Safety and Efficacy of Turoctocog Alfa in Haemophilia A Subjects

• Status: Completed
• Trial end date: 2011-09-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novo Nordisk A/S
• Treatments: Factor VIII

Criteria

Inclusion Criteria:

• Male subjects with the diagnosis of severe (FVIII less than or equal to 1%) haemophilia A from age 12 (except for Israel where the age limit will be 18 for the first 10 subjects recruited in the trial) to 56 years having a weight of 10 to 120 kg

• Documented history of at least 150 exposure days to any other FVIII products (prevention or treatment of bleeds)

• No history of FVIII inhibitors greater than or equal to 0.6 BU/mL. The inhibitor should be measured regularly for at least the last 8 years or since the first treatment of haemophilia A

• No detectable inhibitors to FVIII (greater than or equal to 0.6 BU/mL) (as assessed by a Central Laboratory at the time of screening)

Exclusion Criteria:

• Congenital or acquired coagulation disorders other than haemophilia A

• Creatinine levels 50% above normal level (as defined by central laboratory range)

• Known or suspected allergy to trial product (N8) or related products