Ignite Creation Date:
2024-05-05 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00154427
Status:
TERMINATED
Last Update Posted:
2017-01-12
First Post:
2005-09-09
Brief Title:
Use of Activated Recombinant Human Factor VII in Cardiac Surgery
Sponsor:
Novo Nordisk AS
Organization:
Novo Nordisk AS
Study Overview
Official Title:
A Multi-centre Randomised Double-blind Placebocontrolled Dose Escalation Trial on Safety and Efficacy of Activated Recombinant Factor VII rFVIIaNovoSeven in the Treatment of Post-operative Bleeding in Patients Following Cardiac Surgery Requiring Cardiopulmonary Bypass
Status:
TERMINATED
Status Verified Date:
2017-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Trial terminated after recruiting 172 patients but without proceeding to the highest dosing cohort as this no longer reflects common clinical practice
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This trial is conducted in Africa Asia Europe South America and the United States of America USA
The trial is planned to investigate the safety and efficacy of NovoSeven in the management of post-operative bleeding in patients following cardiac surgery
The trial is planned to investigate the safety and efficacy of NovoSeven in the management of post-operative bleeding in patients following cardiac surgery
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2004-000100-40 | EUDRACT_NUMBER | None | None |