Performance and Safety of MEX-CD1 Low-volume Continuous Veno-venous Haemodialysis Medical Device for Copper-extraction in Patients With Wilson's Disease
Key facts
- Who runs it
- Mexbrain
- Where
- France and Spain4 sites in 2 countriesChoose a country to see its sites
- Trial code
- Status
- Terminated
- People taking part
- 1 person enrolled
- Started
- 24 Jan 2024
- Ended
- 15 Sept 2025
- Type of study
- Interventional
- Treatments tested
- Low-volume continuous veno-venous haemodialysis
- Record updated
- 5 December 2025
- Why it stopped
- Septex kit required has been discontinued by the external supplier
Who can take part
- Age
- 10 years to 80 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
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Who can take part
- 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
Who cannot take part
- Seafood allergy and prior allergy to one of the MEX-CD1 product components
- Participation in another investigation with an investigational drug or another Medical Device (MD) within 30 days preceding, and during the present investigation
- Allergy or contraindication to heparin or citrate
- 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
- Inadequate venous access
- Pregnant or breastfeeding women according to Article 66 of the Regulations (EU) 2017/745 on Medical Devices
This trial has no sites in United States.
It has sites in 2 countries. Choose a country to see its sites.
About the trial
What the trial wants to find out
The goal of this clinical trial is to test the MEX-CD1 hemodialysis medical device in patients suffering from Wilson's Disease. The main questions it aims to answer are:
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* Does the device work as expected by removing the excess of free copper from the blood? * Is the device safe when used according to the instructions for use?
Depending on the severity of their symptoms, patients will receive either 5 or 10 treatments on consecutive days with the MEX-CD1 hemodialysis medical device.
The group in the trial
- MEX-CD1 Low volume CVVHDTreatment being tested
Patients enrolled in the treatment arm will receive MEX-CD1 treatment depending on the severity of their symptoms in addition to standard of care: * Patients with moderate liver injury not requiring extracorporeal blood epuration therapies as standard of care: 5 treatments with MEX-CD1 on consecutive days * Patients requiring extracorporeal blood epuration therapies as standard of care: 10 treatments with MEX-CD1 on consecutive days
Treatment: Low-volume continuous veno-venous haemodialysis
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- MEXWILS - Performance and Safety of MEX-CD1 Low-volume Continuous Veno-venous Haemodialysis Medical Device for Copper-extraction in Patients With Wilson's Disease
- Record updated
- 5 December 2025