Evaluation of Recombinant Factor VIIa in Patients With Severe Bleeding

Phase 3

Terminated

• Conditions: Acquired Bleeding Disorder; Trauma
• Interventions: Drug: eptacog alfa (activated); Drug: placebo

• Registration Number: NCT00184548
• Lead Sponsor: Novo Nordisk A/S

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.

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 Timeline

• Study First Submitted: 2005-09-09
• Study First Submitted QC: 2005-09-09
• Study First Posted: 2005-09-16
• Study Start: 2005-10
• Primary Completion: 2008-09
• Study Completion: 2008-09
• Results First Submitted: 2009-09-04
• Results First Submitted QC: 2009-10-16
• Results First Posted: 2009-11-26
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-13
• Last Update Posted: 2014-06-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 554

Inclusion Criteria

• Trauma injury (blunt and/or penetrating) with evidence of active hemorrhage (torso and/or proximal lower extremity) refractory to blood component therapy and surgical haemostatic procedures at the time of randomisation

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
rFVIIa, Blunt Trauma	eptacog alfa (activated)	-
Placebo, Blunt Trauma	placebo	-
Placebo, Penetrating Trauma	placebo	-
rVIIa, Penetrating Trauma	eptacog alfa (activated)	-

Primary Outcome Measures

Name	Time	Method
Mortality	from day 0 to 30	Number of participants to die from day 0 to day 30 from all causes.
Morbidity	from day 0 to day 30	Morbidity reflects the number of patients who had pulmonary and/or renal dysfunction requiring ongoing medical intervention on day 30.

Secondary Outcome Measures

Name	Time	Method
Number of Days Alive and Free of Pulmonary and/or Renal Dysfunction Requiring Medical Intervention	from day 0 to day 30	The number of days alive and free of pulmonary and/or renal dysfunction requiring medical intervention from day 0 to day 30.
Time to Death From Time of First Dose	from day 0 to day 30	The time of first dose refers to the time of the first dose of rFVIIa or placebo.
Number of Units of Transfused Red Blood Cells From Time of First Dose	from hour 0 to 24	The number of units of transfused red blood cells in the first 24 hours from the time of the first dose of rFVIIa or placebo.
Number of Patients Receiving 10 Units or More (Massive Transfusion) of Red Blood Cells From Time of Injury	from hour 0 to 24	The number of patients receiving 10 units or more of red blood cells in the first 24 hours from the time of injury.
Number of Units of All Allogeneic Transfusions From Time of First Dose	from hour 0 to 24	The number of units of all allogeneic transfusions in the first 24 hours from the time of the first dose of rFVIIa or placebo.

Trial Locations

Locations (1)

Novo Nordisk Clinical Trial Call Center; 🇺🇸 Princeton, New Jersey, United States