HA35 Moderate Alcoholic Hepatitis (AH) Study

Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age21-65
SponsorThe Cleveland Clinic

About this trial

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

Qualifiers

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

MELD <21

Serum total bilirubin >3 mg/dL

AST >50 IU/I; AST:ALT ratio >1.5; Both AST and ALT <400 IU/I

Disqualifiers

Pregnant or breastfeeding women

Patients with gastrointestinal bleeding within 2 weeks

Active infection (positive blood or ascitic fluid culture)

Overt encephalopathy

Trial design

Treatments tested in this trial

  • Sodium Hyaluronate
  • Placebo

Treatment groups

54 Participants
are divided into 2 treatment groups

Sponsors and collaborators