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New combo therapy aims to boost survival in severe alcoholic hepatitis

NCT ID NCT06956482

Disease control Sponsor: University Hospital, Lille Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 3 trial tests whether adding N-acetylcysteine or extending prednisolone treatment beyond the standard 30 days can improve outcomes for people with severe alcoholic hepatitis. About 477 participants will be enrolled. The goal is to see if these strategies increase the number of patients alive with better liver function at 90 days.

What this could mean

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

Active substance
N-acetylcysteine and prednisolone
What this could lead to
If successful, this could provide a new treatment strategy to reduce deaths and liver damage in severe alcoholic hepatitis.
What could go wrong
This is a phase 3 trial, but previous similar strategies have failed. The benefit may be modest, and side effects from steroids or NAC are possible.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 477 people

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

Started

May 2026

Expected to finish

May 2030

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 75 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: * Patients aged 18-75 * Alcohol consumption of more than 40g/day (women) and 50g/day (men) * Recent onset of jaundice (\<3 months) * Biopsy proven alcoholic hepatitis (transjugular liver biopsy) * Maddrey's discriminant function ≥ 32, defining severe alcoholic hepatitis * MELD score ≥ 17 * Patients covered with social insurance * Patients having provided written informed consent to participate Exclusion Criteria: * Hepatocellular carcinoma * Uncontrolled gastrointestinal bleeding * Previous severe allergy or hypersensitivity to N-acetylcysteine (anaphylactic shock, Quincke edema, severe urticaria) * Hypersensitivity to any component of the medication * MELD score \<17 * Type 1 hepatorenal syndrome before the initiation of treatment * Severe extrahepatic disease, with life expectancy \< 6 months * Any malignant tumor \< 2 years (except skin carcinomas) * Ongoing viral or parasitic infection * Untreated bacterial infection * Tuberculosis \< 5 years * Positive blood PCR in patients with positive antibodies against HCV * Patient carrying HBV or HIV * Treatment with corticosteroids, immunosuppression therapy or budesonide within 6 months before the study

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Conditions

The condition(s) this trial relates to.

alcoholic hepatitis Hepatic Insufficiency

As listed by the trial registrant

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

Alcoholic hepatitis

How to take part

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

  1. The places running it

    1 site. 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

  • CHU de Lille, Hôpital Huriez

    RECRUITING

    Lille, 59037, France

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