NCT01563471View on ClinicalTrials.gov

Safety and Tolerability of Intravenous Doses of Activated Recombinant Human Factor VII in Healthy Volunteers

PHASE1CompletedINTERVENTIONAL
Enrollment

39

Participants

Timeline

Start Date

October 31, 2001

Primary Completion Date

July 31, 2002

Study Completion Date

July 31, 2002

Conditions
Congenital Bleeding DisorderHaemophilia A With InhibitorsHaemophilia B With InhibitorsHealthy
Interventions
DRUG

activated recombinant human factor VII

Subjects will be randomised to one of four treatment sequences. Subjects will receive single bolus i.v. injection of 40, 80 or 160 mcg/kg body weight of trial drug or placebo on each day of the three separate visits

DRUG

placebo

Subjects will be randomised to one of four treatment sequences. Subjects will receive single bolus i.v. injection of 40, 80 or 160 mcg/kg body weight of trial drug or placebo on each day of the three separate visits

Trial Locations (1)

75015

Novo Nordisk Investigational Site, Paris

Sponsors

Lead Sponsor

Novo Nordisk A/S
All Listed Sponsors
lead

Novo Nordisk A/S

INDUSTRY