Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:14 PM
Ignite Modification Date:
2025-12-24 @ 11:14 PM
NCT ID:
NCT06855056
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT06855056
Study Brief:
Protocol Section:
NCT06855056