Treatment for Moderate Alcoholic Hepatitis
Mechanism of HA35 in Patients With Alcoholic Liver Disease
This study is testing a new treatment called HA35 to see if it helps people with moderate alcoholic hepatitis feel better compared to a placebo.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 54 (estimated) |
| Ages | 21 Years to 65 Years |
| Sex | All |
| Sponsor | The Cleveland Clinic Academic / other |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT05018481 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of HA35, a sodium hyaluronate treatment, on patients diagnosed with moderate alcoholic hepatitis. Participants will be randomly assigned to receive either HA35 or a placebo for 90 days, during which they will undergo various assessments including physical exams, blood tests, muscle strength evaluations, and gut permeability measurements. The study aims to gather comprehensive data on the treatment's efficacy and safety through in-person visits and follow-up phone assessments.
Who should consider this trial
Good fit: Ideal candidates are adults with a clinical diagnosis of alcoholic hepatitis and specific laboratory criteria.
Not a fit: Patients with severe liver disease, active infections, or those on medications affecting muscle metabolism may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve outcomes for patients suffering from moderate alcoholic hepatitis.
How similar studies have performed: While there have been studies on alcoholic hepatitis, the specific use of HA35 in this context is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Cleveland, Ohio
- Cleveland Clinic — Cleveland, Ohio, United States (Recruiting)
Study contacts
- Study coordinator: Srinivasan Dasarathy, MD
- Email: dasaras@ccf.org
- Phone: 216-318-7010
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.