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 Study in Type 1 Gaucher Patients to Evaluate the Pharmacokinetics, Safety and Pharmacodynamics of AT2101
Terminated
Amicus Therapeutics
Phase 1
2009-04-01
This is an open-label study designed to assess if AT2101 is safe in patients with Gaucher
disease and how AT2101 gets through the body after it is taken by mouth. The study is being
offered to adult patients with type 1 Gaucher disease who are currently receiving a stable
dose of enzyme replacement therapy (ERT) with imiglucerase. During the study, subjects will
not be receiving ERT (up to 35 days).
The study consists of a screening period (~14 days), a treatment period (12 days) and a
follow-up period (7 days after last dose). At two points in the study, subjects will be
housed in an in-patient treatment facility for 3 days/2 nights to accommodate all necessary
blood draws.
A Study of Eliglustat Tartrate (Genz-112638) in Patients With Gaucher Disease Who Have Reached Therapeutic Goals With Enzyme Replacement Therapy (ENCORE)
Completed
Genzyme, a Sanofi Company
Phase 3
2009-09-01
This Phase 3 study was designed to confirm the efficacy and safety of eliglustat tartrate
(Genz-112638) in participants with Gaucher disease type 1 who had reached therapeutic goals
with enzyme replacement therapy (ERT).
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