Hepatolenticular Degeneration; WilsonMEXWILSNCT05917327
Performance and Safety of MEX-CD1 Low-volume Continuous Veno-venous Haemodialysis Medical Device for Copper-extraction in Patients With Wilson's Disease
A study testing Low-volume continuous veno-venous haemodialysis in people with Hepatolenticular Degeneration; Wilson, run by Mexbrain at 4 sites in 2 countries.
Trial summary
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: 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… Read more about this study
- Who is it for?
- Ages 10 to 80 years
- Conditions the study is for
- Hepatolenticular Degeneration; Wilson
- What is being tested?
- Low-volume continuous veno-venous haemodialysis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 24 Jan 2024to 15 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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 join
- 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
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
France2 sites
Hôpital Femme Mère Enfant, Service des urgences et la réanimation pédiatriques
Bron, Auvergne-Rhône-Alpes, 69500
Hôpital Croix Rousse, Service d'hépatologie et gastroentérologie
Lyon, Auvergne-Rhône-Alpes, 69317
Spain2 sites
Hospital Universitario Vall d'Hebron, Unitat de Trasplantament Hepàtic Pediàtric
Barcelona, Catalonia, 08035
Hospital Clinic Barcelona, Liver ICU
Barcelona, Catalonia, 08036
About this study
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
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:
- 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.
Read the detailed description
This study investigates the performance and safety of the MEX-CD1 hemodialysis device in patients suffering from Wilson's Disease. Wilson's Disease is a rare genetic disease (1'000 to 2'000 patients in France) linked to a problem in copper homeostasis. The direct consequence is a progressive accumulation of copper, first in the liver and then in the whole body with two major implications: (i) at the hepatic level and (ii) at the neurological level.
The disease is globally well known and managed in developed countries. It can present itself in several manners:
An acute decompensation of the disease is possible. This concerns mainly big children or young adults, presenting themselves with an acute hepatic deficiency that may need intensive care and a liver transplant.
In most cases, the clinical picture is one of chronic hepatic and/or neurological disease. Treatment must be adapted to the clinical situation. Two phases can be distinguished:
- A primary treatment phase, whose goal it is to eliminate the excess copper deposited in the body. This phase generally takes 1 to 2 years with chelating treatments;
- A maintenance phase, corresponding to the treatment which will allow the copper balance to be maintained and equilibrated.
This lifelong treatment is to be taken daily (with doses of chelators and/or zinc salts).
Finally, during the maintenance phase, periods of lesser observance or escape phases can be observed, those are responsible for severe aggravation of the liver (fulminant hepatitis) or of neurological symptoms that can lead to death.
The proposed medical device allows, by combining dialysis to a hyper-chelating colloidal dialysate (MEX-CD1) to specifically extract copper from the blood (and particularly the exchangeable copper). All patients enrolled in this study will, depending on the severity of their symptoms, receive 4-hour long treatments with MEX-CD1:
- 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 During the MEX-CD1 treatment, the patient's condition will be closely monitored. Additionally, enrolled patients will have a thorough assessment of their Wilson's Disease at the screening visit and at the last visit. Between the last day of treatment and the last visit, enrolled patients will have two rest days.
- Conditions
- Hepatolenticular Degeneration; Wilson
- Being tested
- Low-volume continuous veno-venous haemodialysis
- Keywords
- Wilson's Disease, Low-volume continuous veno-venous hemodialysis, Copper
- Medical subject headings
- Hepatolenticular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-volume continuous veno-venous haemodialysisDevice
MEX-CD1 is a hyper-chelating colloidal solution that can be added to the dialysate to be used in low-volume continuous veno-venous hemodialysis. One treatment will last 4 hours. For non-hospitalized patients, the treatment is performed on an outpatient basis.
| Study group | Role | What they receive |
|---|---|---|
| MEX-CD1 Low volume CVVHD | Experimental | 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 Receives: Device: Low-volume continuous veno-venous haemodialysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance of MEX-CD1
The primary objective is to determine the performance of MEX-CD1 in terms of copper extraction in low-volume continuous veno-venous hemodialysis. This will be measured by the mean net amount of copper extracted per unit time relative to baseline, i.e., a proportion.
Measured: 4 hours; from treatment start (0 hours) to treatment end (4 hours)
Secondary outcomes (12)
Pulse measurement for safety purposes
Assessment of the safety of the MEX-CD1 medical device in low-volume continuous veno-venous hemodialysis. Safety end point measurements are evaluated throughout the study.
Measured: From the start of the first MEX-CD1 treatment until the last visit, assessed up to 2 weeks.
Temperature measurement for safety purposes
Assessment of the safety of the MEX-CD1 medical device in low-volume continuous veno-venous hemodialysis. Safety end point measurements are evaluated throughout the study.
