseling with diet and exercise; some patients may also take Vitamin E or other medications to treat risk factors (such as diabetes, high cholesterol, high blood pressure, and insulin resistance).


What we hope to accomplish

The purpose of the clinical trial is to determine how safe and effective OCA may be in preventing further liver damage or reversing damage already done.

Principal Investigator

Kathleen Corey, MD

Massachusetts General Hospital

Public Profile


  • Adults 18 years and older

  • Cirrhosis caused by NASH

You may not be eligible if you have liver disease related to other casuses (viral hepatitis, alcohol)

You will be asked to come to MGH for study visits about every month for upto 3 years.  If you have not had a liver biopsy within the last year, you will need to have a biopsy to see if you qualify for the study.


Project activities may include:

  • Survey
  • Blood draw
  • Endoscopy
  • Medication
  • Ultrasound
  • Office visit
  • Biopsy

Estimated Time Commitment

19 visits over 27 months


Compensation to be provided for each study visit completed as detailed below:


$150/ completed study visit


$25 - $40/ completed questionnaires  (depending on number of questionnaires completed)


$35/completed fibroscan


$750/liver biopsy


$350/esophagogastroduodenoscopy [EGD]


 

Massachusetts General Hospital - GI Associates (Blake 4th Floor)
55 Fruit Street, Boston MA 02114

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Travel

  • Accessible by public transportation
  • Parking available
  • Parking reimbursed

Travel and Parking Details


ClinicalTrials.gov Identifier

NCT03439254


Study Phase

Phase 3: This project studies a drug or treatment that has already been studied for safety and effectiveness in both healthy volunteers and participants with specific diseases or conditions. It will gather more information about safety and effectiveness. It may look specifically at different groups of people, different dosages, or different combinations of medications or treatments.


Participating Institutions


Funding Source

  • Industry
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