Liver Cirrhosis With Acute DecompensationPREDICTNCT03056612
Predicting Acute-on-Chronic Liver Failure in Cirrhosis (PREDICT) Study
An observational study of Liver Cirrhosis With Acute Decompensation, run by Jonel Trebicka at 45 sites in 14 countries.
Trial summary
The aim of this study is to assess prospectively the critical period prior to the development of Acute-on-Chronic Liver Failure (ACLF) (1), to uncover mechanistic and pathophysiological processes associated with the development and clinical course of ACLF (2) and to identify the precipitating events of ACLF (3). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Cirrhosis With Acute Decompensation
- What is being tested?
- Observation protocol
- How many people
- 1,314 participants
- Where
- 45 sitesin 14 countries
- Study dates
- 31 Mar 2017to 31 Oct 2018
- Phase
- Observational
- 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
Study population: The population of patients would include ca. 1,200 cirrhotic patients over a twelve-months period. These patients will be admitted/referred to the study center because of acute decompensation of cirrhosis (ascites, overt encephalopathy, GI-hemorrhage, new onset of non-obstructive jaundice and/or bacterial infections), without ACLF (as defined according to the CANONIC study ) at hospitalization.
Who may be able to join
- The patients admitted/referred to study center with AD of cirrhosis (ascites, overt encephalopathy, new onset of non-obstructive jaundice, GI-hemorrhage and/or bacterial infections), but without ACLF (as defined according to the CANONIC study) at study inclusion.
Who cannot join
- Presence of ACLF at inclusion;
- Pregnancy;
- Age <18 years;
- Patients with acute or subacute liver failure without underlying cirrhosis;
- Patients with cirrhosis who develop decompensation in the postoperative period following partial hepatectomy;
- Evidence of current malignancy except for non-melanocytic skin cancer and hepatocellular carcinoma within Milan criteria;
Show all 12Show fewer
- Presence or history of severe extra-hepatic diseases (e.g., chronic renal failure requiring hemodialysis, severe heart disease (NYHA > II); severe chronic pulmonary disease (GOLD > III), severe neurological and psychiatric disorders);
- HIV-positive patients
- Previous liver or other transplantation
- Admission/referral of more than 72 hours before inclusion
- Patients who decline to participate or who cannot provide prior written informed consent and when there is documented evidence that the patient has no legal surrogate decision maker and it appears unlikely that the patient will regain consciousness or sufficient ability to provide delayed informed consent;
- Physician´s denial (e.g. the investigator considers that the patient will not follow the protocol scheduled).
Trial locations and contacts
45 sites in 14 countries.
45 sites in 14 countries
Germany8 sites
RTWH Aachen
Aachen
University Hospital Bonn
Bonn
JW Goethe University Hospital
Frankfurt am Main
University Hospital Halle-Wittenberg
Halle
Hannover Medical School
Hanover
University Hospital Jena
Jena
University Hospital Leipzig
Leipzig
University Hospital Munich LMU
Munich
Spain6 sites
Hospital Clinic y Provencial de Barcelona
Barcelona
Hospital de Sant Pau
Barcelona
Hospital Universitari Vall d´Hebron
Barcelona
Hospital General Universitario Gregorio Maranon
Madrid
Hospital Ramon y Cajal
Madrid
Virgen del Rocio
Seville
United Kingdom6 sites
Birmingham University Hospitals
Birmingham
Imperial College
London
King´s College
London
Royal Free Hospital
London
Nottingham University Hospitals
Nottingham
Derriford Hospital, Plymouth Hospitals Trust
Plymouth
Italy5 sites
University of Bologna
Bologna
Internal Medicine PO Ostuni
Brindisi
University Clinic Padova
Padova
Universita Sapienza
Rome
A.O.U. Torino
Torino
Belgium4 sites
University Hospital Antwerp
Antwerp
C.U.B Erasmo
Brussels
Ghent University Hospital
Ghent
University Hospital Leuven
Leuven
Austria3 sites
Medical University Graz
Graz
Medical University of Innsbruck
Innsbruck
Medical University of Vienna
Vienna
France3 sites
Hospital Jean Verdier
Bondy
Hopital Beaujon
Paris
Hopital Paul Brousse
Paris
Switzerland3 sites
Inselspital
Bern
Hôpitaux Universitaires Geneve
Geneva
Cantonal Hospital St. Gallen
Sankt Gallen
Denmark2 sites
Aarhus University Hospital
Aarhus
Hvidovre University Hospital
Copenhagen
Slovakia1 site
Pavol Jozef Sfarik University Kosice/Roosevelt Hospital Bystrica
Košice
About this study
The aim of this study is to assess prospectively the critical period prior to the development of Acute-on-Chronic Liver Failure (ACLF) (1), to uncover mechanistic and pathophysiological processes associated with the development and clinical course of ACLF (2) and to identify the precipitating events of ACLF (3).
