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A phase 3b, randomized, controlled, multicentre study with oral ferric maltol (Feraccru) or intravenous iron (ferric carboxymaltose; FCM), for the treatment of iron deficiency anaemia in subjects with inflammatory bowel disease

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Trial Profile

A phase 3b, randomized, controlled, multicentre study with oral ferric maltol (Feraccru) or intravenous iron (ferric carboxymaltose; FCM), for the treatment of iron deficiency anaemia in subjects with inflammatory bowel disease

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 21 Dec 2022

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At a glance

  • Drugs Ferric maltol (Primary) ; Ferric carboxymaltose
  • Indications Iron deficiency anaemia
  • Focus Registrational; Therapeutic Use
  • Acronyms AEGIS-H2H
  • Sponsors Iron Therapeutics; Shield Therapeutics

Most Recent Events

  • 26 Oct 2022 Results of pooled analysis assessing efficacy assessment of ferric maltol in the treatment of iron deficiency anemia at Week 4, to evaluate early response, and at Week 12 from the combined phase 3 AEGIS 1 and 2 (301/2) studies, and a phase 3b study (304), which included adults with a diagnosis of Crohns disease or ulcerative colitis, presented at the American College of Gastroenterology Annual Scientific Meeting and Postgraduate Course 2022.
  • 11 Oct 2022 Results of a post-hoc analysis (NCT01340872 and NCT02680756) assessing quality of life in patients with Inflammatory bowel disease and Iron deficiency anaemia presented at the 30th United European Gastroenterology Week
  • 02 Mar 2022 Results published in the Inflammatory Bowel Diseases

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