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| Sponsored by: |
Novartis |
|---|---|
| Information provided by: | Novartis |
| ClinicalTrials.gov Identifier: | NCT00303329 |
Purpose
A 1-year randomized Phase II core trial was conducted to investigate the efficacy of deferasirox in regularly transfused patients with β-thalassemia and other rare chronic anemia 2 years of age and older. Patients who successfully completed this main trial may continue in this extension trial to receive chelation therapy with deferasirox for up to 3 years.
The objective of this study is to assess the long-term safety and efficacy of deferasirox in these patient groups.
| Condition | Intervention | Phase |
|---|---|---|
|
Transfusional Iron Overload in Patients With Chronic Anemia |
Drug: Deferasirox |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | Extension Study of Iron Chelation Therapy With Deferasirox in β-Thalassemia and Other Patients With Rare Chronic Anemia and Transfusional Iron Overload |
Eligibility| Ages Eligible for Study: | 2 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria - Congenital or acquired chronic anemias patients with transfusional iron overload who have successfully completed the 1-year chelation treatment in the deferasirox trial and considered by the investigator eligible to continue chelation therapy with deferasirox
Exclusion Criteria
- Pregnant or breast feeding patients
Other protocol-defined inclusion/exclusion criteria may apply
Contacts and Locations| United States, California | |
| Stanford, California, United States | |
| United States, Massachusetts | |
| Oakland, Massachusetts, United States | |
| Boston, Massachusetts, United States | |
| United States, New York | |
| New York, New York, United States | |
| United States, Pennsylvania | |
| Philadelphia, Pennsylvania, United States | |
| Belgium | |
| La Louvière, Belgium | |
| Gent, Belgium | |
| Brugge, Belgium | |
| Leuven, Belgium | |
| Bruxelles, Belgium | |
| Canada | |
| Toronto, Canada | |
| Montreal, Canada | |
| France | |
| Lille, France | |
| Creteil, France | |
| Troyes, France | |
| Le Kremlin Bicetre, France | |
| Germany | |
| Hannover, Germany | |
| Ulm, Germany | |
| Duesseldorf, Germany | |
| Italy | |
| Genova, Italy | |
| Bologna, Italy | |
| Brindisi, Italy | |
| Cagliari, Italy | |
| Milan, Italy | |
| Pavia, Italy | |
| Rome, Italy | |
| Torino, Italy | |
| United Kingdom | |
| London, United Kingdom | |
| Study Chair: | Novartis | Novartis |
More Information
| Study ID Numbers: | CICL670A0108E1 |
| Study First Received: | October 14, 2005 |
| Last Updated: | July 5, 2007 |
| ClinicalTrials.gov Identifier: | NCT00303329 |
| Health Authority: | United States: Food and Drug Administration |
|
β-thalassemia rare chronic anemia iron overload deferasirox |
|
Metabolic Diseases Deferasirox Hematologic Diseases Anemia Anemia, Hemolytic Iron Metabolism Disorders Thalassemia |
Anemia, Hemolytic, Congenital Genetic Diseases, Inborn Hemoglobinopathies Iron Overload Hemoglobinopathy Metabolic disorder Iron |
|
Molecular Mechanisms of Pharmacological Action Iron Chelating Agents Chelating Agents Pharmacologic Actions |
