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

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).

Timeline

Start

2009-10-26

Primary completion

2016-06-28

Completion

2016-06-29

Publications

• Results Ozelo M, Misgav M, Abdul-Karim F, Lentz S, Martin-Salces M, Matytsina I, Saugstrup T, Santagostino E. Stabilization of turoctocog alfa dose administered in a preventive regimen: 3-year interim results of the guardianTM-2 extension trial. Haemophilia - Special Issue: Abstracts of the WFH 2014 World Congress, May 11-15, Melbourne, Australia; 20 (3): 1-200
• Results Recht M, Lentz S, Zupancic-Salek S, Matytsina I, Landorph A, Saugstrup T. Factor VIII Dosing and Preventive Efficacy in Obese Patients with Hemophilia (BMI =30 kg/m2) - a Post-Hoc Sub-Analysis of the guardian™ Trials. American Society of Hematology - 56th Annual Meeting (ASH); Country: US City: San Francisco, CA
• Results Ozelo M, Misgav M, Abdul Karim F, Lentz SR, Martin-Salces M, Matytsina I, Saugstrup T, Santagostino E. Long-term patterns of safety and efficacy of bleeding prophylaxis with turoctocog alfa (NovoEight((R)) ) in previously treated patients with severe haemophilia A: interim results of the guardian() 2 extension trial. Haemophilia. 2015 Sep;21(5):e436-9. doi: 10.1111/hae.12737. Epub 2015 Jun 8. No abstract available.
• Results Lentz SR, Cerqueira M, Janic D, Kempton C, Matytsina I, Misgav M, Oldenburg J, Ozelo M, Recht M, Rosholm A, Savic A, Suzuki T, Tiede A, Santagostino E. Interim results from a large multinational extension trial (guardian() 2) using turoctocog alfa for prophylaxis and treatment of bleeding in patients with severe haemophilia A. Haemophilia. 2016 Sep;22(5):e445-9. doi: 10.1111/hae.12990. Epub 2016 Jun 13. No abstract available.

Drugs

Indications