Conditions: Congenital Bleeding Disorder Haemophilia A
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 150
Healthy volunteers: no

Brief summary:
This trial is conducted in Asia, Europe, and North and South America. The trial consists of a main trial and a sub-trial. The main trial investigates safety and efficacy of turoctocog alfa (recombinant factor VIII, rFVIII (N8)) in haemophilia A subjects, while the sub-trial investigates safety and efficacy of turoctocog alfa in prevention and treatment of bleeding episodes during surgical procedures.

Detailed description:

Arms:
arm 1: None

Interventions: intervention 1: turoctocog alfa
Intervention descriptions: intervention 1: Subjects will receive bleeding preventive treatment (home treatment with self-injection i.v.) with turoctocog alfa at a dose of 20-40 IU/kg body weight every second day or 20-50 IU/kg body weight three times per week at the investigator's discretion.

Protocol document: