Liver DiseasesCHANCENCT04613921
Liver Transplantation in Patients With CirrHosis and Severe Acute-on-Chronic Liver Failure: iNdications and outComEs
An observational study of Liver Diseases and Liver Cirrhosis, run by European Foundation for Study of Chronic Liver Failure at 106 sites in 27 countries.
Trial summary
Management of ACLF is mainly supportive. The poor outcomes lead physicians to consider liver transplantation as an option, even if controversial. In sicker recipients, LT results in immediate survival, but poor medium-term survival rates in some studies. The scarcity of deceased donors obliges to maximize LT success. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Liver Diseases, Liver Cirrhosis, Acute-On-Chronic Liver Failure
- What is being tested?
- Observational Protocol
- How many people
- 3,000 participants
- Where
- 106 sitesin 27 countries
- Study dates
- 8 Jul 2021to 31 Dec 2026
- Phase
- Observational
- 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 18 to 80 years
- All sexes
- Adult, Older adult
Study population: Acute or subacute liver failure. Patients with hepatocellular carcinoma Subjects listed for transplantation other than liver or liver-kidney transplant. Subjects with previous liver transplantation. Vulnerable population. Pregnant and/or breastfeeding woman Patients with relevant comorbidities
Who may be able to join
- 1. Male or female subject ≥18 years of age.
- 2. Subjects with diagnosis of liver cirrhosis (based on clinical, laboratory, endoscopic, and ultrasonographic features or on histology).
- 3. Subjects who have been hospitalized for acute decompensation of liver cirrhosis and referred to the transplant team:
- Group 1: patients listed for liver transplantation with ACLF-2 or 3 at the time of listing or developing ACLF 2-3 while on the waiting list.
- Group 2: patients listed for liver transplantation with decompensated cirrhosis without ACLF-2 or 3 and poor liver function (MELD>20) at the time of listing.
- Group 3: patients having ACLF-2 or 3, are assessed for inclusion in the waiting list, but are finally not listed for liver transplantation.
- 4. Patients (or trusted person, family member or close relation if the patient is unable to express consent) who have been informed and signed their informed consent Inclusion criteria
Who cannot join
- -
Trial locations and contacts
106 sites in 27 countries. Contact the study team or a site near you to ask about taking part.
106 sites in 27 countries
United States18 sites, 16 recruiting
- Recruiting
Piedmont Healthcare
Atlanta, Georgia, 30309
Lance Stein, lance.stein@piedmont.org
Lance Stein
- Recruiting
University of Colorado
Aurora, Colorado, 80045
Michael Kriss, 303-724-1030, michael.kriss@cuanschutz.edu
Michael Kriss
- Recruiting
University of Maryland School of Medicine
Baltimore, Maryland, 21201
Kirti Shetty, 410 3281328, kshetty@som.umaryland.edu
Kirti Shetty
- Not yet recruiting
Northwestern Memorial Hospital
Chicago, Illinois, 60611
Justin R Boike, +1 312-926-2000, justin.boike@nm.org
Justin R Boike
- Recruiting
The University of Chicago Medicine
Chicago, Illinois, 60637
Helen Te, hte@medicine.bsd.uchicago.edu
- Suspended
University of Cincinnati
Cincinnati, Ohio, 45219
- Recruiting
Cleveland Clinic
Cleveland, Ohio, 44195
Bijan Eghtesad, eghtesb@ccf.org
Bijan Eghtesad
- Not yet recruiting
Baylor College of Medicine (Scott & White)
Dallas, Texas, 75246
Amar Gupta, amar.gupta@bswhealth.org
Amar Gupta
- Not yet recruiting
Michael E DeBakey VA Medical Center
Houston, Texas, 77030-4211
Rubén Hernáez, ruben.hernaez@va.gov
Rubén Hernáez
- Recruiting
Baylor St. Luke's Medical Centre
Houston, Texas, 77030
Jalal Prasun, jalal@bcm.edu
Jalal Prasun
- Recruiting
Cedars-Sinai Comprehensive Transplant Center
Los Angeles, California, 90048
Alexander Kuo, Alexander.Kuo@cshs.org
Alexander Kuo
- Not yet recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Manhal Izzy, +1 615-322-5000, manhal.izzy@vumc.org
