Safety and Efficacy of Cerezyme® Infusions Every 4 Weeks Versus Every 2 Weeks in Type 1 Gaucher Disease
Genzyme, a Sanofi Company
This is a multicenter, randomized trial to compare the safety and efficacy of two dosing
frequencies of Cerezyme® in patients with Gaucher disease who are currently being treated
Approximately 90 patients will be randomized in a 2:1 (q4 : q2) ratio to one of two
treatment arms at up to 26 study centers worldwide. Patients will continue to receive the
same total 4-week dose that they were receiving prior to study enrollment, however, they
will be randomized to receive either their total 4-week dose in two infusions, one infusion
every 2 weeks or their total 4-week dose in one infusion every 4 weeks. The randomization
scheme will ensure a 2:1 balance between the every 4-week versus every 2-week infusion
A Multicenter Study of the Efficacy of Cerezyme in Testing Skeletal Disease in Patients With Type I Gaucher Disease.
Genzyme, a Sanofi Company
This is a multicenter, open-label, prospective study of the efficacy of Cerezyme in treating
patients with skeletal manifestations secondary to Type I Gaucher disease.
The study objective is to evaluate and quantify skeletal responses as compared to baseline
in Type I gaucher disease patients receiving Cerezyme therapy for 48 months. Additional
objectives were to assess the usefulness of various skeletal parameters, such as bone pain,
bone crises, bone mineral density, and serum and urine bone markers, as indicative of
treatment response and may be useful in dose management.
Switchover Trial From Imiglucerase to Plant Cell Expressed Recombinant Human Glucocerebrosidase
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.
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