A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating Epoetin Alfa Initiated at 40,000 IU Every Week or 80,000 IU Every Week Versus Placebo in Subjects With IPSS Low- or Interme...

Update Il y a 4 ans
Reference: EUCTR2008-002723-85

A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating Epoetin Alfa Initiated at 40,000 IU Every Week or 80,000 IU Every Week Versus Placebo in Subjects With IPSS Low- or Intermediate-1 Risk Myelodysplastic Syndromes at Risk for Transfusion

Woman and Man

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Extract

The primary objective is to demonstrate that epoetin alfa treatment reduces the proportion of anemic subjects with International Prognostic Scoring Systems (IPSS) Low or Intermediate 1 risk myelodysplastic syndromes (MDS) who require any transfusion, compared with placebo, through Week 48.


Inclusion criteria

  • IPSS Low or Intermediate 1 RISK Myelodysplastic Syndromes at risk for transfusion