Manhal Izzy
- Recruiting
Weill Cornell Medicine
New York, New York, 10021
Russell Rosenblatt, 646-962-5483, rur9017@med.cornell.edu
Russell Rosenblatt
- Recruiting
Icahn School of Medicine at Mount Sinai
New York, New York, 10029-5674
Ghideon Ezaz, ghideon.ezaz@mountsinai.org
Ghideon Ezaz
- Not yet recruiting
Montefiore Medical Center
New York, New York, 10467
Brett Fortune, +1 718-920-4321, bfortune@montefiore.org
Brett Fortune
- Suspended
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
- Recruiting
University of Utah Health
Salt Lake City, Utah, 84132
Juan Gallegos-Orozco, 801.581.7878, juan.gallegos@hsc.utah.edu
Juan Gallego-Orozco
- Not yet recruiting
Tampa General Hospital
Tampa, Florida, 33606
Nyingi Kemmer, nkemmer@tgmg.org
Ningi Kemmer
Germany15 sites, 11 recruiting
- Suspended
University Hospital Aachen
Aachen
- Recruiting
Charité University Hospital
Berlin
Cornelius Engelmann, cornelius.engelmann@charite.de
- Not yet recruiting
Goethe University Clinic
Frankfurt
Alexander Queck, alexander.queck@kgu.de
- Recruiting
University Medical Center, Hamburg Eppendorf
Hamburg
Lutz Fischer, lfischer@uke.de
- Not yet recruiting
Hannover Medical School
Hanover
Richard Taubert, Taubert.richard@mh-hannover.de
- Not yet recruiting
University Hospital Heidelberg
Heidelberg
Arianeb Mehrabi, arianeb.mehrabi@med.uni-heidelberg.de
- Suspended
Jena University Hospital
Jena
- Not yet recruiting
Universitätsklinikum Schleswig-Holstein (UKSH)
Kiel, Schleswig-Holstein
Thomas Becker, Prof, Thomas.Becker@uksh.de
Thomas Becker, Prof
- Recruiting
Universitätsklinikum Schleswig-Holstein (UKSH)
Kiel
Thomas Becker, Thomas.Becker@uksh.de
- Not yet recruiting
Leipzig University Hospital
Leipzig
Thomas Berg, Thomas.Berg@medizin.uni-leipzig.de
Thomas Berg
- Suspended
University Hospital Mainz
Mainz
- Suspended
LMU Großhadern
Munich
- Recruiting
UKM Muenster
Münster
Jonel Trebicka, jonel.trebicka@ukmuenster.de
- Not yet recruiting
University Hospital Regensburg
Regensburg, Eastern Bavaria
Martina Müller-Schilling, MD, martina.mueller-schilling@ukr.de
Martina Müller-Schilling, MD
- Recruiting
University Hospital Tübingen
Tübingen
Silvio Nadalin, Silvio.Nadalin@med.uni-tuebingen.de
Silvio Nadalin
India12 sites, 11 recruiting
- Not yet recruiting
Aster CMI Hospital
Bengaluru, Karnataka
Sonal Asthana, MD, sonal@transplantationliver.com
Sonal Asthana
- Recruiting
Dr.Rela Institute & Medical Centre
Chennai
Mohamed Rela, PI, +91 44 6666 7788, Mohamed.rela@gmail.com
Ashwin Ramohan, ashwinrammohan@gmail.com
- Not yet recruiting
Fortis Hospital Noida, FEHI, FMRI
Gurugramam
Vivek Vij, PI, vivek.vij2@gmail.com
- Not yet recruiting
Medanta Medicity
Gurugramam
Arvinder Singh Soin
- Not yet recruiting
Mahatma Gandhi University of Medical Sciences and Technology
Jaipur, Rajasthan
Vivek Saraswat, Prof, profviveksaraswat@gmail.com
Vivek Saraswat, Prof
- Recruiting
Amrita Institute of Medical Sciences
Kochi
S Sudhindran, +91 484 285 1234, shivsarin@gmail.com
- Not yet recruiting
Kasturba Hospital
Mumbai, Maharashtra
Shiran Shetty, MD, drshiran@gmail.com
Shiran Shetty, MD
- Not yet recruiting
Seth GSMC & KEM Hospital
Mumbai, Maharashtra
Akash Shukla, drakashshukla@yahoo.com
Akash Shukla
- Not yet recruiting
Global Hospital. Super speciality & transplant centre
Mumbai
Samir Shah, Pi, drshahsamir@gmail.com
- Not yet recruiting
Indraprastha Apollo Hospitals
New Delhi, National Capital Territory of Delhi
Ashish Malik, MD, dr1malik@yahoo.co.in
Ashish Malik
- Active, not recruiting
Max Saket Hospital
New Delhi
- Not yet recruiting
Yashoda Hospitals
Secunderabad
Darmesh Kapoor, PI, dharmesh_kapoor@hotmail.com
France9 sites, 9 recruiting
- Recruiting
APHP Beaujon
Clichy
François Durand, francois.durand@bjn.aphp.fr
- Recruiting
APHP Henri Mondor
Créteil
Christophe Duvoux, christophe.duvoux@aphp.fr
- Recruiting
Hôpital de la Croix-Rousse
