ENTRUST, a 5 Year Surveillance of Children Aged 2 to <6 Years With Transfusional Iron Overload Treated With Deferasirox
- Registration Number
- NCT00466063
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
This registry will evaluate long-term safety and efficacy of deferasirox in children with transfusional iron overload.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 108
- History of transfusion-dependent anemia.
- History of iron overload
- Patients with non-transfusional hemosiderosis.
Other protocol-defined inclusion/exclusion criteria may apply.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description ICL670 Deferasirox ICL670
- Primary Outcome Measures
Name Time Method Safety - renal and hepatic function monitoring. 5 years
- Secondary Outcome Measures
Name Time Method Longitudinal ferritin levels 5 years Adverse events 5 years Assessment of auditory and ophthalmologic status 5 years
Trial Locations
- Locations (23)
East Carolina University
🇺🇸Greenville, North Carolina, United States
Children's Hospital of Orange County
🇺🇸Orange, California, United States
Children's Hospital Oakland
🇺🇸Oakland, California, United States
Cook's Children's Medical Center
🇺🇸Fort Worth, Texas, United States
Children's Hospital Boston
🇺🇸Boston, Massachusetts, United States
Texas Children's Hospital
🇺🇸Houston, Texas, United States
MD Anderson Cancer Center - Orlando
🇺🇸Orlando, Florida, United States
SUNY - Upstate Medical University
🇺🇸Syracuse, New York, United States
Akron Children's Hospital
🇺🇸Akron, Ohio, United States
Children's Medical Center
🇺🇸Dayton, Ohio, United States
St. Jude Children's Research Hospital Memphis
🇺🇸Memphis, Tennessee, United States
Penn State University / Milton S. Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
St. Joseph's Children's Hospital of Tampa
🇺🇸Tampa, Florida, United States
Oklahoma State University Health Sciences Center
🇺🇸Oklahoma City, Oklahoma, United States
Hackensack University Medical Center
🇺🇸Hackensack, New Jersey, United States
University of South Alabama Medical Center
🇺🇸Mobile, Alabama, United States
Children's Hospital Los Angeles
🇺🇸Los Angeles, California, United States
Stanford University Medical Center
🇺🇸Stanford, California, United States
Children's Memorial Hospital
🇺🇸Chicago, Illinois, United States
St. Joseph's Children's Hospital
🇺🇸Paterson, New Jersey, United States
Schneider Children's Hospital
🇺🇸New York, New York, United States
The Brooklyn Hospital Center
🇺🇸Brooklyn, New York, United States
Children's Hospital of the King's Daughters
🇺🇸Norfolk, Virginia, United States