NCT04965558

Brief Summary

The investigators aimed to observe the clinical features and outcome in patients with osseomuscular type of Wilson's disease from a large cohort during long-term follow-up

Trial Health

77
On Track

Trial Health Score

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

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
45mo left

Started Jan 2004

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

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Study Timeline

Key milestones and dates

Study Progress86%
Jan 2004Jan 2030

Study Start

First participant enrolled

January 1, 2004

Completed
17.5 years until next milestone

First Submitted

Initial submission to the registry

July 5, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 16, 2021

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
4.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2030

Expected
Last Updated

July 16, 2021

Status Verified

July 1, 2021

Enrollment Period

21.9 years

First QC Date

July 5, 2021

Last Update Submit

July 11, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

  • Urinary Copper Excretion

    The measurement of 24-hour urine copper excretions were collected and measured.

    From 2004 through 2030

Interventions

No intervention

Eligibility Criteria

Age6 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with wilson disease

You may qualify if:

  • genetically diagnosed WD patients

You may not qualify if:

  • Deny follow-up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Second Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310005, China

RECRUITING

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 5, 2021

First Posted

July 16, 2021

Study Start

January 1, 2004

Primary Completion

December 1, 2025

Study Completion (Estimated)

January 1, 2030

Last Updated

July 16, 2021

Record last verified: 2021-07

Locations