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Completed

NCT Number: NCT00466063

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

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

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Key information

Conditions

Anemia Hematologic Diseases Hemic and Lymphatic Diseases Iron Metabolism Disorders Iron Overload Metabolic Diseases Nutritional and Metabolic Diseases

Age range

2 year–5 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of South Alabama Medical Center, Mobile, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Deferasirox

Drug

Primary outcomes

  1. Safety - renal and hepatic function monitoring.

    Time frame: 5 years

Secondary outcomes

  1. Adverse events

    Time frame: 5 years

  2. Longitudinal ferritin levels

    Time frame: 5 years

  3. Assessment of auditory and ophthalmologic status

    Time frame: 5 years

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2015
Study completion
2015
First posted
Apr 27, 2007
Registry last updated
Dec 29, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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