At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 171 enrolled
Drug / intervention
agalsidase alfabiological
Likely dose
agalsidase alfa 0.2 mg/kgfrom 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.
A Multicenter Open-Label Treatment Protocol to Observe the Safety of Replagal® (Agalsidase Alfa) Enzyme Replacement Therapy in Canadian Patients With Fabry Disease
In Brief
A Phase 3 clinical trial evaluating agalsidase alfa for Fabry Disease. Completed, enrolled 171 participants across 12 sites.
Detailed Summary
The purpose of this study is to observe the safety of agalsidase alfa in Canadian patients with Fabry disease.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFabry Disease
CountriesCanada
Collaborators--
Timeline
Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 2011
Enrollment StartAug 2011
Primary CompletionSep 2017
TodayJul 2026
First PostedFeb 17, 2011
Enrollment StartAug 10, 2011
Primary CompletionSep 25, 2017
TodayJul 2, 2026
Enrollment to primary: 6.1 yearsPosted 15.4 years ago
Interventions
agalsidase alfabiological
Cohort 1: 0.2 mg/kg body weight administered as an intravenous (IV) infusion over 40 minutes every other week (EOW) Cohort 2: 0.2 mg/kg body weight administered as an intravenous (IV) infusion over 40 minutes weekly