Safety and Efficacy of Turoctocog Alfa in Previously Treated Male Children With Haemophilia A

• Status: Completed
• Trial end date: 2011-11-01
• Target enrollment: 0
• Participant gender: Male

Summary

This trial is conducted in Asia, Europe, and North and South America. The aim of this clinical trial is to investigate the safety and efficacy of turoctocog alfa (recombinant factor VIII, rFVIII (N8)) in male previously treated paediatric subjects with haemophilia A.

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

Details

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

Criteria

Inclusion Criteria:

• Male patients with severe (baseline FVIII less than or equal to 1%) haemophilia A

• Age below 12 years and weight at least 11 kg

Exclusion Criteria:

• Surgery planned to occur during trial participation (exceptions are port placement, dental extractions, and minor, uncomplicated emergent procedures)

• Congenital or acquired coagulation disorders other than haemophilia A

• Any history of FVIII inhibitors (greater than or equal to 0.6 BU/mL)