CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 31 enrolled
Drug / intervention
Bis-Choline Tetrathiomolybdatedrug
Likely dose
Bis-Choline Tetrathiomolybdate 15 milligramsfrom 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/NCT04422431
NCT04422431Phase 2Completed
CompareCT.gov

A Phase 2, Single-arm Pathologist-blinded 48-week Study Using Liver Biopsy Specimens to Assess Copper Concentration and Histopathologic Changes in ALXN1840-treated Patients With Wilson Disease Followed by an up to 48-weeks Extension Period

Alexion Pharmaceuticals, Inc.·interventional·Posted Jun 9, 2020·Updated Oct 18, 2024

In Brief

A Phase 2 clinical trial evaluating Bis-Choline Tetrathiomolybdate for Wilson Disease. Completed, enrolled 31 participants across 12 sites in 8 countries.

Detailed Summary

The main objective of the study is to evaluate the change in liver copper (Cu) concentration following 48 weeks of treatment with ALXN1840 in adult participants with Wilson Disease (WD) who have been previously treated for at least 1 year with standard of care (that is, trientine, penicillamine, or zinc). In the Treatment Period, efficacy and safety of ALXN1840 will be assessed at Week 48.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsWilson Disease
CountriesCanada, Denmark, New Zealand, Russia, Singapore, Spain, United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedJun 9, 2020
Enrollment StartDec 2, 2020
Primary CompletionMay 21, 2022
Study CompletionMay 17, 2023
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 6.1 years ago

Interventions

Bis-Choline Tetrathiomolybdatedrug

Participants will be initiated at 15 milligrams once daily, then the dose will be increased to 30 milligrams once daily at Week 6.