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

This study has been terminated.
(See termination reason in detailed description)
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00184548
First received: September 9, 2005
Last updated: January 20, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Acquired Bleeding Disorder
Trauma
Drug: eptacog alfa (activated)
Drug: placebo
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Mortality [ Time Frame: from day 0 to 30 ] [ Designated as safety issue: No ]
    Number of participants to die from day 0 to day 30 from all causes.

  • Morbidity [ Time Frame: from day 0 to day 30 ] [ Designated as safety issue: No ]
    Morbidity reflects the number of patients who had pulmonary and/or renal dysfunction requiring ongoing medical intervention on day 30.


Secondary Outcome Measures:
  • Number of Days Alive and Free of Pulmonary and/or Renal Dysfunction Requiring Medical Intervention [ Time Frame: from day 0 to day 30 ] [ Designated as safety issue: No ]
    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 [ Time Frame: from day 0 to day 30 ] [ Designated as safety issue: No ]
    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 [ Time Frame: from hour 0 to 24 ] [ Designated as safety issue: No ]
    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 [ Time Frame: from hour 0 to 24 ] [ Designated as safety issue: No ]
    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 [ Time Frame: from hour 0 to 24 ] [ Designated as safety issue: No ]
    The number of units of all allogeneic transfusions in the first 24 hours from the time of the first dose of rFVIIa or placebo.


Enrollment: 554
Study Start Date: August 2005
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: rFVIIa, Blunt Trauma 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 Comparator: Placebo, Blunt Trauma Drug: placebo
placebo
Experimental: rVIIa, Penetrating Trauma 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 Comparator: Placebo, Penetrating Trauma Drug: placebo
placebo

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00184548

Locations
United States, New Jersey
Novo Nordisk Clinical Trial Call Center
Princeton, New Jersey, United States, 08540
Brazil
Säo Paulo, Brazil, 05001-400
Czech Republic
Prague, Czech Republic, 16000
France
Paris La défense cedex, France, 92932
Germany
Mainz, Germany, 55127
Greece
Vouliagment, Greece, 16671
Hong Kong
Kowloon, Hong Kong
Hungary
Budapest, Hungary, 1025
Italy
Rome, Italy, 00144
Netherlands
Alphen a/d Rijn, Netherlands
South Africa
Sandton, South Africa, 2146
Spain
Madrid, Spain, 28033
Switzerland
Zurich, Switzerland, CH-8050
United Kingdom
Crawley, United Kingdom, RH11 9RT
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00184548     History of Changes
Other Study ID Numbers: F7TRAUMA-1711, 2005-002059-41
Study First Received: September 9, 2005
Results First Received: September 4, 2009
Last Updated: January 20, 2014
Health Authority: Norway: Norwegian Medicines Control Authority
Taiwan: Department of Health
Germany: Federal Institute for Drugs and Medical Devices
Singapore: Health Sciences Authority
Canada: Health Canada
Spain: Spanish Drug Agency and Medicinal Products
Finland: Finnish Medicines Agency
Italy: Ministry of Health
South Africa: Medicines Control Council
Netherlands: Dutch Health Care Inspectorate
Czech Republic: State Institute for Drug Control
Australia: Department of Health and Ageing Therapeutic Goods Administration
Austria: Federal Ministry for Health and Women
New Zealand: Medsafe
Portugal: INFARMED
Switzerland: Swissmedic
United States: Food and Drug Administration
Sweden: Medical Products Agency
Belgium: Federal Agency for Medicines and Healthcare Products
Brazil: National Health Surveillance Agency
Greece: Ministry of Health & Social Solidarity - National Organizaion for Medicines (EOF)
Hong Kong: Department of Health
Hungary: Ministry of Health, Social and Family Affairs
Israel: Israeli Health Ministry Pharmaceutical Administration
United Kingdom: Medicines and Healthcare Products Regulatory Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Blood Coagulation Disorders
Hemostatic Disorders
Hemorrhagic Disorders
Hemorrhage
Wounds and Injuries
Hematologic Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Factor VIII
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014