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Sponsored by: |
Novartis |
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Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00171301 |
Because patients with beta-thalassemia are unable to actively eliminate iron from the body, toxic and eventually lethal levels of iron can accumulate as a result of repeated blood transfusions. This study is a 1-year extension study and will evaluate the long-term efficacy, safety and tolerability of deferasirox.
Condition | Intervention | Phase |
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Beta-Thalassemia Major |
Drug: ICL670; deferasirox |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Extension Study on Efficacy and Safety of Deferasirox Treatment in Patients With Beta-Thalassemia and Transfusional Hemosiderosis |
Estimated Enrollment: | 250 |
Study Start Date: | June 2005 |
Ages Eligible for Study: | 3 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Study ID Numbers: | CICL670A2402E1 |
Study First Received: | September 12, 2005 |
Last Updated: | September 6, 2007 |
ClinicalTrials.gov Identifier: | NCT00171301 |
Health Authority: | Lebanon: Institutional Review Board |
Transfusional hemosiderosis Beta-thalassemia major Deferasirox |
Metabolic Diseases Deferasirox Hematologic Diseases Beta-thalassemia Anemia Anemia, Hemolytic Iron Metabolism Disorders Thalassemia Anemia, Hemolytic, Congenital |
Thalassemia minor Genetic Diseases, Inborn Hemosiderosis Beta-Thalassemia Hemoglobinopathies Iron Overload Metabolic disorder Hemoglobinopathy Iron |
Molecular Mechanisms of Pharmacological Action Iron Chelating Agents Chelating Agents Pharmacologic Actions |