At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 31 enrolled
Drug / intervention
Agalsidase beta +1 morebiological
Likely dose
Agalsidase beta 1.0 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 Randomized, Multicenter, Multinational, Phase 3B, Open-Label, Parallel-Group Study of Fabrazyme (Agalsidase Beta) in Treatment-Naïve Male Pediatric Patients With Fabry Disease Without Severe Symptoms
In Brief
A Phase 3 clinical trial evaluating Agalsidase beta for Fabry Disease. Completed, enrolled 31 participants across 12 sites in 9 countries.
Detailed Summary
The purpose of this study was to determine whether 2 alternative dosing regimens of Fabrazyme (Agalsidase beta) (1.0 mg/kg every 4 weeks or 0.5 mg/kg every 2 weeks) were effective in treatment-naïve pediatric participants without severe symptoms. Participants were to be treated for 5 years.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFabry Disease
CountriesArgentina, Brazil, Canada, Czechia, Netherlands, Norway, Poland, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 2008
Enrollment StartSep 2008
Primary CompletionJun 2015
TodayJul 2026
First PostedJun 19, 2008
Enrollment StartSep 1, 2008
Primary CompletionJun 1, 2015
TodayJul 2, 2026
Enrollment to primary: 6.8 yearsPosted 18.0 years ago
Interventions
Agalsidase betabiological
Powder for concentrate for solution for infusion 1.0 mg/kg/4 weeks
Agalsidase betabiological
Powder for concentrate for solution for infusion 0.5 mg/kg/2 weeks