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NCT05018481
HA35 Moderate Alcoholic Hepatitis (AH) Study
Conditions: Alcoholic Hepatitis
Sex: All
Ages: 21 Years – 65 Years
Healthy volunteers: No
Phase: EARLY_PHASE1
Enrollment: 54
Sponsor: The Cleveland Clinic
Location: Cleveland Clinic Cleveland Ohio
Summary
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.
Eligibility Criteria
Inclusion Criteria:
• 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 \3 mg/dL
* AST \>50 IU/I; AST:ALT ratio \>1.5; Both AST and ALT \2mg/dL
* Platelets \1.7
* Presence of pedal edema
* Use of anti-platelet/anticoagulation drugs or medications that interfere with blood clotting
Source: ClinicalTrials.gov (NCT05018481). StuddyBuddy aggregates publicly available trial information.