A Trial Investigating the Pharmacokinetics and Pharmacodynamics of rFVIIa in Patients With Haemophilia A or B With or Without Inhibitors

An Open-label Single- and Multiple-dose Trial Investigating the Pharmacokinetics and Pharmacodynamics of rFVIIa Following i.v. Administration of One Dose of 270 Microg/kg and Three Doses of 90 Microg/kg in Patients With Haemophilia A or B With or Without Inhibitors

This trial is conducted in Europe. The aim of the trial is to investigate the pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of rFVIIa (activated coagulation factor VII) following one single injection of 270 microg/kg compared to three injections of 90 microg/kg rFVIIa in patients with haemophilia.

Inclusion Criteria:

• Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
• Male patients with confirmed diagnosis of severe congenital haemophilia A or B (higher than 1% FVIII or FIX) with or without inhibitors to coagulation factors VIII or IX, based on medical records

Exclusion Criteria:

• Congenital or acquired coagulation disorder other than congenital haemophilia A or B
• Any clinical signs or known history of arterial thrombotic events or previous deep vein thrombosis or pulmonary embolism (as defined by available medical records)
• Use of any anticoagulant (e.g. un-fractionated or low molecular weight heparin, vitamin-K antagonists, direct thrombin inhibitors or factor Xa inhibitors)
• Bleeding prophylactic treatment or FVIII or FIX immune tolerance induction (ITI) treatment during the trial period