Brief Title
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
Official Title
Safety and Efficacy of N8 in Prevention and On-demand Treatment of Bleeding Episodes in Subjects With Haemophilia A
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 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).
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
Frequency of Development of FVIII Inhibitors (Greater Than or Equal to 0.6 Bethesda Units (BU)/mL)
Secondary Outcome
Frequency of Adverse Events and Serious Adverse Events
Condition
Congenital Bleeding Disorder
Intervention
turoctocog alfa
Study Arms / Comparison Groups
Turoctocog alfa
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
214
Start Date
October 26, 2009
Completion Date
June 29, 2016
Primary Completion Date
June 28, 2016
Eligibility Criteria
Inclusion Criteria: - 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NN7008-3893 or NN7008-4015 Exclusion Criteria: - Previous participation in the current trial (defined as withdrawal) or withdrawn subjects from NN7008-3522, NN7008-3543, NN7008-3545, NN7008-3600, NN7008-3893 or NN7008-4015 after administration of trial product
Gender
Male
Ages
6 Months - 70 Years
Accepts Healthy Volunteers
No
Contacts
Global Clinical Registry (GCR, 1452), ,
Location Countries
Brazil
Location Countries
Brazil
Administrative Informations
NCT ID
NCT00984126
Organization ID
NN7008-3568
Secondary IDs
2008-005945-46
Responsible Party
Sponsor
Study Sponsor
Novo Nordisk A/S
Study Sponsor
Global Clinical Registry (GCR, 1452), Study Director, Novo Nordisk A/S
Verification Date
June 2017