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SSP-004184 in chronic iron overload
NCT01604941Phase 2
Key facts
- Status
- Terminated
- Start
- Sep 2012
- Primary completion
- Apr 2014
- Countries
- 5
- Sponsor
- Takeda
- Drugs
- deferitazole
- Conditions
- iron overload
01
Overview
Phase 2, open-label, single-arm trial of deferitazole in iron overload, sponsored by Takeda. Primary endpoints: Change From Baseline in Liver Iron Concentration (LIC) as Assessed by FerriScan R2 Magnetic Resonance Imaging (MRI) at 24 weeks and Change From Baseline in LIC Adjusted by Transfusional Iron Intake And Assessed by FerriScan R2 MRI at 24 weeks. Started Sep 2012; status: terminated.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
SPD602 Arm
Single group receiving deferitazole 50 mg/kg/day
03
Who it enrols
Adults aged 18-60 with transfusional iron overload (serum ferritin >500ng/mL, LIC >=5mg/g) requiring chronic chelation therapy, who have received >20 transfusions.
04
Endpoints
Primary
Change From Baseline in Liver Iron Concentration (LIC) as Assessed by FerriScan R2 Magnetic Resonance Imaging (MRI)
Change From Baseline in LIC Adjusted by Transfusional Iron Intake And Assessed by FerriScan R2 MRI
Secondary
Change From Baseline in LIC as Assessed by R2* MRI
Change From Baseline in Cardiac T2* Relaxation Rate
Change From Baseline in Serum Ferritin
Number of Participants Classified as a Responder by FerriScan R2 MRI Analysis of LIC
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