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Alcoholic HepatitisQuickTransNCT01756794

Validation of the Procedure of Early Liver Transplantation in Alcoholic Hepatitis Resisting to Medical Treatment

A study testing Liver transplantation in people with Alcoholic Hepatitis and Alcoholic Cirrhosis, run by University Hospital, Lille at 32 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to validate a strategy of identification of patients for early liver transplantation in severe alcoholic hepatitis. In this setting, short-term survival is very low (approx. 25% at 6 months) and a pilot study has suggested (mathurin et al. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Alcoholic Hepatitis, Alcoholic Cirrhosis
What is being tested?
Liver transplantation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
284 participants
Where
32 sitesin 2 countries
Study dates
5 Dec 2012to 5 Dec 2019
Phase
Interventional
Are there results?
None posted in the registry

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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 19Show fewer
  • 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

Who cannot join

None listed.

Trial locations and contacts

32 sites in 2 countries.

32 sites in 2 countries

France28 sites

  • Univesity hospital

    Amiens, 80054

  • University hospital

    Angers, 49933

  • University hospital

    Besançon, 25030

  • Hôpital Jean Verdier (AH-HP)

    Bondy, 93143

  • University hospital

    Brest, 29609

  • University hospital

    Caen, 14000

  • Univesity hospital

    Chambray-lès-Tours, 37170

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

    Clamart, 92141

  • Hôpital Beaujon (AH-HP)

    Clichy, 92118

  • Hôpital Henri Mondor (AP-HP)

    Créteil, 94000

  • University hospital

    Dijon, 21079

  • University hospital

    Grenoble, 38043

  • University hospital

    Lille, 59037

  • University hospital

    Lyon, 69437

  • University Hospital

    Montpellier, 34295

  • University hospital

    Nancy, 54500

  • University hospital

    Nantes, 44035

  • University hospital

    Nice, 06202

  • Hôpital Saint Antoine (AP-HP)

    Paris, 75012

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

    Paris, 75013

  • Hôpital Cochin (AH-HP)

    Paris, 75014

  • University Hospital

    Pessac, 33604

  • University hospital

    Poitiers, 86021

  • University hospital

    Reims, 51092

  • University hospital

    Rennes, 35033

  • University Hospital

    Strasbourg, 67100

  • University hospital

    Toulouse, 31059

  • Hôpital Paul Brousse (AH-HP)

    Villejuif, 94000

Other trials in France

Belgium4 sites

  • UZA

    Antwerp, Edegem, B-2650

  • ULB, Erasme

    Brussels, 1070

  • Study site

    Ghent

  • Hospital Sart Tilman

    Liège

Other trials in Belgium

About this study

Official title: Validation of an Accelerated Procedure of Selection in Early Liver Transplantation for Severe Alcoholic Hepatitis Not Responding to Medical Treatment QuickTransHAA.

The purpose of this study is to validate a strategy of identification of patients for early liver transplantation in severe alcoholic hepatitis. In this setting, short-term survival is very low (approx. 25% at 6 months) and a pilot study has suggested (mathurin et al. N Engl J Med 2011) that liver transplantation may be an option in very carefully selected patients who did not respond to medical treatment. This selection process deserves to be confirmed in a population of greater size. We hypothesized that patients selected with this process would have a same alcohol relapse rate after liver transplantation than patients transplanted for alcoholic cirrhosis and selected using a 6-month sobriety period

Read the detailed description

Non-inferiority of alcohol relapse in early liver transplantation for severe alcoholic hepatitis as compared to patients transplanted for alcoholic cirrhosis.

