Clinical Trial Results:
AN INTERNATIONAL, MULTI-CENTRE, PROSPECTIVE, OPEN-LABEL, NON-RANDOMISED, UNCONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF PROTHROMPLEX TOTAL IN ORAL ANTICOAGULANT REVERSAL IN PATIENTS WITH ACQUIRED PROTHROMBIN COMPLEX COAGULATION FACTORS (II, VII, IX, X) DEFICIENCY
Summary
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EudraCT number |
2010-019250-41 |
Trial protocol |
HU AT |
Global completion date |
07 Apr 2012
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Paediatric regulatory details
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Is the trial part of an agreed EMA paediatric investigation plan? |
No
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Is the trial in scope of article 45 of Regulation (EC) No 1901/2006? |
No
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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 |
01 May 2016
|
First version publication date |
01 May 2016
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Other versions |
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Summary report(s) |
Prothromplex_220901_CSR_Synopsis_2012OCT22_Redacted_20160405 |
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.