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Safety and Efficacy of Deferasirox (ICL670) in Patients With Iron Overload Resulting From Hereditary Hemochromatosis | Clinical Trials | Clareo Health

COMPLETEDPHASE1/PHASE2

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

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.

NCT00395629•Novartis Pharmaceuticals

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

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

Locations (18)

UC Irvine/Long Beach

Long Beach, California, United States

University of Connecticut Health Center

Farmington, Connecticut, United States

Henry Ford Health System

Detroit, Michigan, United States

Mayo Clinic

Rochester, Minnesota, United States

St. Louis University

St Louis, Missouri, United States

Rochester General Hospital

Rochester, New York, United States

Carolinas Medical Center

Charlotte, North Carolina, United States

Ohio State University Medical Center

Columbus, Ohio, United States

Three Medical Park

Columbia, South Carolina, United States

Novartis Investigative Site

Brisbane, Australia

Key Dates

Start Date

August 1, 2006

Primary Completion Date

December 1, 2007

Completion Date

March 1, 2009

Last Updated

May 30, 2011

Enrollment

ACTUAL participants

Conditions

Iron OverloadHereditary Hemochromatosis

Interventions

Deferasirox (ICL670)

DRUG

PTG-300 in Subjects With Hereditary Hemochromatosis

NCT04202965

Hereditary Hemochromatosis

View study

COMPLETEDNA

Inhibitory Effect of a Polyphenol Supplement on Dietary Iron Absorption in Adults with Thalassemia

NCT05326503

ThalassemiaIron Overload

View study

COMPLETEDNA

Comparison of Deferasirox and Desferoxamine in Patients of β-Thalassemia Major With Iron Overload

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 30, 2011Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

PTG-300 in Subjects With Hereditary Hemochromatosis

Inhibitory Effect of a Polyphenol Supplement on Dietary Iron Absorption in Adults with Thalassemia

Comparison of Deferasirox and Desferoxamine in Patients of β-Thalassemia Major With Iron Overload

Quality and Biologic Characteristics of Red Blood Concentrates Obtained From Individuals With Elevated Ferritin.

Chelation Therapy of Iron Overload With Pyridoxal Isonicotinoyl Hydrazone

A Study of LJPC-401 for the Treatment of Iron Overload in Adult Patients With Hereditary Hemochromatosis