NCT05018481 · The Cleveland Clinic
HA35 Moderate Alcoholic Hepatitis (AH) Study
What this study 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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- 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
- Other end-stage organ diseases
- 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
Where
- Cleveland, Ohio
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Nov 17, 2025 · Source of record for eligibility and locations