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New dialysis device for Wilson's disease tested but trial stopped early

NCT ID NCT05917327

What the study statuses mean

This study's is highlighted.

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
The trial has finished. Results may not be published yet.
Stopped early This study
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
The full record has not been published yet, so there is little to show here.
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This status has not been confirmed recently, so it may be out of date.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 trial tested a special dialysis device (MEX-CD1) designed to remove extra copper from the blood of people with Wilson's disease, a genetic condition that causes copper buildup. The study planned to give 5 to 10 treatments over consecutive days and check if the device worked safely. However, the trial was stopped early after enrolling only one person, so results are very limited.

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

1 person

The number who actually took part.

Started

Jan 2024

Finished

Sep 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

10 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: * Males and females aged between 10 years and 80 years and weighing 30 kg and more * Established diagnosis of Wilson disease (current Leipzig score ≥ 4). (For patients to whom Leipzig score can't be calculated at time of screening (while waiting for the genetic results), we assume a score of 4 (mutation detected on 2 chromosomes by default) if the two parents are Wilsonian. * Adequate venous access to allow the setting up of recirculated low-volume continuous veno-venous hemodialysis (dialysis catheter ≥11.5 F, medium blood flow rate 100-200 mL/min) and the collection of blood samples. * Both the patients already under Standard Of Care (SOC) or not under SOC. * Patients must present at least one moderate hepatic or Neuropsychiatric symptom(s). (please refer 3.4 for the severity criteria) * Patient, or parent or guardian in the case of minor, must have been informed about the nature of the clinical investigation, and must have agreed to participate in the clinical investigation, and signed the Informed Consent Form (ICF) prior to participation in any clinical investigation-related activities. Minors under the age of 14 must provide oral consent to participate in the clinical investigation. Exclusion Criteria: * Males and females weighing less than 30 kg * Patients suffering from copper deficiency * Patients who are unwilling or unable to comply with clinical investigation procedures * Seafood allergy and prior allergy to one of the MEX-CD1 product components * Allergy or contraindication to heparin or citrate * Inadequate venous access * Participation in another investigation with an investigational drug or another Medical Device (MD) within 30 days preceding, and during the present investigation * Pregnant or breastfeeding women according to Article 66 of the Regulations (EU) 2017/745 on Medical Devices

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Hospital Clinic Barcelona, Liver ICU

    Barcelona, Catalonia, 08036, Spain

  • Hospital Universitario Vall d'Hebron, Unitat de Trasplantament Hepàtic Pediàtric

    Barcelona, Catalonia, 08035, Spain

  • Hôpital Croix Rousse, Service d'hépatologie et gastroentérologie

    Lyon, Auvergne-Rhône-Alpes, 69317, France

  • Hôpital Femme Mère Enfant, Service des urgences et la réanimation pédiatriques

    Bron, Auvergne-Rhône-Alpes, 69500, France