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Phase II Study of Safety & Efficacy of Deferasirox Given for 1 Year in Patients With Chronic Anemias and Transfusional Hemosiderosis Unable to be Treated With Deferoxamine

Trial Profile

Phase II Study of Safety & Efficacy of Deferasirox Given for 1 Year in Patients With Chronic Anemias and Transfusional Hemosiderosis Unable to be Treated With Deferoxamine

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 28 Dec 2017

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At a glance

  • Drugs Deferasirox (Primary)
  • Indications Haemosiderosis
  • Focus Therapeutic Use
  • Sponsors Novartis; Novartis Pharmaceuticals
  • Most Recent Events

    • 28 Dec 2017 Data (12-month) from this controlled registration study (ICL670A108) was used to developed a model which was then applied to both deferasirox film-coated tablet (FCT) and dispersible tablet (DT) arms of ECLIPSE trial for predicting serum ferritin levels in patients from ECLIPSE trial if they continued both arms for 6-12 months, presented at the 59th Annual Meeting and Exposition of the American Society of Hematology.
    • 25 Jun 2017 Results (n=282) of retrospective analysis in subgroups of Italian patients assessing serum creatinine using patient data from the registration studies (studies 105, 106 and CICL670 0107, CICL670A0108, CICL670A0109), presented at the 22nd Congress of the European Haematology Association
    • 08 Dec 2015 Results (n=219) assessing correlation of hepatocyte iron score and liver iron ratio with alanine aminotransferase from this and other trial (see profile 248855) presented at the 57th Annual Meeting and Exposition of the American Society of Hematology
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