Ignite Creation Date:
2024-05-05 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00184548
Status:
TERMINATED
Last Update Posted:
2014-06-25
First Post:
2005-09-09
Brief Title:
Evaluation of Recombinant Factor VIIa in Patients With Severe Bleeding
Sponsor:
Novo Nordisk AS
Organization:
Novo Nordisk AS
Study Overview
Official Title:
A Multi-centre Randomised Double-blind Parallel Group Placebo Controlled Trial to Evaluate the Efficacy and Safety of Activated Recombinant Factor VII rFVIIaNovoSevenNiaStase in Severely Injured Trauma Patients With Bleeding Refractory to Standard Treatment
Status:
TERMINATED
Status Verified Date:
2014-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
See termination reason in detailed description
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CONTROL
Brief Summary:
This trial is conducted globally The purpose of the trial is to evaluate that activated recombinant human factor VII eptacog alfa activated is safe and effective in severely injured trauma patients by assessing mortality and morbidity
Please note that this trial and trial F7TRAUMA-1648 NCT00323570 have been merged
Please note that this trial and trial F7TRAUMA-1648 NCT00323570 have been merged
Detailed Description:
The decision to discontinue the F7TRAUMA-1711 trial is not due to any safety concerns The result of the pre-planned futility analysis performed in June 2008 predicted a very low likelihood of reaching a successful outcome on the primary efficacy endpoint at the end of the trial and as a consequence the company has decided to close the trial as this juncture
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 |
|---|---|---|---|
| 2005-002059-41 | EUDRACT_NUMBER | None | None |