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Last Updated: March 28, 2024

CLINICAL TRIALS PROFILE FOR DEFERASIROX


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505(b)(2) Clinical Trials for DEFERASIROX

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
New Formulation NCT02435212 ↗ Study to Evaluate Treatment Compliance, Efficacy and Safety of an Improved Deferasirox Formulation (Granules) in Pediatric Patients (2-<18 Years Old) With Iron Overload Active, not recruiting Novartis Pharmaceuticals Phase 2 2015-10-21 This is a randomized, open-label, multicenter, two arm, phase II study to evaluate treatment compliance and change in serum ferritin of a deferasirox granule formulation and a deferasirox DT formulation in children and adolescents aged ≥ 2 and < 18 years at enrollment with any transfusion-dependent anemia requiring chelation therapy due to iron overload, to demonstrate the effect of improved compliance on iron burden. Randomization will be stratified by age groups (2 to <10 years, 10 to <18 years) and prior iron chelation therapy (Yes/ No). There will be two study phases which include a 1 year core phase where patients will be randomized to a 48 week treatment period to either Deferasirox DT or granules, and an optional extension phase where all patients will receive the granules up to 5 years. Patients who demonstrated benefit to granules or DT in the core phase, and/or express the wish to continue in the optional extension phase on granules, will be offered this possibility until there is local access to the new formulation (granules or FCT) or up to 5 years, whichever occurs first.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for DEFERASIROX

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00061750 ↗ Safety & Efficacy of ICL670 vs. Deferoxamine in Beta-thalassemia Patients With Iron Overload Due to Blood Transfusions Completed Novartis Pharmaceuticals Phase 3 2003-05-01 The purpose of this study is to deterimine if the new orally active iron chelator, ICL670, is as effective and as safe as deferoxamine in preventing accumulation of iron in the body while a patient is undergoing repeated blood transfusions.
NCT00061763 ↗ Study of Deferasirox in Iron Overload From Beta-thalassemia Unable to be Treated With Deferoxamine or Chronic Anemias Completed Novartis Pharmaceuticals Phase 2 2003-05-01 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.
NCT00067080 ↗ Safety of ICL670 vs. Deferoxamine in Sickle Cell Disease Patients With Iron Overload Due to Blood Transfusions Completed Novartis Pharmaceuticals Phase 2 2003-05-01 The purpose of this study is to determine if the new orally active iron chelator, ICL670, is as safe as deferoxamine in preventing accumulation of iron in the body while a patient is undergoing repeated blood transfusions.
NCT00110266 ↗ Study of Deferasirox for Treatment of Transfusional Iron Overload in Myelodysplastic Patients Completed Novartis Pharmaceuticals Phase 2 2005-07-25 The purpose of this trial is to examine the safety and efficacy of deferasirox in patients with Myelodysplastic Syndrome (MDS) and chronic iron overload from blood transfusions.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for DEFERASIROX

Condition Name

Condition Name for DEFERASIROX
Intervention Trials
Iron Overload 16
Myelodysplastic Syndromes 12
Transfusional Iron Overload 7
Beta-Thalassemia 7
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Condition MeSH

Condition MeSH for DEFERASIROX
Intervention Trials
Iron Overload 52
Thalassemia 35
Preleukemia 25
Myelodysplastic Syndromes 25
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Clinical Trial Locations for DEFERASIROX

Trials by Country

Trials by Country for DEFERASIROX
Location Trials
United States 206
Italy 71
Canada 21
United Kingdom 19
China 19
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Trials by US State

Trials by US State for DEFERASIROX
Location Trials
California 23
New York 18
Illinois 15
Pennsylvania 14
Texas 12
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Clinical Trial Progress for DEFERASIROX

Clinical Trial Phase

Clinical Trial Phase for DEFERASIROX
Clinical Trial Phase Trials
Phase 4 21
Phase 3 11
Phase 2/Phase 3 2
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Clinical Trial Status

Clinical Trial Status for DEFERASIROX
Clinical Trial Phase Trials
Completed 61
Terminated 14
Unknown status 11
[disabled in preview] 4
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Clinical Trial Sponsors for DEFERASIROX

Sponsor Name

Sponsor Name for DEFERASIROX
Sponsor Trials
Novartis Pharmaceuticals 52
Novartis 11
Soroka University Medical Center 2
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Sponsor Type

Sponsor Type for DEFERASIROX
Sponsor Trials
Other 87
Industry 69
NIH 3
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