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Clinical Trial Summary

Wilson's disease (WD) is a genetic disorder characterized by an accumulation of copper in the body, mainly in the liver and brain. Patients suffering from this disease are monitored by liver function tests, blood copper levels, and 24-hour urinary copper determinations. Treatment is based either on chelating the copper accumulated in the body using D-penicillamine or Trientine or on limiting intestinal copper absorption with zinc salts. Monitoring copper elimination in urine collected over 24 hours is essential for estimating a patient's copper load, adapting treatment dosage, and detecting any copper deficiency. Nevertheless, urine collection is often complicated for patients, given the obvious constraints of collecting urine over 24 hours. Without this, clinical decisions are usually made based on spot urine. There is no official recommendation for monitoring urinary copper elimination other than on 24-hour urine. According to studies on healthy volunteers under physiological conditions, urinary copper elimination occurs according to a circadian rhythm, with minimal copper elimination between 8 pm and 4 am and maximum between 8 am and noon. The study would aim to find the period of the day best correlated with 24h urinary copper excretion


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT06430359
Study type Observational
Source Hospices Civils de Lyon
Contact Eduardo COUCHONNAL, Dr
Phone 04 27 35 70 50
Email eduardo.couchonnal-bedoya@chu-lyon.fr
Status Not yet recruiting
Phase
Start date July 1, 2024
Completion date August 1, 2025

See also
  Status Clinical Trial Phase
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Completed NCT03539952 - Trientine Tetrahydrochloride (TETA 4HCL) for the Treatment of Wilson's Disease Phase 3
Active, not recruiting NCT04884815 - Study of UX701 Gene Transfer for the Treatment of Wilson Disease Phase 1/Phase 2
Not yet recruiting NCT03659331 - A Controlled Study of Potential Therapeutic Effect of Oral Zinc in Manifesting Carriers of Wilson Disease N/A
Recruiting NCT05687474 - Baby Detect : Genomic Newborn Screening
Completed NCT04965571 - Clinical Features and Outcome of Wilson's Disease With Generalized Epilepsy in Chinese Patients
Terminated NCT05047523 - Study of ALXN1840 Versus Standard of Care in Pediatric Participants With Wilson Disease Phase 3
Completed NCT04526210 - Study of ALXN1840 on the Metabolism of a CYP2B6 Substrate in Healthy Participants Phase 1
Completed NCT00004338 - Study of Zinc for Wilson Disease Phase 4
Enrolling by invitation NCT03655223 - Early Check: Expanded Screening in Newborns
Completed NCT02273596 - Efficacy and Safety Study of WTX101 (ALXN1840) in Adult Wilson Disease Patients Phase 2
Completed NCT02763215 - The Assessment of Copper Parameters in Wilson Disease Participants on Standard of Care Treatment
Recruiting NCT05444127 - Oral Health and Wilson's Disease: SOMAWI
Completed NCT04408300 - Study of Retinal Vascular Parameters in Patients With Wilson's Disease N/A
Active, not recruiting NCT05783687 - Real World Evidence Study in Subjects With Wilson's Disease
Terminated NCT04909346 - Adeno-Associated Virus (AAV) Antibody Study in Subjects OTC Deficiency, GSDIa, and Wilson Disease
Completed NCT03867526 - Establishment of Human Cellular Disease Models for Wilson Disease
Enrolling by invitation NCT03589820 - Plasma Exchange and Continuous Hemodiafiltration in Treatment of Wilson's Disease-related Liver Failure N/A
Completed NCT04526197 - Phase 1 Study of ALXN1840 on the Metabolism of a CYP2C9 Substrate in Healthy Participants. Phase 1
Completed NCT04910581 - rTMS in Wilson Disease Dysarthria N/A