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.
Name: Deferasirox (ICL670)
Type: DrugICL670 (Deferasirox)
Description: Mean absolute change in serum ferritin from baseline to the end of the extension study.
Measure: Absolute Change of Serum Ferritin From Baseline to the End of Extension, by Dose Cohort (Extension Per-protocol Population) Time: 0 to 48 weeksDescription: A blood sample was collected just prior to administration of the next dose of Deferasirox (pre-dose trough level) or approximately 24 hours after the previous dose at weeks 4, 8, 12, 16, 20 and 24. The mean trough concentration at each time point was calculated.
Measure: Trough Concentrations of Deferasirox (ICL670), by Dose Cohort (Per-protocol Population) Time: 4, 8, 12, 16, 20, and 24 weeksAllocation: Non-Randomized
Single Group Assignment
There is one SNP
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.. Safety and Efficacy of Deferasirox (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. --- C282Y ---
The mean trough concentration at each time point was calculated.. Inclusion Criteria: - Age 18 years of age or older - Male or female patients homozygous for the C282Y mutation. --- C282Y ---
Inclusion Criteria: - Age 18 years of age or older - Male or female patients homozygous for the C282Y mutation. --- C282Y ---