At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 19 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 Adult Subjects With Gaucher Disease
In Brief
A Phase 3 clinical trial evaluating Taliglucerase alfa for Gaucher Disease. Completed, enrolled 19 participants.
Detailed Summary
This is a multi-center trial to further extend the assessment of the safety and efficacy of taliglucerase alfa in adult subjects (≥18 years old) with Gaucher disease who have enrolled in Protocol PB-06-003. Subjects will continue to receive an intravenous (IV) infusion of taliglucerase alfa every two weeks. The duration of treatment will be a maximum of 21 months or until taliglucerase alfa is commercially available to the subject at the discretion of the Sponsor.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGaucher Disease
Countries--
Collaborators--
Timeline
Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
Enrollment StartAug 2011
First PostedAug 2011
Primary CompletionMay 2014
Study CompletionSep 2014
TodayJul 2026
First PostedAug 23, 2011
Enrollment StartAug 1, 2011
Primary CompletionMay 1, 2014
Study CompletionSep 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 14.9 years ago
Interventions
Taliglucerase alfadrug
Taliglucerase infusion every two weeks for 21 months