40
Participants
Start Date
March 31, 2012
Primary Completion Date
June 30, 2012
Study Completion Date
July 31, 2012
rVIIa-FP
Recombinant VIIa-FP (rVIIa-FP) is a fusion protein linking coagulation factor VIIa with albumin and will be administered by intravenous infusion in escalating doses up to 1000 mcg/kg. Participants will receive pre-treatment with an oral anticoagulant starting 7 days prior to administration of study product and continuing for 7 days after study product has been administered.
Placebo (0.9% normal saline)
Placebo will be administered by intravenous infusion. Participants will receive pre-treatment with an oral anticoagulant starting 7 days prior to administration of placebo and continuing for 7 days after placebo has been administered.
Phase I Unit, Berlin
Lead Sponsor
CSL Behring
INDUSTRY