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

This study is currently recruiting participants.

Verified by Novartis, December 2008

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00466063

Purpose

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

Condition	Intervention	Phase
Anemia	Drug: Deferasirox	Phase IV

MedlinePlus related topics: Anemia

Drug Information available for: Deferasirox

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

Further study details as provided by Novartis:

Primary Outcome Measures:

Secondary Outcome Measures:

Estimated Enrollment:	200
Study Start Date:	May 2007
Estimated Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

Other protocol-defined inclusion/exclusion criteria may apply.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00466063

Contacts

Contact: Novartis

41 61 324 1111

Locations

United States, Alabama
	Recruiting
Mobile, Alabama, United States, 36604
United States, California
	Recruiting
Oakland, California, United States, 94609
	Recruiting
Stanford, California, United States, 94304
	Recruiting
Orange, California, United States, 92868-3874
United States, Illinois
	Recruiting
Chicago, Illinois, United States, 60614-3394
United States, Louisiana
	Recruiting
Shreveport, Louisiana, United States, 71130
United States, Massachusetts
	Recruiting
Boston, Massachusetts, United States, 02115
United States, New Jersey
	Recruiting
Hackensack, New Jersey, United States, 07601
	Recruiting
Paterson, New Jersey, United States, 07503
United States, New York
	Recruiting
New York, New York, United States, 10021
	Recruiting
Syracuse, New York, United States, 13210
United States, Ohio
	Recruiting
Akron, Ohio, United States, 44308-1062
	Active, not recruiting
Cincinnati, Ohio, United States, 45229-3039
United States, Pennsylvania
	Recruiting
Hershey, Pennsylvania, United States, 17033-0850
	Active, not recruiting
Philadelphia, Pennsylvania, United States, 19104

Sponsors and Collaborators

Novartis

Investigators

Study Chair:

Novartis

More Information

Responsible Party:	Novartis ( External Affairs )
Study ID Numbers:	CICL670A2411
Study First Received:	April 25, 2007
Last Updated:	December 15, 2008
ClinicalTrials.gov Identifier:	NCT00466063
Health Authority:	United States: Food and Drug Administration; United Kingdom: Medicines and Healthcare Products Regulatory Agency; Turkey: Ministry of Health; Thailand: Food and Drug Administration; Spain: Spanish Agency of Medicines; Malaysia: National Pharmaceutical Control Bureau; Italy: The Italian Medicines Agency; Greece: National Organization of Medicines; France: Afssaps - French Health Products Safety Agency; Egypt: Ministry of Health and Population; Canada: Therapeutic Products Directorate; Brazil: National Health Surveillance Agency; Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by Novartis:

Iron overload
children
deferasirox
Transfusion-dependent anemia

Study placed in the following topic categories:

Metabolic Diseases
Deferasirox
Hematologic Diseases
Hemosiderosis
Anemia

Iron Metabolism Disorders
Iron Overload
Metabolic disorder
Iron

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Iron Chelating Agents
Chelating Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009