Status:
COMPLETED
Safety and Efficacy of Deferasirox (ICL670) in Patients With Iron Overload Resulting From Hereditary Hemochromatosis
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Iron Overload
Hereditary Hemochromatosis
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT00395629
Start Date
August 1 2006
End Date
March 1 2009
Last Update
May 30 2011
Active Locations (18)
Enter a location and click search to find clinical trials sorted by distance.
1
UC Irvine/Long Beach
Long Beach, California, United States, 90822
2
University of Connecticut Health Center
Farmington, Connecticut, United States, 06030
3
Henry Ford Health System
Detroit, Michigan, United States, 48202
4
Mayo Clinic
Rochester, Minnesota, United States, 55905