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The Assessment of Copper Parameters in Wilson Disease Participants on Standard of Care Treatment

Wilson Disease Clinical Trial

Official title:
Multi-Center Study for the Assessment of Copper Parameters in Wilson Disease Subjects on Standard of Care Treatment

Clinical Trial Summary

This was a 24-month study to assess copper parameters in participants with Wilson disease (WD) treated with standard of care (SoC) medications. 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02763215
Study type Observational
Source Alexion Pharmaceuticals
Contact
Status Completed
Phase
Start date May 19, 2016
Completion date January 21, 2019
View Details
See also
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