Evaluation of Recombinant Factor VIIa in Patients With Severe Bleeding

PHASE3TerminatedINTERVENTIONAL
Enrollment

554

Participants

Timeline

Start Date

October 31, 2005

Primary Completion Date

September 30, 2008

Study Completion Date

September 30, 2008

Conditions
Acquired Bleeding DisorderTrauma
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

Trial Locations (14)

1025

Budapest

2146

Sandton

16000

Prague

16671

Vouliagment

28033

Madrid

55127

Mainz

92932

Paris La Défense Cedex

08540

Novo Nordisk Clinical Trial Call Center, Princeton

05001-400

Säo Paulo

Unknown

Kowloon

Alphen aan den Rijn

00144

Rome

CH-8050

Zurich

RH11 9RT

Crawley

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Novo Nordisk A/S

INDUSTRY

NCT00184548 - Evaluation of Recombinant Factor VIIa in Patients With Severe Bleeding | Biotech Hunter | Biotech Hunter