At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 31 enrolled
Drug / intervention
Taliglucerase alfadrug
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 Phase 3 Multicenter, Open-label, Switchover Trial to Assess the Safety and Efficacy of Plant Cell Expressed Recombinant Human Glucocerebrosidase in Patients With Gaucher Disease Treated With Imiglucerase
In Brief
A Phase 3 clinical trial evaluating Taliglucerase alfa for Gaucher Disease. Completed, enrolled 31 participants across 10 sites in 6 countries.
Detailed Summary
This is a multi-center, open-label, switchover trial to assess the safety of taliglucerase alfa in 30 patients with Gaucher disease who are currently being treated with imiglucerase (Cerezyme®) enzyme replacement therapy.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGaucher Disease
CountriesAustralia, Canada, Israel, Spain, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 2008
Enrollment StartDec 2008
Primary CompletionApr 2013
Study CompletionMay 2013
TodayJul 2026
First PostedJul 10, 2008
Enrollment StartDec 1, 2008
Primary CompletionApr 1, 2013
Study CompletionMay 1, 2013
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 18.0 years ago
Interventions
Taliglucerase alfadrug
Intravenous infusion every 2 weeks