Trial Results

Protocol
Available Languages: English
Statistical Analysis Plan
Available Languages: English

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

Study Identifier:
WTX101-203
ClinicalTrials.gov Identifier:
EudraCT Identifier:
N/A
Sponsor:
Alexion Pharmaceuticals, Inc.
Study Contact Information:
N/A
Study Complete

Study Details

Medical Condition
  • Unmapped
Study Drug
  • Drug: Standard of Care Medications
Date
May 2016 - Jan 2019
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18+ years
Requirements Information
Sex
Female & Male
Age
18+ years

Study Details

Medical Condition
  • Unmapped
Study Drug
  • Drug: Standard of Care Medications
Date
May 2016 - Jan 2019
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18+ years years
Requirements Information

Protocol 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.

Trial Locations

Location
Status
Location
Clinical Trial Site
New Haven, Connecticut, United States, 06504
Status
N/A
Location
Clinical Trial Site
Chicago, Illinois, United States, 60611
Status
N/A
Location
Clinical Trial Site
Ann Arbor, Michigan, United States, 48109
Status
N/A
Location
Clinical Trial Site
Nashville, Tennessee, United States, 37240
Status
N/A
Location
Clinical Trial Site
Seattle, Washington, United States, 98105
Status
N/A
Location
Clinical Trial Site
Vienna, Austria, 1090
Status
N/A