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Sponsored by: |
Novartis |
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Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00061763 |
The purpose of this study is to determine the effects of the oral iron chelator Deferasirox on liver iron content after one year of treatment in patients with iron overload from repeated blood transfusions. Beta-thalassemia patients unable to be treated with deferoxamine or patients with rare chronic anemias such as Myelodysplastic Syndrome, Fanconi's Syndrome, Blackfan-Diamond Syndrome, and Pure Red Blood Cell Anemia are eligible for this study. Liver iron content will be measured by liver biopsy at the beginning of the study and after one year of treatment. However, those patients living in the San Francisco/Oakland area may have a SQUID in place of the liver biopsy if the biopsy is not medically possible for them. The SQUID is a non-invasive magnetic means to measure liver iron content.
Condition | Intervention | Phase |
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Beta-Thalassemia Myelodysplastic Syndromes Fanconi Syndrome Anemia, Diamond-Blackfan Anemia, Aplastic |
Drug: Deferasirox |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase II Study of Safety & Efficacy of Deferasirox Given for 1 Year in Patients With Chronic Anemias and Transfusional Hemosiderosis Unable to be Treated With Deferoxamine |
Estimated Enrollment: | 175 |
Study Start Date: | May 2003 |
Ages Eligible for Study: | 2 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
Children's Hospital Oakland | |
Oakland, California, United States, 94609 | |
Stanford Hospital | |
Stanford, California, United States, 94305-5208 | |
United States, Illinois | |
Northwest Medical Specialists | |
Arlington Heights, Illinois, United States, 60004 | |
United States, Massachusetts | |
Children's Hospital Boston | |
Boston, Massachusetts, United States, 02115 | |
United States, New York | |
Weill Medical College of Cornell University | |
New York, New York, United States, 10021 | |
United States, Pennsylvania | |
Children's Hospital of Philadelphia | |
Philadelphia, Pennsylvania, United States, 19104-4318 |
Study Chair: | Novartis | Novartis |
Study ID Numbers: | CICL670A0108 |
Study First Received: | June 3, 2003 |
Last Updated: | September 25, 2007 |
ClinicalTrials.gov Identifier: | NCT00061763 |
Health Authority: | United States: Food and Drug Administration |
beta-thalassemia iron overload deferoxamine Myelodysplastic Syndromes |
Fanconi Syndrome Anemia, Diamond-Blackfan Anemia, Aplastic |
Precancerous Conditions Iron Metabolism Disorders Red-Cell Aplasia, Pure Metabolism, Inborn Errors Preleukemia Urologic Diseases Hemosiderosis Anemia, Diamond-Blackfan Anemia, Aplastic Fanconi Syndrome Kidney Diseases Hemoglobinopathy Deferoxamine Myelodysplastic syndromes Metabolic Diseases |
Deferasirox Hematologic Diseases Beta-thalassemia Myelodysplastic Syndromes Myelodysplasia Fanconi renotubular syndrome Anemia Anemia, Hemolytic Thalassemia Anemia, Hemolytic, Congenital Thalassemia minor Nephropathic cystinosis Genetic Diseases, Inborn Beta-Thalassemia Hemoglobinopathies |
Neoplasms Anemia, Hypoplastic, Congenital Pathologic Processes Disease Molecular Mechanisms of Pharmacological Action Syndrome |
Iron Chelating Agents Chelating Agents Renal Tubular Transport, Inborn Errors Pharmacologic Actions Siderophores |