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

NCT ID: NCT06340269

Last Updated: 2025-05-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-21
• Study Completion Date: 2025-10-31

Brief 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.

Detailed 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.

Conditions

Acute on Chronic Liver Failure; Multiple Organ Failure

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MEX-CD1 Slow Low volume CVVHD

Patients enrolled in the treatment arm will receive 3 sessions of MEX-CD1 treatment in addition to standard of care

Group Type: EXPERIMENTAL

MEX-CD1 Dialysis

Intervention Type: DEVICE

MEX-CD1 is a hyper-chelating colloidal solution that can be added to the dialysate to be used in Slow low-volume continuous veno-venous hemodialysis. One treatment will last 3 hours and 20 minutes.

Patients enrolled are hospitalized in Intensive Care Unit.

Interventions

MEX-CD1 Dialysis

MEX-CD1 is a hyper-chelating colloidal solution that can be added to the dialysate to be used in Slow low-volume continuous veno-venous hemodialysis. One treatment will last 3 hours and 20 minutes.

Patients enrolled are hospitalized in Intensive Care Unit.

Intervention Type: DEVICE

Other Intervention Names

Slow Low-volume continuous veno-venous haemodialysis

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Slb Pharma

OTHER

Sponsor Role: collaborator

Mexbrain

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Céline GUICHON, MD

Role: PRINCIPAL_INVESTIGATOR

Hôpital Croix Rousse, Service d'hépatologie et gastroentérologie

Locations

Hôpital Croix Rousse, Service d'hépatologie et gastroentérologie

Lyon, Auvergne-Rhône-Alpes, France

Site Status: RECRUITING

CHU Pontchaillou

Rennes, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Karen GILLANT

Role: CONTACT

Karen.gillant@MEXBRAIN.COM

+33674152663

Facility Contacts

Céline GUICHON, MD

Role: primary

celine.guichon@chu-lyon.fr

+33426109351

Valentin Coirier, MD

Role: primary

valentin.coirier@chu-rennes.fr

Other Identifiers

PJ2308-0025

Identifier Type: -

Identifier Source: org_study_id