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

NCT05917327 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2025-12-05

No results posted yet for this study

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 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.

Conditions

  • Hepatolenticular Degeneration; Wilson

Interventions

DEVICE

Low-volume continuous veno-venous haemodialysis

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.

Sponsors & Collaborators

  • Integrated Scientific Services (ISS) AG

    collaborator UNKNOWN

  • Mexbrain

    lead INDUSTRY

Principal Investigators

  • Edouardo COUCHONNAL-BEDOYA · Hôpital Femme Mère Enfant, Service Hépato-Gastroentérologie et Nutrition Pédiatrique

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
10 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-24
Primary Completion
2025-09-15
Completion
2025-09-15

Countries

  • France
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05917327 on ClinicalTrials.gov