Lyon
Sylvie Radenne, sylvie.radenne@chu-lyon.fr
- Recruiting
CHU Montpellier-Hôpital Saint Eloi
Montpellier
Georges Phlippe Pageaux, gp-pageaux@chu-montpellier.fr
- Recruiting
APHP Hôpitaux Universitaires Pitié Salpêtrière
Paris
Filomena Conti, filomena.conti@aphp.fr
- Recruiting
CHU Rennes, Hôpital De Pontchaillou
Rennes
Pauline Houssel-Debry, pauline.houssel-debry@chu-rennes.fr
- Recruiting
Hautepièrre Hospital, Service de Réanimation Médicale
Strasbourg
Thierry Artzner, thierry.artzner@chru-strasbourg.fr
- Recruiting
Trousseau Hospital,
Tours
Laure Elkrief, l.elkrief@chu-tours.fr
- Recruiting
Hôpital Paul Brousse
Villejuif
Didier Samuel, didier.samuel@pbr.aphp.fr
Spain7 sites, 7 recruiting
- Recruiting
Hospital Clinic in Barcelona
Barcelona
Javier Fernández Gómez, 934932271400, javier.fernandez@efclif.com
Javier Fernández Gómez
- Recruiting
Hospital Vall d'Hebron
Barcelona
Isabel Campos, icampos@vhebron.net
Víctor Vargas, vvargas@vhebron.net
- Recruiting
Hospital Universitario 12 de Octubre
Madrid
Carmelo Loinaz, cloinaz@yahoo.es
- Recruiting
Hospital Universitario Ramón y Cajal
Madrid
Agustín Albillos, agustin.albillos@uah.es
Agustín Albillos
- Recruiting
Hospital Marqués de Valdecilla
Santander
José Ignacio Fortea, jifortea@gmail.com
José Ignacio Fortea
- Recruiting
Hospital Universitario Virgen del Rocío
Seville
Miguel Ángel Gómez Bravo, miagbravo@gmail.com
- Recruiting
Hospital Universitari i Politècnic La Fe
Valencia
Marina Carmen Berenguer Haym, marina.berenguer@uv.es
Carmen Vinaixa
Italy5 sites, 5 recruiting
- Not yet recruiting
Ospedale Papa Giovanni XXIII-
Bergamo
Stefano Fagiouli, sfagiuoli@asst-pg23.it
- Recruiting
S.Orsola Hospital - Alma Mater Studiorum University of Bologna
Bologna
Cristina Morelli, morelli@aosp.bo.it
- Recruiting
Ca' Granda. Policlinico Milano
Milan
Angelo Sangiovanni, angelo.sangiovanni@policlinico.mi.it
- Recruiting
Niguarda Hospital
Milan
Giovanni Perricone, 39 02 6444.4454, giovanni.perricone@ospedaleniguarda.it
Luca Belli
- Recruiting
University and Hospital of Padova
Padova
Salvatore Piano, salvatorepiano@gmail.com
Paolo Angeli
Japan5 sites, 5 recruiting
- Recruiting
Kyushu University Hospital
Fukuoka
Tomoharo Yoshizumi, tomyoshi@surg2.med.kyushu-u.ac.jp
- Recruiting
Hiroshima University Hospital
Hiroshima
Masahiro Ohira, mohira@hiroshima-u.ac.jp
- Recruiting
Kyoto University Hospital
Kyoto
Shintaro Yagi, shintaro@kuhp.kyoto-u.ac.jp
- Recruiting
Nagasaki University Hospital
Nagasaki
Takanobu Hara, 81 095-819-7316, harataka@nagasaki-u.ac.jp
- Recruiting
Tokyo University Hospital
Tokyo
Nobuhisa Akamatsu, Nakamats-tky@umin.ac.jp
United Kingdom5 sites, 5 recruiting
- Recruiting
Queen Elizabeth Hospital Birmingham
Birmingham
Abhishek Chauhab, Abhishek.Chauhan@uhb.nhs.uk
- Recruiting
Scottish Liver Transplant Unit, Royal Infirmary
Edinburgh
Ken Simpson, K.SIMPSON@ED.AC.UK
- Recruiting
Leeds Teaching Hospitals NHS Trust
Leeds
Joanna Moore, Joanna.moore@nhs.net
- Recruiting
King's College Hospital
London
William Bernal, william.bernal@kcl.ac.uk
Tasneem Pirani
- Recruiting
Royal Free Hospital
London
Rajiv Jalan, 442074332795, r.jalan@ucl.ac.uk
Rachel Westbrook
Argentina3 sites, 3 recruiting
- Recruiting
Austral University Hospital
Buenos Aires
Marcelo Silva, 54 0230 448 - 2422, msilva@cas.austral.edu.ar
Manuel Mendizábal, md
- Recruiting
Hospital Alemán
Buenos Aires
María Margarita Anders, 54 11 4827-7000 ext. 2320, manders@hospitalaleman.com
- Recruiting
Italian Hospital in Buenos Aires
Buenos Aires
Sebastián Marciano, 54-11-49590200 ext. 5370, sebastian.marciano@hospitalitaliano.org.ar
Adrián Gadano, MD
Australia3 sites, 2 recruiting
- Recruiting
Austin Hospital
Heidelberg
Marie Sinclair, Marie.SINCLAIR@austin.org.au
- Suspended
Sir Charles Gairdner Hospital
Nedlands
- Recruiting
Royal Prince Alfred Hospital
Sydney
Avik Majumdar, Avik.majumdar@health.nsw.gov.au
Belgium3 sites, 3 recruiting
- Recruiting
