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RECRUITING
NCT05018481
EARLY_PHASE1

HA35 Moderate Alcoholic Hepatitis (AH) Study

Sponsor: The Cleveland Clinic

View on ClinicalTrials.gov

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.

Official title: Mechanism of HA35 in Patients With Alcoholic Liver Disease

Key Details

Gender

All

Age Range

21 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

54

Start Date

2022-09-01

Completion Date

2027-10-01

Last Updated

2025-11-17

Healthy Volunteers

No

Interventions

DRUG

Sodium Hyaluronate

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

DRUG

Placebo

A placebo will be given in capsule form to study participants

Locations (1)

Cleveland Clinic

Cleveland, Ohio, United States