NCT06466291

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
56mo left

Started Dec 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress49%
Dec 2021Dec 2030

Study Start

First participant enrolled

December 2, 2021

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

June 14, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 20, 2024

Completed
6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2030

Last Updated

June 20, 2024

Status Verified

June 1, 2024

Enrollment Period

9 years

First QC Date

June 14, 2024

Last Update Submit

June 14, 2024

Conditions

Wilson Disease

Keywords

Genetic diseaseRegistryCopperWilson Disease

Outcome Measures

Primary Outcomes (1)

  • To know the current status of Wilson Disease in Spain

    2025

Secondary Outcomes (2)

  • To analyse the prevalence of Wilson Disease in Spain

    2025

  • To analyse the incidence of Wilson Disease in Spain

    2025

Other Outcomes (1)

  • To define future areas of interest in Wilson Disease

    2025

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • Patients with a confirmed Wilson Disease diagnosis

You may not qualify if:

  • Refusal to sign the informed consent for the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Clinic

Barcelona, 08036, Spain

RECRUITING

MeSH Terms

Conditions

Hepatolenticular DegenerationGenetic Diseases, Inborn

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesBrain Diseases, Metabolic, InbornBrain Diseases, MetabolicMovement DisordersHeredodegenerative Disorders, Nervous SystemNeurodegenerative DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesMetabolism, Inborn ErrorsMetal Metabolism, Inborn ErrorsMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Zoe Mariño

    Asociación Española para el Estudio del Hígado

    STUDY DIRECTOR

Central Study Contacts

Asociación Española para el Estudio del Hígado Asociación Española para el Estudio del Hígado

CONTACT

0034915551119registrowilsonaeeh@gmail.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
OTHER
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 14, 2024

First Posted

June 20, 2024

Study Start

December 2, 2021

Primary Completion (Estimated)

December 1, 2030

Study Completion (Estimated)

December 1, 2030

Last Updated

June 20, 2024

Record last verified: 2024-06

Locations

ES(1)