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Evaluation of Recombinant Factor VIIa in Patients With Severe Bleeding

NCT ID: NCT00184548

Last Updated: 2014-06-25

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

554 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-31

Study Completion Date

2008-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Acquired Bleeding Disorder Trauma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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rFVIIa, Blunt Trauma

Group Type EXPERIMENTAL

eptacog alfa (activated)

Intervention Type 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.

Placebo, Blunt Trauma

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

placebo

rVIIa, Penetrating Trauma

Group Type EXPERIMENTAL

eptacog alfa (activated)

Intervention Type 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.

Placebo, Penetrating Trauma

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

placebo

Interventions

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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.

Intervention Type DRUG

placebo

placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Global Clinical Registry (GCR, 1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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Novo Nordisk Clinical Trial Call Center

Princeton, New Jersey, United States

Site Status

Säo Paulo, , Brazil

Site Status

Prague, , Czechia

Site Status

Paris La Défense Cedex, , France

Site Status

Mainz, , Germany

Site Status

Vouliagment, , Greece

Site Status

Kowloon, , Hong Kong

Site Status

Budapest, , Hungary

Site Status

Rome, , Italy

Site Status

Alphen aan den Rijn, , Netherlands

Site Status

Sandton, , South Africa

Site Status

Madrid, , Spain

Site Status

Zurich, , Switzerland

Site Status

Crawley, , United Kingdom

Site Status

Countries

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

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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2005-002059-41

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

F7TRAUMA-1711

Identifier Type: -

Identifier Source: org_study_id

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