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

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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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

49 participants in 1 patient group

ICL670 (Deferasirox)
Experimental group
Description:
Three dose cohorts: 5 mg/kg/day, 10 mg/kg/day, 15 mg/kg/day
Treatment:
Drug: Deferasirox (ICL670)

Trial contacts and locations

18

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Data sourced from clinicaltrials.gov

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