Clinical Trial Results:
A multi-centre, randomised, double-blind, placebo-controlled Phase II study to evaluate the efficacy, safety, tolerability, and pharmacokinetics of 2-iminobiotin (2-IB) in neonates with gestational age of ≥36 weeks with moderate to severe perinatal asphyxia.
Summary
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EudraCT number |
2011-002502-74 |
Trial protocol |
LT Outside EU/EEA |
Global completion date |
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Paediatric regulatory details
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Is the trial part of an agreed EMA paediatric investigation plan? |
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Is the trial in scope of article 45 of Regulation (EC) No 1901/2006? |
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Is the trial in scope of article 46 of Regulation (EC) No 1901/2006? |
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Results information
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Results version number |
v1(current) |
This version publication date |
01 Oct 2021
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First version publication date |
01 Oct 2021
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Other versions |
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Summary report(s) |
EudraCT 2011-002502-74 abstract results |
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.