A Multi-centre, Open-label, Non-controlled Trial on Safety and Efficacy of N8 in Prevention and Treatment of Bleeds in Previously Treated Subjects With Haemophilia A. Sub-trial: Safety and Efficacy of N8 in Prevention and Treatment of Bleeding During Surgical Procedures in Subjects With Haemophilia A
A Multi-centre, Open-label, Non-controlled Trial on Safety and Efficacy of N8 in Prevention and Treatment of Bleeds in Previously Treated Subjects With Haemophilia A. Sub-trial: Safety and Efficacy of N8 in Prevention and Treatment of Bleeding During Surgical Procedures in Subjects With Haemophilia A
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.
Inclusion Criteria:
Exclusion Criteria:
Hiroshima-shi, Hiroshima, 734 8551, Japan
Kashihara-shi, Nara, 634 8522, Japan
Nagoya-shi, Aichi, 466 8560, Japan
Shizuoka-shi, Shizuoka, 4208660, Japan
Belgrade, 11000, Serbia and Montenegro
Belgrade, 11070, Serbia and Montenegro
Nis, 18000, Serbia and Montenegro
Novi Sad, 21 000, Serbia and Montenegro
Novi Sad, 21000, Serbia and Montenegro
Bornova-IZMIR, 35100, Turkey (Türkiye)