CUB Erasme Hospital
Brussels
Thierry Gustot, Thierry.Gustot@erasme.ulb.ac.be
- Recruiting
Ghent University Hospital
Ghent
Hans Van Vlierberghe, Hans.vanvlierberghe@uzgent.be
Xavier Verhelst, Xavier.Verhelst@uzgent.be
- Recruiting
UZ Leuven
Leuven
Wim Laleman, wim.laleman@uzleuven.be
Wim Laleman
Brazil3 sites, 3 recruiting
- Recruiting
Walter Cantídio University Hospital
Fortaleza
Lívia Carone Linhares, +55 85 3366-8167, liviacarone@gmail.com
- Recruiting
Irmandade Santa Casa de Misericórdia de Porto Alegre
Porto Alegre
Ângelo Zambam de Mattos, +55 51 3214-8080, angmattos@hotmail.com
- Recruiting
Hospital das Clínicas da Universidade de São Paulo
São Paulo
Alberto Farias, +55 11 2661-0000, alberto.farias@hc.fm.usp.br
Canada2 sites, 2 recruiting
- Recruiting
University of Alberta
Edmonton
Dean Karvellas, Cjk2@ualberta.ca
- Recruiting
University of Toronto, Multiorgan Transplant Program
Toronto
Nazia Selzner, Nazia.selzner@uhn.ca
Netherlands2 sites, 2 recruiting
- Not yet recruiting
University Medical Center Groningen (UMCG)
Groningen
Aad Van den Berg, a.p.van.den.berg@umcg.nl
- Recruiting
Erasmus MC University Medical Center
Rotterdam
Caroline Den Hoed, c.denhoed@erasmusmc.nl
Turkey (Türkiye)2 sites, 1 recruiting
- Suspended
Istanbul Memorial Bahcelievler Hospital
Istanbul
- Recruiting
Inonu University, Liver Transplantation Institute
Malatya, Anatolia
Sezai Yilmaz, Prof, sezai.yilmaz@inonu.edu.tr
Sezai Yilmaz
Austria1 site, 1 recruiting
- Recruiting
Medical University of Vienna, Department of Transplant Surgery
Vienna
Gabriela Berlakovitch, gabriela.berlakovich@meduniwien.ac.at
Andreas Rosenstingl, andreas.rosenstingl@meduniwien.ac.at
Colombia1 site, 1 recruiting
- Recruiting
Pablo Tobón Uribe Hospital
Medellín
Juan Ignacio Marín, +57 604 4459000, jmarin@hptu.org.co
Czechia1 site, 1 recruiting
- Not yet recruiting
Institute for Clinical and Experimental Medicine
Prague
Eva Kieslichová, evki@ikem.cz
Pavel Taimr, pata@ikem.cz
Hong Kong1 site
- Suspended
Queen Mary Hospital, The University of Hong Kong
Hong Kong
Mexico1 site, 1 recruiting
- Recruiting
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
Mexico City
Graciela Elia Castro Narro, +52 55 5487 0900, gracastron@yahoo.com
New Zealand1 site
- Suspended
Auckland City Hospital- New Zealand Liver Transplant Unit
Auckland
Poland1 site, 1 recruiting
- Recruiting
Medical University of Warsaw, Dept. of General, Transplant & Liver Surgery
Warsaw
Krzysztof Zieniewicz, krzysztof.zieniewicz@wum.edu.pl
Portugal1 site, 1 recruiting
- Recruiting
Hospital Curry Cabral
Lisbon
Luis Bagulho, luis.bagulho@chlc.min-saude.pt
South Korea1 site, 1 recruiting
- Not yet recruiting
Samsung Medical Center
Seoul
Jong Man Kim, Yjongman21@gmail.com
Sweden1 site, 1 recruiting
- Recruiting
Karolinska Institutet
Stockholm, Stockholm County, 171 77
Magnus Holmer, PI, 08-524 800 00, magnus.holmer@ki.se
Christina Villard, PI, 08-524 800 00, christina.villard@ki.se
Switzerland1 site, 1 recruiting
- Not yet recruiting
Geneva University Hospital (HUG)
Geneva
Christian Toso, Christian.Toso@hcuge.ch
Nicolas Goosens
Taiwan1 site, 1 recruiting
- Recruiting
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City
Chee Chien Yong, ccyong3980@gmail.com
About this study
Official title: Liver Transplantation in Patients With CirrHosis and Severe Acute-on-Chronic Liver Failure (ACLF): iNdications and outComEs
Management of ACLF is mainly supportive. The poor outcomes lead physicians to consider liver transplantation as an option, even if controversial. In sicker recipients, LT results in immediate survival, but poor medium-term survival rates in some studies. The scarcity of deceased donors obliges to maximize LT success. Alternative strategies, as living-donor LT, should be explored. LDLT has impressive results in Eastern centers, but it is restrained in Western countries, due to potential life-threatening complications in the donor.
