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

Completed · Phase 1/Phase 2

Conditions studied: Iron Overload, Hereditary Hemochromatosis

In brief

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.

Key facts

Study ID

NCT00395629

Run by

Novartis Pharmaceuticals

People needed

49

Starts

2006-08-01

Expected to finish

2009-03-01

Last updated by the study team

2011-05-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• UC Irvine/Long Beach — Long Beach, California, United States
• University of Connecticut Health Center — Farmington, Connecticut, United States
• 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
• Novartis Investigative Site — London, Ontario, Canada
• Novartis Investigative Site — Rennes, France
• Novartis Investigative Site — Chemnitz, Germany
• Novartis Investigative Site — Heidelberg, Germany
• Novartis Investigative Site — Magdeburg, Germany
• Novartis Investigative Site — Oberhausen, Germany
• Novartis Investigative Site — Modena, Italy
• Novartis Investigative Site — Monza, Italy

Full record on ClinicalTrials.gov

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