CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 68 enrolled
Drug / intervention
migalastat hydrochloride +1 moredrug
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/NCT01218659
NCT01218659Phase 3Completed
CompareCT.gov

A Randomized, Open-Label Study to Compare the Efficacy and Safety of AT1001 and Enzyme Replacement Therapy (ERT) in Patients With Fabry Disease and AT1001-Responsive GLA Mutations, Who Were Previously Treated With ERT

Amicus Therapeutics·interventional·Posted Oct 11, 2010·Updated Nov 1, 2018

In Brief

A Phase 3 clinical trial evaluating migalastat hydrochloride and agalsidase for Fabry Disease. Completed, enrolled 68 participants across 25 sites in 10 countries.

Detailed Summary

Study to compare the efficacy and safety of migalastat and enzyme replacement therapy (ERT) in male and female participants with Fabry disease who are currently receiving ERT and who have an alpha galactosidase-A (α Gal-A) mutation that is amenable to migalastat, based on the clinical trial human embryonic kidney cell (HEK) assay.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFabry Disease
CountriesAustralia, Austria, Belgium, Brazil, Denmark, France, Italy, Japan, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedOct 11, 2010
Enrollment StartSep 8, 2011
Primary CompletionMay 27, 2014
Study CompletionMay 28, 2015
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 15.7 years ago

Interventions

migalastat hydrochloridedrug

150-mg capsule administered orally QOD

agalsidasebiological

Agalsidase via intravenous infusion as prescribed by the participant's treating physician and in accordance with the approved prescribing information