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

NCT02763215 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 64

Last updated 2020-12-01

Study results available
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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

DRUG

Standard of Care Medications

Standard of care medications could include penicillamine, trientine, zinc, or a combination of a copper chelator and zinc.

Sponsors & Collaborators

  • Alexion Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Alexion Pharmaceuticals, Inc. · Alexion Pharmaceuticals, Inc.

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-19
Primary Completion
2019-01-21
Completion
2019-01-21

Countries

  • United States
  • Austria
  • Germany
  • Poland
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02763215 on ClinicalTrials.gov