ENTRUST, a 5 Year Surveillance of Children Aged 2 to <6 Years With Transfusional Iron Overload Treated With Deferasirox

N/ACompletedNCT00466063

Novartis Pharmaceuticals108 enrolled

Overview

This registry will evaluate long-term safety and efficacy of deferasirox in children with transfusional iron overload.

Study Type

OBSERVATIONAL

Enrollment

108

Conditions

Anemia

Interventions

DeferasiroxDRUG

Eligibility

Sex: ALLMin age: 2 YearsMax age: 5 Years

Medical Language ↔ Plain English

Inclusion Criteria: * History of transfusion-dependent anemia. * History of iron overload Exclusion Criteria: * Patients with non-transfusional hemosiderosis. Other protocol-defined inclusion/exclusion criteria may apply.

Locations (23)

University of South Alabama Medical Center

Mobile, Alabama, United States

Outcomes

Primary Outcomes

Safety - renal and hepatic function monitoring.

Time frame: 5 years

Secondary Outcomes

Adverse events

Time frame: 5 years

Longitudinal ferritin levels

Time frame: 5 years

Assessment of auditory and ophthalmologic status

Time frame: 5 years

Data from ClinicalTrials.gov

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