At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 15 enrolled
Drug / intervention
Replagal (agalsidase alfa)biological
Likely dose
Replagal (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.
An Open-Label Clinical Trial of Replagal® Enzyme Replacement Therapy in Children With Fabry Disease Who Are Naive to Enzyme Replacement Therapy
In Brief
A Phase 2 clinical trial evaluating Replagal (agalsidase alfa) for Fabry Disease. Completed, enrolled 15 participants across 5 sites.
Detailed Summary
The purpose of this study is to assess the safety of Replagal in children with Fabry disease who who have not previously been treated with enzyme replacement therapy (ERT).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFabry Disease
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartMay 2011
First PostedJun 2011
Primary CompletionApr 2013
TodayJul 2026
First PostedJun 1, 2011
Enrollment StartMay 12, 2011
Primary CompletionApr 17, 2013
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 15.1 years ago
Interventions
Replagal (agalsidase alfa)biological
0.2 mg/kg administered over 40 minutes every other week (EOW)