Read the detailed description
The aim of this study is to compare 1-year graft and patient survival rates after liver transplantation (LT) in patients with ACLF-2 or 3 at the time of LT, with patients with decompensated cirrhosis without ACLF-2 or 3 at the time of LT and also with transplant-free survival of patients with ACLF-2 or 3 not listed for LT.
Secondary objectives are as follows:
- To assess the proportion of patients with ACLF-2 or 3 referred to transplant team who are listed or not and reasons of this decision.
- To evaluate the outcomes of patients listed with ACLF-2 or 3 on the waiting list compared with those of patients listed with decompensated cirrhosis without ACLF-2 or 3.
- To define independent predictive factors of death/delisting on the waiting list for patients listed with ACLF-2 or 3 and develop a new prognostic model based on ACLF criteria to predict mortality on the waiting list and to improve the allocation of organs.
- To compare the characteristics of accepted grafts for patients listed with ACLF-2 or 3 with those of patients listed with decompensated cirrhosis without ACLF-2 or 3 and their impact on post-LT outcomes.
- To explore independent predictive factors of death after LT for patients transplanted with ACLF-2 or 3 to design futility criteria for LT.
- To compare post-LT survival rates of patients with ACLF-2 or 3 at listing and patients without ACLF at listing who develop ACLF-2 or 3 on the waiting list.
- To compare post-LT quality of life (QoL) for patients listed with ACLF-2 or 3 with those of patients listed with decompensated cirrhosis without ACLF-2 or 3.
- Conditions
- Liver Diseases, Liver Cirrhosis, Acute-On-Chronic Liver Failure, Liver Transplant; Complications
- Being tested
- Observational Protocol
- Medical subject headings
- Liver Diseases, Liver Cirrhosis, Acute-On-Chronic Liver Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational ProtocolOther
The cohorts will be followed for one year after LT transplantation except for group 3 (1-year follow-up after inclusion)
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | patients listed for liver transplantation with ACLF-2 or 3 at the time of listing or developing ACLF 2-3 while on the waiting list (n=2,000) Receives: Other: Observational Protocol | |
| Group 2 | patients listed for liver transplantation with decompensated cirrhosis without ACLF-2 or 3 and poor liver function (MELD > 20) at the time of listing (n=500) Receives: Other: Observational Protocol | |
| Group 3 | patients having ACLF-2 or 3, are assessed for inclusion in the waiting list, but are finally not listed for liver transplantation (n=500) Receives: Other: Observational Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
survival
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2020
- Study start8 Jul 2021
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Liver DiseasesStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- European Foundation for Study of Chronic Liver Failure
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04613921
- Sponsor's protocol ID
- 2020/01325
- Acronym
- CHANCE
- Status last verified
- Oct 2025
- First submitted
- 28 Oct 2020
- Last updated
- 20 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gustot T, Fernandez J, Garcia E, Morando F, Caraceni P, Alessandria C, Laleman W, Trebicka J, Elkrief L, Hopf C, Solis-Munoz P, Saliba F, Zeuzem S, Albillos A, Benten D, Montero-Alvarez JL, Chivas MT, Concepcion M, Cordoba J, McCormick A, Stauber R, Vogel W, de Gottardi A, Welzel TM, Domenicali M, Risso A, Wendon J, Deulofeu C, Angeli P, Durand F, Pavesi M, Gerbes A, Jalan R, Moreau R, Gines P, Bernardi M, Arroyo V; CANONIC Study Investigators of the EASL-CLIF Consortium. Clinical Course of acute-on-chronic liver failure syndrome and effects on prognosis. Hepatology. 2015 Jul;62(1):243-52. doi: 10.1002/hep.27849. Epub 2015 May 29.
