NCT00984126

Safety and Efficacy of Turoctocog Alfa (N8) in Prevention and On-demand Treatment of Bleeding Episodes in Subjects With Haemophilia A: An Extension to Trials NN7008-3543, NN7008-3545, NN7008-3600, NN7008-3893 and NN7008-4015

Safety and Efficacy of N8 in Prevention and On-demand Treatment of Bleeding Episodes in Subjects With Haemophilia A

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 214 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: Male
• Age: 6 Months – 70 Years
• Healthy volunteers: Not accepted

Summary

This trial is conducted in Asia, Europe, Japan, Oceania, North America and South America. The aim of the trial is to investigate the safety and efficacy of turoctocog alfa (N8) in Haemophilia A patients. The trial is an extension to trials NN7008-3543 (start: March 2009, stop: September 2011) and NN7008-3545 (start: May 2010, stop: November 2011) and the pharmacokinetic trials NN7008-3600 (start: November 2010, stop: October 2011), NN7008-3893 (start: June 2011, stop: September 2011) and NN7008-4015 (start: August 2012, stop: March 2013).

Conditions

• Congenital Bleeding Disorder
• Haemophilia A

Interventions

Type	Name	Description
DRUG	turoctocog alfa	The preventative treatment is administered intravenously (i.v.) at specific intervals either every second day or three times a week. Bleeding treatment will be administered if a bleed should occur.
DRUG	turoctocog alfa	Treatment is administered intravenously (i.v.) during bleeds and occasionally as a preventative treatment (e.g. before physical activity)

Timeline

• Start date: 2009-10-26
• Primary completion: 2016-06-28
• Completion: 2016-06-29
• First posted: 2009-09-25
• Last updated: 2017-07-27
• Results posted: 2017-07-27

Locations

57 sites across 20 countries: United States, Brazil, Croatia, Germany, Israel, Italy, Japan, Latvia, Lithuania, Malaysia, North Macedonia, Poland, Puerto Rico, Russia, Serbia, Spain, Switzerland, Taiwan, Turkey (Türkiye), United Kingdom