A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating Epoetin Alfa Versus Placebo in Anemic Patients With IPSS Low- or Intermediate-1-Risk Myelodysplastic Syndromes

Trial Profile

A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating Epoetin Alfa Versus Placebo in Anemic Patients With IPSS Low- or Intermediate-1-Risk Myelodysplastic Syndromes

Completed
Phase of Trial: Phase III

Latest Information Update: 24 Mar 2017

At a glance

  • Drugs Epoetin alfa (Primary)
  • Indications Anaemia; Myelodysplastic syndromes
  • Focus Registrational; Therapeutic Use
  • Sponsors Janssen-Cilag
  • Most Recent Events

    • 24 Mar 2017 According to a Janssen-Cilag media release, Pierre Fenaux is a principal investigator of this trial.
    • 24 Mar 2017 According to a Janssen-Cilag media release, based on the results from this trial and data from three registry studies from across Europe, Agence Nationale de Securite du Medicament et des Produits de Sante (ANSM), has approved EPREX (epoetin alfa) for the treatment of symptomatic anaemia (haemoglobin concentration of =10 g/dL) in adults with low- or intermediate-1-risk primary myelodysplastic syndromes (MDS) who have low serum erythropoietin (<200 mU/mL) and extended Marketing Authorisation.
    • 11 Jun 2016 Primary endpoint has been met, (Erythroid response), according to a Janssen-Cilag media release.
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