PubMed 25877702Artru F, Louvet A, Ruiz I, Levesque E, Labreuche J, Ursic-Bedoya J, Lassailly G, Dharancy S, Boleslawski E, Lebuffe G, Kipnis E, Ichai P, Coilly A, De Martin E, Antonini TM, Vibert E, Jaber S, Herrerro A, Samuel D, Duhamel A, Pageaux GP, Mathurin P, Saliba F. Liver transplantation in the most severely ill cirrhotic patients: A multicenter study in acute-on-chronic liver failure grade 3. J Hepatol. 2017 Oct;67(4):708-715. doi: 10.1016/j.jhep.2017.06.009. Epub 2017 Jun 21.
PubMed 28645736Sundaram V, Jalan R, Wu T, Volk ML, Asrani SK, Klein AS, Wong RJ. Factors Associated with Survival of Patients With Severe Acute-On-Chronic Liver Failure Before and After Liver Transplantation. Gastroenterology. 2019 Apr;156(5):1381-1391.e3. doi: 10.1053/j.gastro.2018.12.007. Epub 2018 Dec 18.
PubMed 30576643Gustot T, Bernal W, Fernandez J, Uson-Raposo E, Diaz JM, Farias AQ, Rammohan A, Marciano S, Kuo A, Perricone G, Bateman R, Bagulho L, Surendran S, Colmenero J, Mendizabal M, Kemmer N, Gallegos-Orozco JF, Selzner N, Elkrief L, Lindenmeyer CC, Jalal PK, Anders M, Lucidi V, Vinaixa Aunes C, Vizioli L, Zieniewicz K, Della Penna A, Mattos AZ, Kriss M, Lampertico P, Carone Linhares LM, Gambino C, Castro-Narro GE, Hoed CD, Shetty K, Pirani T, Giguet B, Michard B, Te HS, Yilmaz S, Saraf N, Chauhan A, Hara T, Martin-Mateos R, Lebosse F, Toshima T, Laleman W, Brol MJ, Campos-Varela I, Weiss E, Ohdan H, Braun F, Karvellas CJ, Sinclair M, Engelmann C, Moore J, Coilly A, Loinaz C, Pageaux GP, Van Vlierberghe H, Liu K, Williams MJ, Yong CC, Stein LL, Restrepo JC, Hasegawa K, Berlakovich G, Momoyo-Zitelli P, Jothimani D, Nissen NN, D'Amico F, Cardoso FS, Mohamed ZU, Ruiz P, Pages J, Dhanireddy K, Salame E, Eghtesad B, Bhongade M, Brutti J, Putignano A, Montalva-Oron E, Di Donato R, Raszeja-Wyszomirska J, Zanotelli ML, Carneiro d'Albuquerque LA, Radhakrishnan S, Martinez J, Palomique J, Marques HP, Paul A, Pagano G, Inge-Cox RA, Carrilho FJ, Martin CA, Gomez Perdiguero G, Andraus W, Gadano A, Rela M, Westbrook RH, Berenguer M, Nadalin S, Duvoux C, Belli LS, Sundaram V, Tokat Y, Polak WG, Fondevila C, Eguchi S, McCaughan G, Pomfret E, Bosch-Comas A, Claria J, Angeli P, Trebicka J, Sanchez-Garrido C, Samuel D, Moreau R, Arroyo V, Jalan R; Investigators of the CHANCE study group. Survival outcomes after liver transplantation in acute-on-chronic liver failure: A prospective study. J Hepatol. 2026 Sep 30:S0168-8278(26)02908-9. doi: 10.1016/j.jhep.2026.09.015. Online ahead of print.
