New dialysis device for Wilson's disease tested but trial stopped early
NCT ID NCT05917327
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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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
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1 person
The number who actually took part.
- Started
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Jan 2024
- Finished
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Sep 2025
- Lead sponsor
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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
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10 to 80 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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Hospital Clinic Barcelona, Liver ICU
Barcelona, Catalonia, 08036, Spain
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Hospital Universitario Vall d'Hebron, Unitat de Trasplantament Hepàtic Pediàtric
Barcelona, Catalonia, 08035, Spain
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Hôpital Croix Rousse, Service d'hépatologie et gastroentérologie
Lyon, Auvergne-Rhône-Alpes, 69317, France
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Hôpital Femme Mère Enfant, Service des urgences et la réanimation pédiatriques
Bron, Auvergne-Rhône-Alpes, 69500, France