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
1 other identifier
observational
108
1 country
23
Brief Summary
This registry will evaluate long-term safety and efficacy of deferasirox in children with transfusional iron overload.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started May 2007
Longer than P75 for all trials
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 25, 2007
CompletedFirst Posted
Study publicly available on registry
April 27, 2007
CompletedStudy Start
First participant enrolled
May 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2015
CompletedDecember 29, 2015
December 1, 2015
8.2 years
April 25, 2007
December 26, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety - renal and hepatic function monitoring.
5 years
Secondary Outcomes (3)
Adverse events
5 years
Longitudinal ferritin levels
5 years
Assessment of auditory and ophthalmologic status
5 years
Study Arms (1)
ICL670
ICL670
Interventions
Eligibility Criteria
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.
You may qualify if:
- History of transfusion-dependent anemia.
- History of iron overload
You may not qualify if:
- Patients with non-transfusional hemosiderosis.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (23)
University of South Alabama Medical Center
Mobile, Alabama, 36604, United States
Children's Hospital Los Angeles
Los Angeles, California, 90027, United States
Children's Hospital Oakland
Oakland, California, 94609, United States
Children's Hospital of Orange County
Orange, California, 92868-3874, United States
Stanford University Medical Center
Stanford, California, 94304, United States
MD Anderson Cancer Center - Orlando
Orlando, Florida, 32806, United States
St. Joseph's Children's Hospital of Tampa
Tampa, Florida, 33609, United States
Children's Memorial Hospital
Chicago, Illinois, 60614-3394, United States
Children's Hospital Boston
Boston, Massachusetts, 02115, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
St. Joseph's Children's Hospital
Paterson, New Jersey, 07503, United States
The Brooklyn Hospital Center
Brooklyn, New York, 11201, United States
Schneider Children's Hospital
New York, New York, 11040, United States
SUNY - Upstate Medical University
Syracuse, New York, 13210, United States
East Carolina University
Greenville, North Carolina, 27858, United States
Akron Children's Hospital
Akron, Ohio, 44308-1062, United States
Children's Medical Center
Dayton, Ohio, 45404, United States
Oklahoma State University Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
Penn State University / Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033-0850, United States
St. Jude Children's Research Hospital Memphis
Memphis, Tennessee, 38105-2794, United States
Cook's Children's Medical Center
Fort Worth, Texas, 76104, United States
Texas Children's Hospital
Houston, Texas, 77030, United States
Children's Hospital of the King's Daughters
Norfolk, Virginia, 23507, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 25, 2007
First Posted
April 27, 2007
Study Start
May 1, 2007
Primary Completion
July 1, 2015
Study Completion
July 1, 2015
Last Updated
December 29, 2015
Record last verified: 2015-12