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
This project is not recruiting.
Overview
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.
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Principal Investigator
Who can participate
Who cannot participate
You may not be eligible if you have liver disease related to other casuses (viral hepatitis, alcohol)
What you may be asked to do
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
What You May Get
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]
Location
Massachusetts General Hospital - GI Associates (Blake 4th Floor)
55 Fruit Street, Boston MA 02114
Travel
- Accessible by public transportation
- Parking available
- Parking reimbursed
Travel and Parking Details
Additional Information
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.
Funding Source
- Industry