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

December 26, 2015 updated by: Novartis Pharmaceuticals

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

108

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Mobile, Alabama, United States, 36604
        • University of South Alabama Medical Center
    • California
      • Los Angeles, California, United States, 90027
        • Children's Hospital Los Angeles
      • Oakland, California, United States, 94609
        • Children's Hospital Oakland
      • Orange, California, United States, 92868-3874
        • Children's Hospital of Orange County
      • Stanford, California, United States, 94304
        • Stanford University Medical Center
    • Florida
      • Orlando, Florida, United States, 32806
        • MD Anderson Cancer Center - Orlando
      • Tampa, Florida, United States, 33609
        • St. Joseph's Children's Hospital of Tampa
    • Illinois
      • Chicago, Illinois, United States, 60614-3394
        • Children's Memorial Hospital
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Children's Hospital Boston
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Hackensack University Medical Center
      • Paterson, New Jersey, United States, 07503
        • St. Joseph's Children's Hospital
    • New York
      • Brooklyn, New York, United States, 11201
        • The Brooklyn Hospital Center
      • New York, New York, United States, 11040
        • Schneider Children's Hospital
      • Syracuse, New York, United States, 13210
        • SUNY - Upstate Medical University
    • North Carolina
      • Greenville, North Carolina, United States, 27858
        • East Carolina University
    • Ohio
      • Akron, Ohio, United States, 44308-1062
        • Akron Children's Hospital
      • Dayton, Ohio, United States, 45404
        • Children's Medical Center
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Oklahoma State University Health Sciences Center
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033-0850
        • Penn State University / Milton S. Hershey Medical Center
    • Tennessee
      • Memphis, Tennessee, United States, 38105-2794
        • St. Jude Children's Research Hospital Memphis
    • Texas
      • Fort Worth, Texas, United States, 76104
        • Cook's Children's Medical Center
      • Houston, Texas, United States, 77030
        • Texas Children's Hospital
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Children's Hospital of The King's Daughters

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 5 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

200 unselected children aged from 2 to <6 years at enrolment with chronic iron overload due to repeated blood transfusions. The participating countries were selected on the basis of both a high incidence of young children with thalassemia or other transfusion dependent anemias and on the basis that the drug is approved and 'on the market' in the country selected.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
ICL670
Drug: Deferasirox

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety - renal and hepatic function monitoring.
Time Frame: 5 years
5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Adverse events
Time Frame: 5 years
5 years
Longitudinal ferritin levels
Time Frame: 5 years
5 years
Assessment of auditory and ophthalmologic status
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

April 25, 2007

First Submitted That Met QC Criteria

April 25, 2007

First Posted (Estimate)

April 27, 2007

Study Record Updates

Last Update Posted (Estimate)

December 29, 2015

Last Update Submitted That Met QC Criteria

December 26, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CICL670A2411

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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