Ignite Creation Date:
2024-05-05 @ 5:01 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00364858
Status:
COMPLETED
Last Update Posted:
2015-04-03
First Post:
2006-08-15
Brief Title:
Safety and Efficacy of Cerezyme Infusions Every 4 Weeks Versus Every 2 Weeks in Type 1 Gaucher Disease
Sponsor:
Genzyme a Sanofi Company
Organization:
Sanofi
Study Overview
Official Title:
A Phase IV Multicenter Randomized Dose Frequency Study of the Safety and Efficacy of Cerezyme Infusions Every Four Weeks Versus Every Two Weeks in the Maintenance Therapy of Patients With Type 1 Gaucher Disease
Status:
COMPLETED
Status Verified Date:
2015-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 21 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 21 balance between the every 4-week versus every 2-week infusion groups respectively
Approximately 90 patients will be randomized in a 21 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 21 balance between the every 4-week versus every 2-week infusion groups respectively
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None