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

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

This trial is conducted in Europe. The aim of this trial is to determine the pharmacokinetics of activated recombinant human factor VII (NovoSeven®) in haemophiliac patients in a non-bleeding state.

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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