Trials / Completed
CompletedNCT02273596
Efficacy and Safety Study of WTX101 (ALXN1840) in Adult Wilson Disease Patients
A Phase 2, Multi-centre, Open-label, Study to Evaluate the Efficacy and Safety of WTX101 Administered for 24 Weeks in Newly Diagnosed Wilson Disease Patients Aged 18 and Older With an Extension Phase of 36 Months
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 29 (actual)
- Sponsor
- Alexion Pharmaceuticals, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ALXN1840 | Individualized oral doses of ALXN1840. |
Timeline
- Start date
- 2014-11-24
- Primary completion
- 2016-10-27
- Completion
- 2018-11-07
- First posted
- 2014-10-24
- Last updated
- 2021-09-29
- Results posted
- 2021-09-29
Locations
9 sites across 5 countries: United States, Austria, Germany, Poland, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02273596. Inclusion in this directory is not an endorsement.