Safety and Efficacy of Cerezyme® Infusions Every 4 Weeks Versus Every 2 Weeks in Type 1 Gaucher Disease
Status:
Completed
Trial end date:
2007-02-01
Target enrollment:
Participant gender:
Summary
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
with Cerezyme®.
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 groups,
respectively.