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

NCT06340269 | Completed DMC

• 1 other identifier: PJ2308-0025
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 2

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.

Conditions

Acute on Chronic Liver Failure; Multiple Organ Failure

Keywords

ACLF; Intensive Care Unit; Iron; Hemodialysis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• SAE for Safety purpose

  From the start of the first MEX-CD1 treatment until the last visit, assessed up to 7 days.

• Performance of MEX-CD1

  3 hours and 20 minutes; from treatment start (0 hours) to treatment end (3h20)

• Change in Acute on Chronic Liver Failure (ACLF) Grade

  Between the screening visit and the last visit, assessed up to 7 days.

• Change in CLIF-C ACLF score

  Between the screening visit and the last visit, assessed up to 7 days.

• Improvement in individual organ function

  Between the screening visit and the last visit, assessed up to 7 days.

Study Arms (1)

MEX-CD1 Slow Low volume CVVHD

EXPERIMENTAL

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

Device: MEX-CD1 Dialysis

Interventions

MEX-CD1 Dialysis 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.

Also known as: Slow Low-volume continuous veno-venous haemodialysis

MEX-CD1 Slow Low volume CVVHD

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mexbrain: lead
• Slb Pharma: collaborator

Study Sites (2)

Hôpital Croix Rousse, Service d'hépatologie et gastroentérologie

Lyon, Auvergne-Rhône-Alpes, 69317, France

Location

CHU Pontchaillou

Rennes, 35000, France

Location

MeSH Terms

Conditions

Acute-On-Chronic Liver Failure; Multiple Organ Failure

Condition Hierarchy (Ancestors)

Liver Failure, Acute; Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases; Shock; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Céline GUICHON, MD

  Hôpital Croix Rousse, Service d'hépatologie et gastroentérologie

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, national, monocentric, single-arm, open label, feasibility pilot clinical trial.

Study Record Dates

• First Submitted: March 25, 2024
• First Posted: April 1, 2024
• Study Start: June 21, 2024
• Primary Completion: October 23, 2025
• Study Completion: October 23, 2025
• Last Updated: April 29, 2026

Record last verified: 2026-04

Locations

FR (2)