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

NCT ID: NCT00395629

Last Updated: 2011-05-30

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-31

Study Completion Date

2009-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Iron Overload Hereditary Hemochromatosis

Keywords

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Deferasirox ICL670A Iron chelators Deferiprone Transfusional Hemochromatosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ICL670 (Deferasirox)

Three dose cohorts: 5 mg/kg/day, 10 mg/kg/day, 15 mg/kg/day

Group Type EXPERIMENTAL

Deferasirox (ICL670)

Intervention Type DRUG

Interventions

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Deferasirox (ICL670)

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Novartis Pharmaceuticals

Principal Investigators

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Novartis Pharmaceuticals, M.D.

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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UC Irvine/Long Beach

Long Beach, California, United States

Site Status

University of Connecticut Health Center

Farmington, Connecticut, United States

Site Status

Henry Ford Health System

Detroit, Michigan, United States

Site Status

Mayo Clinic

Rochester, Minnesota, United States

Site Status

St. Louis University

St Louis, Missouri, United States

Site Status

Rochester General Hospital

Rochester, New York, United States

Site Status

Carolinas Medical Center

Charlotte, North Carolina, United States

Site Status

Ohio State University Medical Center

Columbus, Ohio, United States

Site Status

Three Medical Park

Columbia, South Carolina, United States

Site Status

Novartis Investigative Site

Brisbane, , Australia

Site Status

Novartis Investigative Site

London, Ontario, Canada

Site Status

Novartis Investigative Site

Rennes, , France

Site Status

Novartis Investigative Site

Chemnitz, , Germany

Site Status

Novartis Investigative Site

Heidelberg, , Germany

Site Status

Novartis Investigative Site

Magdeburg, , Germany

Site Status

Novartis Investigative Site

Oberhausen, , Germany

Site Status

Novartis Investigative Site

Modena, , Italy

Site Status

Novartis Investigative Site

Monza, , Italy

Site Status

Countries

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United States Australia Canada France Germany Italy

Related Links

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http://www.novartisclinicaltrials.com/

Related Info

Other Identifiers

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EudraCT no. 2006-002102-57

Identifier Type: REGISTRY

Identifier Source: secondary_id

CICL670A2202

Identifier Type: -

Identifier Source: org_study_id