CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 29 enrolled
Drug / intervention
ALXN1840drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02273596
NCT02273596Phase 2Completed

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

Alexion Pharmaceuticals, Inc.·interventional·Posted Oct 24, 2014·Updated Sep 29, 2021

In Brief

A Phase 2 clinical trial evaluating ALXN1840 for Wilson Disease. Completed, enrolled 29 participants across 9 sites in 5 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsWilson Disease
CountriesAustria, Germany, Poland, United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedOct 24, 2014
Enrollment StartNov 24, 2014
Primary CompletionOct 27, 2016
Study CompletionNov 7, 2018
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 11.7 years ago

Interventions

ALXN1840drug

Individualized oral doses of ALXN1840.