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Sponsored by: |
Novartis |
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Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00564941 |
This study will evaluate the safety and efficacy of deferasirox in transfusion dependent Myelodysplastic Syndrome, Beta-thalassaemia major patients with chronic iron overload
Condition | Intervention | Phase |
---|---|---|
Myelodysplastic Syndromes Beta-Thalassemia |
Drug: deferasirox |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Evaluating the Efficacy of Deferasirox in Transfusion Dependent Chronic Anaemias (Myelodysplastic Syndrome, Beta-Thalassaemia Patients) With Chronic Iron Overload |
Estimated Enrollment: | 309 |
Study Start Date: | December 2007 |
Arms | Assigned Interventions |
---|---|
1: Experimental | Drug: deferasirox |
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria
Exclusion criteria
Other protocol-defined inclusion/exclusion criteria may apply
Contact: Novartis | +41 61 324 1111 |
Hungary | |
Novartis Investigative Site | Recruiting |
Budapest, Hungary | |
Novartis Investigative Site | Recruiting |
Debrecen, Hungary | |
Novartis Investigative Site | Not yet recruiting |
Pecs, Hungary | |
Novartis Investigative Site | Not yet recruiting |
Szeged, Hungary |
Study Chair: | Novartis | Novartis |
Responsible Party: | Novartis ( External Affairs ) |
Study ID Numbers: | CICL670AHU02 |
Study First Received: | November 28, 2007 |
Last Updated: | January 9, 2009 |
ClinicalTrials.gov Identifier: | NCT00564941 |
Health Authority: | Hungary: National Institute of Pharmacy |
Myelodysplastic Syndromes beta-Thalassemia Iron Overload Iron Chelating Agents deferasirox |
Myelodysplastic syndromes Metabolic Diseases Precancerous Conditions Deferasirox Hematologic Diseases Beta-thalassemia Myelodysplasia Myelodysplastic Syndromes Anemia Anemia, Hemolytic Iron Metabolism Disorders Thalassemia |
Anemia, Hemolytic, Congenital Thalassemia minor Preleukemia Genetic Diseases, Inborn Beta-Thalassemia Hemoglobinopathies Iron Overload Metabolic disorder Hemoglobinopathy Bone Marrow Diseases Iron |
Neoplasms Pathologic Processes Disease Molecular Mechanisms of Pharmacological Action |
Syndrome Iron Chelating Agents Chelating Agents Pharmacologic Actions |