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A Protocol to Allow Treatment With ICL670 for Patients With or at Risk of Life-threatening Complications of Transfusional Iron Overload Who Are Unable to Tolerate Other Iron Chelators Because of Documented Severe Toxicity | Clinical Trials | Clareo Health

COMPLETEDPHASE2

A Protocol to Allow Treatment With ICL670 for Patients With or at Risk of Life-threatening Complications of Transfusional Iron Overload Who Are Unable to Tolerate Other Iron Chelators Because of Documented Severe Toxicity

NCT01044186•Novartis Pharmaceuticals

View on ClinicalTrials.gov

Summary

The purpose of this open-label, non-comparative, multi-center protocol was to further evaluate safety and to provide treatment with ICL670 to patients who had or were at risk of life threatening complications due to transfusional iron overload with a documented inability to tolerate any of the commercially available iron chelators due to severe toxicity rendering continued therapy either impossible or hazardous. Patients who were also ineligible for all on-going registration trials with ICL670 were included in the study. In exceptional cases, patients with a degree of iron overload which was not immediately life-threatening and who were ineligible for the registration trials were also enrolled provided they had a well-documented, sound justification for alternative chelation therapy.

Eligibility

Age

2 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients had to be at risk of life-threatening complications due to transfusional iron overload and be unable to tolerate therapy with any of the commercially available iron chelators (mainly deferoxamine and/or deferiprone) because of documented severe toxicity.
•Patients with a degree of iron overload which was not immediately life-threatening and who were ineligible for other trials with ICL670 could also be enrolled providing they had a well-documented, sound justification for alternative chelation therapy.
•Serum ferritin ≥ 8000 μg/L.
•Serum ferritin \< 8000μg/L and LIC of ≥ 7 mg Fe/g dry weight.
•Patients for whom ≥ 8 blood transfusions per year were required in order to maintain the Hemoglobin level at \> 9 g/dL.
•Female patients who have reached menarche and who were sexually active had to use double barrier contraception (oral plus barrier contraception), or had to have undergone total hysterectomy and/or ovariectomy, or tubal ligation.
•Written, voluntary informed consent.

Exclusion Criteria

•Patients with transfusional iron overload who were not experiencing severe toxicities during therapy with other iron chelators (e.g. deferoxamine and/or deferiprone).
•Patients with non-transfusional hemosiderosis.
•Patients with severe liver failure as defined by a score of ≥ 10 points on the Child-Pugh scale.
•Patients with serum creatinine 1.5 times the upper limit of normal (ULN) at screening.
•Patients with a history of nephrotic syndrome.
•Patients with a diagnosis of clinically relevant cataract or a previous history of clinically relevant ocular toxicity related to iron chelation therapy.
•Patients with severe systemic diseases unrelated to iron overload and which would prevent them from undergoing treatment with ICL670.
•Patients with psychiatric or addictive disorders which prevent them from giving informed consent or undergoing treatment with ICL670.
•Pregnant or breast feeding patients.
•Patients treated with systemic investigational drugs within the past four weeks or topical investigational drugs within the past seven days.
+6 more criteria

Locations (18)

Children's Hospital and Research Center - Oakland

Oakland, California, United States

Children's Hospital of Orange County

Orange, California, United States

Children's Hospital Boston

Boston, Massachusetts, United States

Queens Hospital Center

Jamaica, New York, United States

New York Presbyterian Hospital/Weill Medical College of Cornell University

New York, New York, United States

New York Methodist Hospital

New York, New York, United States

Cincinnatti Children's Hospital Medical center

Cincinnatti, Ohio, United States

Novartis Investigative Site

Houston, Texas, United States

Novartis investigative Site

Athens, Greece

Novartis Investigative Site

Ancona, Italy

Key Dates

Start Date

June 1, 2003

Primary Completion Date

December 1, 2007

Last Updated

February 23, 2017

Enrollment

ACTUAL participants

Conditions

Transfusional Iron Overload

Interventions

ICL670

DRUG

A 4-year Extension Study to Core 1-year Study of Iron Chelation Therapy With Deferasirox in β-thalassemia Major Pediatric Patients With Transfusional Iron Overload.

NCT00390858

Transfusional Iron Overloadβ-thalassemia Major+1 more

View study

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: February 23, 2017Data 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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