Back to resultsEvaluation of Recombinant Factor VIIa in Patients With Severe Bleeding (CONTROL)
Primary Purpose
Acquired Bleeding Disorder, Trauma
Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
eptacog alfa (activated)
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Acquired Bleeding Disorder
Eligibility 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
Sites / Locations
- Novo Nordisk Clinical Trial Call Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Arm Label
rFVIIa, Blunt Trauma
Placebo, Blunt Trauma
rVIIa, Penetrating Trauma
Placebo, Penetrating Trauma
Arm Description
Outcomes
Primary Outcome Measures
Mortality
Number of participants to die from day 0 to day 30 from all causes.
Morbidity
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
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
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
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
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
The number of units of all allogeneic transfusions in the first 24 hours from the time of the first dose of rFVIIa or placebo.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00184548
Brief Title
Evaluation of Recombinant Factor VIIa in Patients With Severe Bleeding
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2014
Overall Recruitment Status
Terminated
Why Stopped
See termination reason in detailed description
Study Start Date
October 2005 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
September 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acquired Bleeding Disorder, Trauma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
554 (Actual)
8. Arms, Groups, and Interventions
Arm Title
rFVIIa, Blunt Trauma
Arm Type
Experimental
Arm Title
Placebo, Blunt Trauma
Arm Type
Placebo Comparator
Arm Title
rVIIa, Penetrating Trauma
Arm Type
Experimental
Arm Title
Placebo, Penetrating Trauma
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
eptacog alfa (activated)
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo
Primary Outcome Measure Information:
Title
Mortality
Description
Number of participants to die from day 0 to day 30 from all causes.
Time Frame
from day 0 to 30
Title
Morbidity
Description
Morbidity reflects the number of patients who had pulmonary and/or renal dysfunction requiring ongoing medical intervention on day 30.
Time Frame
from day 0 to day 30
Secondary Outcome Measure Information:
Title
Number of Days Alive and Free of Pulmonary and/or Renal Dysfunction Requiring Medical Intervention
Description
The number of days alive and free of pulmonary and/or renal dysfunction requiring medical intervention from day 0 to day 30.
Time Frame
from day 0 to day 30
Title
Time to Death From Time of First Dose
Description
The time of first dose refers to the time of the first dose of rFVIIa or placebo.
Time Frame
from day 0 to day 30
Title
Number of Units of Transfused Red Blood Cells From Time of First Dose
Description
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.
Time Frame
from hour 0 to 24
Title
Number of Patients Receiving 10 Units or More (Massive Transfusion) of Red Blood Cells From Time of Injury
Description
The number of patients receiving 10 units or more of red blood cells in the first 24 hours from the time of injury.
Time Frame
from hour 0 to 24
Title
Number of Units of All Allogeneic Transfusions From Time of First Dose
Description
The number of units of all allogeneic transfusions in the first 24 hours from the time of the first dose of rFVIIa or placebo.
Time Frame
from hour 0 to 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Registry (GCR, 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Clinical Trial Call Center
City
Princeton
State/Province
New Jersey
ZIP/Postal Code
08540
Country
United States
City
Säo Paulo
ZIP/Postal Code
05001-400
Country
Brazil
City
Prague
ZIP/Postal Code
16000
Country
Czech Republic
City
Paris La défense cedex
ZIP/Postal Code
92932
Country
France
City
Mainz
ZIP/Postal Code
55127
Country
Germany
City
Vouliagment
ZIP/Postal Code
16671
Country
Greece
City
Kowloon
Country
Hong Kong
City
Budapest
ZIP/Postal Code
1025
Country
Hungary
City
Rome
ZIP/Postal Code
00144
Country
Italy
City
Alphen a/d Rijn
Country
Netherlands
City
Sandton
ZIP/Postal Code
2146
Country
South Africa
City
Madrid
ZIP/Postal Code
28033
Country
Spain
City
Zurich
ZIP/Postal Code
CH-8050
Country
Switzerland
City
Crawley
ZIP/Postal Code
RH11 9RT
Country
United Kingdom
12. IPD Sharing Statement
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk
Learn more about this trial
Evaluation of Recombinant Factor VIIa in Patients With Severe Bleeding
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