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Sponsored by: |
Novartis |
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Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00171821 |
This study uses a single arm, multi-center, open-label trial design. The study will assess the efficacy and safety of 52 weeks of treatment with deferasirox (ICL670) in patients with evidence of transfusion induced iron overload.
Condition | Intervention | Phase |
---|---|---|
Transfusion-Dependent Iron Overload |
Drug: Deferasirox |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Study Assessing the Efficacy and Safety of Deferasirox in Patients With Transfusion-Dependent Iron Overload |
Estimated Enrollment: | 1541 |
Study Start Date: | April 2005 |
Ages Eligible for Study: | 2 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Additional Inclusion Criteria for Adult Patients:
Additional Inclusion Criteria for Pediatric Patients:
Exclusion Criteria:
Any other surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of any drug. The investigator should be guided by evidence of any of the following:
Exclusion Criteria for Pediatric Patients:
Other protocol-defined inclusion/exclusion criteria may apply.
Study ID Numbers: | CICL670A2409 |
Study First Received: | September 13, 2005 |
Last Updated: | November 27, 2007 |
ClinicalTrials.gov Identifier: | NCT00171821 |
Health Authority: | Switzerland: Swissmedic |
Thalassemia Myelodysplastic Syndrome MDS Sickle cell Diamond-Blackfan anemia |
Transfusion Anemia Fanconi Chelation Deferasirox |
Myelodysplastic syndromes Metabolic Diseases Deferasirox Myelodysplastic Syndromes Myelodysplasia Anemia Aase syndrome Iron Metabolism Disorders |
Thalassemia Preleukemia Diamond Blackfan anemia Anemia, Diamond-Blackfan Iron Overload Metabolic disorder Iron |
Molecular Mechanisms of Pharmacological Action Iron Chelating Agents Chelating Agents Pharmacologic Actions |