Wilson DiseaseNCT06466291
Spanish Wilson Disease Registry
An observational study of Wilson Disease, run by Asociación Española para el Estudio del Hígado at 1 site in Spain.
Trial summary
The main objective and purpose of the Registry is to know the current status of Wilson Disease in Spain. As secondary objectives, the prevalence and incidence of the disease will be analysed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wilson Disease
- How many people
- 600 participants
- Where
- 1 siteSpain
- Study dates
- 2 Dec 2021to Dec 2030
- How long will I take part?
- 10 Years
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Wilson Disease patients under follow-up in participating centres in Spain who agree to participate in the registry by signing the informed consent form.
Who may be able to join
- Patients with a confirmed Wilson Disease diagnosis
Who cannot join
- Refusal to sign the informed consent for the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Asociación Española para el Estudio del Hígado Asociación Española para el Estudio del Hígado contact
About this study
Official title: Registro de Enfermedad de Wilson en España
The main objective and purpose of the Registry is to know the current status of Wilson Disease in Spain.
As secondary objectives, the prevalence and incidence of the disease will be analysed.
Likewise, the analysis aims to define future areas of interest in its pathogenesis, diagnosis, natural history, follow-up, prognosis and treatment.
Improving knowledge at a national level can help to design screening strategies and improve diagnostic circuits.
Read the detailed description
Retrospective and prospective study.
- Conditions
- Wilson Disease
- Keywords
- Genetic disease, Registry, Copper, Wilson Disease
- Medical subject headings
- Hepatolenticular Degeneration, Genetic Diseases, Inborn
What is being measured
The primary outcome is the main question the study is designed to answer.
To know the current status of Wilson Disease in Spain
Measured: 2025
Secondary outcomes (2)
To analyse the prevalence of Wilson Disease in Spain
Measured: 2025
To analyse the incidence of Wilson Disease in Spain
Measured: 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2024
- Study start2 Dec 2021
- Primary completionDec 2030 (estimated)
- Study completionDec 2030 (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.
- 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
- Case only
- Time perspective
- Other
- Enrolment
- 600 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Asociación Española para el Estudio del Hígado
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zoe Mariño, Study director, Asociación Española para el Estudio del Hígado
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06466291
- Sponsor's protocol ID
- HCB/2021/1099
- Status last verified
- Jun 2024
- First submitted
- 14 Jun 2024
- Last updated
- 20 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registro de Enfermedad de Wilson en España
- ClinicalTrials.gov ID
- NCT06466291
- Acronym / sponsor ID
- HCB/2021/1099
- Conditions
- Wilson Disease
- Keywords
- Genetic disease, Registry, Copper, Wilson Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Asociación Española para el Estudio del HígadoUniversity, hospital or other
- Study start
- 2 Dec 2021 (actual)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 20 Jun 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.
The main objective and purpose of the Registry is to know the current status of Wilson Disease in Spain.
As secondary objectives, the prevalence and incidence of the disease will be analysed.
Likewise, the analysis aims to define future areas of interest in its pathogenesis, diagnosis, natural history, follow-up, prognosis and treatment.
Improving knowledge at a national level can help to design screening strategies and improve diagnostic circuits.
Detailed description
Retrospective and prospective study.
Study design
- Observational model
- Case only
- Time perspective
- Other
- Target follow-up
- 10 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Wilson Disease patients under follow-up in participating centres in Spain who agree to participate in the registry by signing the informed consent form.
Key inclusion criteria (1 listed)
- Patients with a confirmed Wilson Disease diagnosis
Key exclusion criteria (1 listed)
- Refusal to sign the informed consent for the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To know the current status of Wilson Disease in Spain
Time frame: 2025
2 secondary outcomes
To analyse the prevalence of Wilson Disease in Spain
Time frame: 2025
To analyse the incidence of Wilson Disease in Spain
Time frame: 2025
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 20 Jun 2024.
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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.
Asociación Española para el Estudio del Hígado Asociación Española para el Estudio del Hígado contact
Zoe Mariño study director
Asociación Española para el Estudio del Hígado
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 Asociación Española para el Estudio del Hígado at 1 site in Spain.
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 1 inclusion and 1 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 20 Jun 2024. 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 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?
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 Asociación Española para el Estudio del Hígado Asociación Española para el Estudio del Hígado (0034915551119, registrowilsonaeeh@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To know the current status of Wilson Disease in Spain (time frame: 2025). 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 20 Jun 2024; AzTrials last refreshed its copy on 27 Oct 2026.