HA35 Moderate Alcoholic Hepatitis (AH) Study

• Status: Not yet recruiting
• Trial end date: 2024-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Cleveland Clinic
• Treatments: Hyaluronic Acid

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