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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04012658
Other study ID # MRCTA,ECFAH OF FMU[2019]197
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 1, 2019
Est. completion date December 2049

Study information

Verified date September 2019
Source First Affiliated Hospital of Fujian Medical University
Contact Jin He, MD
Phone 86-0591-87982772
Email hejinfjmu@hotmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The aim of this study is to determine the clinical spectrum and natural progression of Wilson's Disease in a prospective multicenter natural history study, to assess the clinical, genetic, epigenetic features and biomarkers of patients with Wilson's Disease to optimize clinical management.


Recruitment information / eligibility

Status Recruiting
Enrollment 2000
Est. completion date December 2049
Est. primary completion date December 2039
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- Patients with the genetic diagnosis of Wilson's Disease

- Asymptomatic Wilson's Disease carriers

- Relatives of Wilson's Disease patients or carriers

- Unrelated healthy controls

- Participants or Parent(s)/legal guardian(s) willing and able to complete the informed consent process

Exclusion Criteria:

* Participants are unable to comply with study procedures and visit schedule

Study Design


Related Conditions & MeSH terms


Intervention

Other:
No intervention
No intervention

Locations

Country Name City State
China First Affiliated Hospital of Fujian Medical University Fuzhou

Sponsors (1)

Lead Sponsor Collaborator
Wan-Jin Chen

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary The change of Unified Wilson's Disease Rating Scale (UWDRS) Disease severity will be assessed by application of the Unified Wilson's Disease Rating Scale (UWDRS), a clinical rating scale consists of three subscales. Higher UWDRS total scores indicate more severe disease. Up to 30years
See also
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