Clinical Trial Results:
A Multi-Centre, Randomised, Double-Blind, Placebo
Controlled Trial on Efficacy and Safety of FXIII
Replenishment with two different Doses of Recombinant
Factor XIII following Cardiopulmonary Bypass Surgery
Due to the EudraCT – Results system being out of service between 31 July 2015 and 12 January 2016, these results have been published in compliance with revised timelines
Summary
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EudraCT number |
2008-006324-62 |
Trial protocol |
SE DK ES GB IT DE |
Global completion date |
23 Feb 2011
|
Paediatric regulatory details
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|
Is the trial part of an agreed EMA paediatric investigation plan? |
No
|
Is the trial in scope of article 45 of Regulation (EC) No 1901/2006? |
No
|
Is the trial in scope of article 46 of Regulation (EC) No 1901/2006? |
No
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Results information
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|
Results version number |
v1(current) |
This version publication date |
02 Oct 2016
|
First version publication date |
02 Oct 2016
|
Other versions |
|
Summary report(s) |
Synopsis |
Note: The legislation allows summary attachments to be posted instead of the full dataset for this trial. Refer to Commission Guideline 2012/C 302/03
for further information.