Evaluation of Recombinant Factor VIIa in Patients With Severe Bleeding

Trauma Clinical Trial

— CONTROL  

Official title:

A Multi-centre, Randomised, Double-blind, Parallel Group, Placebo Controlled Trial to Evaluate the Efficacy and Safety of Activated Recombinant Factor VII (rFVIIa/NovoSeven®/NiaStase®) in Severely Injured Trauma Patients With Bleeding Refractory to Standard Treatment

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00184548
• Other study ID #: F7TRAUMA-1711
• Secondary ID: 2005-002059-41
• Status: Terminated
• Phase: Phase 3
• First received: September 9, 2005
• Last updated: June 13, 2014
• Start date: October 2005
• Est. completion date: September 2008

Study information

• Verified date: June 2014
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Norwegian Medicines Control AuthorityTaiwan: Department of HealthGermany: Federal Institute for Drugs and Medical DevicesSingapore: Health Sciences AuthorityCanada: Health CanadaSpain: Spanish Drug Agency and Medicinal ProductsFinland: Finnish Medicines AgencyItaly: Ministry of HealthSouth Africa: Medicines Control CouncilNetherlands: Dutch Health Care InspectorateCzech Republic: State Institute for Drug ControlAustralia: Department of Health and Ageing Therapeutic Goods AdministrationAustria: Federal Ministry for Health and WomenNew Zealand: MedsafePortugal: INFARMEDSwitzerland: SwissmedicUnited States: Food and Drug AdministrationSweden: Medical Products AgencyBelgium: Federal Agency for Medicines and Healthcare ProductsBrazil: National Health Surveillance AgencyGreece: Ministry of Health & Social Solidarity - National Organizaion for Medicines (EOF)Hong Kong: Department of HealthHungary: Ministry of Health, Social and Family AffairsIsrael: Israeli Health Ministry Pharmaceutical AdministrationUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 554
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acquired Bleeding Disorder
• Blood Coagulation Disorders
• Hemorrhage
• Hemostatic Disorders
• Trauma

Intervention

Drug:
• eptacog alfa (activated)
Sterile, freeze-dried powder in single-use vials to be reconstituted with sterile water for injection. Three doses of 200, 100 and 100 mcg/kg to be administered bolus i.v. (intravenous) over approx. three hours.
• placebo
placebo

Locations

Country	Name	City	State
United States	Novo Nordisk Clinical Trial Call Center	Princeton	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

United States,  Brazil,  Czech Republic,  France,  Germany,  Greece,  Hong Kong,  Hungary,  Italy,  Netherlands,  South Africa,  Spain,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality	Number of participants to die from day 0 to day 30 from all causes.	from day 0 to 30	No
Primary	Morbidity	Morbidity reflects the number of patients who had pulmonary and/or renal dysfunction requiring ongoing medical intervention on day 30.	from day 0 to day 30	No
Secondary	Number of Days Alive and Free of Pulmonary and/or Renal Dysfunction Requiring Medical Intervention	The number of days alive and free of pulmonary and/or renal dysfunction requiring medical intervention from day 0 to day 30.	from day 0 to day 30	No
Secondary	Time to Death From Time of First Dose	The time of first dose refers to the time of the first dose of rFVIIa or placebo.	from day 0 to day 30	No
Secondary	Number of Units of Transfused Red Blood Cells From Time of First Dose	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.	from hour 0 to 24	No
Secondary	Number of Patients Receiving 10 Units or More (Massive Transfusion) of Red Blood Cells From Time of Injury	The number of patients receiving 10 units or more of red blood cells in the first 24 hours from the time of injury.	from hour 0 to 24	No
Secondary	Number of Units of All Allogeneic Transfusions From Time of First Dose	The number of units of all allogeneic transfusions in the first 24 hours from the time of the first dose of rFVIIa or placebo.	from hour 0 to 24	No

External Links

•   Clinical Trials at Novo Nordisk