Clinical Trial Results:
A Randomised, Two-way, Blinded, Crossover-Design Study to Establish the Bioequivalence of B-Domain Deleted Recombinant Factor VIII (BDDrFVIII, ReFacto AF) with a Full-Length Recombinant Factor VIII Preparation (FLrFVIII, Advate), Followed by an Open-Label Trial of the Safety and Efficacy of ReFacto AF in Previously Treated Patients with Hemophilia A
Summary
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EudraCT number |
2005-000720-16 |
Trial protocol |
HU ES DE SE FI BE IT |
Global completion date |
01 Nov 2006
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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 |
09 Oct 2016
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First version publication date |
09 Oct 2016
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Other versions |
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Summary report(s) |
3082B2-310_Public Disclosure 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.