What this study is
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.
What's being tested
- Sodium Hyaluronate
Intervention · DRUG
Sodium hyaluronate of molecular weight 35kDa will be given in capsule form to study participants
- Placebo
Intervention · DRUG
A placebo will be given in capsule form to study participants
Study details
- Official title
- Mechanism of HA35 in Patients With Alcoholic Liver Disease
- Sponsor
- The Cleveland Clinic
- Conditions
- Alcoholic Hepatitis
- Enrolling
- 54 people
- Starts
- 2022-09-01
- Est. completion
- 2028-10-01
- Design
- Triple-blind, randomized, parallel groups, Early Phase 1
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 21 Years – 65 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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.
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openCleveland Clinic
Cleveland, Ohio, United States
- Annette Bellar · Contact
Recruiting
Study team
Sponsor
The Cleveland Clinic
Study ID 21-605
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.