Performance and Safety of MEX-CD1 Low-volume Continuous Veno-venous Haemodialysis Medical Device for Copper-extraction in Patients With Wilson's Disease

Ki vehet részt

• 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

Ki nem vehet részt

• 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