A study of intravenous iron isomaltoside 1000 (Monofer®) compared to placebo in subjects with iron deficiency anaemia who are Intolerant or unresponsive to oral iron therapy

Mise à jour : Il y a 4 ans
Référence : EUCTR2014-001518-25

Femme et Homme

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Extrait

The primary objective of the study is to evaluate and compare the effect of iron isomaltoside 1000 to placebo in its ability to increase haemoglobin (Hb) in subjects with IDA when oral iron preparations are ineffective or cannot be used.


Critère d'inclusion

  • Subjects with iron deficiency anaemia (IDA) caused by different aetiologies such as abnormal uterine bleeding, gastrointestinal diseases (e.g. inflammatory bowel disease), cancer, preoperative anaemia (e.g. orthopaedic surgery), and other conditions leading to IDA and with a documented history of intolerance or unresponsiveness to oral iron therapy

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