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:
2025-12-25 @ 1:18 AM
Ignite Modification Date:
2025-12-25 @ 1:18 AM
NCT ID:
NCT06223893
Eligibility Criteria:
Inclusion criteria:
1. Adults ≥ 18 years and diagnosed with cirrhosis of any aetiology.
2. Cirrhosis defined by standard clinical criteria, ultrasonographic findings and/or histology. Cirrhosis of any aetiology may be included. However, participants with cirrhosis due to autoimmune hepatitis must be on a stable corticosteroid dose for ≥3-month period before study inclusion (to be recorded on concomitant log).
3. Cirrhosis severity-risk defined by European-Foundation Consortium Liver Failure - Acute Decompensation score (CLIF-C AD score) ≥42 points but ≤65 points at the time of screening.
4. Hospitalisation for acute decompensation \[determined as one or more of the following: increasing ascites, variceal haemorrhage, overt hepatic encephalopathy, spontaneous bacterial peritonitis (SBP) or hepatorenal syndrome - acute kidney injury (HRS-AKI)\].
5. Participants able to give informed consent.
Exclusion criteria:
1. Participants with ACLF grade 2 and above according to the criteria published by Moreau
2. Participants with CLIF-C AD score ≥ 66, who have a high mortality similar to ACLF ≥2 participants.
3. Current overt hepatic encephalopathy, defined as grade II-IV hepatic encephalopathy according to the West-Haven classification, unable to give consent.
4. Participants with active hepatocellular carcinoma (HCC) or history of HCC that is in remission for less than six months for uninodular HCC or for less than 12 months for multinodular HCC within Milan criteria.
5. Participants with a history of significant extra hepatic disease with impaired short-term prognosis, including congestive heart failure New York Heart Association Grade III/IV, COPD GOLD \>2, chronic kidney disease with serum creatinine \>2mg/dL or under renal replacement therapy.
6. Participants with documented refractory ascites on a palliative pathway.
7. Participants who are active on the transplant waiting list.
8. Participants with current extra hepatic malignancies including solid tumours and hematologic disorders.
9. Participants with mental incapacity, significant language barriers, or any other reason considered by the investigator precluding adequate understanding, cooperation or compliance in the study.
10. Participants with active viral infections, or yet to achieve clear response to anti-viral therapy.
11. Any disorders likely to impact on study engagement, including severe frailty, severe addiction history (including opioids) with evidence of multiple recent relapses.
12. Any other reason that the PI considers would make the participant unsuitable to enter CirrhoCare (e.g., participants on an end-of-life palliative care pathway).
13. Participants enrolled in other interventional trials.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06223893
Study Brief:
Protocol Section:
NCT06223893