The AEGIS-H2H study was intended and designed to provide data comparing oral Feraccru /Accrufer against intravenous (IV) iron therapy from which health economics data and other analysis could be generated. The study was not intended as a registration study and the regulatory status of Feraccru /Accrufer is unaffected by the study. On
The Feraccru/Accrufer AEGIS-H2H study was a multi-national Phase IIIb randomised study in 250 inflammatory bowel disease (IBD) patients with mild to severe iron deficiency anaemia (IDA) and baseline haemoglobin (Hb) measurements at the start of the study as low as 8.0g/dL. The main objectives of the study were to compare the impact of Feraccru /Accrufer on Hb levels over 52 weeks with that of Ferinject (ferric carboxymaltose (FCM)), the market-leading intravenously (IV) delivered iron replacement therapy treatment. Patients were monitored 5 times during the course of the study, at weeks 4, 12, 24, 36 and 52. Reflecting clinical practice, IV FCM was administered in the study according to each physician's local prescribing information which allow, in some participating countries, for multiple additional IV dosing whereas Feraccru/Accrufer could only be given 30 mg twice daily in line with the US and European approved label.
The first 12-week phase compared the initial Hb response in patients, with a 'response' defined for the purpose of the primary endpoint as the normalisation of Hb levels or an increase of at least 2g/dL in Hb from patients' baseline levels. The primary endpoint of the study was defined as achieving non-inferiority in the proportion of responders in both the 'intention to treat' (ITT)(1) and 'per protocol' (PP)(1) populations at the end of the initial 12 weeks. The
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Shield is a de-risked, specialty pharmaceutical company focused on commercialising its lead product, Feraccru/Accrufer, a novel, stable, non-salt based oral therapy for adults with iron deficiency with or without anaemia. Feraccru/Accrufer has been approved for use in
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