Status:
COMPLETED
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
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Congenital Bleeding Disorder
Haemophilia A
Eligibility:
MALE
6-70 years
Phase:
PHASE3
Brief 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 patie...
Eligibility Criteria
Inclusion
- Informed Consent obtained before any trial-related activities
- Completion of trial NN7008-3543 or paediatric trial NN7008-3545 or Japanese trial NN7008-3600 or pharmacokinetic trial NN7008-3893 or NN7008-4015
Exclusion
- Previous participation in the current trial (defined as withdrawal) or withdrawn subjects from NN7008-3522, NN7008-3543, NN7008-3545, NN7008-3600, NN7008-3893 or NN7008-4015 after administration of trial product
Key Trial Info
Start Date :
October 26 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 29 2016
Estimated Enrollment :
214 Patients enrolled
Trial Details
Trial ID
NCT00984126
Start Date
October 26 2009
End Date
June 29 2016
Last Update
July 27 2017
Active Locations (57)
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1
Novo Nordisk Investigational Site
Phoenix, Arizona, United States, 85016-7710
2
Novo Nordisk Investigational Site
Long Beach, California, United States, 90806
3
Novo Nordisk Investigational Site
Tampa, Florida, United States, 33607
4
Novo Nordisk Investigational Site
Atlanta, Georgia, United States, 30322