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

Novartis

Status and phase

Completed

Phase 2

Phase 1

Conditions

Hereditary Hemochromatosis

Iron Overload

Treatments

Drug: Deferasirox (ICL670)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00395629

CICL670A2202

EudraCT no. 2006-002102-57 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment

49 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Other protocol-defined inclusion/exclusion criteria may apply.