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A Prospective, Multicentre, Randomised, Double-blind, Placebo Controlled Study With Oral ST10-021 for the Treatment of Iron Deficiency Anaemia in Subjects With Quiescent Crohn's Disease Where Oral Ferrous Preparations Have Failed or Cannot be Used (AEGIS 2)

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A Prospective, Multicentre, Randomised, Double-blind, Placebo Controlled Study With Oral ST10-021 for the Treatment of Iron Deficiency Anaemia in Subjects With Quiescent Crohn's Disease Where Oral Ferrous Preparations Have Failed or Cannot be Used (AEGIS 2)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 21 Dec 2022

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At a glance

  • Drugs Ferric maltol (Primary)
  • Indications Iron deficiency anaemia
  • Focus Registrational; Therapeutic Use
  • Acronyms AEGIS-2
  • Sponsors Iron 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.
    • 27 Jun 2019 Trial has been completed in UK, according to European Clinical Trials Database record.
    • 05 Feb 2018 According to a Shield Therapeutics media release, final decision from the EMA on this application during the first half of 2018.

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