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

A 5 Year Observational Study (Registry) of Children Aged 2 to <6 Years at Enrollment With Transfusional Hemosiderosis Treated With Deferasirox

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00466063

Enrollment

108

Registered

2007-04-27

Start date

2007-05-31

Completion date

2015-07-31

Last updated

2015-12-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anemia

Keywords

Iron overload, children, deferasirox, Transfusion-dependent anemia

Brief summary

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

Interventions

DRUGDeferasirox

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

2 Years to 5 Years

Healthy volunteers

Inclusion criteria

* History of transfusion-dependent anemia. * History of iron overload

Exclusion criteria

* Patients with non-transfusional hemosiderosis. Other protocol-defined inclusion/

Design outcomes

Primary

Measure	Time frame
Safety - renal and hepatic function monitoring.	5 years

Secondary

Measure	Time frame
Adverse events	5 years
Longitudinal ferritin levels	5 years
Assessment of auditory and ophthalmologic status	5 years

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026