NCT02763215

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 64 (actual)
• Sponsor: Alexion Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Wilson Disease

Interventions

Type	Name	Description
DRUG	Standard of Care Medications	Standard of care medications could include penicillamine, trientine, zinc, or a combination of a copper chelator and zinc.

Timeline

• Start date: 2016-05-19
• Primary completion: 2019-01-21
• Completion: 2019-01-21
• First posted: 2016-05-05
• Last updated: 2020-12-01
• Results posted: 2020-10-26

Locations

10 sites across 5 countries: United States, Austria, Germany, Poland, United Kingdom