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HA35 Moderate Alcoholic Hepatitis (AH) Study

RecruitingEARLY Phase 1Ages 21 Years - 65 YearsAllThe Cleveland Clinic
NCT05018481 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

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📋 Eligibility rules (as published)
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
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What it tests

  • Sodium Hyaluronate
  • Placebo
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Where

1 site
Cleveland Clinic
Cleveland, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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