Being tested
Liver transplantation
Keywords
Alcoholic hepatitis, Liver transplantation, Alcohol relapse, Alcoholic cirrhosis
Medical subject headings
Hepatitis, Alcoholic, Liver Cirrhosis, Alcoholic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Liver transplantationProcedure or surgery

Study groups in NCT01756794
Study groupRoleWhat they receive
Transplantation of alcoholic hepatitisOtherPatients of this arm will be selected for early liver transplantation for severe alcoholic hepatitis not responding to medical therapy. Selection process will be based on a specific algorithm and follow-up time will be 2 years
Receives: Procedure: Liver transplantation
Transplantation for alcoholic cirrhosisOtherPatients of this arm will be selected for liver transplantation for alcoholic cirrhosis using an abstinence period of 6 months. Outcome of these patients will be compared to that of patients transplanted for severe alcoholic hepatitis.
Receives: Procedure: Liver transplantation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Non-inferiority of alcohol relapse in early liver transplantation for severe alcoholic hepatitis as compared to patients transplanted for alcoholic cirrhosis.

    Aim is to demonstrate that alcohol relapse within the 2-year follow-up period in patients selected for early liver transplantation for severe alcoholic hepatitis is not inferior to that of patients transplanted for alcoholic cirrhosis using the 6-month sobriety period.

    Measured: 2 years

Secondary outcomes (4)

  1. Validation of the survival benefit of transplanted patients as compared to non-transplanted patients with severe alcoholic hepatitis

    First secondary aim is to confirm the survival benefit of patients transplanted for severe alcoholic hepatitis as compared to patients suffering for severe alcoholic hepatitis not responding to medical treatment and not selected for early liver transplantation

    Measured: 2 years

  2. Reproducibility of an algorithm of selection for candidates to liver transplantation

    Second secondary aim is to evaluate the reproducibility of the algorithm for selection of candidates for liver transplantation in three centers

    Measured: 2 years

  3. Incidence of alcohol relapse

    Third secondary endpoint is to compare the incidence of alcohol relapse in patients selected for early transplantation for severe alcoholic hepatitis as compared to patients transplanted for alcoholic cirrhosis using the 6-month sobriety period rule

    Measured: 2 years

  4. Pattern of alcohol relapse in the two groups of transplanted patients

    Fourth secondary endpoint is to assess the pattern of alcohol relapse in the group of patients transplanted for severe alcoholic hepatitis to the group of patients transplanted for alcoholic cirrhosis using the 6-month sobriety rule.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Dec 2012 (estimated)
  2. Study start5 Dec 2012
  3. Primary completion7 Jun 2018
  4. Study completion5 Dec 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
284 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01756794
Sponsor's protocol ID
2010-26
Other IDs
2012-A00088-35
Acronym
QuickTrans
Status last verified
Mar 2020
First submitted
20 Dec 2012
Last updated
22 Dec 2025
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Louvet A, Labreuche J, Moreno C, Vanlemmens C, Moirand R, Feray C, Dumortier J, Pageaux GP, Bureau C, Chermak F, Duvoux C, Thabut D, Leroy V, Carbonell N, Rolland B, Salame E, Anty R, Gournay J, Delwaide J, Silvain C, Lucidi V, Lassailly G, Dharancy S, Nguyen-Khac E, Samuel D, Duhamel A, Mathurin P; QuickTrans trial study group. Early liver transplantation for severe alcohol-related hepatitis not responding to medical treatment: a prospective controlled study. Lancet Gastroenterol Hepatol. 2022 May;7(5):416-425. doi: 10.1016/S2468-1253(21)00430-1. Epub 2022 Feb 23.

    PubMed 35202597

Questions about this trial

What is this clinical trial studying?

A study testing Liver transplantation in people with Alcoholic Hepatitis and Alcoholic Cirrhosis, run by University Hospital, Lille at 32 sites in 2 countries.

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 19 inclusion and 0 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: finished, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 32 sites in France, Belgium. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Non-inferiority of alcohol relapse in early liver transplantation for severe alcoholic hepatitis as compared to patients transplanted for alcoholic cirrhosis. (time frame: 2 years). 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 NCT01756794, 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 22 Dec 2025.

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