IDA-301 Study and ResultsIDA-301 was a double-blind, placebo-controlled trial designed to compare the safety and efficacy of a one gram intravenous (IV) course of ferumoxytol to IV saline given as placebo. In this study, 608 subjects were treated with ferumoxytol and 200 received placebo, with the demographics and all baseline parameters well balanced between the two treatment groups. The primary efficacy endpoint for U.S. regulators is the proportion of subjects who achieved a ≥ 2.0 g/dL increase in hemoglobin at any time from baseline to week 5; the primary efficacy endpoint for European Union (E.U.) regulators is the mean change in hemoglobin from baseline to week 5.
AMAG Pharmaceuticals Announces New Data From Ferumoxytol Pivotal Phase III Broad Iron Deficiency Anemia Program Presented At ASH
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