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Deferasirox

Phase 3

Beta-thalassemia | Small molecule | Hematology |Novartis AG|Last Updated: Jun 14, 2021

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials3
Total Enrollment457
FDA Designations
No designations recorded
Clinical Trials (3)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00171171A Study of Long-term Treatment With Deferasirox in Patients With Beta-thalassemia and Transfusional HemosiderosisPHASE3 COMPLETED 252May 1, 2004 -Mar 1, 20175 Egypt, Lebanon +3
NCT00447694Cardiac T2* in Beta-thalassemia Patients on Deferasirox TreatmentPHASE2 COMPLETED 30Feb 1, 2006Nov 1, 2009Jun 14, 20213 United States
NCT00061763Study of Deferasirox in Iron Overload From Beta-thalassemia Unable to be Treated With Deferoxamine or Chronic AnemiasPHASE2 COMPLETED 175May 1, 2003 -Aug 22, 20176 United States
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Study Endpoints
Primary Endpoints
Liver Iron Concentration (as measured by biopsy)
at baseline and after 1 yeor of ICL670 treatment
Magnetic Resonance Imaging (MRI) T2* and Absolute Change From Baseline in MRI T2*
From Baseline to 25, 49, 77 Week

Cardiac T2\* was measured in the short axis plane at the widest point of a 4-chamber localizer using custom breath-hold R2\* gradient echo sequences modeled after techniques used by Anderson et al (2001) and Westwood et al (2003).

To evaluate the effects of treatment on the liver iron content(LIC)
Secondary Endpoints
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
monthly assessments for 1 year
Adverse events
during 1 year ICL670 treatment
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
DeferasiroxEXPERIMENTAL -
deferasirox every day for 77 weeksEXPERIMENTALParticipants received Deferasirox 30 milligrams per kilogram per day (mg/kg/day) orally once daily (OD), 30 minutes before breakfast, preferably around the same time every morning if possible. Deferasirox tablets were dropped into water or orange juice, or apple juice and stirred until completely dispersed. For doses less than 1 gram (g), tablets were dissolved in at least 100 milliliter (mL) of liquid; for doses of 1 to 3 g, tablets were dissolved in at least 200 mL. After tablets were fully disintegrated, the liquid was promptly consumed.
Interventions
NameTypeDescription
deferasiroxDRUG -
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Eligibility Criteria
Age Range2 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites5

Inclusion Criteria: * Beta-thalassemia outpatients with transfusional hemosiderosis and unable to be chelated with deferoxamine (DFO) due to DFO being contra-indicated and/or due to documented unacceptable toxicity of DFO or documented poor response to DFO despite proper compliance, or documented n...

Countries:EgyptLebanonOmanSaudi ArabiaSyriaUnited States
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