Measured: From the start of the first MEX-CD1 treatment until the last visit, assessed up to 2 weeks.
Arterial blood pressure measurement every hour during treatment phase for safety purposes
Assessment of the safety of the MEX-CD1 medical device in low-volume continuous veno-venous hemodialysis. Safety end point measurements are evaluated throughout the study.
Measured: Once at screening and last visit and every hour during treatment phase, assessed up to 2 weeks.
Weight measurement for Safety purposes
Assessment of the safety of the MEX-CD1 medical device in low-volume continuous veno-venous hemodialysis. Safety end point measurements are evaluated throughout the study.
Weight measurement before and after each treatment.
Measured: From the start of the first MEX-CD1 treatment until the last visit, assessed up to 2 weeks.
AE recording
Assessment of the safety of the MEX-CD1 medical device in low-volume continuous veno-venous hemodialysis. Safety end point measurements are evaluated throughout the study.
Measured: From the start of the first MEX-CD1 treatment until the last visit, assessed up to 2 weeks.
Number of participants with abnormal laboratory test results
Safety measurements via blood sample analysis before and after each 4-hour dialysis session
Measured: From the start of the first MEX-CD1 treatment until the last visit, assessed up to 2 weeks.
Responder rate
The responder rate is defined as the proportion of patients with >50% of the baseline net amount of exchangeable copper extracted throughout the study.
Measured: 4 hours; from treatment start (0 hours) to treatment end (4 hours)
Copper kinetics
Kinetics of Copper measurement at time 0h, time 1h, time 2h, time 3h and time 4h
Measured: 4 hours; from treatment start (0 hours) to treatment end (4 hours)
Changes in copper concentration between screening visit and last visit
Assessment of the change in non-ceruloplasmin-bound copper (NCC) concentration between the baseline and the patient release
Measured: Between the screening visit and the last visit, assessed up to 2 weeks.
Hepatic function evolution
Assessment of the stability or improvement of hepatic function between the enrolment and the last visit of the patient according to the history of the disease.
Hepatic function is assessed through medical imaging, transient elastography (FibroScan or FibroTest), LiverMultiScan™, assessment of presence/absence of jaundice, assessment of presence/absence of haemolysis, ascites detection per sonography.
Measured: Between the screening visit and the last visit, assessed up to 2 weeks.
Neurologic and psychiatric status evolution
Assessment of the stability or improvement of the neurological and psychiatric status between the enrolment and the last visit of the patient.
Neurological and psychiatric status is evaluated with UWDRS scores, Clinical Global Impression-Improvement Scale (CGI-S versus CGI-I), MRI. (no units for all the scales)
Measured: Between the screening visit and the last visit, assessed up to 2 weeks.
Wilson's Disease evolution
Assessment of the stability or improvement of the WD by Global Assessment Scale for WD between the enrolment and the last visit of the patient.
Measured: Between the screening visit and the last visit, assessed up to 2 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2023
- Study start24 Jan 2024
- Primary completion15 Sep 2025
- Study completion15 Sep 2025
Why it stopped: Septex kit required has been discontinued by the external supplier
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatolenticular Degeneration; WilsonStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, multinational, multicentric, single-arm, open label, pivotal/registration clinical trial.
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mexbrain
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Integrated Scientific Services (ISS) AG
- Responsible party
- Sponsor
- Investigators
- Edouardo COUCHONNAL-BEDOYA, Principal investigator, Hôpital Femme Mère Enfant, Service Hépato-Gastroentérologie et Nutrition Pédiatrique
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05917327
- Sponsor's protocol ID
- PJ2104-0003
- Acronym
- MEXWILS
- Status last verified
- Nov 2025
- First submitted
- 6 Apr 2023
- Last updated
- 5 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05917327
- Acronym / sponsor ID
- MEXWILS / PJ2104-0003
- Conditions
- Hepatolenticular Degeneration; Wilson
- Keywords
- Wilson's Disease, Low-volume continuous veno-venous hemodialysis, Copper
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Septex kit required has been discontinued by the external supplier
- Enrolment
- 1 participants (actual)
- Lead sponsor
- MexbrainIndustry (pharma, biotech, devices)
- Collaborators
- Integrated Scientific Services (ISS) AG
- Study start
- 24 Jan 2024 (actual)
- Primary completion
- 15 Sep 2025 (actual)
- Study completion
- 15 Sep 2025 (actual)
- First posted
- 23 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Detailed description
This study investigates the performance and safety of the MEX-CD1 hemodialysis device in patients suffering from Wilson's Disease. Wilson's Disease is a rare genetic disease (1'000 to 2'000 patients in France) linked to a problem in copper homeostasis. The direct consequence is a progressive accumulation of copper, first in the liver and then in the whole body with two major implications: (i) at the hepatic level and (ii) at the neurological level.
