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

Feasibility Pilot Study to Evaluate the Safety and Performance of the MEX-CD1 Medical Device in Acute on Chronic Liver Failure (ACLF)

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.

Study Overview

• Status: Completed
• Conditions: Multiple Organ Failure; Acute on Chronic Liver Failure
• Intervention / Treatment: Device: MEX-CD1 Dialysis

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.

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Rennes, France, 35000
    • CHU Pontchaillou
  • Auvergne-Rhône-Alpes
    • Lyon, Auvergne-Rhône-Alpes, France, 69317
      • Hôpital Croix Rousse, Service d'hépatologie et gastroentérologie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Device: 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.; Other Names: Slow Low-volume continuous veno-venous haemodialysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SADE for Safety purpose	The safety will be assessed by percentage of subjects who discontinued MexACLF due to a serious adverse device event (SADE) between Day 1 and Day 7.	From the enrollment until the last visit, assessed up to 7 days.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SAE for Safety purpose	The safety will be assessed by the percentage of patients who experience at least one related Serious Adverse Event (SAE) between Day 1 and Day 7.	From the start of the first MEX-CD1 treatment until the last visit, assessed up to 7 days.
Performance of MEX-CD1	The performance of the MEX-CD1 slow low-volume CVVHD treatment in terms of iron extraction will be measured by the amount of iron extracted in the dialysate bags per treatment.	3 hours and 20 minutes; from treatment start (0 hours) to treatment end (3h20)
Development of secondary infection	Assessment of development of secondary infection by need for new antibiotic therapy	Between the screening visit and the last visit, assessed up to 7 days.
Status of ICU	Length of stay in ICU	Between the screening visit and the last visit, assessed up to 28 days.
hospital discharge	Length of stay at hospital	Between the screening visit and the last visit, assessed up to 28 days.
Mortality	Assessment of the survival rate	Between the screening visit and the last visit, assessed up to 28 days.
Change in Acute on Chronic Liver Failure (ACLF) Grade	Assessment of the change in ACLF Grade between the baseline and the end of study Min value = 0 (no ACLF) Max value=3b (Worse outcome)	Between the screening visit and the last visit, assessed up to 7 days.
Change in CLIF-C ACLF score	Assessment of the change in Chronic Liver Failure-Consortium (CLIF-C) ACLF score between the baseline and the end of study. CLIF-C ACLF = 10 × (0.33 × CLIF-C OFs + 0.04 x Age + 0.63 × ln (WBC count)-2) CLIF-OFs= Chronic Liver Failure Consortium Organe Failure Min value=6 (No organe Failure) Max value=18 (6 organe failures)	Between the screening visit and the last visit, assessed up to 7 days.
Improvement in individual organ function	Assessment of the change in individual organ function by using the CLIF sequential OF score From 1 (no organe failure) to 3 (worse outcome) for the 6 organes below: Liver ; kidney ; Brain ; Coagulation ; Circulation ; Respiratory	Between the screening visit and the last visit, assessed up to 7 days.

Collaborators and Investigators

• Sponsor: Mexbrain
• Collaborators: Slb Pharma
• Investigators: Principal Investigator: Céline GUICHON, MD, Hôpital Croix Rousse, Service d'hépatologie et gastroentérologie

Study record dates

Study Major Dates

• Study Start (Actual): June 21, 2024
• Primary Completion (Actual): October 23, 2025
• Study Completion (Actual): October 23, 2025

Study Registration Dates

• First Submitted: March 25, 2024
• First Submitted That Met QC Criteria: March 25, 2024
• First Posted (Actual): April 1, 2024

Study Record Updates

• Last Update Posted (Actual): April 29, 2026
• Last Update Submitted That Met QC Criteria: April 23, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Iron; Intensive Care Unit; Hemodialysis; ACLF
• Additional Relevant MeSH Terms: Pathologic Processes; Digestive System Diseases; Liver Diseases; Liver Failure; Hepatic Insufficiency; Shock; Liver Failure, Acute; Pathological Conditions, Signs and Symptoms; Multiple Organ Failure; Acute-On-Chronic Liver Failure
• Other Study ID Numbers: PJ2308-0025

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No