Alcoholic HepatitisEarly Phase 1NCT05018481
HA35 Moderate Alcoholic Hepatitis (AH) Study
A Early Phase 1 study testing Sodium Hyaluronate in people with Alcoholic Hepatitis, run by The Cleveland Clinic at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Alcoholic Hepatitis
- What is being tested?
- Sodium Hyaluronate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2022to 1 Oct 2028
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 19Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Annette Bellar contact
United States1 site, 1 recruiting
- Recruiting
Cleveland Clinic
Cleveland, Ohio, 44195
Annette Bellar
About this study
Official title: Mechanism of HA35 in Patients With Alcoholic Liver Disease
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.
Read the detailed description
Written informed consent will be obtained during the baseline visit (day 1). Patients will given a physical exam and a blood test will be obtained if not in their medical chart. The subjects who meet the criteria after the screening visit will have the following procedures: A. Body composition will be quantified by whole-body dual energy X-ray absorptiometry (DEXA), Bioelectric Impedance Analysis (BIA), chair stands, 3 position balance and hand grip strength by dynamometry. B. Muscle biopsy from the lateral portion of vastus lateralis, about 20 cm above knee, C. Questionnaires, D. Blood collection, E. Collection of stool samples, F. Sugar cocktail administration, and G. Urine collection (24 hour)
After baseline measures have been completed, patients will be randomized in a 1:1 ratio to either standard of care (SOC) + HA35 or SOC + placebo (140 mg/d) for a total of 3 months post enrollment.
The subjects will be recalled after 3 months. The visit and the procedures conducted on day 90 will be similar to the baseline study visit.
- Conditions
- Alcoholic Hepatitis
- Being tested
- Sodium Hyaluronate, Placebo
- Medical subject headings
- Hepatitis, Alcoholic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium HyaluronateDrug
Also called HA35
Sodium hyaluronate of molecular weight 35kDa will be given in capsule form to study participants
PlaceboDrug
A placebo will be given in capsule form to study participants
| Study group | Role | What they receive |
|---|---|---|
| HA35 Placebo Group | Placebo comparator | 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. Receives: Drug: Placebo |
| HA35 Treatment Group | Active comparator | 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. Receives: Drug: Sodium Hyaluronate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare percent change of skeletal muscle mass
Measured: Baseline to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2021
- Study start1 Sep 2022
- Primary completion1 Oct 2028 (estimated)
- Study completion1 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alcoholic HepatitisStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Srinivasan Dasarathy, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05018481
- Sponsor's protocol ID
- 21-605
- Status last verified
- Sep 2026
- First submitted
- 18 Aug 2021
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Welch N, Kannan P, Davuluri G, Bellar A, Attaway AH, Mishra S, Cunningham JA, Kumar A, Musich R, Ertugral EG, Agrawal V, Hsu IL, Harford TJ, Weisleder NL, Vachharajani VT, Kothapalli CR, de la Motte CA, Nagy LE, Dasarathy S. Hyaluronan 35 prevents endotoxin-mediated dysregulated skeletal muscle proteostasis during ethanol exposure. Am J Physiol Endocrinol Metab. 2026 Feb 1;330(2):E212-E232. doi: 10.1152/ajpendo.00283.2025. Epub 2026 Jan 6.
PubMed 41494657
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanism of HA35 in Patients With Alcoholic Liver Disease
- ClinicalTrials.gov ID
- NCT05018481
- Acronym / sponsor ID
- 21-605
- Conditions
- Alcoholic Hepatitis
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 1 Oct 2028 (estimated)
- Study completion
- 1 Oct 2028 (estimated)
- First posted
- 24 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Written informed consent will be obtained during the baseline visit (day 1). Patients will given a physical exam and a blood test will be obtained if not in their medical chart. The subjects who meet the criteria after the screening visit will have the following procedures: A. Body composition will be quantified by whole-body dual energy X-ray absorptiometry (DEXA), Bioelectric Impedance Analysis (BIA), chair stands, 3 position balance and hand grip strength by dynamometry. B. Muscle biopsy from the lateral portion of vastus lateralis, about 20 cm above knee, C. Questionnaires, D. Blood collection, E. Collection of stool samples, F. Sugar cocktail administration, and G. Urine collection (24 hour)
After baseline measures have been completed, patients will be randomized in a 1:1 ratio to either standard of care (SOC) + HA35 or SOC + placebo (140 mg/d) for a total of 3 months post enrollment.
The subjects will be recalled after 3 months. The visit and the procedures conducted on day 90 will be similar to the baseline study visit.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HA35 Placebo Group | Placebo comparator | Drug: Placebo24 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. |
| HA35 Treatment Group | Active comparator | Drug: Sodium Hyaluronate24 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. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sodium HyaluronateAlso: HA35Sodium hyaluronate of molecular weight 35kDa will be given in capsule form to study participants | Drug | HA35 Treatment Group |
| PlaceboA placebo will be given in capsule form to study participants | Drug | HA35 Placebo Group |
Primary outcome
Compare percent change of skeletal muscle mass
Time frame: Baseline to 90 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Derived from this study: PubMed 41494657Welch N, Kannan P, Davuluri G, Bellar A, Attaway AH, Mishra S, Cunningham JA, Kumar A, Musich R, Ertugral EG, Agrawal V, Hsu IL, Harford TJ, Weisleder NL, Vachharajani VT, Kothapalli CR, de la Motte CA, Nagy LE, Dasarathy S. Hyaluronan 35 prevents endotoxin-mediated dysregulated skeletal muscle proteostasis during ethanol exposure. Am J Physiol Endocrinol Metab. 2026 Feb 1;330(2):E212-E232. doi: 10.1152/ajpendo.00283.2025. Epub 2026 Jan 6.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Annette Bellar contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Sodium Hyaluronate in people with Alcoholic Hepatitis, run by The Cleveland Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Srinivasan Dasarathy, MD (216-318-7010, dasaras@ccf.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare percent change of skeletal muscle mass (time frame: Baseline to 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05018481, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.