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)
Phase of Trial: Phase III
Latest Information Update: 03 Aug 2017
At a glance
- Drugs Iron isomaltoside 1000 (Primary) ; Ferrous sulfate
- Indications Cancer; Chemotherapy-induced anaemia
- Focus Registrational; Therapeutic Use
- Acronyms PROFOUND
- Sponsors Pharmacosmos
- 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.