Lead Sponsor

Novo Nordisk A/S

Age

3 - 55 years

Sex

MALE

Healthy Volunteers

No

•Age 18-55 years and congenital haemophilia A or B male with severe FVIII or FX deficiency +/-inhibitors
•Age between 3-12 years and congenital haemophilia A or B male with record of inhibitors

•Known hypersensitivity to activated recombinant human factor VII or any of its components
•Known clinical relevant coagulation diseases or insufficiencies other than congenital haemophilia
•Clinical manifestation of HIV (human immunodeficiency virus) and/or protease inhibitor treatment
•Clinical manifestation of active/recent bleeding
•Administration of coagulation factor preparations within 24 hours of NovoSeven trial product dose administration
•Body Mass Index (BMI) outside normal range
•Known abuse of elicit drugs and/or alcohol
•Renal insufficiency
•Hepatic disease
•Cardiovascular disease
•Any disease or condition which, judged by the Investigator, could imply a potential hazard to the patient, interfere with the trial participation or trial outcome

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Pharmacokinetics of Single Bolus Dose of NovoSeven® in Paediatric and Adult Patients With Haemophilia A or B in a Non- Bleeding State