Clinical Trial Details

Overview

Research Study Summary

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

Purpose

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.

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CW ID: 210600
Date Last Changed: September 30, 2015

Clinical Trial Snapshot

Gender
Both Male and Female
Age
10 to 18 Years
Overall Status
Recruiting
Lead Sponsor
Novartis
Facility Type
N/A

Eligibility

Inclusion criteria:

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

More Info

Protocol Number: CICL670E2422

Contact

Emma Gonzalez
University of South Florida- South Tampa Center for Advanced Healthcare
2 Tampa General Circle
Tampa, FL 33606
Phone: 813-259-8813

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