Read the detailed description
- This International-European, investigator-initiated, multicenter, prospective, observational study will be performed in centers that belong to the European Foundation for the Study of Chronic Liver failure (EF-CLIF)-European Association for Study of the Liver (EASL)-EASL-CLIF Consortium.
- The population of patients would include ca. 1,200 cirrhotic patients over a twelve-months period. These patients will be admitted/referred to the study center because of acute decompensation (AD) of cirrhosis (ascites, overt encephalopathy, GI-hemorrhage, new onset of non-obstructive jaundice and/or bacterial infections), without ACLF (as defined according to the Canonic study ) at hospitalization.
- After the enrolment visit, the patients will be stratified into two groups: Group 1 patients with high risk of ACLF development (CLIF-C AD score ≥ 50) and in Group 2 patients with low risk of ACLF (CLIF-C AD score <50). The whole cohort will be followed for 3 months, while Group 1 will be followed more closely. Development of ACLF is an end-point and in this case a final visit 7-10 days after ACLF development is planned. Data on liver transplantation, mortality and causes of mortality 3 months, 6 months and 12 months will be collected in the whole cohort.
- Prospective collection of biological material and performance of ancillary studies investigating predictors for development and pathogenesis of ACLF.
Specific goals of the study:
- To identify early clinical predictors, biomarkers, mechanisms and precipitating events during the critical period prior to and involved in the development and clinical course of ACLF (with special emphasis to medical trajectory and drug history) in patients admitted/referred to study center with acute decompensation of cirrhosis (ascites, GI-hemorrhage, overt encephalopathy, new onset of non-obstructive jaundice and/or bacterial infections) and the chronological relationship of the events with occurrence and dynamics of ACLF development.
- To develop a score predicting ACLF development (CLIF-PREDICT score) and assess 28-day, 90-day, 6-month and 1-year all-cause mortality in cirrhotic patients with acute AD, but without ACLF.
- To serve as a core (hub) study for prospective ancillary studies regarding diagnosis, prognosis and pathogenesis of AD and ACLF.
Main endpoints
- Assessment of the critical period prior to ACLF development
- Characterization of mechanisms responsible for ACLF development
- Predictors of clinical course dynamics of ACLF evolution and mortality.
- Identification and role of precipitating events for ACLF development.
- To elaborate a CLIF-PREDICT score 2. Secondary endpoints
- Prospective core ancillary studies to investigate the pathogenesis of ACLF.
- Being tested
- Observation protocol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observation protocolOther
The whole cohort will be followed for 3 months, while Group 1 will be followed more closely.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Group 1 patients with high risk of ACLF development (CLIF-C AD score ≥ 50) Receives: Other: Observation protocol | |
| Group 2 | Group 2 patients with low risk of ACLF (CLIF-C AD score <50) Receives: Other: Observation protocol | |
| ACLF | ACLF-patients were specified the patients who were admitted at hospital with ACLF, Receives: Other: Observation protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients developing ACLF within 12 weeks and severity of ACLF development
- Characterization of mechanisms responsible for ACLF development
- Predictors of clinical course dynamics of ACLF evolution and mortality.
