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A Multicenter, Randomized, Active-Controlled Study to Investigate the Efficacy and Safety of Intravenous Ferric Carboxymaltose in Pediatric Patients With Iron Deficiency Anemia

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Trial Profile

A Multicenter, Randomized, Active-Controlled Study to Investigate the Efficacy and Safety of Intravenous Ferric Carboxymaltose in Pediatric Patients With Iron Deficiency Anemia

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 20 Mar 2024

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At a glance

  • Drugs Ferric carboxymaltose (Primary) ; Ferrous sulfate
  • Indications Iron deficiency anaemia
  • Focus Registrational; Therapeutic Use
  • Sponsors American Regent; Luitpold Pharmaceuticals

Most Recent Events

  • 19 Mar 2024 According to a CSL Vifor media release, company announced that Health Canada has authorized Ferinject (ferric carboxymaltose) for the intravenous (IV) treatment of iron deficiency anemia in adult and pediatric patients one year of age and older when oral iron preparations are not tolerated or are ineffective, as well as for the treatment of iron deficiency in adult patients with heart failure and New York Heart Association (NYHA) class II/III to improve exercise capacity.
  • 16 Mar 2021 Status changed from recruiting to completed.
  • 09 Oct 2020 This trial has been completed in Poland, according to European Clinical Trials Database record.

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