Ignite Creation Date:
2024-05-05 @ 5:09 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00395876
Status:
COMPLETED
Last Update Posted:
2010-08-10
First Post:
2006-11-02
Brief Title:
A Study of Tenecteplase for Restoration of Function in Dysfunctional Central Venous Catheters
Sponsor:
Genentech Inc
Organization:
Genentech Inc
Study Overview
Official Title:
A Phase III Randomized Double-Blind Placebo-Controlled Study of Tenecteplase for Restoration of Function in Dysfunctional Central Venous Catheters
Status:
COMPLETED
Status Verified Date:
2010-07
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:
TROPICS 1
Brief Summary:
This was a Phase III randomized double-blind placebo-controlled study that was conducted at 24 centers in the United States and Canada 100 adult and pediatric patients with dysfunctional central venous catheters CVCs were randomly assigned in a 11 ratio to receive an initial dose of either placebo Arm A or tenecteplase Arm B
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