- Identification and role of precipitating events for ACLF development.
Measured: 12 weeks
Secondary outcomes (1)
Score to PREDICT ACLF
-Calculate a Score to predict ACLF
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2017
- Study start31 Mar 2017
- Primary completion31 Jul 2018
- Study completion31 Oct 2018
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 Cirrhosis With Acute DecompensationStudies 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
- 1,314 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jonel Trebicka
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jonel Trebicka, European Foundation for Study of Chronic Liver Failure
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03056612
- Sponsor's protocol ID
- PREDICT
- Acronym
- PREDICT
- Status last verified
- Apr 2019
- First submitted
- 13 Feb 2017
- Last updated
- 12 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Van Espen L, Brol MJ, Close L, Schierwagen R, Gu W, Keller MI, Balogh B, Fullam A, De Coninck L, Nakamura T, Kuhn M, Bork P, Laleman W, Bajaj JS, Papp M, Schnabl B, Trebicka J, Matthijnssens J; MICROB-PREDICT. L actococcus A phages predict ACLF while Enterococcus B phages predict bacterial infection in decompensated cirrhosis. JHEP Rep. 2025 Oct 10;8(1):101622. doi: 10.1016/j.jhepr.2025.101622. eCollection 2026 Jan.
PubMed 41438339Weiss E, de la Pena-Ramirez C, Aguilar F, Lozano JJ, Sanchez-Garrido C, Sierra P, Martin PI, Diaz JM, Fenaille F, Castelli FA, Gustot T, Laleman W, Albillos A, Alessandria C, Domenicali M, Caraceni P, Piano S, Saliba F, Zeuzem S, Gerbes AL, Wendon JA, Jansen C, Gu W, Papp M, Mookerjee R, Gambino CG, Jimenez C, Giovo I, Zaccherini G, Merli M, Putignano A, Uschner FE, Berg T, Bruns T, Trautwein C, Zipprich A, Banares R, Presa J, Genesca J, Vargas V, Fernandez J, Bernardi M, Angeli P, Jalan R, Claria J, Junot C, Moreau R, Trebicka J, Arroyo V. Sympathetic nervous activation, mitochondrial dysfunction and outcome in acutely decompensated cirrhosis: the metabolomic prognostic models (CLIF-C MET). Gut. 2023 Aug;72(8):1581-1591. doi: 10.1136/gutjnl-2022-328708. Epub 2023 Feb 14.
PubMed 36788015Trebicka J, Fernandez J, Papp M, Caraceni P, Laleman W, Gambino C, Giovo I, Uschner FE, Jansen C, Jimenez C, Mookerjee R, Gustot T, Albillos A, Banares R, Jarcuska P, Steib C, Reiberger T, Acevedo J, Gatti P, Shawcross DL, Zeuzem S, Zipprich A, Piano S, Berg T, Bruns T, Danielsen KV, Coenraad M, Merli M, Stauber R, Zoller H, Ramos JP, Sole C, Soriano G, de Gottardi A, Gronbaek H, Saliba F, Trautwein C, Kani HT, Francque S, Ryder S, Nahon P, Romero-Gomez M, Van Vlierberghe H, Francoz C, Manns M, Garcia-Lopez E, Tufoni M, Amoros A, Pavesi M, Sanchez C, Praktiknjo M, Curto A, Pitarch C, Putignano A, Moreno E, Bernal W, Aguilar F, Claria J, Ponzo P, Vitalis Z, Zaccherini G, Balogh B, Gerbes A, Vargas V, Alessandria C, Bernardi M, Gines P, Moreau R, Angeli P, Jalan R, Arroyo V; PREDICT STUDY group of the EASL-CLIF CONSORTIUM. PREDICT identifies precipitating events associated with the clinical course of acutely decompensated cirrhosis. J Hepatol. 2021 May;74(5):1097-1108. doi: 10.1016/j.jhep.2020.11.019. Epub 2020 Nov 20.
