Status:
COMPLETED
A Multicenter Extension Study of Taliglucerase Alfa in Pediatric Subjects With Gaucher Disease
Lead Sponsor:
Pfizer
Conditions:
Gaucher Disease
Eligibility:
All Genders
2-18 years
Phase:
PHASE3
Brief 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 comple...
Eligibility Criteria
Inclusion
- Successful completion of Protocol PB-06-002 or PB-06-005
- The subject, parent(s) or legal guardian(s) signs an informed consent and/or assent
Exclusion
- Currently taking another investigational drug for any condition.
- Presence of neurological signs and symptoms characteristic of Gaucher disease with complex neuronopathic features other than longstanding oculomotor gaze palsy.
- Presence of any medical, emotional, behavioral or psychological condition that in the judgment of the Investigator would interfere with the subject's compliance with the requirements of the study.
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2014
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT01411228
Start Date
September 1 2011
End Date
August 1 2014
Last Update
September 7 2018
Active Locations (3)
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1
Shaare Zedek Medical Center
Jerusalem, Israel
2
Instituto Privado de Hematologia E Investigacion Clinica (I.P.H.I.C)
Barrio Asunción, Paraguay
3
Morningside Medi-Clinic
Morningside, South Africa