PubMed 42822699
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Liver Transplantation in Patients With CirrHosis and Severe Acute-on-Chronic Liver Failure (ACLF): iNdications and outComEs
- ClinicalTrials.gov ID
- NCT04613921
- Acronym / sponsor ID
- CHANCE / 2020/01325
- Conditions
- Liver Diseases, Liver Cirrhosis, Acute-On-Chronic Liver Failure, Liver Transplant; Complications
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- European Foundation for Study of Chronic Liver FailureUniversity, hospital or other
- Study start
- 8 Jul 2021 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 3 Nov 2020 (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.
Management of ACLF is mainly supportive. The poor outcomes lead physicians to consider liver transplantation as an option, even if controversial. In sicker recipients, LT results in immediate survival, but poor medium-term survival rates in some studies. The scarcity of deceased donors obliges to maximize LT success. Alternative strategies, as living-donor LT, should be explored. LDLT has impressive results in Eastern centers, but it is restrained in Western countries, due to potential life-threatening complications in the donor.
Detailed description
The aim of this study is to compare 1-year graft and patient survival rates after liver transplantation (LT) in patients with ACLF-2 or 3 at the time of LT, with patients with decompensated cirrhosis without ACLF-2 or 3 at the time of LT and also with transplant-free survival of patients with ACLF-2 or 3 not listed for LT.
Secondary objectives are as follows:
- To assess the proportion of patients with ACLF-2 or 3 referred to transplant team who are listed or not and reasons of this decision.
- To evaluate the outcomes of patients listed with ACLF-2 or 3 on the waiting list compared with those of patients listed with decompensated cirrhosis without ACLF-2 or 3.
- To define independent predictive factors of death/delisting on the waiting list for patients listed with ACLF-2 or 3 and develop a new prognostic model based on ACLF criteria to predict mortality on the waiting list and to improve the allocation of organs.
- To compare the characteristics of accepted grafts for patients listed with ACLF-2 or 3 with those of patients listed with decompensated cirrhosis without ACLF-2 or 3 and their impact on post-LT outcomes.
- To explore independent predictive factors of death after LT for patients transplanted with ACLF-2 or 3 to design futility criteria for LT.
- To compare post-LT survival rates of patients with ACLF-2 or 3 at listing and patients without ACLF at listing who develop ACLF-2 or 3 on the waiting list.
- To compare post-LT quality of life (QoL) for patients listed with ACLF-2 or 3 with those of patients listed with decompensated cirrhosis without ACLF-2 or 3.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Other: Observational Protocolpatients listed for liver transplantation with ACLF-2 or 3 at the time of listing or developing ACLF 2-3 while on the waiting list (n=2,000) |
| Group 2 | – | Other: Observational Protocolpatients listed for liver transplantation with decompensated cirrhosis without ACLF-2 or 3 and poor liver function (MELD > 20) at the time of listing (n=500) |
| Group 3 | – | Other: Observational Protocolpatients having ACLF-2 or 3, are assessed for inclusion in the waiting list, but are finally not listed for liver transplantation (n=500) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Acute or subacute liver failure. Patients with hepatocellular carcinoma Subjects listed for transplantation other than liver or liver-kidney transplant. Subjects with previous liver transplantation. Vulnerable population. Pregnant and/or breastfeeding woman Patients with relevant comorbidities
Key inclusion criteria (7 listed)
- 1. Male or female subject ≥18 years of age.
- 2. Subjects with diagnosis of liver cirrhosis (based on clinical, laboratory, endoscopic, and ultrasonographic features or on histology).
- 3. Subjects who have been hospitalized for acute decompensation of liver cirrhosis and referred to the transplant team:
- Group 1: patients listed for liver transplantation with ACLF-2 or 3 at the time of listing or developing ACLF 2-3 while on the waiting list.
- Group 2: patients listed for liver transplantation with decompensated cirrhosis without ACLF-2 or 3 and poor liver function (MELD>20) at the time of listing.
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Observational ProtocolThe cohorts will be followed for one year after LT transplantation except for group 3 (1-year follow-up after inclusion) | Other | Group 1, Group 2, Group 3 |
Primary outcome
Survival
Time frame: 1 year
survival
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 20 Oct 2025.
- Background: PubMed 25877702Gustot T, Fernandez J, Garcia E, Morando F, Caraceni P, Alessandria C, Laleman W, Trebicka J, Elkrief L, Hopf C, Solis-Munoz P, Saliba F, Zeuzem S, Albillos A, Benten D, Montero-Alvarez JL, Chivas MT, Concepcion M, Cordoba J, McCormick A, Stauber R, Vogel W, de Gottardi A, Welzel TM, Domenicali M, Risso A, Wendon J, Deulofeu C, Angeli P, Durand F, Pavesi M, Gerbes A, Jalan R, Moreau R, Gines P, Bernardi M, Arroyo V; CANONIC Study Investigators of the EASL-CLIF Consortium. Clinical Course of acute-on-chronic liver failure syndrome and effects on prognosis. Hepatology. 2015 Jul;62(1):243-52. doi: 10.1002/hep.27849. Epub 2015 May 29.
