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Evaluation of Recombinant Factor VIIa in Patients With Severe Bleeding

NCT00184548 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 554

Last updated 2014-06-25

Study results available
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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.

Conditions

  • Acquired Bleeding Disorder
  • Trauma

Interventions

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.

DRUG

placebo

placebo

Sponsors & Collaborators

Principal Investigators

  • Global Clinical Registry (GCR, 1452) · Novo Nordisk A/S

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-10-31
Primary Completion
2008-09-30
Completion
2008-09-30

Countries

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

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00184548 on ClinicalTrials.gov