Efficacy and Safety Study of WTX101 (ALXN1840) in Adult Wilson Disease Patients
Study Identifier:
WTX101-201
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: ALXN1840
Date
Nov 2014 - Oct 2016
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: ALXN1840
Date
Nov 2014 - Oct 2016
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18+ years years
Requirements Information
Protocol Summary
The main purpose of the study was to evaluate the efficacy of ALXN1840 (formerly WTX101) for 24 weeks on non-ceruloplasmin-bound copper (NCC) concentrations adjusted for molybdenum plasma concentration in participants newly diagnosed with Wilson Disease (WD) who were aged 18 and older and who had NCC concentrations within or above the reference range at the time of enrollment in the study. The study consisted of a 24-week Treatment Period, followed by a planned 36-month Extension Period.
Trial Locations
Location
Status
Location
Clinical Trial Site
Los Angeles, California, United States, 90095
Status
N/A
Location
Clinical Trial Site
New Haven, Connecticut, United States, 06519
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
Vienna, Austria, 1090
Status
N/A
Location
Clinical Trial Site
Heidelberg, Germany, 69120
Status
N/A