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.

A 4-year Extension to a Phase II a Multicenter Study Evaluating Long-term Safety, Tolerability, Pharmacokinetics and Effects on Liver Iron Concentration of Repeated Doses of 10 mg/kg/Day of Deferasirox in Pediatric Patients With Transfusion Dependent β-thalassemia Major.

NCT00390858•Novartis Pharmaceuticals

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Summary

In this 4-year extension study the safety, efficacy and and pharmacokinetics of deferasirox in regularly transfused pediatric patients with β-thalassemia major was assessed. Patients who successfully completed the main 1 year trial (NCT00390858) were eligible to continue in this extension trial and receive chelation therapy with deferasirox for up to 4 years.

Eligibility

Age

1 - 18 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Completion of the planned 12-month core trial, (NCT00390858).
•Female patients who have reached menarche and who were sexually active were to use double-barrier contraception, oral contraceptive plus barrier contraceptive, or must have undergone clinically documented total hysterectomy and/or ovariectomy, or tubal ligation.
•Written informed consent obtained from the patient, and/or from the parent or legal guardian in accordance with the national legislation.

Exclusion Criteria

•Pregnant or breast feeding patients
•Patients with a history of non-compliance to medical regimens and patients who are considered by the investigator as potentially unreliable.

Locations (4)

Novartis Investigative Site

Lyon, France

Novartis Investigative Site

Cagliari, Italy

Novartis Investigative Site

Genova, Italy

Novartis Investigative Site

Torino, Italy

Key Dates

Start Date

September 1, 2003

Primary Completion Date

February 1, 2008

Completion Date

February 1, 2008

Last Updated

March 20, 2017

Enrollment

ACTUAL participants

Conditions

Transfusional Iron Overloadβ-thalassemia MajorPediatric Rare Anemia

Interventions

Deferasirox

DRUG

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

NCT06468423

Pateints of β-thalassemia Major With Iron Overload

View study

TERMINATEDPHASE1/PHASE2

β-globin Restored Autologous HSC in β-thalassemia Major Patients

NCT04205435

β-thalassemia Major

View study

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

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: March 20, 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.

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