A One Year Open Label, Non-comparative Extension to a Randomized, Multicenter, Phase II Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK) and Effects on Liver Iron Concentration (LIC) of Repeated Doses of 5-30mg/kg/Day ICL670 Relative to Deferoxamine (DFO) in Sickle Cell Disease (SCD) Patients With Transfusional Hemosideresis (THS) [Amendment 3: Extension Prolonged to 4-years]

Trial Profile

A One Year Open Label, Non-comparative Extension to a Randomized, Multicenter, Phase II Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK) and Effects on Liver Iron Concentration (LIC) of Repeated Doses of 5-30mg/kg/Day ICL670 Relative to Deferoxamine (DFO) in Sickle Cell Disease (SCD) Patients With Transfusional Hemosideresis (THS) [Amendment 3: Extension Prolonged to 4-years]

Completed
Phase of Trial: Phase II

Latest Information Update: 21 Mar 2016

At a glance

  • Drugs Deferasirox (Primary)
  • Indications Iron overload
  • Focus Adverse reactions
  • Sponsors Novartis
  • Most Recent Events

    • 07 Jun 2017 Biomarkers information updated
    • 21 Mar 2016 New source identified and integrated (ISRCTN: Current Controlled Trials; 05896089)
    • 10 Sep 2014 New trial record
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