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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
49
UC Irvine/Long Beach
Long Beach, California, United States
University of Connecticut Health Center
Farmington, Connecticut, United States
Absolute Change of Serum Ferritin From Baseline to the End of Extension, by Dose Cohort (Extension Per-protocol Population)
Mean absolute change in serum ferritin from baseline to the end of the extension study.
Time frame: 0 to 48 weeks
Trough Concentrations of Deferasirox (ICL670), by Dose Cohort (Per-protocol Population)
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.
Time frame: 4, 8, 12, 16, 20, and 24 weeks
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Henry Ford Health System
Detroit, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
St. Louis University
St Louis, Missouri, United States
Rochester General Hospital
Rochester, New York, United States
Carolinas Medical Center
Charlotte, North Carolina, United States
Ohio State University Medical Center
Columbus, Ohio, United States
Three Medical Park
Columbia, South Carolina, United States
Novartis Investigative Site
Brisbane, Australia
...and 8 more locations