Safety and Efficacy of Deferasirox (ICL670) in Patients With Iron Overload Resulting From Hereditary Hemochromatosis

A Phase I/II Open Label, Dose Escalation Trial and a Six Month Extension to Explore the Safety and Efficacy of ICL670 in Patients With Iron Overload Resulting From Hereditary Hemochromatosis.

Brief Summary: This study was designed to explore a safe dose and characterize the preliminary safety and efficacy of ICL670 in adult patients with previously documented history of homozygous C282Y.

Inclusion Criteria:

• Age 18 years of age or older
• Male or female patients homozygous for the C282Y mutation.
• Iron overload as documented by serum ferritin and transferrin saturation
• No known allergy or contraindication to the administration of deferasirox
• Ability to comply with all study-related procedures, medications, and evaluations
• Effective use of birth control measures.

Exclusion Criteria:

• Iron overload not due to hereditary hemochromatosis
• Males with hemoglobin <13 mg/dL, females with hemoglobin <12 mg/dL
• Desferal treatment within 1 month of the screening visit
• Patients currently or previously treated with deferiprone or deferasirox
• Significant medical condition interfering with the ability to partake in this study
• Presence of a surgical or medical condition that might significantly alter the absorption, distribution, metabolism or excretion of any study drug
• Clinical evidence of Active Hepatitis B or C
• Positive HIV serology
• Pregnant or breast feeding patients
• Patients treated with systemic investigational drug within 4 weeks prior or with topical investigational drug within 7 days prior to the screening visit

Other protocol-defined inclusion/exclusion criteria may apply.