At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 95 enrolled
Drug / intervention
VPRIV®biological
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.
An Open-Label Extension Study of Gene-Activated® Human Glucocerebrosidase (GA-GCB) Enzyme Replacement Therapy in Patients With Type 1 Gaucher Disease
In Brief
A Phase 3 clinical trial evaluating VPRIV® for Gaucher Disease, Type 1. Completed, enrolled 95 participants across 21 sites in 11 countries.
Detailed Summary
The purpose of this study is to evaluate the long-term safety of every other week dosing of Gene-Activated® human glucocerebrosidase (GA-GCB, velaglucerase alfa) intravenously in patients with type 1 Gaucher disease.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGaucher Disease, Type 1
CountriesArgentina, India, Israel, Paraguay, Poland, Russia, South Korea, Spain, Tunisia, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 2008
Enrollment StartMar 2008
Primary CompletionDec 2012
TodayJul 2026
First PostedMar 13, 2008
Enrollment StartMar 13, 2008
Primary CompletionDec 28, 2012
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 18.3 years ago
Interventions
VPRIV®biological
Intravenous infusion, every other week (EOW)