Actively Recruiting

Early Phase 1
Age: 21Years - 65Years
All Genders
NCT05018481

HA35 Moderate Alcoholic Hepatitis (AH) Study

Led by The Cleveland Clinic · Updated on 2025-11-17

54

Participants Needed

1

Research Sites

265 weeks

Total Duration

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AI-Summary

What this Trial Is About

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

Official Title

HA35 Moderate Alcoholic Hepatitis (AH) Study

Who Can Participate

Age: 21Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Clinical diagnosis of alcoholic hepatitis defined as regular alcohol consumption: >60 g daily or >420 g weekly on average for men, >40 g daily or >280 g weekly on average for women for 6 months or more
  • MELD score less than 21
  • Serum total bilirubin greater than 3 mg/dL
  • AST greater than 50 IU/l; AST:ALT ratio greater than 1.5; both AST and ALT less than 400 IU/l
  • Histologic evidence of alcoholic hepatitis
  • Age between 21 and 65 years
Not Eligible

You will not qualify if you...

  • Pregnant or breastfeeding women
  • Gastrointestinal bleeding within 2 weeks
  • Active infection (positive blood or ascitic fluid culture)
  • Overt encephalopathy
  • Renal failure and/or on dialysis
  • Use of medications that alter muscle protein metabolism
  • Presence of 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 besides alcoholic liver disease
  • Inability to provide consent
  • Creatinine greater than 2 mg/dL
  • Platelets less than 60,000 k/µl
  • Prothrombin time/INR greater than 1.7
  • Presence of pedal edema
  • Use of anti-platelet, anticoagulation drugs, or medications that interfere with blood clotting

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Cleveland Clinic

Cleveland, Ohio, United States, 44195

Actively Recruiting

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Research Team

S

Srinivasan Dasarathy, MD

CONTACT

A

Annette Bellar

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

BASIC_SCIENCE

Number of Arms

2

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