NCT05018481 HA35 Moderate Alcoholic Hepatitis (AH) Study
| NCT ID | NCT05018481 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | The Cleveland Clinic |
| Condition | Alcoholic Hepatitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 54 participants |
| Start Date | 2022-09-01 |
| Primary Completion | 2026-10-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 54 participants in total. It began in 2022-09-01 with a primary completion date of 2026-10-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05018481 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, up to 65 Years, studying Alcoholic Hepatitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05018481 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05018481 currently recruiting?
Yes, NCT05018481 is actively recruiting participants. Contact the research team at dasaras@ccf.org for enrollment information.
Where is the NCT05018481 trial being conducted?
This trial is being conducted at Cleveland, United States.
Who is sponsoring the NCT05018481 clinical trial?
NCT05018481 is sponsored by The Cleveland Clinic. The trial plans to enroll 54 participants.