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A Multicenter Extension Study of Taliglucerase Alfa in Adult Subjects With Gaucher Disease
A Multicenter Extension Study of Taliglucerase Alfa in Adult Subjects With Gaucher Disease

NCT01422187

CompletedPhase 3

Sponsor: Pfizer

Conditions: Gaucher Disease

Interventions: Taliglucerase alfa

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.

Eligibility overview

Sex: ALL

Age: 18 Years to

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

* Successfully completed Protocol PB-06-001 and enrolled in Protocol PB-06-003
* The subject signs an informed consent

Exclusion Criteria:

* Currently taking another investigational drug for any condition.
* 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.