NCT06855056 Validation of New Prognostic Biomarkers in Patients With Decompensated Cirrhosis
| NCT ID | NCT06855056 |
| Status | Recruiting |
| Phase | — |
| Sponsor | European Foundation for Study of Chronic Liver Failure |
| Condition | Liver Cirrhosis |
| Study Type | OBSERVATIONAL |
| Enrollment | 189 participants |
| Start Date | 2025-03-01 |
| Primary Completion | 2026-03-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 189 participants in total. It began in 2025-03-01 with a primary completion date of 2026-03-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Eligibility Criteria
Inclusion Criteria: 1. Age between 18 and 80 years. 2. 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. 3. Recovery from AD and expected to be discharged within the next 48 hours. Exclusion Criteria: 1. Admission for planned diagnostic or therapeutic procedures 2. Active malignancy (except for hepatocellular carcinoma within the Milan criteria or nonmelanocytic skin cancer) 3. Antiviral treatment for hepatitis C, B and delta initiated in the last 6 months or planned to be initiated in the following 6 months. 4. HIV positive (except undergoing treatment and who do not exhibit clinical manifestations of AIDS). 5. Ongoing alcohol use disorder with an expected low adherence to prescriptions as judged by physician 6. Previous liver or other organ transplantation 7. Patients with TIPS or other surgical porto-caval shunts 8. Chronic organic renal failure stage IV and V or estimated Glomerular Filtration Rate \<20 ml/min according to the MDRD equations 9. Chronic heart failure NYHA class III or IV 10. Pulmonary disease GOLD III or IV 11. Patients with a history of significant extrahepatic disease with life expectancy \<6 months 12. Severe psychiatric disorders 13. Pregnancy and breast-feeding 14. Expected low adherence to study protocol as judged by physician 15. Patients who cannot provide written informed consent or refuse to participate
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06855056 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Liver Cirrhosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06855056 currently recruiting?
Yes, NCT06855056 is actively recruiting participants. Contact the research team at anna.bosch@efclif.com for enrollment information.
Where is the NCT06855056 trial being conducted?
This trial is being conducted at Clichy, France, Aachen, Germany, Münster, Germany, Bologna, Italy and 5 additional locations.
Who is sponsoring the NCT06855056 clinical trial?
NCT06855056 is sponsored by European Foundation for Study of Chronic Liver Failure. The trial plans to enroll 189 participants.