The disease is globally well known and managed in developed countries. It can present itself in several manners:
An acute decompensation of the disease is possible. This concerns mainly big children or young adults, presenting themselves with an acute hepatic deficiency that may need intensive care and a liver transplant.
In most cases, the clinical picture is one of chronic hepatic and/or neurological disease. Treatment must be adapted to the clinical situation. Two phases can be distinguished:
- A primary treatment phase, whose goal it is to eliminate the excess copper deposited in the body. This phase generally takes 1 to 2 years with chelating treatments;
- A maintenance phase, corresponding to the treatment which will allow the copper balance to be maintained and equilibrated.
This lifelong treatment is to be taken daily (with doses of chelators and/or zinc salts).
Finally, during the maintenance phase, periods of lesser observance or escape phases can be observed, those are responsible for severe aggravation of the liver (fulminant hepatitis) or of neurological symptoms that can lead to death.
The proposed medical device allows, by combining dialysis to a hyper-chelating colloidal dialysate (MEX-CD1) to specifically extract copper from the blood (and particularly the exchangeable copper). All patients enrolled in this study will, depending on the severity of their symptoms, receive 4-hour long treatments with MEX-CD1:
- 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 During the MEX-CD1 treatment, the patient's condition will be closely monitored. Additionally, enrolled patients will have a thorough assessment of their Wilson's Disease at the screening visit and at the last visit. Between the last day of treatment and the last visit, enrolled patients will have two rest days.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, multinational, multicentric, single-arm, open label, pivotal/registration clinical trial.
| Arm | Type | Receives |
|---|---|---|
| MEX-CD1 Low volume CVVHD | Experimental | Device: Low-volume continuous veno-venous haemodialysisPatients 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 |
Who may qualify
- Ages
- 10 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low-volume continuous veno-venous haemodialysisMEX-CD1 is a hyper-chelating colloidal solution that can be added to the dialysate to be used in low-volume continuous veno-venous hemodialysis. One treatment will last 4 hours. For non-hospitalized patients, the treatment is performed on an outpatient basis. | Device | MEX-CD1 Low volume CVVHD |
Primary outcome
Performance of MEX-CD1
Time frame: 4 hours; from treatment start (0 hours) to treatment end (4 hours)
The primary objective is to determine the performance of MEX-CD1 in terms of copper extraction in low-volume continuous veno-venous hemodialysis. This will be measured by the mean net amount of copper extracted per unit time relative to baseline, i.e., a proportion.
12 secondary outcomes
Pulse measurement for safety purposes
Time frame: From the start of the first MEX-CD1 treatment until the last visit, assessed up to 2 weeks.
Temperature measurement for safety purposes
Time frame: From the start of the first MEX-CD1 treatment until the last visit, assessed up to 2 weeks.
Arterial blood pressure measurement every hour during treatment phase for safety purposes
Time frame: Once at screening and last visit and every hour during treatment phase, assessed up to 2 weeks.
Weight measurement for Safety purposes
Time frame: From the start of the first MEX-CD1 treatment until the last visit, assessed up to 2 weeks.
AE recording
Time frame: From the start of the first MEX-CD1 treatment until the last visit, assessed up to 2 weeks.
Number of participants with abnormal laboratory test results
Time frame: From the start of the first MEX-CD1 treatment until the last visit, assessed up to 2 weeks.
Responder rate
Time frame: 4 hours; from treatment start (0 hours) to treatment end (4 hours)
Copper kinetics
Time frame: 4 hours; from treatment start (0 hours) to treatment end (4 hours)
Changes in copper concentration between screening visit and last visit
Time frame: Between the screening visit and the last visit, assessed up to 2 weeks.
Hepatic function evolution
Time frame: Between the screening visit and the last visit, assessed up to 2 weeks.
Neurologic and psychiatric status evolution
Time frame: Between the screening visit and the last visit, assessed up to 2 weeks.
Wilson's Disease evolution
Time frame: Between the screening visit and the last visit, assessed up to 2 weeks.
Results and safety
The study was stopped early (reason given: Septex kit required has been discontinued by the external supplier). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edouardo COUCHONNAL-BEDOYA principal investigator
Hôpital Femme Mère Enfant, Service Hépato-Gastroentérologie et Nutrition Pédiatrique
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-volume continuous veno-venous haemodialysis in people with Hepatolenticular Degeneration; Wilson, run by Mexbrain at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Septex kit required has been discontinued by the external supplier). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance of MEX-CD1 (time frame: 4 hours; from treatment start (0 hours) to treatment end (4 hours)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2025.