PubMed 33227350Trebicka J, Fernandez J, Papp M, Caraceni P, Laleman W, Gambino C, Giovo I, Uschner FE, Jimenez C, Mookerjee R, Gustot T, Albillos A, Banares R, Janicko M, Steib C, Reiberger T, Acevedo J, Gatti P, Bernal W, Zeuzem S, Zipprich A, Piano S, Berg T, Bruns T, Bendtsen F, Coenraad M, Merli M, Stauber R, Zoller H, Ramos JP, Sole C, Soriano G, de Gottardi A, Gronbaek H, Saliba F, Trautwein C, Ozdogan OC, Francque S, Ryder S, Nahon P, Romero-Gomez M, Van Vlierberghe H, Francoz C, Manns M, Garcia E, Tufoni M, Amoros A, Pavesi M, Sanchez C, Curto A, Pitarch C, Putignano A, Moreno E, Shawcross D, Aguilar F, Claria J, Ponzo P, Jansen C, Vitalis Z, Zaccherini G, Balogh B, Vargas V, Montagnese S, Alessandria C, Bernardi M, Gines P, Jalan R, Moreau R, Angeli P, Arroyo V; PREDICT STUDY group of the EASL-CLIF Consortium. The PREDICT study uncovers three clinical courses of acutely decompensated cirrhosis that have distinct pathophysiology. J Hepatol. 2020 Oct;73(4):842-854. doi: 10.1016/j.jhep.2020.06.013. Epub 2020 Jul 13.
PubMed 32673741
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting Acute-on-Chronic Liver Failure in Cirrhosis (PREDICT) Study
- ClinicalTrials.gov ID
- NCT03056612
- Acronym / sponsor ID
- PREDICT / PREDICT
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,314 participants (actual)
- Lead sponsor
- Jonel TrebickaUniversity, hospital or other
- Study start
- 31 Mar 2017 (actual)
- Primary completion
- 31 Jul 2018 (actual)
- Study completion
- 31 Oct 2018 (actual)
- First posted
- 17 Feb 2017 (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.
The aim of this study is to assess prospectively the critical period prior to the development of Acute-on-Chronic Liver Failure (ACLF) (1), to uncover mechanistic and pathophysiological processes associated with the development and clinical course of ACLF (2) and to identify the precipitating events of ACLF (3).
Detailed description
- This International-European, investigator-initiated, multicenter, prospective, observational study will be performed in centers that belong to the European Foundation for the Study of Chronic Liver failure (EF-CLIF)-European Association for Study of the Liver (EASL)-EASL-CLIF Consortium.
- The population of patients would include ca. 1,200 cirrhotic patients over a twelve-months period. These patients will be admitted/referred to the study center because of acute decompensation (AD) of cirrhosis (ascites, overt encephalopathy, GI-hemorrhage, new onset of non-obstructive jaundice and/or bacterial infections), without ACLF (as defined according to the Canonic study ) at hospitalization.
- After the enrolment visit, the patients will be stratified into two groups: Group 1 patients with high risk of ACLF development (CLIF-C AD score ≥ 50) and in Group 2 patients with low risk of ACLF (CLIF-C AD score <50). The whole cohort will be followed for 3 months, while Group 1 will be followed more closely. Development of ACLF is an end-point and in this case a final visit 7-10 days after ACLF development is planned. Data on liver transplantation, mortality and causes of mortality 3 months, 6 months and 12 months will be collected in the whole cohort.
- Prospective collection of biological material and performance of ancillary studies investigating predictors for development and pathogenesis of ACLF.
Specific goals of the study:
- To identify early clinical predictors, biomarkers, mechanisms and precipitating events during the critical period prior to and involved in the development and clinical course of ACLF (with special emphasis to medical trajectory and drug history) in patients admitted/referred to study center with acute decompensation of cirrhosis (ascites, GI-hemorrhage, overt encephalopathy, new onset of non-obstructive jaundice and/or bacterial infections) and the chronological relationship of the events with occurrence and dynamics of ACLF development.
