Study Details
Testing the Study Drug INT-787 for Adults with Severe Alcohol-Associated Hepatitis
(IRB#: IRB_00176542)
Severe Alcohol-Associated Hepatitis is inflammation and damage to the liver causing serious health issues such as scarring of the liver. This study will test a drug called INT-787 for people with this condition. The study wants to see if the drug will help people and is safe. People in this study will be randomly chosen to be treated with INT-787 or a placebo. The placebo looks like the study drug but does not have the treatment. People in the study will have an ultrasound. This is a small handheld device placed on the top of the skin to take an image. For this study, the image is of the stomach area. People will also have a CT scan of the stomach. This is to see the liver and gallbladder (an organ in the body that stores fluid for the liver). Participation requires attending in-person visits at the study clinic and lasts about 84 days. Medical tests will be done to track the health of participants.
- All genders
- Over 18 years old
- Volunteers with special conditions
- In Person
- Paid
Who can participate?
Gender: All genders
Age: Over 18 years old
Volunteers: Volunteers with special conditions
Location: In Person
Inclusion Criteria
- Ages 18 to 65 years and older
- Diagnosis of Severe Alcohol-Associated Hepatitis
- Childbearing participants must agree to use specific birth control
- Agree to participate in an alcohol use disorder program during the study period
- Able to attend in person at the study clinic
Exclusion Criteria
- Pregnant or breastfeeding
- A condition that prevents full participation
- History of liver transplantation
- Kidney injury
- Other causes of liver disease
Will I be paid for my time?
Yes
IRB#: IRB_00176542
PI: Juan Gallegos-Orozco
Department: GASTROENTEROLOGY
Approval Date: 2024-08-14 06:00:00
Specialties: Gastroenterology
I am Interested