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 @ 10:54 PM
Ignite Modification Date:
2025-12-24 @ 10:54 PM
NCT ID:
NCT06340269
Eligibility Criteria:
Inclusion Criteria:
* Male or female subjects ≥18 years and ≤80 years
* Subject is able to provide informed consent to participate in the study, otherwise written consent must be obtained on behalf of the subject by a next of kin or legal representative in accordance with local ethical and legal requirements
* History of an acute decompensation event (including but not limited to ascites, gastrointestinal bleeding, hepatic encephalopathy and/or acute bacterial infections), occurring within ≤6 weeks of screening
* Cirrhosis (diagnosed based on clinical, biological, morphological parameters or liver biopsy)
* Subject with:
* ACLF Grade 2, 3a or 3b based on the CLIF-C OF score
* Under continuous renal replacement therapy (CRRT) or any organ support device that requires catheter placement
Exclusion Criteria:
* Subjects with acute or sub-acute liver failure without an underlying cirrhosis
* Subjects not considered appropriate for full active treatment including organ support or those with a Do Not Attempt Cardio-Pulmonary Resuscitation order (DNACPR)
* Subjects who have received any investigational drug or device within 30 days of dosing or who are scheduled to receive another investigational drug or device in the course of the study; concomitant observational studies are allowed
* Evidence of uncontrolled seizures
* In females: known pregnancy or lactating
* Patients with a known allergy to shellfish
* Patients for who, in the opinion of the investigator, it would be unsafe to be considered for the study
* Vulnerable population according to Articles 64 to 68 of the Regulations (EU) 2017/745 on Medical Devices
* Patient with weight \< 30 kg
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT06340269
Study Brief:
Protocol Section:
NCT06340269