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Early liver transplant offers hope for severe alcoholic hepatitis patients

NCT ID NCT01756794

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 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looked at whether early liver transplantation can help people with severe alcoholic hepatitis who did not get better with medical treatment. Researchers compared alcohol relapse rates in 284 patients who received early transplants to those transplanted after a 6-month sobriety period. The goal was to see if early transplantation is a safe and effective option for carefully selected patients.

What this could mean

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

Active substance
liver transplantation
What this could lead to
If successful, this could confirm that early liver transplantation is a viable option for carefully selected patients with severe alcoholic hepatitis, potentially saving lives.
What could go wrong
This is a completed study, but results may not apply to all patients. Alcohol relapse remains a risk, and the selection process is very strict, limiting who can benefit.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

284 people

The number who actually took part.

Started

Dec 2012

Finished

Dec 2019

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 years and older

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 (Group A): * Age \> 18 years * Maddrey score \> 32 * Liver biopsy confirming the diagnosis of alcoholic hepatitis * Non-response to medical treatment: Lille score ≥ 0.45 at day 7, or early worsening of liver function (MELD score \> 25) despite a low Lille score (\< 0.45) * Hospitalization stay \< 1 month * Algorithm score ≥ 220/250. Inclusion Criteria (Group B): * Age \>18 years * Diagnosis of alcoholic cirrhosis * Alcoholic withdrawal of 6 months minimum before inscription on the transplant list * MELD score ≥ 15 for patients with hepatocellular carcinoma responding to Milan criteria (1 node \< 5 cm or 3 nodes \< 3 cm) * MELD score ≥ 20 preferably for patients not displaying hepatocellular carcinoma and that did not obtain an "expert" component * No recommendation of MELD score for patients having obtained an "expert" component Non-inclusion Criteria (Group A and B): * Bacterial or viral infection uncontrolled by medical treatment * Fungal or aspergillosis uncontrolled infection * Hepatocellular carcinoma or invasive cancer * Positive test for HBsAg, Positive test for HIV,Positive PCR for HCV * Portal thrombosis * Pregnancy or breast-feeding woman

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Conditions

The condition(s) this trial relates to.

alcoholic hepatitis alcoholic liver cirrhosis

As listed by the trial registrant

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

Alcoholic cirrhosis Alcoholic hepatitis

Contacts and locations

Locations

  • Study site

    Ghent, Belgium

  • Hospital Antoine Béclère (Assistance Publique des Hôpiaux de Paris)

    Clamart, 92141, France

  • Hospital Sart Tilman

    Liège, Belgium

  • Hôpital Beaujon (AH-HP)

    Clichy, 92118, France

  • Hôpital Cochin (AH-HP)

    Paris, 75014, France

  • Hôpital Henri Mondor (AP-HP)

    Créteil, 94000, France

  • Hôpital Jean Verdier (AH-HP)

    Bondy, 93143, France

  • Hôpital Paul Brousse (AH-HP)

    Villejuif, 94000, France

  • Hôpital Saint Antoine (AP-HP)

    Paris, 75012, France

  • Hôpital de la Pitié-Salpétrière (AP-HP)

    Paris, 75013, France

  • ULB, Erasme

    Brussels, 1070, Belgium

  • UZA

    Antwerp, Edegem, B-2650, Belgium

  • University Hospital

    Montpellier, 34295, France

  • University Hospital

    Pessac, 33604, France

  • University Hospital

    Strasbourg, 67100, France

  • University hospital

    Angers, 49933, France

  • University hospital

    Besançon, 25030, France

  • University hospital

    Brest, 29609, France

  • University hospital

    Caen, 14000, France

  • University hospital

    Dijon, 21079, France

  • University hospital

    Grenoble, 38043, France

  • University hospital

    Lille, 59037, France

  • University hospital

    Lyon, 69437, France

  • University hospital

    Nancy, 54500, France

  • University hospital

    Nantes, 44035, France

  • University hospital

    Nice, 06202, France

  • University hospital

    Poitiers, 86021, France

  • University hospital

    Reims, 51092, France

  • University hospital

    Rennes, 35033, France

  • University hospital

    Toulouse, 31059, France

  • Univesity hospital

    Amiens, 80054, France

  • Univesity hospital

    Chambray-lès-Tours, 37170, France

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