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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04965545
Other study ID # WD-Biochemical assays
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2004
Est. completion date January 1, 2030

Study information

Verified date July 2021
Source Second Affiliated Hospital, School of Medicine, Zhejiang University
Contact Yi Dong, Ph.D.
Phone +8618367129345
Email dongyi720@zju.edu.cn
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The investigators aimed to identify factors associated with symptoms and features of Wilson disease from a large cohort during long-term follow-up


Description:

Wilson disease is an autosomal recessive disorder that impairs copper homeostasis and is caused by homozygous or compound heterozygous mutations in ATP7B, which encodes a copper-transporting P-type ATPase. Patients have variable clinical manifestations and laboratory test results, resulting in diagnostic dilemmas. Therefore, the investigators aimed to identify factors associated with symptoms and features of Wilson disease, thereby give timely diagnosis for patients.


Recruitment information / eligibility

Status Recruiting
Enrollment 1000
Est. completion date January 1, 2030
Est. primary completion date December 1, 2025
Accepts healthy volunteers No
Gender All
Age group 6 Years to 65 Years
Eligibility Inclusion Criteria: - genetically diagnosed patients with wilson disease Exclusion Criteria: - Deny follow-up

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
low copper diet
All patients with wilson disease should receive low copper diet

Locations

Country Name City State
China Second Affiliated Hospital, Zhejiang University School of Medicine Hangzhou Zhejiang

Sponsors (1)

Lead Sponsor Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Serum ceruloplasmin Serum ceruloplasmin levels were collected among patients with wilson disease. After confirming a non-Gaussian distribution, the reference range of serum ceruloplasmin level was determined. From 2004 through 2030
Primary Urinary Copper Excretion The measurement of 24-hour urine copper excretions were collected and measured. From 2004 through 2030
Primary Kayser-Fleischer Rings The presence of Kayser-Fleischer Rings among patients with wilson disease were confirmed via slit lamp. From 2004 through 2030
Primary Brain Magnetic Resonance Imaging Brain Magnetic Resonance Imaging of all patients were collected and analyzed. From 2004 through 2030
See also
  Status Clinical Trial Phase
Completed NCT04573309 - Copper and Molybdenum Balance in Participants With Wilson Disease Treated With ALXN1840 Phase 2
Completed NCT03539952 - Trientine Tetrahydrochloride (TETA 4HCL) for the Treatment of Wilson's Disease Phase 3
Active, not recruiting NCT04884815 - Study of UX701 Gene Transfer for the Treatment of Wilson Disease Phase 1/Phase 2
Not yet recruiting NCT03659331 - A Controlled Study of Potential Therapeutic Effect of Oral Zinc in Manifesting Carriers of Wilson Disease N/A
Recruiting NCT05687474 - Baby Detect : Genomic Newborn Screening
Completed NCT04965571 - Clinical Features and Outcome of Wilson's Disease With Generalized Epilepsy in Chinese Patients
Terminated NCT05047523 - Study of ALXN1840 Versus Standard of Care in Pediatric Participants With Wilson Disease Phase 3
Completed NCT04526210 - Study of ALXN1840 on the Metabolism of a CYP2B6 Substrate in Healthy Participants Phase 1
Completed NCT00004338 - Study of Zinc for Wilson Disease Phase 4
Enrolling by invitation NCT03655223 - Early Check: Expanded Screening in Newborns
Completed NCT02273596 - Efficacy and Safety Study of WTX101 (ALXN1840) in Adult Wilson Disease Patients Phase 2
Completed NCT02763215 - The Assessment of Copper Parameters in Wilson Disease Participants on Standard of Care Treatment
Recruiting NCT05444127 - Oral Health and Wilson's Disease: SOMAWI
Completed NCT04408300 - Study of Retinal Vascular Parameters in Patients With Wilson's Disease N/A
Active, not recruiting NCT05783687 - Real World Evidence Study in Subjects With Wilson's Disease
Terminated NCT04909346 - Adeno-Associated Virus (AAV) Antibody Study in Subjects OTC Deficiency, GSDIa, and Wilson Disease
Completed NCT03867526 - Establishment of Human Cellular Disease Models for Wilson Disease
Enrolling by invitation NCT03589820 - Plasma Exchange and Continuous Hemodiafiltration in Treatment of Wilson's Disease-related Liver Failure N/A
Completed NCT04526197 - Phase 1 Study of ALXN1840 on the Metabolism of a CYP2C9 Substrate in Healthy Participants. Phase 1
Not yet recruiting NCT06430359 - Circadian Variation of Urinary Copper Excretion in Wilson Disease Patients