Ignite Creation Date:
2024-05-05 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00140621
Status:
COMPLETED
Last Update Posted:
2015-05-12
First Post:
2005-08-30
Brief Title:
A Safety and Efficacy Study of Fabrazyme Replacement Therapy in Patients With Cardiac Fabry Disease
Sponsor:
Genzyme a Sanofi Company
Organization:
Sanofi
Study Overview
Official Title:
A Multicenter Open-label Study of the Safety and Efficacy of α-galactosidase A R-h α-GAL Replacement Therapy in Patients With Cardiac Fabry Disease
Status:
COMPLETED
Status Verified Date:
2015-04
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 multi-center open label phase IV study conducted to evaluate the efficacy and safety of agalsidase beta Fabrazyme recombinant form administered by intravenous drip infusion in participants with cardiac Fabry disease
Participants participated for 4 weeks or less in the baseline period and 156 weeks for the treatment period
Participants participated for 4 weeks or less in the baseline period and 156 weeks for the treatment period
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