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Sodium Hyaluronate for Alcoholic Hepatitis
Phase < 1
Recruiting
Research Sponsored by The Cleveland Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 90 days
Awards & highlights
Study Summary
This trialinvolves physical exams, tests, questionnaires and collections over 90 days with two in-person visits and two phone visits. A sugar cocktail and muscle biopsy are also required.
Who is the study for?
This trial is for adults who've been drinking heavily (over 60g/day for men, over 40g/day for women) and have moderate alcoholic hepatitis but not severe liver damage or other serious health issues. Pregnant women, those with recent surgeries, kidney failure, certain blood disorders, active infections or cancers can't participate.Check my eligibility
What is being tested?
Participants will take either Sodium Hyaluronate or a placebo capsule daily for 90 days to see if it helps with alcoholic hepatitis. They'll have two in-person visits with exams and tests plus phone check-ins. A muscle biopsy and gut permeability test are also part of the study.See study design
What are the potential side effects?
While specific side effects aren't listed here, participants may experience discomfort from procedures like muscle biopsies and potential unknown side effects from Sodium Hyaluronate or the placebo.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with alcoholic hepatitis, meet the alcohol intake criteria, and my liver function tests match the specified levels.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to 90 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 90 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Compare percent change of skeletal muscle mass
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: HA35 Treatment GroupActive Control1 Intervention
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.
Group II: HA35 Placebo GroupPlacebo Group1 Intervention
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.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Alcoholic Hepatitis (AH) often focus on reducing liver inflammation, improving liver function, and addressing nutritional deficiencies. Nutritional supplements, such as those enhancing muscle strength and gut health, play a crucial role.
These supplements may contain branched-chain amino acids, which help in muscle protein synthesis and reduce muscle wasting, and probiotics or prebiotics, which improve gut barrier function and reduce systemic inflammation. This is particularly important for AH patients, as muscle wasting and gut permeability are common complications that exacerbate liver disease.
By addressing these issues, such treatments can improve overall patient outcomes and quality of life.
Agomelatine for the treatment of generalized anxiety disorder.Branched-chain amino acid supplementation in adults with cirrhosis and porto-systemic encephalopathy: systematic review.
Agomelatine for the treatment of generalized anxiety disorder.Branched-chain amino acid supplementation in adults with cirrhosis and porto-systemic encephalopathy: systematic review.
Find a Location
Who is running the clinical trial?
The Cleveland ClinicLead Sponsor
1,034 Previous Clinical Trials
1,365,371 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am unable to give consent myself.I have been diagnosed with alcoholic hepatitis, meet the alcohol intake criteria, and my liver function tests match the specified levels.I have liver disease not only from alcohol.I have a muscle disease.I have experienced severe confusion due to liver problems.I am not taking drugs that affect muscle growth or breakdown.I had surgery on my upper stomach area in the last 6 months.I have not had gastrointestinal bleeding in the last 2 weeks.I have had an organ or bone marrow transplant.I am taking medication that affects blood clotting.I have swelling in my feet.I do not have any end-stage organ diseases.I have been diagnosed with cancer.I have kidney failure or am on dialysis.
Research Study Groups:
This trial has the following groups:- Group 1: HA35 Placebo Group
- Group 2: HA35 Treatment Group
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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