New device aims to filter toxic iron from blood in liver failure patients

NCT ID NCT06340269

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
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Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new medical device called MEX-CD1 in 11 adults with acute-on-chronic liver failure (ACLF), a serious condition where the liver suddenly stops working. The device works like a dialysis machine to filter excess iron from the blood. The main goals were to see if the device is safe and if it removes iron as expected. Each participant received three treatments over one week.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

11 people

The number who actually took part.

Started

Jun 2024

Finished

Oct 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Acute-On-Chronic Liver Failure multiple organ dysfunction syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • CHU Pontchaillou

    Rennes, 35000, France

  • Hôpital Croix Rousse, Service d'hépatologie et gastroentérologie

    Lyon, Auvergne-Rhône-Alpes, 69317, France

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