RecruitingEarly Phase 1NCT05018481

HA35 Moderate Alcoholic Hepatitis (AH) Study

Mechanism of HA35 in Patients With Alcoholic Liver Disease


Sponsor

The Cleveland Clinic

Enrollment

54 participants

Start Date

Sep 1, 2022

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 21 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Placebo and a drug called Sodium Hyaluronate for people with alcoholic hepatitis. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSodium Hyaluronate

Sodium hyaluronate of molecular weight 35kDa will be given in capsule form to study participants

DRUGPlacebo

A placebo will be given in capsule form to study participants


Locations(1)

Cleveland Clinic

Cleveland, Ohio, United States

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NCT05018481


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