HA35 Moderate Alcoholic Hepatitis (AH) Study
Eligible age
21–65 yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
See if you qualify for this study
Answer a few quick questions about your location and health. Takes about a minute.
About this study
Eligible participants will be asked to take a placebo/treatment capsule for 90 days and participate in two in-person study visits, one at the start of the 90 days and the second at the completion of study supplement administration. Both visits will include a physical exam, clinical labs, body composition measurements, muscle strength tests, questionnaires, and urine and stool collections. Additionally, a sugar cocktail will be consumed to measure gut permeability and a muscle biopsy will be collected. The day after the visits, you will need to return to drop off the 24-hour urine collection. Two phone visits will be performed in between the in-person visits at day 30 and 60 where you will be asked a series of questionnaires as well as asked about study supplement compliance.
Sponsor: The Cleveland Clinic
You may qualify if…
- ✓ Clinical diagnosis of alcoholic hepatitis defined as:
- ✓ Regular consumption of alcohol with an intake of \>60 g daily or \>420 g weekly on average for men and \>40 g daily or \>280 g weekly on average for women for 6 months or more
- ✓ AND
- ✓ MELD \<21
- ✓ Serum total bilirubin \>3 mg/dL
- ✓ AST \>50 IU/I; AST:ALT ratio \>1.5; Both AST and ALT \<400 IU/I
- ✓ OR Histologic evidence of AH.
You may not qualify if…
- ✕ Pregnant or breastfeeding women
- ✕ Patients with gastrointestinal bleeding within 2 weeks
- ✕ Active infection (positive blood or ascitic fluid culture)
- ✕ Overt encephalopathy
- ✕ Renal failure and/or on dialysis
- ✕ Medications that alter muscle protein metabolism
- ✕ Myopathies
- ✕ Other end-stage organ diseases
Where it's recruiting
Cleveland
Source: ClinicalTrials.gov · NCT05018481 · last updated 2026-09-24