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A Phase III, Randomized, Open-label Study of Intravenous Iron Isomaltoside 1000 (Monofer) as Mono Therapy (Without Erythropoiesis Stimulating Agents) in Comparison With Oral Iron Sulfate in Subjects With Non-myeloid Malignancies Associated With Chemotherapy Induced Anaemia (CIA)

Trial Profile

A Phase III, Randomized, Open-label Study of Intravenous Iron Isomaltoside 1000 (Monofer) as Mono Therapy (Without Erythropoiesis Stimulating Agents) in Comparison With Oral Iron Sulfate in Subjects With Non-myeloid Malignancies Associated With Chemotherapy Induced Anaemia (CIA)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 03 Jul 2019

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At a glance

  • Drugs Ferric derisomaltose (Primary) ; Ferrous sulfate
  • Indications Chemotherapy-induced anaemia
  • Focus Registrational; Therapeutic Use
  • Acronyms PROFOUND
  • Sponsors Pharmacosmos
  • Most Recent Events

    • 01 Mar 2016 Primary endpoint has been met, (Change in Hb Concentration), according to the results published.
    • 01 Mar 2016 Results published in the Pharmacotherapy.
    • 26 Jul 2014 According to the European Clinical Trials Database record, status changed from active, no longer recruiting to completed.
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