Efficacy and Safety of Deferasirox in Patients With Myelodysplastic Syndrome and Transfusion-dependent Iron Overload
The purpose of this study is to investigate the effects of iron chelation using deferasirox in low and INT-1 risk (referring to the international prognostic scoring system, IPSS) MDS patients who show signs of iron overload due to repeated blood transfusions.
This trial is not recruiting patients in the United States.
|Myelodysplastic Syndromes Transfusion Dependent Iron Overload||Drug: ICL670/Deferasirox||Phase 4|
|Study Design:||Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
|Official Title:||A One-year, Open-label, Single Arm, Multi-center Trial Evaluating the Efficacy and Safety of Oral ICL670 in Patients Diagnosed With Low and INT-1 Risk Myelodysplastic Syndrome (MDS) and Transfusion-dependent Iron Overload|
- To assess iron chelation by comparing serum ferritin values at baseline vs. 52 weeks of treatment with deferasirox [ Time Frame: 52 weeks ]
- Safety and tolerability of deferasirox assessed by monitoring and recording all adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: 52 weeks ]
|Study Start Date:||May 2007|
|Primary Completion Date:||November 2010 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00481143
|Novartis Investigative Site|
|Berlin, Germany, 12200|
|Study Director:||Novartis Pharmaceuticals||Novartis Pharmeceuticals|