HA35 Moderate Alcoholic Hepatitis (AH) Study

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
The Cleveland Clinic
Study ID
NCT05018481
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

  • Alcoholic Hepatitis

Eligibility Criteria

Sex
ALL
Age
21 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Sodium Hyaluronate — DRUG
    Sodium hyaluronate of molecular weight 35kDa will be given in capsule form to study participants
  • Placebo — DRUG
    A placebo will be given in capsule form to study participants

Study Details

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.

Key Dates

Start date
Sep 1, 2022
Status verified
Nov 2025
Primary completion
Oct 1, 2026
Completion
Oct 1, 2027

Study Design

Enrollment
54 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Placebo Comparator: HA35 Placebo Group
    24 study participants will receive the standard of care treatment for AH and a 90-day supply of a placebo to take once a day with breakfast.
  • Active Comparator: HA35 Treatment Group
    24 study participants will receive the standard of care treatment for AH and a 90-day supply of a HA35 to take once a day with breakfast.

Primary Outcome Measure

Compare percent change of skeletal muscle mass [ Time Frame: Baseline to 90 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cleveland ClinicClevelandOhio44195
Annette Bellar

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