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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 will evaluate the efficacy, safety and tolerability of deferasirox.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Deferasirox | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| deferasirox | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Liver Iron Concentration (as measured by biopsy) | at baseline and after 1 yeor of ICL670 treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Iron balance, i.e. Total Body Iron Excretion (based on the iron influx as determined by the amount of red cells transfused and the change in total body iron (TBI) stores) | after 1 year of ICL670 treatment | |
| Putative surrogate markers such as serum ferritin serum iron, serum transferrin and transferrin saturation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ali Taher, Ass.Prof. | American University of Beirut Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Cairo | Egypt | ||||
| Ali Taher |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20424435 | Result | Taher A, Al Jefri A, Elalfy MS, Al Zir K, Daar S, Rofail D, Baladi JF, Habr D, Kriemler-Krahn U, El-Beshlawy A. Improved treatment satisfaction and convenience with deferasirox in iron-overloaded patients with beta-Thalassemia: Results from the ESCALATOR Trial. Acta Haematol. 2010;123(4):220-5. doi: 10.1159/000313447. Epub 2010 Apr 27. |
| Label | URL |
|---|---|
| Results for CICL670A2402 from the Novartis Clinical Trials website | View source |
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| ID | Term |
|---|---|
| D017086 | beta-Thalassemia |
| D006486 | Hemosiderosis |
| D013789 | Thalassemia |
| ID | Term |
|---|---|
| D000745 | Anemia, Hemolytic, Congenital |
| D000743 | Anemia, Hemolytic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
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| ID | Term |
|---|---|
| D000077588 | Deferasirox |
| ID | Term |
|---|---|
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| monthly assessments for 1 year |
| Adverse events | during 1 year ICL670 treatment |
| hematology and biochemistry, urinalysis | monthly assessments for 1 year ICL670 treatment |
| ECG and Echocardiography | 6-monthly for 1 year ICL670 treatment |
| Beirut |
| Riad El Solh 1107 2020 |
| Lebanon |
| Novartis Investigative Site | Muscat | Oman |
| Novartis Investigative Site | Riyadh | Saudi Arabia |
| Novartis Investigative Site | Damascus | Syria |
| D006425 |
| Hemic and Lymphatic Diseases |
| D006453 | Hemoglobinopathies |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D019190 | Iron Overload |
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D001555 |
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |