Clinical Trial Results:
Advate (rAHF-PFM): Pharmacokinetic comparison of 3000 IU Advate (rAHF-PFM) (using one 3000 IU potency vial) with 3000 IU Advate (rAHF-PFM) (using two 1500 IU potency vials) in previously treated patients with severe hemophilia A: a Phase IV, open-label, prospective, randomized, controlled, crossover, multiple center study
Summary
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EudraCT number |
2008-007347-13 |
Trial protocol |
BG |
Global completion date |
01 Apr 2010
|
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 |
28 Apr 2016
|
First version publication date |
28 Apr 2016
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Other versions |
|
Summary report(s) |
Advate_060801_CSR_Synopsis_2010AUG13_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.