NCT05018481

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P50-P75 for early_phase_1

Timeline
16mo left

Started Sep 2022

Longer than P75 for early_phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress75%
Sep 2022Oct 2027

First Submitted

Initial submission to the registry

August 18, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 24, 2021

Completed
1 year until next milestone

Study Start

First participant enrolled

September 1, 2022

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2027

Last Updated

November 17, 2025

Status Verified

November 1, 2025

Enrollment Period

4.1 years

First QC Date

August 18, 2021

Last Update Submit

November 14, 2025

Conditions

Alcoholic Hepatitis

Outcome Measures

Primary Outcomes (1)

  • Compare percent change of skeletal muscle mass

    Baseline to 90 days

Study Arms (2)

HA35 Placebo Group

PLACEBO COMPARATOR

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.

Drug: Placebo

HA35 Treatment Group

ACTIVE COMPARATOR

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.

Drug: Sodium Hyaluronate

Interventions

Sodium HyaluronateDRUG

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

Also known as: HA35
HA35 Treatment Group
PlaceboDRUG

A placebo will be given in capsule form to study participants

HA35 Placebo Group

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

RECRUITING

Related Publications (1)

  • Welch N, Kannan P, Davuluri G, Bellar A, Attaway AH, Mishra S, Cunningham J, Kumar A, Musich R, Ertugal EG, Agrawal V, Hsu I, Harford T, Weisleder NL, Vachharajani V, Kothapalli CR, de la Motte C, Nagy LE, Dasarathy S. Hyaluronan 35 prevents endotoxin-mediated dysregulated skeletal muscle proteostasis during ethanol exposure. Am J Physiol Endocrinol Metab. 2026 Jan 6. doi: 10.1152/ajpendo.00283.2025. Online ahead of print.

    PMID: 41494657DERIVED

MeSH Terms

Conditions

Hepatitis, Alcoholic

Interventions

Hyaluronic Acid

Condition Hierarchy (Ancestors)

HepatitisLiver DiseasesDigestive System DiseasesLiver Diseases, AlcoholicAlcohol-Induced DisordersAlcohol-Related DisordersSubstance-Related DisordersChemically-Induced Disorders

Intervention Hierarchy (Ancestors)

GlycosaminoglycansPolysaccharidesCarbohydrates

Central Study Contacts

Srinivasan Dasarathy, MD

CONTACT

216-318-7010dasaras@ccf.org

Annette Bellar

CONTACT

bellara@ccf.org

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Staff Physician

Study Record Dates

First Submitted

August 18, 2021

First Posted

August 24, 2021

Study Start

September 1, 2022

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2027

Last Updated

November 17, 2025

Record last verified: 2025-11

Locations

US(1)