Safety and Mode of Action of a Single Dose and Multiple Doses of Long Acting Activated Recombinant Human Factor VII in Patients With Haemophilia A and B

PHASE1CompletedINTERVENTIONAL

Enrollment

Participants

Timeline

Start Date

June 30, 2009

Primary Completion Date

September 30, 2009

Study Completion Date

September 30, 2009

Conditions

Congenital Bleeding DisorderHaemophilia AHaemophilia B

Interventions

DRUG

activated recombinant human factor VII, long acting

Single dose of 0,2 mg/kg LA-rFVIIa injected i.v. (intravenous) of 2 minutes duration

DRUG

activated recombinant human factor VII, long acting

Multiple doses of 100 mg/kg LA-rFVIIa injected i.v. (intravenous) of 2 minutes duration every 48 hours

Trial Locations (1)

Madrid