Ignite Creation Date:
2024-05-05 @ 4:44 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00307580
Status:
COMPLETED
Last Update Posted:
2014-04-09
First Post:
2006-03-25
Brief Title:
Cathflo Activase Pediatric Study
Sponsor:
Genentech Inc
Organization:
Genentech Inc
Study Overview
Official Title:
Cathflo Activase Alteplase Pediatric Study CAPS
Status:
COMPLETED
Status Verified Date:
2014-04
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 was a Phase IV open-label single-arm multicenter trial that was to be conducted at 60 sites in the United States Approximately 300 pediatric subjects with dysfunctional CVADs including catheters with valves multiple lumens umbilical catheters and implanted ports were to be treated with up to two serially instilled doses of Cathflo Activase
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