ClinicalTrials.Veeva

Menu

Evaluation of Recombinant Factor VIIa in Patients With Severe Bleeding (CONTROL)

Novo Nordisk logo

Novo Nordisk

Status and phase

Terminated
Phase 3

Conditions

Trauma
Acquired Bleeding Disorder

Treatments

Drug: placebo
Drug: eptacog alfa (activated)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00184548
2005-002059-41 (EudraCT Number)
F7TRAUMA-1711

Details and patient eligibility

About

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.

Full 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.

Enrollment

554 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

554 participants in 4 patient groups, including a placebo group

rFVIIa, Blunt Trauma
Experimental group
Treatment:
Drug: eptacog alfa (activated)
Placebo, Blunt Trauma
Placebo Comparator group
Treatment:
Drug: placebo
rVIIa, Penetrating Trauma
Experimental group
Treatment:
Drug: eptacog alfa (activated)
Placebo, Penetrating Trauma
Placebo Comparator group
Treatment:
Drug: placebo

Trial contacts and locations

14

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems