Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

New trial aims to treat both liver damage and alcohol addiction at once

NCT ID NCT07060638

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 16, 2026 · Updated 4 times

Summary

This study tests whether adding alcohol use disorder treatments (acamprosate and counseling) to standard liver therapy improves outcomes for people with severe alcohol-associated hepatitis. It also compares a new drug, F-652, against prednisone for liver treatment. About 216 adults aged 18-70 with severe liver inflammation and heavy alcohol use will participate. The goal is to see if the combined approach reduces death, liver complications, and return to drinking over 6 months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
F-652 (IL-22), prednisone, acamprosate, and motivational interviewing
What this could lead to
If successful, this could point toward a combined treatment approach that improves both liver health and alcohol abstinence in people with severe alcohol-associated hepatitis.
What could go wrong
This is an early phase 2 trial with 216 participants, so results may not apply to everyone. The treatments may not improve outcomes or could cause side effects like infections or liver complications.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 216 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2026

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria 1. Age ≥18, \<70 2. MELD 20-35 3. Definitive or probable diagnosis of sAH as defined by the NIAAA criteria4, 5 A. Onset of jaundice (defined as serum total bilirubin \>3 mg/dL) within the prior 8 weeks B. Ongoing average consumption of \> 40 gm (for females) and \> 60 gm (for males) alcohol daily for 6 months or more with less than 8 weeks of abstinence before onset of jaundice; OR If, in the investigator's judgment, alcohol use may have been underreported, available clinical evidence-including collateral history, medical records, prior documentation of alcohol use, alcohol biomarkers such as PEth, or other relevant evidence-indicates that the participant met the protocol-defined alcohol consumption requirement within the 8 weeks before screening. C. AST \> 50 IU/L, D. AST: ALT \> 1.5 E. ALT and AST values \< 400 IU/L F. Liver biopsy findings consistent with AH \*In patients with possible AH or AH with confounding factors such as possible ischemic hepatitis, possible DILI, uncertain history of alcohol use (e.g., patient denies excessive alcohol use), and atypical/abnormal laboratory tests (e.g., AST \< 50 IU/L or \> 400 IU/L, AST/ALT ratio \< 1.5), antinuclear antibody \> 1:160 or SMA \> 1:80, a standard of care liver biopsy will be considered during current hospital admission to confirm AH and exclude competing etiologies. 4. Females of childbearing (reproductive) potential must have a negative serum or urine pregnancy test at screening. Exclusion Criteria 1. Active listing for liver transplantation before screening 2. MELD score \<20 or \> 35 3. Uncontrolled infection (persistent positive blood or other body fluid cultures despite 48 hours of antibiotic therapy) 4. Progressive hemodynamic compromise requiring intravenous pressors 5. Pneumonia as evidenced by clinical and/or radiological examination (will not perform radiology if not indicated by clinical exam) 6. Renal failure defined by estimated GFR (CKD-EPI) \<35 mL/min. 7. Clinically active C. diff infection 8. Evidence of other liver diseases (such as autoimmune hepatitis, primary biliary cholangiopathy, primary sclerosing cholangitis, ischemic, sepsis- or drug-induced liver disease) 9. History or presence of cancer (including hepatocellular carcinoma) other than non-melanoma skin cancer 10. Prior exposure to systemic corticosteroid (glucocorticoid) or TNF-alpha inhibitors for more than 4 days within the previous 30 days prior to screening, specifically for the treatment of sAH. 11. Clinically significant pancreatitis- abdominal pain, elevated lipase (\> 3 X ULN), and at least edema of pancreas with fat-stranding on CT scan 12. Active gastrointestinal bleeding defined as hematemesis or melena with a decrease in hemoglobin more than 2 g/dl in 24 hours due to gastrointestinal bleeding, or with a decrease in mean arterial BP to \< 65 mmHg 13. Significant concomitant medical illnesses (such as uncontrolled congestive heart failure or COPD or progressive multi-organ failure) as determined by the study investigator 14. Uncontrolled mental illness as determined by the study investigator 15. Uncontrolled HBV, HIV, or HCV infection with persistent viremia. However, subjects with controlled (undetectable viral load) HIV and HBV on viral suppressive therapies will be enrolled and subjects with history of HCV will be enrolled if they have evidence of SVR within one year prior to enrollment 16. Active illicit opiates, cocaine, ketamine, or methamphetamine use in the last 30 days via patient report or medical chart review. 17. Uncontrolled diabetes mellitus with A1c \> 9 18. Pregnancy or breastfeeding 19. Known allergy or intolerance to therapeutic agents to be tested 20. Unwillingness to stop alcohol use and to undergo AUD treatment 21. Unwillingness to either abstain from sexual intercourse, or if sexually active, use a reliable method of birth control during the study and for at least 30 days after the last dose of the study medication. Examples of acceptable birth control methods include double barrier method such as condom and occlusive cap (diaphragm or cervical cap) with spermicidal foam/gel/film/cream/suppository; birth control pills, patches, injections, or implants; intrauterine device (IUD); vasectomy and tubal ligation. 22. Participant has any condition or circumstance that adversely affects the participant, could cause noncompliance with treatment or visits, may impact the interpretation of clinical data, could cause bias, or may otherwise contraindicate the participant's participation in the study.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Alcohol use disorder are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    6 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Cleveland Clinic

    RECRUITING

    Cleveland, Ohio, 44195, United States

  • Indiana University

    RECRUITING

    Indianapolis, Indiana, 46202, United States

  • Mayo Clinic

    RECRUITING

    Rochester, Minnesota, 55902, United States

  • University of Louisville

    RECRUITING

    Louisville, Kentucky, 40292, United States

  • University of Texas Southwestern Medical School

    RECRUITING

    Dallas, Texas, 15260, United States

  • Virginia Commonwealth University

    RECRUITING

    Richmond, Virginia, 23284, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.