HA35 Moderate Alcoholic Hepatitis (AH) Study
ConditionAlcoholic Hepatitis
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Sodium Hyaluronate
DrugSodium hyaluronate of molecular weight 35kDa will be given in capsule form to study participants
Placebo
DrugA placebo will be given in capsule form to study participants
Treatment groups
54 Participants
are divided into 2 treatment groupsGroup A: HA35 Placebo GroupPlacebo comparator 1 intervention
Group B: HA35 Treatment GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Compare percent change of skeletal muscle mass
Time frame
Baseline to 90 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov