drugset / Trial / NCT05018481

HA35 Moderate Alcoholic Hepatitis (AH) Study

NCT05018481

Phase 0 Recruiting 54 enrolled The Cleveland Clinic
RandomizedParallel-groupTriple-blindBasic science

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.

Timeline

Start
2022-09-01
Primary completion
2026-10-01
Completion
2027-10-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Sodium Hyaluronate Other / unclassified

Indications