At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 35 enrolled
Drug / intervention
Replagalbiological
Likely dose
Replagal 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 Extension of Study TKT028 Evaluating Safety and Clinical Outcomes of Replagal® Enzyme Replacement Therapy Administered to Adult Patients With Fabry Disease
In Brief
A Phase 3 clinical trial evaluating Replagal for Fabry Disease. Completed, enrolled 35 participants across 9 sites in 7 countries.
Detailed Summary
This study will evaluate safety and clinical outcomes of treatment with Replagal in adult participants with Fabry disease who have completed Study TKT028 (NCT00864851).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFabry Disease
CountriesAustralia, Czechia, Finland, Poland, Slovenia, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartApr 2010
First PostedMay 2010
Primary CompletionJul 2013
TodayJul 2026
First PostedMay 17, 2010
Enrollment StartApr 13, 2010
Primary CompletionJul 8, 2013
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 16.1 years ago
Interventions
Replagalbiological
0.2 mg/kg administered intravenously \[IV\] every other week