Clinical Trial

HA35 Moderate Alcoholic Hepatitis (AH) Study

Recruiting Early Phase 1
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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.
Protocol Amendment History 10 amendments
This ClinicalTrials.gov record has been amended 10 times since 2021-08-18; most recent amendment 2025-11-14.
Status change: Not Yet Recruiting → Recruiting 2022-10-19
Trial Details
NCT Number NCT05018481
Lead Sponsor The Cleveland Clinic
Conditions Alcoholic Hepatitis
Enrollment 54 participants
Start Date 2022-09-01
Primary Completion 2026-10-01 (estimated)
Study Completion 2027-10-01 (estimated)
Updated on ClinicalTrials.gov 2025-11-17