Wilson DiseaseVARCUWICNCT06430359
Circadian Variation of Urinary Copper Excretion in Wilson Disease Patients
An observational study of Wilson Disease, run by Hospices Civils de Lyon at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 6 to 70 years
- Conditions the study is for
- Wilson Disease
- What is being tested?
- urine and blood test
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 10 Jan 2025to 10 Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 6 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: - Patients with a confirmed diagnosis of Wilson's Disease (Leipzig score ˃4).
Who may be able to join
- Patients with a confirmed diagnosis of Wilson's Disease (Leipzig score ˃4).
- Age ≥ 6 years and ≤70 years.
- Patient able to perform 24h urine.
- Current treatment with D-Pencillamine, Trientine or Zinc.
- Non-opposition of patient and/or legal representatives for minor patients.
Who cannot join
- Patients who had a change in treatment within the last 6 months before the inclusion
- Patients who have undergone liver transplantation
- Patients with known chronic renal failure (GFR < 30 ml/min)
- Patients on long-term diuretic or corticosteroid therapy
- Persons deprived of liberty by a judicial or administrative decision
- Patient under judicial protection, unable to express consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Service de Gastroentérologie, Hépatologie et Nutrition Pédiatriques - Hôpital Femme Mère Enfant
Bron, Rhone, 69500
Eduardo Couchonnal, Dr, 04 27 35 70 50 ext. +33, eduardo.couchonnal-bedoya@chu-lyon.fr
Abdelouahed BELMALIH, PhD, 04 27 85 62 67 ext. +33, abdelouahed.belmalih@chu-lyon.fr
About this study
Official title: Circadian Variation of Urinary Copper Excretion in Wilson Disease Patients Treated With Chelators or Zinc Salts
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.
Read more
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
- Conditions
- Wilson Disease
- Being tested
- urine and blood test
- Keywords
- Wilson disease, urinary copper, chelator
- Medical subject headings
- Hepatolenticular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
urine and blood testDiagnostic test
3 urine collections of an 8h period. One blood sample for liver function test and copper assessment
| Study group | Role | What they receive |
|---|---|---|
| Group 1 - DP | Patients with a confirmed diagnosis of Wilson's Disease (Leipzig score ˃4 ). Aged between 6 years and 70 years. Treated with D-Pencillamine Receives: Diagnostic Test: urine and blood test | |
| Group 2 - Trientine | Patients with a confirmed diagnosis of Wilson's Disease (Leipzig score ˃4 ). Aged between 6 years and 70 years. Treated with Trientine Receives: Diagnostic Test: urine and blood test | |
| Group 3 - ZINC | Patients with a confirmed diagnosis of Wilson's Disease (Leipzig score ˃4 ). Aged between 6 years and 70 years. Treated with Zinc. Receives: Diagnostic Test: urine and blood test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation factor
Correlation between 24-hour urinary copper excretion and 8-hour urinary copper excretion collected between midnight and 8 am).
Measured: Two 24-hour urine recollection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2024
- Study start10 Jan 2025
- Primary completion10 Feb 2027 (estimated)
- Study completion10 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wilson DiseaseStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06430359
- Sponsor's protocol ID
- 69HCL23_1227
- Acronym
- VARCUWIC
- Status last verified
- Jan 2026
- First submitted
- 21 May 2024
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circadian Variation of Urinary Copper Excretion in Wilson Disease Patients Treated With Chelators or Zinc Salts
- ClinicalTrials.gov ID
- NCT06430359
- Acronym / sponsor ID
- VARCUWIC / 69HCL23_1227
- Conditions
- Wilson Disease
- Keywords
- Wilson disease, urinary copper, chelator
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 10 Jan 2025 (actual)
- Primary completion
- 10 Feb 2027 (estimated)
- Study completion
- 10 Feb 2027 (estimated)
- First posted
- 28 May 2024 (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.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 - DP | – | Diagnostic Test: urine and blood testPatients with a confirmed diagnosis of Wilson's Disease (Leipzig score ˃4 ). Aged between 6 years and 70 years. Treated with D-Pencillamine |
| Group 2 - Trientine | – | Diagnostic Test: urine and blood testPatients with a confirmed diagnosis of Wilson's Disease (Leipzig score ˃4 ). Aged between 6 years and 70 years. Treated with Trientine |
| Group 3 - ZINC | – | Diagnostic Test: urine and blood testPatients with a confirmed diagnosis of Wilson's Disease (Leipzig score ˃4 ). Aged between 6 years and 70 years. Treated with Zinc. |
Who may qualify
- Ages
- 6 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- - Patients with a confirmed diagnosis of Wilson's Disease (Leipzig score ˃4).
Key inclusion criteria (5 listed)
- Patients with a confirmed diagnosis of Wilson's Disease (Leipzig score ˃4).
- Age ≥ 6 years and ≤70 years.
- Patient able to perform 24h urine.
- Current treatment with D-Pencillamine, Trientine or Zinc.
- Non-opposition of patient and/or legal representatives for minor patients.
Key exclusion criteria (6 listed)
- Patients who had a change in treatment within the last 6 months before the inclusion
- Patients who have undergone liver transplantation
- Patients with known chronic renal failure (GFR < 30 ml/min)
- Patients on long-term diuretic or corticosteroid therapy
- Persons deprived of liberty by a judicial or administrative decision
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 |
|---|---|---|
| urine and blood test3 urine collections of an 8h period. One blood sample for liver function test and copper assessment | Diagnostic test | Group 1 - DP, Group 2 - Trientine, Group 3 - ZINC |
Primary outcome
Correlation factor
Time frame: Two 24-hour urine recollection
Correlation between 24-hour urinary copper excretion and 8-hour urinary copper excretion collected between midnight and 8 am).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Wilson Disease, run by Hospices Civils de Lyon at 1 site in France.
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 5 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eduardo COUCHONNAL, Dr (04 27 35 70 50 ext. +33, eduardo.couchonnal-bedoya@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation factor (time frame: Two 24-hour urine recollection). 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 15 Jan 2026.