Use of Activated Recombinant Human Factor VII to Reduce Bleeding Caused by Warfarin Treatment

PHASE1CompletedINTERVENTIONAL
Enrollment

127

Participants

Timeline

Start Date

January 31, 2007

Primary Completion Date

July 31, 2008

Study Completion Date

July 31, 2008

Conditions
HaemostasisHealthy
Interventions
DRUG

warfarin

After a baseline punch biopsy (B0), warfarin is administered over a period of approximately 7-14 days. Dose is adjusted individually to achieve INR target. Once a stable INR is achieved, a second biopsy (B1) will be performed

DRUG

eptacog alfa (activated)

If the subject is eligible to continue in trial part B, trial drug will be administered i.v. as a slow bolus injection over 2 to 5 minutes in five different doses followed by two biopsies (B2) and (B3) 15 minutes and 5 hours and 15 minutes, respectively, after trial drug administration

DRUG

placebo

If the subject is eligible to continue in trial part B, trial drug will be administered i.v. as a slow bolus injection over 2 to 5 minutes in five different doses followed by two biopsies (B2) and (B3) 15 minutes and 5 hours and 15 minutes, respectively, after trial drug administration

Trial Locations (1)

66211

Novo Nordisk Investigational Site, Overland Park

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Novo Nordisk A/S

INDUSTRY