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Recruiting NCT05018481

HA35 Moderate Alcoholic Hepatitis (AH) Study

Early Phase I Interventional Alcoholic Hepatitis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Sodium Hyaluronate, Placebo.
Who it may be relevant to
Registry conditions: Alcoholic Hepatitis. Basic parameters: 21 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Mechanism of HA35 in Patients With Alcoholic Liver Disease

Overview

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.

Detailed description

Written informed consent will be obtained during the baseline visit (day 1). Patients will given a physical exam and a blood test will be obtained if not in their medical chart. The subjects who meet the criteria after the screening visit will have the following procedures: A. Body composition will be quantified by whole-body dual energy X-ray absorptiometry (DEXA), Bioelectric Impedance Analysis (BIA), chair stands, 3 position balance and hand grip strength by dynamometry. B. Muscle biopsy from the lateral portion of vastus lateralis, about 20 cm above knee, C. Questionnaires, D. Blood collection, E. Collection of stool samples, F. Sugar cocktail administration, and G. Urine collection (24 hour)

After baseline measures have been completed, patients will be randomized in a 1:1 ratio to either standard of care (SOC) + HA35 or SOC + placebo (140 mg/d) for a total of 3 months post enrollment.

The subjects will be recalled after 3 months. The visit and the procedures conducted on day 90 will be similar to the baseline study visit.

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

Primary outcome measures

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

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Basic science

Study locations

United States · 1 center
  • Cleveland Clinic — Cleveland

Publications

  • Welch N, Kannan P, Davuluri G, Bellar A, Attaway AH, Mishra S, Cunningham JA, Kumar A, Musich R, Ertugral EG, Agrawal V, Hsu IL, Harford TJ, Weisleder NL, Vachharajani VT, Kothapalli CR, de la Motte CA, Nagy LE, Dasarathy S. Hyaluronan 35 prevents endotoxin-mediated dysregulated skeletal muscle proteostasis during ethanol exposure. Am J Physiol Endocrinol Metab. 2026 Feb 1;330(2):E212-E232. doi: 1 PMID 41494657

Identifiers

NCT: NCT05018481 · 21-605

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