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

Mexbrain

Status

Enrolling

Conditions

Multiple Organ Failure

Acute on Chronic Liver Failure

Treatments

Device: MEX-CD1 Dialysis

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT06340269

PJ2308-0025

Details and patient eligibility

About

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.

Full description

This study investigates the safety and performance of the MEX-CD1 slow low volume CVVHD device in patients suffering from ACLF.

Acute-on-chronic liver failure (ACLF) is defined as a syndrome in patients with acutely decompensated cirrhosis, associated with single or multiple organ failures, and characterized by a high short-term mortality. ACLF is frequently triggered by a precipitating event (alcoholic hepatitis, infection, gastrointestinal haemorrhage) and characterized by an intense systemic inflammatory response driven per pathogen-associated molecular patterns (PAMPs) and/or damage-associated molecular patterns (DAMPs) responsible of the development of organs failure through tissues hypoperfusion, immune-mediated tissue damages and mitochondrial dysfunction.

Very importantly, ACLF is a very dynamic syndrome that has potential for reversibility. It is hypothesized that the extraction of non-transferrin bound iron (NTBI) could break down the vicious cycle of the excessive inflammatory responses, reduce oxidative stress and inhibit pathogen proliferation in ACLF patients.

As a consequence, it is hypothesized that the extraction of NTBI could promote improvement of ACLF grade n to ACLF grade n-1 or no ACLF. It is hypothesized that the extraction of NTBI could stop the progression of ACLF by preventing further organ failures and by reducing bacterial infection. Thereby, the extraction of NTBI could restore the eligibility of ACLF patients to liver transplantation, and, with or without liver transplantation, allow an earlier discharge from intensive care and prolong survival.

The proposed medical device, by combining dialysis to a hyper-chelating colloidal dialysate (MEX-CD1), specifically extracts free iron from the blood.

All patients enrolled in this study will receive 3 MEX-CD1 Slow Low volume CVVHD within 1 week. The duration of each MEX-CD1 Slow Low volume CVVHD session is 3h20.

Enrollment

10 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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