At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 15 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 Extension Study of Taliglucerase Alfa in Pediatric Subjects With Gaucher Disease
In Brief
A Phase 3 clinical trial evaluating Taliglucerase alfa for Gaucher Disease. Completed, enrolled 15 participants across 3 sites in 3 countries.
Detailed Summary
A protocol to extend the assessment of the safety and efficacy of taliglucerase alfa in pediatric subjects (2 to \<18 years old) with symptoms and clinical manifestations of Gaucher disease who completed treatment in Protocols PB-06-002 (switchover study from imiglucerase) or PB-06-005 (naïve treatment with taliglucerase alfa).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGaucher Disease
CountriesIsrael, Paraguay, South Africa
Collaborators--
Timeline
Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedAug 2011
Enrollment StartSep 2011
Primary CompletionJul 2014
Study CompletionAug 2014
TodayJul 2026
First PostedAug 8, 2011
Enrollment StartSep 1, 2011
Primary CompletionJul 1, 2014
Study CompletionAug 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 14.9 years ago
Interventions
Taliglucerase alfadrug
Taliglucerase alfa for infusion every two weeks for 24 months