WithdrawnPhase 2

Treatment of Iron Overload Requiring Chelation Therapy

Stopped: This study was withdrawn until the evaluation of the nonclinical rat findings is complete.

0Started 2014-11-20

Plain-language summary

The purpose of this open-label study is to assess liver iron concentration using MRI imaging in subjects with beta-thalassemia when administered with either SPD602 or deferasirox for the treatment of chronic transfusional iron overload.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Post-menopausal (12 consecutive months of spontaneous amenorrhea)
✓. Surgically sterile, or
✓. Females of child-bearing potential must have a negative serum Beta-HCG pregnancy test at the Screening Visit (Visit 1) and a negative urine pregnancy test at the Baseline Visit (Visit 3). Females of child-bearing potential must agree to abstain from sexual activity that could result in pregnancy or agree to use acceptable methods of contraception.

Exclusion criteria

✕. Have used an investigational product
✕. Have been enrolled in a clinical study (including vaccine studies) that, in the investigator's opinion, may impact this study.

What they're measuring

Change in Liver Iron Concentration (LIC) from Baseline Utilizing R2 Magnetic Resonance Imaging (MRI)

Timeframe: 48 Weeks

Trial details

NCT IDNCT01927913

SponsorShire

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2015-10-30

View on ClinicalTrials.gov More Transfusional Iron Overload trials