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Sodium Hyaluronate for Alcoholic Hepatitis

Q: Is this trial enrolling new participants currently?

Potential enrollees must be within the ages of 21 and 65, as well as suffering from alcoholic hepatitis (AH). The total number of individuals that can join this trial is 54.

Q: Could you please give a synopsis of the research conducted on HA35 Treatment Group?

At present, 16 trials are actively exploring the efficacy of HA35 Treatment Group with 4 currently in their final phase. The bulk of research is taking place in Morgantown, <a href="https://www.withpower.com/clinical-trials/west-virginia">West virginia</a> but there also exist 31 different sites conducting studies on this medication.

Q: Is participation in this investigative study still available?

That is correct. According to the information posted on clinicaltrials.gov, this investigation is actively seeking participants and has been since September 1st 2022. The study requires 54 individuals from a single location as of October 19th 2022.

Q: How many participants have signed up to take part in this clinical trial?

Affirmative. Clinicaltrials.gov attests that this study, initially posted on September 1st 2022, is currently seeking volunteers and has been recently updated as of October 19th 2022. This medical trial aims to enroll 54 patients at a single site.

Q: Does this clinical research encompass geriatric patients?

The minimum age for entry into this study is 21, whereas the maximum age requirement is 65.

Q: What health conditions is HA35 Treatment Group employed to alleviate?

HA35 Treatment Group is commonly used for alleviating skin discomfort and inflammation. Additionally, it has been found to be beneficial when treating <a href="https://www.withpower.com/clinical-trials/osteoarthritis">osteoarthritis</a> (OA), dermabrasion, and certain types of dermatological issues.

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 below

Select...

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 90 days for reporting.

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.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

The Cleveland ClinicLead Sponsor

1,026 Previous Clinical Trials

1,366,022 Total Patients Enrolled

Media Library

HA35 Treatment Group Clinical Trial Eligibility Overview. Trial Name: NCT05018481 — Phase < 1

Alcoholic Hepatitis Research Study Groups: HA35 Placebo Group, HA35 Treatment Group

Alcoholic Hepatitis Clinical Trial 2023: HA35 Treatment Group Highlights & Side Effects. Trial Name: NCT05018481 — Phase < 1

HA35 Treatment Group 2023 Treatment Timeline for Medical Study. Trial Name: NCT05018481 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this trial enrolling new participants currently?

"Potential enrollees must be within the ages of 21 and 65, as well as suffering from alcoholic hepatitis (AH). The total number of individuals that can join this trial is 54."

Answered by AI

Could you please give a synopsis of the research conducted on HA35 Treatment Group?

"At present, 16 trials are actively exploring the efficacy of HA35 Treatment Group with 4 currently in their final phase. The bulk of research is taking place in Morgantown, West virginia but there also exist 31 different sites conducting studies on this medication."

Answered by AI

Is participation in this investigative study still available?

"That is correct. According to the information posted on clinicaltrials.gov, this investigation is actively seeking participants and has been since September 1st 2022. The study requires 54 individuals from a single location as of October 19th 2022."

Answered by AI

How many participants have signed up to take part in this clinical trial?

"Affirmative. Clinicaltrials.gov attests that this study, initially posted on September 1st 2022, is currently seeking volunteers and has been recently updated as of October 19th 2022. This medical trial aims to enroll 54 patients at a single site."

Answered by AI

Does this clinical research encompass geriatric patients?

"The minimum age for entry into this study is 21, whereas the maximum age requirement is 65."

Answered by AI

What health conditions is HA35 Treatment Group employed to alleviate?

"HA35 Treatment Group is commonly used for alleviating skin discomfort and inflammation. Additionally, it has been found to be beneficial when treating osteoarthritis (OA), dermabrasion, and certain types of dermatological issues."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

HA35 Moderate Alcoholic Hepatitis (AH) Study

Srinivasan Dasarathy 2022. "HA35 Moderate Alcoholic Hepatitis (AH) Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05018481.

All > Autoimmune Hepatitis