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Sponsored by: |
Novartis |
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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 |
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Myelodysplastic Syndromes Transfusion Dependent Iron Overload |
Drug: ICL670/Deferasirox |
Phase IV |
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 |
Study First Received: | May 31, 2007 |
Last Updated: | June 30, 2008 |
ClinicalTrials.gov Identifier: | NCT00481143 History of Changes |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Myelodysplastic Syndrome MDS iron overload chelation chelators ICL670 Deferasirox serum ferritin |
LIC transfusional hemosiderosis Refractory Anemia RA Refractory Anemia with Ringed Sideroblasts RARS blood transfusions Mydelodysplastic Syndrome(s) |
Metabolic Diseases Precancerous Conditions Deferasirox Hematologic Diseases Myelodysplastic Syndromes Anemia Iron Metabolism Disorders Refractory Anemia |
Preleukemia Anemia, Refractory Hemosiderosis Chelating Agents Iron Overload Bone Marrow Diseases Iron Metabolic Disorder |
Disease Metabolic Diseases Molecular Mechanisms of Pharmacological Action Precancerous Conditions Hematologic Diseases Deferasirox Myelodysplastic Syndromes Iron Chelating Agents Iron Metabolism Disorders |
Pharmacologic Actions Preleukemia Neoplasms Pathologic Processes Syndrome Chelating Agents Iron Overload Bone Marrow Diseases |