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NCT00466063 Clinical Trial

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

Anemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00466063
Other study ID # CICL670A2411
Secondary ID
Status Completed
Phase Phase 4
First received April 25, 2007
Last updated December 26, 2015
Start date May 2007
Est. completion date July 2015

Study information
Verified date December 2015
Source Novartis
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyTurkey: Ministry of HealthThailand: Food and Drug AdministrationSpain: Spanish Agency of MedicinesMalaysia: National Pharmaceutical Control BureauItaly: The Italian Medicines AgencyGreece: National Organization of MedicinesFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Egypt: Ministry of Health and PopulationCanada: Therapeutic Products DirectorateBrazil: National Health Surveillance AgencyBelgium: Federal Agency for Medicinal Products and Health Products
Study type Observational

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 108
Est. completion date July 2015
Est. primary completion date July 2015
Accepts healthy volunteers No
Gender Both
Age group 2 Years to 5 Years
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Drug:
• Deferasirox

Locations
Country Name City State
United States Akron Children's Hospital Akron Ohio
United States Children's Hospital Boston Boston Massachusetts
United States The Brooklyn Hospital Center Brooklyn New York
United States Children's Memorial Hospital Chicago Illinois
United States Children's Medical Center Dayton Ohio
United States Cook's Children's Medical Center Fort Worth Texas
United States East Carolina University Greenville North Carolina
United States Hackensack University Medical Center Hackensack New Jersey
United States Penn State University / Milton S. Hershey Medical Center Hershey Pennsylvania
United States Texas Children's Hospital Houston Texas
United States Children's Hospital Los Angeles Los Angeles California
United States St. Jude Children's Research Hospital Memphis Memphis Tennessee
United States University of South Alabama Medical Center Mobile Alabama
United States Schneider Children's Hospital New York New York
United States Children's Hospital of the King's Daughters Norfolk Virginia
United States Children's Hospital Oakland Oakland California
United States Oklahoma State University Health Sciences Center Oklahoma City Oklahoma
United States Children's Hospital of Orange County Orange California
United States MD Anderson Cancer Center - Orlando Orlando Florida
United States St. Joseph's Children's Hospital Paterson New Jersey
United States Stanford University Medical Center Stanford California
United States SUNY - Upstate Medical University Syracuse New York
United States St. Joseph's Children's Hospital of Tampa Tampa Florida

Sponsors (1)
Lead Sponsor Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Safety - renal and hepatic function monitoring. 5 years Yes
Secondary Adverse events 5 years Yes
Secondary Longitudinal ferritin levels 5 years No
Secondary Assessment of auditory and ophthalmologic status 5 years Yes
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