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Sponsored by: |
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
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Information provided by: | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
ClinicalTrials.gov Identifier: | NCT00004982 |
Patients with beta-thalassemia (Cooley's Anemia) continue to suffer from the transfusion-induced iron overload due to the inadequacies of current iron-chelation therapy. Compliance with the use of the only FDA-approved drug for removing excess iron from patients (Desferal) continues to be a major problem despite convincing evidence that it markedly reduces morbidity and prolongs life. The full potential of iron-chelation therapy will not be realized until an orally-effective drug is available. This small trial is testing the premise that a combination of drugs as a new approach to iron chelation therapy may reduce side effects and increase efficacy. If both drugs can be given orally, there may be a better chance of finding a suitable alternative to Desferal. Several combinations of experimental iron chelating drugs are being used in this trial.
Condition | Intervention | Phase |
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Iron Overload Thalassemia |
Drug: Combination Iron Chelation Therapy |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label |
Ages Eligible for Study: | 7 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | CHELATION, 1R01DK55463-01 |
Study First Received: | March 13, 2000 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00004982 |
Health Authority: | United States: Federal Government |
chelation therapy combination chemotherapy iron poisoning thalassemia |
chelating agent deferoxamine drug screening /evaluation therapy evaluation |
Metabolic Diseases Hematologic Diseases Poisoning Anemia Anemia, Hemolytic Iron Metabolism Disorders Thalassemia Anemia, Hemolytic, Congenital |
Genetic Diseases, Inborn Hemoglobinopathies Iron Overload Hemoglobinopathy Metabolic disorder Iron Deferoxamine |