RECRUITING Early Phase 1 ClinicalTrials.gov

HA35 Moderate Alcoholic Hepatitis (AH) Study

Sponsor: The Cleveland Clinic • ClinicalTrials.gov ID: NCT05018481

Registry updated: 2026-09-24

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Description

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.

Interventions

Sodium Hyaluronate (Drug)
Sodium hyaluronate of molecular weight 35kDa will be given in capsule form to study participants
Placebo (Drug)
A placebo will be given in capsule form to study participants

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 \<21 * Serum total bilirubin \>3 mg/dL * AST \>50 IU/I; AST:ALT ratio \>1.5; Both AST and ALT \<400 IU/I OR Histologic evidence of AH. Exclusion Criteria: * Pregnant or breastfeeding women * Patients with gastrointestinal bleeding within 2 weeks * Active infection (positive blood or ascitic fluid culture) * Overt encephalopathy * Renal failure and/or on dialysis * Medications that alter muscle protein metabolism * Myopathies * Other end-stage organ diseases * Malignancy * Solid organ or hematopoietic transplantation * Active alcohol withdrawal or ongoing participation in a Clinical Institute Withdrawal Assessment (CIWA) protocol * History of recent upper gastrointestinal resection within past 6 months * Acute or chronic liver disease due to other active causes, in addition to alcoholic liver disease * Inability to provide consent * Creatinine \>2mg/dL * Platelets \<60,000k/ul * PT/INR \>1.7 * Presence of pedal edema * Use of anti-platelet/anticoagulation drugs or medications that interfere with blood clotting

Conditions

Alcoholic Hepatitis

Locations

Cleveland Clinic — Cleveland, Ohio, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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