The Assessment of Copper Parameters in Wilson Disease Participants on Standard of Care Treatment
NCT ID: NCT02763215
Last Updated: 2020-12-01
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
64 participants
OBSERVATIONAL
2016-05-19
2019-01-21
Brief Summary
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After providing informed consent, participants meeting all inclusion and no exclusion criteria were enrolled into the study as outpatients. The participants' routine clinic visits were scheduled according to the standard clinical practice at the study center and at the discretion of the treating physician at approximate 6-month intervals.
At the time of enrollment, participants were receiving SoC medications for the treatment of WD, which could include penicillamine, trientine, zinc, or a combination of a copper chelator and zinc. If treatment was interrupted or stopped during the course of the study, participants continued in the study and biological samples and clinical data were continued to be collected for the full 24-month study period. Dosing with SoC agents was individualized and managed by the treating physician at the study center according to standard clinical practice at the site.
Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Total
Standard of Care Medications
Standard of care medications could include penicillamine, trientine, zinc, or a combination of a copper chelator and zinc.
Interventions
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Standard of Care Medications
Standard of care medications could include penicillamine, trientine, zinc, or a combination of a copper chelator and zinc.
Eligibility Criteria
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Inclusion Criteria
* Male or female participants, aged 18 years or older as of signing the informed consent form.
* Receiving SoC medications (penicillamine, trientine, zinc, or copper chelators with zinc) for the treatment of WD at the time of enrollment and for no more than 60 months prior to enrollment.
* Able to understand and willing to comply with study procedures and requirements, as judged by the Investigator.
* Established diagnosis of WD.
* Adequate venous access to allow for collection of blood samples.
Exclusion Criteria
* In the opinion of the Investigator, the participant was likely to be non-compliant or uncooperative during the study.
18 Years
ALL
No
Sponsors
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Alexion Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Alexion Pharmaceuticals, Inc.
Role: STUDY_DIRECTOR
Alexion Pharmaceuticals, Inc.
Locations
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Clinical Trial Site
New Haven, Connecticut, United States
Clinical Trial Site
Chicago, Illinois, United States
Clinical Trial Site
Ann Arbor, Michigan, United States
Clinical Trial Site
Nashville, Tennessee, United States
Clinical Trial Site
Seattle, Washington, United States
Clinical Trial Site
Vienna, , Austria
Clinical Trial Site
Heidelberg, , Germany
Clinical Trial Site
Warsaw, , Poland
Clinical Trial Site
Birmingham, , United Kingdom
Clinical Trial Site
Guildford, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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WTX101-203
Identifier Type: -
Identifier Source: org_study_id