Ignite Creation Date:
2024-05-05 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00074984
Status:
COMPLETED
Last Update Posted:
2013-12-27
First Post:
2003-12-24
Brief Title:
A Study of the Safety and Efficacy of Fabrazyme Agalsidase Beta as Compared to Placebo in Patients With Advanced Fabry Disease
Sponsor:
Genzyme a Sanofi Company
Organization:
Sanofi
Study Overview
Official Title:
Multi-Center Randomized Double-Blind Placebo-Controlled Study of the Safety and Efficacy of Fabrazyme on Progression of Renal Disease and Significant Clinical Events in Patients With Fabry Disease
Status:
COMPLETED
Status Verified Date:
2013-12
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:
People with Fabry disease have an alteration in their genetic material DNA which causes a deficiency of the a-galactosidase A enzyme Fabrazyme agalsidase beta is a drug that helps to breakdown and remove certain types of fatty substances called glycolipids These glycolipids are normally present within the body in most cells In Fabry disease glycolipids build up in various tissues such as the liver kidney skin and blood vessels because a-galactosidase A is not present or is present in small quantities The build up of glycolipid globotriaosylceramide or GL-3 levels in these tissues in particular is thought to cause the clinical symptoms that are common to Fabry disease This study will test the safety and efficacy of Fabrazyme in the treatment of patients with Fabry disease
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