Feasibility Pilot Study to Evaluate the Safety and Performance of the MEX-CD1 Medical Device in ACLF

Summary

The goal of this clinical trial is to test the MEX-CD1 hemodialysis medical device in patients suffering from ACLF. The main questions it aims to answer are: * Is the device safe when used according to the instructions for use? * Does the device work as expected by removing the excess of free iron from the blood? Patients will receive 3 MEX-CD1 Slow Low volume CVVHD within 1 week.

Eligibility

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

Conditions3

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