Treatment of Iron Overload Requiring Chelation Therapy

Exclusion Criteria

• •Severe iron overload including: (a) cardiac T2\* MRI less than 10.0ms; or (b) LIC by FerriScan® R2 MRI greater than or equal to 30.0mg/g liver (dw) as assessed at the Screening Visit (Visit 1).
• •Iron overload from causes other than transfusional siderosis.
• •Subjects with thalassemia intermedia
• •Unable to undergo MRI assessment.
• •Cardiac LVEF less than 50% at baseline testing by MRI.
• •Subjects with documented liver failure (presence of portal hypertension, hepatic edema, ascites, cirrhosis), Child-Pugh C hepatic impairment, or biliary disorder.
• •Platelet count \<100 x 109/L at the Screening Visit (Visit 1).
• •Absolute neutrophils counts of \<1500mm3 at the Screening Visit (Visit 1).
• •Evidence of renal insufficiency eg, creatinine clearance \<60mL/min or serum creatinine \>1.5x ULN at the Screening Visit (Visit 1).
• •Clinically significant laboratory assessments at the Screening Visit (Visit 1).
• •Significant proteinuria: urinary protein/creatinine ratio \>1.0 in a non-first void urine sample at the Screening Visit (Visit 1).
• •Current or recurrent disease that could affect the action, absorption, or disposition of the investigational product, or clinical or laboratory assessments.
• •Current or relevant history of physical or psychiatric illness, any medical disorder that may require treatment or make the subject unlikely to fully complete the study, or any condition, including pregnancy, that presents undue risk from the investigational product or procedures.
• •Current use of any medication contraindicated in the deferasirox prescribing information/SmPC.
• •Known or suspected intolerance or hypersensitivity to SSP-004184AQ, deferasirox, closely-related compounds, or any of the stated ingredients in either medication.
• •Known history of alcohol or other substance abuse within the last year.
• •Within 30 days prior to the Baseline Visit (Visit 3):
• •1. Have used an investigational product
• •2. Have been enrolled in a clinical study (including vaccine studies) that, in the investigator's opinion, may impact this study.
• •History of malignancy within the past 5 years, with the exception of basal cell or squamous cell skin carcinoma or cervical carcinoma in situ or completely resected colon carcinoma in situ.
• •Insufficient venous access that precludes prescribed blood draws for safety laboratory assessments.
• •Pregnant or lactating females.