Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Observational
Official Title: Multi-Center Study for the Assessment of Copper Parameters in Wilson Disease Subjects on Standard of Care Treatment
Brief Summary:
This is a 24-month study to assess copper (Cu) parameters in subjects with Wilson Disease treated with standard of care (SOC) medications. Data will be collected during routinely scheduled Wilson Disease clinic visits at approximately 6-month intervals.
After providing informed consent, subjects meeting all inclusion and no exclusion criteria will be enrolled into the study as outpatients. Subject's routine Wilson Disease clinic visits will be 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, subjects will be receiving SOC therapeutic agents for the treatment of Wilson Disease. If treatment is interrupted or stopped during the course of the study, subjects will continue in the study and biological samples and clinical data will continue to be collected for the full 24-month study period. Dosing with SOC agents, which can include penicillamine, trientine, zinc, or a combination of a Cu chelator and zinc, will be individualized and managed by the treating physician at the study center according to standard clinical practice at the site.