Validation of New Prognostic Biomarkers in Patients With Decompensated Cirrhosis

NCT06855056 | Recruiting

• 2 other identifiers: PROSPECT847949
• Study Type: observational
• Target: 189
• Locations: 5 countries
• Sites: 9

Brief Summary

The study aims to test the effectiveness of new biomarkers (measurable molecules in our body) in predicting the health outcome of patients with liver cirrhosis discharged from the hospital after a serious complication of the disease

Conditions

Liver Cirrhosis; Decompensated Cirrhosis of Liver

Keywords

Decompensated Liver Cirrhosis; Acute on Chronic Liver Failure (ACLF); Liver Diseases; Liver Cirrhosis; Biomarkers

Outcome Measures

Primary Outcomes (1)

• To test the prognostic accuracy of novel biomarkers identified within the DECISION project.

  The primary objective will be evaluated assessing the following end-point: ● Survival at 3 months

  Until September 30th 2025

Secondary Outcomes (1)

• To characterize the clinical and biological features at the time of discharge predicting the 6-month outcome and the different trajectories of patients surviving a hospitalization for AD complicated or not by ACLF.

  Until September 30th 2025

Study Arms (1)

Patients with Decompensated Liver Cirrhosis

Patients eligible for this study will be patients with decompensated cirrhosis expected to be discharged from the hospital within 48 hours after an index admission for AD according to the EASL-CLIF criteria

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients eligible for this study will be patients with decompensated cirrhosis expected to be discharged from the hospital within 48 hours after an index admission for AD according to the EASL-CLIF criteria.

You may qualify if:

• Age between 18 and 80 years.
• Patients with decompensated cirrhosis admitted to hospital due to AD according to the EASL-CLIF criteria (rapid onset of ascites, hepatic encephalopathy, portal hypertensive- related gastrointestinal bleeding, bacterial infection, or any combination of these), including those who presented ACLF during hospitalization.
• Recovery from AD and expected to be discharged within the next 48 hours.

You may not qualify if:

• Admission for planned diagnostic or therapeutic procedures
• Active malignancy (except for hepatocellular carcinoma within the Milan criteria or nonmelanocytic skin cancer)
• Antiviral treatment for hepatitis C, B and delta initiated in the last 6 months or planned to be initiated in the following 6 months.
• HIV positive (except undergoing treatment and who do not exhibit clinical manifestations of AIDS).
• Ongoing alcohol use disorder with an expected low adherence to prescriptions as judged by physician
• Previous liver or other organ transplantation
• Patients with TIPS or other surgical porto-caval shunts
• Chronic organic renal failure stage IV and V or estimated Glomerular Filtration Rate \<20 ml/min according to the MDRD equations
• Chronic heart failure NYHA class III or IV
• Pulmonary disease GOLD III or IV
• Patients with a history of significant extrahepatic disease with life expectancy \<6 months
• Severe psychiatric disorders
• Pregnancy and breast-feeding
• Expected low adherence to study protocol as judged by physician
• Patients who cannot provide written informed consent or refuse to participate

Sponsors & Collaborators

• European Foundation for Study of Chronic Liver Failure: lead
• Universität Münster: collaborator
• IRCCS Azienda Ospedaliero-Universitaria di Bologna: collaborator
• Hospital Universitari Vall d'Hebron Research Institute: collaborator
• Hospital Clinic de Barcelona, Barcelona, Spain: collaborator
• Hospital Universitario Ramon y Cajal: collaborator
• Beaujon Hospital: collaborator
• University Hospital, Aachen: collaborator
• A.O.U. Città della Salute e della Scienza: collaborator

Study Sites (9)

Hospital Beaujon

Clichy, France, 92110, France

RECRUITING

University Hospital, Aachen

Aachen, Germany, 52074, Germany

RECRUITING

Universitätsklinikum Münster

Münster, Germany, 48149, Germany

RECRUITING

IRCCS Azienda Ospedaliero Universitaria di Bologna Policlinico di S.Orsola

Bologna, Italia, 40138, Italy

RECRUITING

A.O.U. Città della Salute e della Scienza di Torino

Torino, Italy, 10126, Italy

RECRUITING

Hospital Universitari Vall d'Hebron Research Institute

Barcelona, Spain, 08035, Spain

RECRUITING

Hospital Clinic de Barcelona

Barcelona, Spain, 08036, Spain

RECRUITING

Hospital Universitario Ramon y Cajal

Madrid, Spain, 28034, Spain

RECRUITING

Royal Free Hospital

London, United Kingdom, NW3 2QG, United Kingdom

NOT YET RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

MeSH Terms

Conditions

Liver Cirrhosis; Acute-On-Chronic Liver Failure; Liver Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Liver Failure, Acute; Liver Failure; Hepatic Insufficiency

Central Study Contacts

Anna Bosch

CONTACT

+34 93 227 14 03; anna.bosch@efclif.com

Cristina Sánchez-Garrido

CONTACT

cristina.sanchez@efclif.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2025
• First Posted: March 3, 2025
• Study Start: March 1, 2025
• Primary Completion: March 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: August 6, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2); ES (3); FR (1); IT (2); GB (1)