NCT06051734

Brief Summary

Wilson disease (WD) is a rare autosomal recessive disorder caused by a genetic defect in ATP7B resulting in limited excretion of excess copper into the bile Pathological copper accumulation occurs in the entire body, with the liver and the brain being primarily affected

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
41mo left

Started Oct 2023

Longer than P75 for all trials

Status
not yet 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 Progress43%
Oct 2023Sep 2029

First Submitted

Initial submission to the registry

September 16, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 25, 2023

Completed
6 days until next milestone

Study Start

First participant enrolled

October 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2024

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2029

Expected
Last Updated

September 25, 2023

Status Verified

September 1, 2023

Enrollment Period

1 year

First QC Date

September 16, 2023

Last Update Submit

September 21, 2023

Conditions

Cardiovascular DiseasesWilson's Disease

Keywords

Wilson'sCMRCardiac magnetic resonance

Outcome Measures

Primary Outcomes (1)

  • evaluate spectrum of cardiac affection by copper deposition in Wilson disease patients and detect early cardiac affection

    Evaluate the effect of copper on EF and diastolic function of LV and RV

    1 year

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All patients with Wilson's disease attending outpatient clinic

You may qualify if:

  • All patients diagnosed with Wilson's

You may not qualify if:

  • Claustrophobia
  • Refusal to share information
  • Heart failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cardiovascular DiseasesHepatolenticular Degeneration

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Salma Taha, Ass.Professor

CONTACT

+201003329108esmaeil.salma@gmail.com

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ass.Prof.

Study Record Dates

First Submitted

September 16, 2023

First Posted

September 25, 2023

Study Start

October 1, 2023

Primary Completion

September 30, 2024

Study Completion (Estimated)

September 30, 2029

Last Updated

September 25, 2023

Record last verified: 2023-09