- Background: PubMed 28645736Artru F, Louvet A, Ruiz I, Levesque E, Labreuche J, Ursic-Bedoya J, Lassailly G, Dharancy S, Boleslawski E, Lebuffe G, Kipnis E, Ichai P, Coilly A, De Martin E, Antonini TM, Vibert E, Jaber S, Herrerro A, Samuel D, Duhamel A, Pageaux GP, Mathurin P, Saliba F. Liver transplantation in the most severely ill cirrhotic patients: A multicenter study in acute-on-chronic liver failure grade 3. J Hepatol. 2017 Oct;67(4):708-715. doi: 10.1016/j.jhep.2017.06.009. Epub 2017 Jun 21.
- Background: PubMed 30576643Sundaram V, Jalan R, Wu T, Volk ML, Asrani SK, Klein AS, Wong RJ. Factors Associated with Survival of Patients With Severe Acute-On-Chronic Liver Failure Before and After Liver Transplantation. Gastroenterology. 2019 Apr;156(5):1381-1391.e3. doi: 10.1053/j.gastro.2018.12.007. Epub 2018 Dec 18.
- Derived from this study: PubMed 42822699Gustot T, Bernal W, Fernandez J, Uson-Raposo E, Diaz JM, Farias AQ, Rammohan A, Marciano S, Kuo A, Perricone G, Bateman R, Bagulho L, Surendran S, Colmenero J, Mendizabal M, Kemmer N, Gallegos-Orozco JF, Selzner N, Elkrief L, Lindenmeyer CC, Jalal PK, Anders M, Lucidi V, Vinaixa Aunes C, Vizioli L, Zieniewicz K, Della Penna A, Mattos AZ, Kriss M, Lampertico P, Carone Linhares LM, Gambino C, Castro-Narro GE, Hoed CD, Shetty K, Pirani T, Giguet B, Michard B, Te HS, Yilmaz S, Saraf N, Chauhan A, Hara T, Martin-Mateos R, Lebosse F, Toshima T, Laleman W, Brol MJ, Campos-Varela I, Weiss E, Ohdan H, Braun F, Karvellas CJ, Sinclair M, Engelmann C, Moore J, Coilly A, Loinaz C, Pageaux GP, Van Vlierberghe H, Liu K, Williams MJ, Yong CC, Stein LL, Restrepo JC, Hasegawa K, Berlakovich G, Momoyo-Zitelli P, Jothimani D, Nissen NN, D'Amico F, Cardoso FS, Mohamed ZU, Ruiz P, Pages J, Dhanireddy K, Salame E, Eghtesad B, Bhongade M, Brutti J, Putignano A, Montalva-Oron E, Di Donato R, Raszeja-Wyszomirska J, Zanotelli ML, Carneiro d'Albuquerque LA, Radhakrishnan S, Martinez J, Palomique J, Marques HP, Paul A, Pagano G, Inge-Cox RA, Carrilho FJ, Martin CA, Gomez Perdiguero G, Andraus W, Gadano A, Rela M, Westbrook RH, Berenguer M, Nadalin S, Duvoux C, Belli LS, Sundaram V, Tokat Y, Polak WG, Fondevila C, Eguchi S, McCaughan G, Pomfret E, Bosch-Comas A, Claria J, Angeli P, Trebicka J, Sanchez-Garrido C, Samuel D, Moreau R, Arroyo V, Jalan R; Investigators of the CHANCE study group. Survival outcomes after liver transplantation in acute-on-chronic liver failure: A prospective study. J Hepatol. 2026 Sep 30:S0168-8278(26)02908-9. doi: 10.1016/j.jhep.2026.09.015. Online ahead of print.
- Individual participant dataSharing planned: No
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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.
106 sites in 27 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Diseases and Liver Cirrhosis, run by European Foundation for Study of Chronic Liver Failure at 106 sites in 27 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 7 inclusion and 1 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 20 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 106 sites in United States, Germany, India, France, Spain and 22 more countries. 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?
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 Anna Bosch (34 93 227 1400, anna.bosch@efclif.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival (time frame: 1 year). 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 NCT04613921, which also lists 4 linked publications.
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 20 Oct 2025.