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

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT00466063

Collaborator

(none)

108

Enrollment

Locations

Duration (Months)

4.7

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Anemia	Drug: Deferasirox

Study Design

Study Type:

Observational

Actual Enrollment :

108 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

May 1, 2007

Actual Primary Completion Date :

Jul 1, 2015

Actual Study Completion Date :

Jul 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
ICL670 ICL670	Drug: Deferasirox

Arm

Intervention/Treatment

ICL670

Drug: Deferasirox

Outcome Measures

Primary Outcome Measures

Safety - renal and hepatic function monitoring. [5 years]

Secondary Outcome Measures

Adverse events [5 years]
Longitudinal ferritin levels [5 years]
Assessment of auditory and ophthalmologic status [5 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years to 5 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of South Alabama Medical Center	Mobile	Alabama	United States	36604
2	Children's Hospital Los Angeles	Los Angeles	California	United States	90027
3	Children's Hospital Oakland	Oakland	California	United States	94609
4	Children's Hospital of Orange County	Orange	California	United States	92868-3874
5	Stanford University Medical Center	Stanford	California	United States	94304
6	MD Anderson Cancer Center - Orlando	Orlando	Florida	United States	32806
7	St. Joseph's Children's Hospital of Tampa	Tampa	Florida	United States	33609
8	Children's Memorial Hospital	Chicago	Illinois	United States	60614-3394
9	Children's Hospital Boston	Boston	Massachusetts	United States	02115
10	Hackensack University Medical Center	Hackensack	New Jersey	United States	07601
11	St. Joseph's Children's Hospital	Paterson	New Jersey	United States	07503
12	The Brooklyn Hospital Center	Brooklyn	New York	United States	11201
13	Schneider Children's Hospital	New York	New York	United States	11040
14	SUNY - Upstate Medical University	Syracuse	New York	United States	13210
15	East Carolina University	Greenville	North Carolina	United States	27858
16	Akron Children's Hospital	Akron	Ohio	United States	44308-1062
17	Children's Medical Center	Dayton	Ohio	United States	45404
18	Oklahoma State University Health Sciences Center	Oklahoma City	Oklahoma	United States	73104
19	Penn State University / Milton S. Hershey Medical Center	Hershey	Pennsylvania	United States	17033-0850
20	St. Jude Children's Research Hospital Memphis	Memphis	Tennessee	United States	38105-2794
21	Cook's Children's Medical Center	Fort Worth	Texas	United States	76104
22	Texas Children's Hospital	Houston	Texas	United States	77030
23	Children's Hospital of the King's Daughters	Norfolk	Virginia	United States	23507