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

An Open, Non-Randomised Single and Multiple Dose Trial Investigating the Safety and Pharmacokinetics of Intravenous Administration of Long Acting rFVIIa (LA-rFVIIa) in Patients With Haemophilia A and B

This trial is conducted in Europe. The aim of this clinical trial is to investigate the safety and pharmacokinetics (the effect of the body on the investigated drug) of long acting activated recombinant human factor VII (LA-rFVIIa) in patients with haemophilia.

Inclusion Criteria:

• Haemophilia A or B
• Bodyweight max 100 kg
• Body Mass Index (BMI) max 30 kg/m2
• Adequate venous access

Exclusion Criteria:

• Known or suspected allergy to trial product(s) or related products (including NovoSeven®)
• The receipt of any investigational product within 30 days prior to enrolment in this trial
• Receipt of Immune Tolerance Induction (ITI) within the last 1 month prior to participation in this trial
• The receipt of any haemostatic treatment for control of a bleeding episode within the last 5 days prior to administration of trial product
• Receipt of FVIII or FIX replacement therapy within 48 hours prior to trial product administration
• Known pseudo tumours
• Congenital or acquired coagulation disorders other than haemophilia A or B
• Any major and/or orthopaedic surgery within one month prior to trial start
• Advanced atherosclerotic disease (defined as known history of ischemic heart disease, ischemic stroke, etc.)
• Clinical signs of renal dysfunction
• Use of platelet inhibitors, including NSAIDs, one week prior to administration of trial drug
• Use of non-prescribed opiate substances