- To develop a score predicting ACLF development (CLIF-PREDICT score) and assess 28-day, 90-day, 6-month and 1-year all-cause mortality in cirrhotic patients with acute AD, but without ACLF.
- To serve as a core (hub) study for prospective ancillary studies regarding diagnosis, prognosis and pathogenesis of AD and ACLF.
Main endpoints
- Assessment of the critical period prior to ACLF development
- Characterization of mechanisms responsible for ACLF development
- Predictors of clinical course dynamics of ACLF evolution and mortality.
- Identification and role of precipitating events for ACLF development.
- To elaborate a CLIF-PREDICT score 2. Secondary endpoints
- Prospective core ancillary studies to investigate the pathogenesis of ACLF.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Other: Observation protocolGroup 1 patients with high risk of ACLF development (CLIF-C AD score ≥ 50) |
| Group 2 | – | Other: Observation protocolGroup 2 patients with low risk of ACLF (CLIF-C AD score <50) |
| ACLF | – | Other: Observation protocolACLF-patients were specified the patients who were admitted at hospital with ACLF, |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The population of patients would include ca. 1,200 cirrhotic patients over a twelve-months period. These patients will be admitted/referred to the study center because of acute decompensation of cirrhosis (ascites, overt encephalopathy, GI-hemorrhage, new onset of non-obstructive jaundice and/or bacterial infections), without ACLF (as defined according to the CANONIC study ) at hospitalization.
Key inclusion criteria (1 listed)
- The patients admitted/referred to study center with AD of cirrhosis (ascites, overt encephalopathy, new onset of non-obstructive jaundice, GI-hemorrhage and/or bacterial infections), but without ACLF (as defined according to the CANONIC study) at study inclusion.
Key exclusion criteria (12 listed)
- Presence of ACLF at inclusion;
- Pregnancy;
- Age <18 years;
- Patients with acute or subacute liver failure without underlying cirrhosis;
- Patients with cirrhosis who develop decompensation in the postoperative period following partial hepatectomy;
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 |
|---|---|---|
| Observation protocolThe whole cohort will be followed for 3 months, while Group 1 will be followed more closely. | Other | ACLF, Group 1, Group 2 |
Primary outcome
Number of patients developing ACLF within 12 weeks and severity of ACLF development
Time frame: 12 weeks
* Characterization of mechanisms responsible for ACLF development * Predictors of clinical course dynamics of ACLF evolution and mortality. * Identification and role of precipitating events for ACLF development.
1 secondary outcome
Score to PREDICT ACLF
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2019.
- Derived from this study: PubMed 41438339Van Espen L, Brol MJ, Close L, Schierwagen R, Gu W, Keller MI, Balogh B, Fullam A, De Coninck L, Nakamura T, Kuhn M, Bork P, Laleman W, Bajaj JS, Papp M, Schnabl B, Trebicka J, Matthijnssens J; MICROB-PREDICT. L actococcus A phages predict ACLF while Enterococcus B phages predict bacterial infection in decompensated cirrhosis. JHEP Rep. 2025 Oct 10;8(1):101622. doi: 10.1016/j.jhepr.2025.101622. eCollection 2026 Jan.
- Derived from this study: PubMed 36788015Weiss E, de la Pena-Ramirez C, Aguilar F, Lozano JJ, Sanchez-Garrido C, Sierra P, Martin PI, Diaz JM, Fenaille F, Castelli FA, Gustot T, Laleman W, Albillos A, Alessandria C, Domenicali M, Caraceni P, Piano S, Saliba F, Zeuzem S, Gerbes AL, Wendon JA, Jansen C, Gu W, Papp M, Mookerjee R, Gambino CG, Jimenez C, Giovo I, Zaccherini G, Merli M, Putignano A, Uschner FE, Berg T, Bruns T, Trautwein C, Zipprich A, Banares R, Presa J, Genesca J, Vargas V, Fernandez J, Bernardi M, Angeli P, Jalan R, Claria J, Junot C, Moreau R, Trebicka J, Arroyo V. Sympathetic nervous activation, mitochondrial dysfunction and outcome in acutely decompensated cirrhosis: the metabolomic prognostic models (CLIF-C MET). Gut. 2023 Aug;72(8):1581-1591. doi: 10.1136/gutjnl-2022-328708. Epub 2023 Feb 14.
