NCT00840086

Safety and Efficacy of Turoctocog Alfa in Haemophilia A Subjects

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: Male
• Age: 12 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Congenital Bleeding Disorder
• Haemophilia A

Interventions

Type	Name	Description
DRUG	turoctocog alfa	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.

Timeline

• Start date: 2009-04-01
• Primary completion: 2011-09-01
• Completion: 2011-09-01
• First posted: 2009-02-10
• Last updated: 2017-03-17
• Results posted: 2014-09-04

Locations

63 sites across 18 countries: United States, Brazil, Croatia, Denmark, Germany, Hungary, Israel, Italy, Japan, Malaysia, Russia, Serbia and Montenegro, Serbia, Spain, Switzerland, Taiwan, Turkey (Türkiye), United Kingdom