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Deferasirox and Deferoxamine

Phase 2

Cardiac Iron Overload | Small molecule | Hematology |Novartis AG|Last Updated: Jul 26, 2021

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment60

FDA Designations

No designations recorded

Clinical trial landscape

Deferasirox and Deferoxamine · 1 trial · 1 indication

Phase 2 1
NCT01254227Efficacy and Safety of Deferasirox in Combination With Deferoxamine Followed by Deferasirox Monotherapy in Severe Cardiac Iron OverloadCardiac Iron Overload
COMPLETED60 Analytics
PHASE2COMPLETED
Efficacy and Safety of Deferasirox in Combination With Deferoxamine Followed by Deferasirox Monotherapy in Severe Cardiac Iron Overload
Cardiac Iron OverloadUnlock trial analytics

Study Endpoints

Primary Endpoints

Change in Cardiac Iron Content From Baseline to Month 12
From Baseline to Month 12

Cardiac T2\* is the most sensitive and reproducible test in detecting myocardial iron load. A cardiac T2\* value of \<10 ms is defined as severe cardiac iron overload. Participants who do not have baseline T2\* or do not have any post-baseline T2\* are excluded from the analysis.

Secondary Endpoints

Percentage of Participants With T2*>=10 ms and at Least 10% Relative Increase From Baseline at Month 6, 12, 18 and 24
From the Months 6, 12, 18 and 24
Change in Cardiac Iron Content From Baseline to Month 6,18 and 24
From Baseline to Months 6, 18 and 24
Change in Left Ventricular Ejection Fraction (LVEF) From Baseline to Month 6, 12, 18 and 24
From the Months 6, 12, 18 and 24
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
DeferasiroxEXPERIMENTALDeferoxamine combination followed by Deferasirox monotherapy

Interventions

NameTypeDescription
Deferasirox and DeferoxamineDRUG -
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Eligibility Criteria

Age Range10 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites15

Inclusion Criteria: * Patients with β-thalassemia major or Diamond-Blackfan anemia (DBA) or congenital sideroblastic anemia on chronic transfusion therapy * Myocardial T2\* value that is ≥ 5 and \< 10 ms * Left ventricular ejection fraction (LVEF) ≥ 56% as determined by Magnetic resonance imaging (...

Countries:CanadaEgyptGreeceItalyTaiwanThailandTurkey (Türkiye)United Kingdom
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Frequently asked questions about Deferasirox and Deferoxamine

What is Deferasirox used for?

Deferasirox is an oral iron chelator used to treat transfusional iron overload in beta-thalassemia and other chronic anemias, including sickle cell disease and myelodysplastic syndromes. It is also studied for cardiac iron overload. The drug binds excess iron in the body, allowing its excretion, thereby reducing iron-related organ damage.

What does Deferasirox target?

Deferasirox targets iron by binding free and labile plasma iron to form a stable complex that is excreted primarily through the feces. This reduces total body iron stores in patients with transfusional iron overload. It is a small molecule iron chelator, not a conventional molecular target like a receptor or enzyme.

Who makes Deferasirox?

Deferasirox is developed by Novartis AG, a multinational pharmaceutical company headquartered in Basel, Switzerland. Novartis trades on the New York Stock Exchange under the ticker symbol NVS. The drug is also known by the brand name Exjade or Jadenu in some markets.

What phase is Deferasirox in?

Deferasirox is in Phase 2 clinical development for myelodysplastic syndromes, according to the trial NCT00940602. However, it has completed Phase 3 trials for beta-thalassemia and transfusional iron overload. The drug is investigational for these indications and not yet approved in the studied settings.

What clinical trials is Deferasirox in?

Deferasirox has been studied in several completed trials. NCT00171210 evaluated iron chelation in beta-thalassemia patients with transfusional iron overload. NCT00171821 assessed efficacy and safety in transfusion-dependent iron overload. NCT00940602 is a Phase 2 study in myelodysplastic syndromes. All trials are completed.

Is Deferasirox the same as Exjade?

Yes, Deferasirox is the same as Exjade, a brand name used by Novartis. It is also marketed as Jadenu in some regions. The generic name is deferasirox, and it is an oral iron chelator used to treat chronic iron overload from blood transfusions.