Clinical Trial Results:
An Open-label, Multi-Centre, Non-Randomised Extension Study to Assess the Ability to Maintain a Stable Haemoglobin and to Assess Safety of Iron Isomaltoside 1000 (Monofer®) in Subjects with Inflammatory Bowel Disease
Summary
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EudraCT number |
2011-001593-25 |
Trial protocol |
AT HU |
Global completion date |
11 Jul 2013
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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 |
30 Mar 2016
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First version publication date |
30 Mar 2016
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Other versions |
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Summary report(s) |
An open-label, multi-centre, non-randomised extension study to assess the ability to maintain a stable haemoglobin and to assess safety of iron isomaltoside 1000 (Monofer®) in subjects with inflammato |
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.