At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 44 enrolled
Drug / intervention
Replagalbiological
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.
A Multi-Center, Open-Label, Randomized Study Evaluating the Safety and Efficacy of Three Dosing Regimens of Replagal Enzyme Replacement Therapy in Adult Patients With Fabry Disease
In Brief
A Phase 3 clinical trial evaluating Replagal for Fabry Disease. Completed, enrolled 44 participants across 12 sites in 8 countries.
Detailed Summary
The purpose of this study is to compare the safety and effectiveness of various doses of Replagal in patients with cardiomyopathy due to Fabry disease.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFabry Disease
CountriesAustralia, Czechia, Finland, Paraguay, Poland, Slovenia, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartDec 2008
First PostedMar 2009
Primary CompletionJun 2012
Study CompletionJul 2012
TodayJul 2026
First PostedMar 19, 2009
Enrollment StartDec 29, 2008
Primary CompletionJun 1, 2012
Study CompletionJul 5, 2012
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 17.3 years ago
Interventions
Replagalbiological
Intravenous (IV) infusion for 12 months