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.

Novartis Pharmaceuticals10 sites in 2 countries49 target enrollmentAugust 2006

ConditionsIron Overload Hereditary Hemochromatosis

InterventionsDeferasirox (ICL670)

DrugsDeferasirox (ICL670)

Overview

Phase: Phase 1
Intervention: Deferasirox (ICL670)
Conditions: Iron Overload
Sponsor: Novartis Pharmaceuticals
Enrollment: 49
Locations: 10
Primary Endpoint: Absolute Change of Serum Ferritin From Baseline to the End of Extension, by Dose Cohort (Extension Per-protocol Population)
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

August 2006

End Date

March 2009

Last Updated

14 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Novartis Pharmaceuticals

Eligibility 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