At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 45 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 Multicenter, Double-Blind, Extension Trial of Two Parallel Dose Groups of Plant Cell Expressed Recombinant Human Glucocerebrosidase (prGCD) in Patients With Gaucher Disease
In Brief
A Phase 3 clinical trial evaluating Taliglucerase alfa for Gaucher Disease. Completed, enrolled 45 participants across 11 sites in 8 countries.
Detailed Summary
Gaucher disease, the most prevalent lysosomal storage disorder, is caused by mutations in the human glucocerebrosidase gene (GCD) leading to reduced activity of the lysosomal enzyme glucocerebrosidase and thereby to the accumulation of substrate glucocerebroside (GlcCer) in the cells of the monocyte-macrophage system. This is an extension trial to Study NCT00376168 and NCT00712348.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGaucher Disease
CountriesAustralia, Canada, Chile, Israel, South Africa, Spain, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJun 2008
First PostedJun 2008
Primary CompletionMay 2012
Study CompletionAug 2013
TodayJul 2026
First PostedJun 27, 2008
Enrollment StartJun 1, 2008
Primary CompletionMay 1, 2012
Study CompletionAug 1, 2013
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 18.0 years ago
Interventions
Taliglucerase alfadrug
Intravenous infusion every 2 weeks