An observational, multi-center study to evaluate the safety of deferasirox in the treatment of pediatric patients with non-transfusion-dependent iron overload.

  • STATUS
    Recruiting
  • sponsor
    Novartis
Updated on 25 March 2021

Summary

An observational, multi-center study to evaluate the safety of deferasirox in the treatment of pediatric patients with non-transfusion-dependent iron overload.

Description

The purpose of this observational study is to provide further assessment of the safety of deferasirox in NTDT pediatric patients with documented iron overload as defined in a local product label.

Protocol Number: CICL670E2422

Details
Clinical Study IdentifierTX141485
SponsorNovartis
Last Modified on25 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 10 yrs and 18 yrs?
Gender: Male or Female
Patients eligible for inclusion in this study must meet all of the following
criteria
Male or female aged ≥ 10 but <18 years old with non-transfusion-dependent thalassemia syndromes inclusive of beta-thalassemia intermedia, HbE beta-thalassemia or alpha thalassemia intermedia (HbH disease) and chronic iron overload
AND
Patients currently treated for a maximum of 12 months or patients planned to be treated with deferasirox
AND
Written informed consent obtained prior to any screening procedures. The consent form will be signed by the patient’s legal guardian

Exclusion Criteria

Patients treated with deferasirox in an interventional clinical study
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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