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

• Status: Completed
• Trial end date: 2009-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Deferasirox

Criteria

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.