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
| Status: | Completed |
|---|---|
| Conditions: | Hematology |
| Therapuetic Areas: | Hematology |
| Healthy: | No |
| Age Range: | Any - 70 |
| Updated: | 6/1/2017 |
| Start Date: | October 26, 2009 |
| End Date: | June 29, 2016 |
Safety and Efficacy of N8 in Prevention and On-demand Treatment of Bleeding Episodes in Subjects With Haemophilia A
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).
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).
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- Previous participation in the current trial (defined as withdrawal) or withdrawn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
We found this trial at
14
sites
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