- Derived from this study: PubMed 33227350Trebicka J, Fernandez J, Papp M, Caraceni P, Laleman W, Gambino C, Giovo I, Uschner FE, Jansen C, Jimenez C, Mookerjee R, Gustot T, Albillos A, Banares R, Jarcuska P, Steib C, Reiberger T, Acevedo J, Gatti P, Shawcross DL, Zeuzem S, Zipprich A, Piano S, Berg T, Bruns T, Danielsen KV, Coenraad M, Merli M, Stauber R, Zoller H, Ramos JP, Sole C, Soriano G, de Gottardi A, Gronbaek H, Saliba F, Trautwein C, Kani HT, Francque S, Ryder S, Nahon P, Romero-Gomez M, Van Vlierberghe H, Francoz C, Manns M, Garcia-Lopez E, Tufoni M, Amoros A, Pavesi M, Sanchez C, Praktiknjo M, Curto A, Pitarch C, Putignano A, Moreno E, Bernal W, Aguilar F, Claria J, Ponzo P, Vitalis Z, Zaccherini G, Balogh B, Gerbes A, Vargas V, Alessandria C, Bernardi M, Gines P, Moreau R, Angeli P, Jalan R, Arroyo V; PREDICT STUDY group of the EASL-CLIF CONSORTIUM. PREDICT identifies precipitating events associated with the clinical course of acutely decompensated cirrhosis. J Hepatol. 2021 May;74(5):1097-1108. doi: 10.1016/j.jhep.2020.11.019. Epub 2020 Nov 20.
- Derived from this study: PubMed 32673741Trebicka J, Fernandez J, Papp M, Caraceni P, Laleman W, Gambino C, Giovo I, Uschner FE, Jimenez C, Mookerjee R, Gustot T, Albillos A, Banares R, Janicko M, Steib C, Reiberger T, Acevedo J, Gatti P, Bernal W, Zeuzem S, Zipprich A, Piano S, Berg T, Bruns T, Bendtsen F, Coenraad M, Merli M, Stauber R, Zoller H, Ramos JP, Sole C, Soriano G, de Gottardi A, Gronbaek H, Saliba F, Trautwein C, Ozdogan OC, Francque S, Ryder S, Nahon P, Romero-Gomez M, Van Vlierberghe H, Francoz C, Manns M, Garcia E, Tufoni M, Amoros A, Pavesi M, Sanchez C, Curto A, Pitarch C, Putignano A, Moreno E, Shawcross D, Aguilar F, Claria J, Ponzo P, Jansen C, Vitalis Z, Zaccherini G, Balogh B, Vargas V, Montagnese S, Alessandria C, Bernardi M, Gines P, Jalan R, Moreau R, Angeli P, Arroyo V; PREDICT STUDY group of the EASL-CLIF Consortium. The PREDICT study uncovers three clinical courses of acutely decompensated cirrhosis that have distinct pathophysiology. J Hepatol. 2020 Oct;73(4):842-854. doi: 10.1016/j.jhep.2020.06.013. Epub 2020 Jul 13.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
45 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Cirrhosis With Acute Decompensation, run by Jonel Trebicka at 45 sites in 14 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 1 inclusion and 12 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 12 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 45 sites in Germany, Spain, United Kingdom, Italy, Belgium and 9 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?
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?
Number of patients developing ACLF within 12 weeks and severity of ACLF development (time frame: 12 weeks). 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 NCT03056612, 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 12 Apr 2019.