HA35 Study for Moderate Alcoholic Hepatitis

This study is looking into how Sodium Hyaluronate (HA35) affects people with moderate alcoholic hepatitis. Alcoholic hepatitis is a serious liver condition caused by heavy alcohol use. You might be eligible if you are between 21 and 65 years old, have a specific diagnosis of alcoholic hepatitis, and meet certain lab test results, including a MELD score (a measure of liver disease severity) less than 21. The study aims to see if Sodium Hyaluronate can help improve skeletal muscle mass over 90 days. Participants will receive either Sodium Hyaluronate or a placebo (an inactive capsule) for 90 days. The study's current recruitment status is unclear.

Study design
This interventional study plans to enroll 54 participants. Participants will be randomly assigned to receive either Sodium Hyaluronate or a placebo.
What's involved
You would take a capsule daily for 90 days, attend two in-person visits (at the start and end of the 90 days), and have two phone visits. In-person visits include physical exams, blood tests, body composition measurements, muscle strength tests, questionnaires, urine and stool collections, a sugar cocktail, and a muscle biopsy. You'll also return for a 24-hour urine collection drop-off.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint measures changes from baseline to 90 days, indicating follow-up during this period.

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NCT05018481

HA35 Moderate Alcoholic Hepatitis (AH) Study

Recruiting
EARLY_PHASE1Ages 21–65InterventionalBasic science
The Cleveland Clinic
~54 participants
Updated 2025-11-17 on ClinicalTrials.gov
What's tested:Sodium HyaluronatePlacebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Compare percent change of skeletal muscle mass
Measured over Baseline to 90 days
Alcoholic Hepatitis
1 sites across 1 states
Ohio1

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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
MELD \<21
Serum total bilirubin \>3 mg/dL
AST \>50 IU/I; AST:ALT ratio \>1.5; Both AST and ALT \<400 IU/I

Exclusion

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
  • Compare percent change of skeletal muscle massBaseline to 90 days