Treatment for Moderate Alcoholic Hepatitis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Cleveland Clinic
  Cleveland, Ohio, United States Recruiting

Study contacts

• Study coordinator: Srinivasan Dasarathy, MD
• Email: dasaras@ccf.org
• Phone: 216-318-7010

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.