High Dose of Activated Recombinant Human Factor VII for Treatment of Mild/Moderate Joint Bleeds in Haemophilia Patients With Inhibitors

rFVIIa (NovoSeven®) for Treatment of Mild/Moderate Joint Bleeds in Haemophilia Patients With Inhibitors: A Double-blind Study of a Single High Dose Versus Standard Multiple Doses of rFVIIa

This trial is conducted in Europe. The aim of this trial is to evaluate the efficacy and safety of two dose schedules of activated recombinant human factor VII in treatment of joint bleeds in haemophilia patients with inhibitors.

Inclusion Criteria:

• Diagnosed of congenital haemophilia A or B with inhibitors to factor VIII or IX, respectively
• A history of 3 or more joint bleeds during the last 12 months

Exclusion Criteria:

• Joint bleeding within 7 days prior to trial start
• Treatment for bleeds within the last 5 days prior to trial start
• Clinically relevant coagulation disorders other than congenital haemophilia A or B