Recruiting

Early Phase 1

HA35HA35 Moderate Alcoholic Hepatitis (AH) Study

Sponsor:

The Cleveland Clinic

Code:

NCT05018481

Conditions

Alcoholic Hepatitis

Eligibility Criteria

Sex: All

Age: 21 - 65

Healthy Volunteers: Not accepted

Interventions

Sodium Hyaluronate

Placebo

Study Details

Brief 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.

Conditions

Alcoholic Hepatitis

Study ID

NCT05018481

Start date

Sep 1, 2022

Status verified date

Sep, 2026

Completion date

Oct 1, 2028

Anticipated

Primary completion date

Oct 1, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 21 - 65

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

54 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

placebo comparator: HA35 Placebo Group

24 study participants will receive the standard of care treatment for AH and a 90-day supply of a placebo to take once a day with breakfast.

active comparator: HA35 Treatment Group

24 study participants will receive the standard of care treatment for AH and a 90-day supply of a HA35 to take once a day with breakfast.

Interventions

Sodium Hyaluronate

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

Placebo

A placebo will be given in capsule form to study participants

Primary outcome measure

Compare percent change of skeletal muscle mass [ Time Frame: Baseline to 90 days ]

Central Contacts and Locations

Central contacts

Srinivasan Dasarathy, MD

216-318-7010 dasaras@ccf.org

Annette Bellar

bellara@ccf.org

Locations

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

More Information

Sponsor

The Cleveland Clinic

Last update posted

Sep 24, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-27. This information was provided to ClinicalTrials.gov by The Cleveland Clinic on 2026-09-24. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.