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Sponsored by: |
Novartis |
Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00481143 |
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.
Condition | Intervention | Phase |
Myelodysplastic Syndromes Transfusion Dependent Iron Overload |
Drug: ICL670/Deferasirox |
Phase IV |
MedlinePlus related topics: | Blood Transfusion and Donation |
ChemIDplus related topics: | Deferasirox Ferritin |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 120 |
Study Start Date: | May 2007 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply.
Responsible Party: | Novartis ( External Affairs ) |
Study ID Numbers: | CICL670ADE03 |
First Received: | May 31, 2007 |
Last Updated: | June 30, 2008 |
ClinicalTrials.gov Identifier: | NCT00481143 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
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