Switchover Trial From Imiglucerase to Plant Cell Expressed Recombinant Human Glucocerebrosidase
Completed
Pfizer
Phase 3
2008-12-01
This is a multi-center, open-label, switchover trial to assess the safety of taliglucerase
alfa in 30 patients with Gaucher disease who are currently being treated with imiglucerase
(Cerezyme®) enzyme replacement therapy.
Switchover Trial From Imiglucerase to Plant Cell Expressed Recombinant Human Glucocerebrosidase
Completed
Protalix
Phase 3
2008-12-01
This is a multi-center, open-label, switchover trial to assess the safety of taliglucerase
alfa in 30 patients with Gaucher disease who are currently being treated with imiglucerase
(Cerezyme®) enzyme replacement therapy.
A Safety and Efficacy Study of Two Dose Levels of Taliglucerase Alfa in Pediatric Subjects With Gaucher Disease
Completed
Pfizer
Phase 4
2010-08-01
This is a multi-center, double-blind trial to assess the safety and efficacy of taliglucerase
alfa in untreated subjects (2 to <18 years old) with Gaucher disease randomly assigned to
treatment with one of two doses, 30 or 60 units/kg. Subjects will receive an intravenous (IV)
infusion of taliglucerase alfa every two weeks. The total duration of treatment will be 12
months. At the end of the 12-month treatment period eligible subjects will be offered
enrollment in an open-label extension study if taliglucerase alfa is not commercially
available.
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