NCT00184548

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.

Trial Health

68
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
554

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Oct 2005

Typical duration for phase_3

Geographic Reach
14 countries

14 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 9, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
15 days until next milestone

Study Start

First participant enrolled

October 1, 2005

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

November 26, 2009

Completed
Last Updated

June 25, 2014

Status Verified

June 1, 2014

Enrollment Period

2.9 years

First QC Date

September 9, 2005

Results QC Date

September 4, 2009

Last Update Submit

June 13, 2014

Conditions

Acquired Bleeding DisorderTrauma

Outcome Measures

Primary Outcomes (2)

  • Mortality

    Number of participants to die from day 0 to day 30 from all causes.

    from day 0 to 30

  • 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

Secondary Outcomes (5)

  • 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

  • Number of Units of Transfused Red Blood Cells From Time of First Dose

    from hour 0 to 24

  • Number of Patients Receiving 10 Units or More (Massive Transfusion) of Red Blood Cells From Time of Injury

    from hour 0 to 24

  • Number of Units of All Allogeneic Transfusions From Time of First Dose

    from hour 0 to 24

Study Arms (4)

rFVIIa, Blunt Trauma

EXPERIMENTAL
Drug: eptacog alfa (activated)

Placebo, Blunt Trauma

PLACEBO COMPARATOR
Drug: placebo

rVIIa, Penetrating Trauma

EXPERIMENTAL
Drug: eptacog alfa (activated)

Placebo, Penetrating Trauma

PLACEBO COMPARATOR
Drug: placebo

Interventions

eptacog alfa (activated)DRUG

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.

rFVIIa, Blunt TraumarVIIa, Penetrating Trauma
placeboDRUG

placebo

Placebo, Blunt TraumaPlacebo, Penetrating Trauma

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Novo Nordisk Clinical Trial Call Center

Princeton, New Jersey, 08540, United States

Location

Unknown Facility

Säo Paulo, 05001-400, Brazil

Location

Unknown Facility

Prague, 16000, Czechia

Location

Unknown Facility

Paris La Défense Cedex, 92932, France

Location

Unknown Facility

Mainz, 55127, Germany

Location

Unknown Facility

Vouliagment, 16671, Greece

Location

Unknown Facility

Kowloon, Hong Kong

Location

Unknown Facility

Budapest, 1025, Hungary

Location

Unknown Facility

Rome, 00144, Italy

Location

Unknown Facility

Alphen aan den Rijn, Netherlands

Location

Unknown Facility

Sandton, 2146, South Africa

Location

Unknown Facility

Madrid, 28033, Spain

Location

Unknown Facility

Zurich, CH-8050, Switzerland

Location

Unknown Facility

Crawley, RH11 9RT, United Kingdom

Location

Related Links

MeSH Terms

Conditions

Wounds and Injuries

Interventions

Factor VII

Intervention Hierarchy (Ancestors)

Enzyme PrecursorsEnzymes and CoenzymesBlood Coagulation FactorsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsProtein PrecursorsBiological Factors

Limitations and Caveats

Trial was terminated after planned interim analysis for futility showed a lower than expected conditional power for showing superiority (11.2% \[actual\] vs. 50% \[required\]). 554 of 1502 planned patients were included in the intent-to-treat population.

Results Point of Contact

Title
Public Access to Clinical Trials
Organization
Novo Nordisk A/S
clinicaltrials@novonordisk.com

Study Officials

  • Global Clinical Registry (GCR, 1452)

    Novo Nordisk A/S

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 16, 2005

Study Start

October 1, 2005

Primary Completion

September 1, 2008

Study Completion

September 1, 2008

Last Updated

June 25, 2014

Results First Posted

November 26, 2009

Record last verified: 2014-06

Locations

GB(1)IT(1)HU(1)ES(1)US(1)FR(1)GR(1)NL(1)ZA(1)CH(1)HK(1)DE(1)BR(1)CZ(1)