ENTRUST, a 5 Year Surveillance of Children Aged 2 to <6 Y... | NCT00466063

Status Module

Record Verification Date

Dec 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2007

Primary Completion Date

Jul 2015Actual

Completion Date

Jul 2015Actual

First Submitted Date

Apr 25, 2007

First Submission Date that Met QC Criteria

Apr 25, 2007

First Posted Date

Apr 27, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 26, 2015

Last Update Posted Date

Dec 29, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

108Actual

Label	Type	Description	Intervention Names
ICL670		ICL670	Drug: Deferasirox

Name	Type	Description	Arm Group Labels	Other Names
Deferasirox	Drug		ICL670

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety - renal and hepatic function monitoring.		5 years

Secondary Outcomes

Measure	Description	Time Frame
Adverse events		5 years
Longitudinal ferritin levels		5 years
Assessment of auditory and ophthalmologic status

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Years

Maximum Age

5 Years

Standard Ages

Child

Study Population

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Novartis Pharmaceuticals	Novartis Pharmaceuticals	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of South Alabama Medical Center		Mobile	Alabama	36604	United States
Children's Hospital Los Angeles

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

MeSH Terms

ID	Term
D000740	Anemia
D019190	Iron Overload

ID	Term
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases
D019189	Iron Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

ID	Term
D000077588	Deferasirox

Ancestor Terms

ID	Term
D001565	Benzoates
D000146	Acids, Carbocyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals
D001555	Benzene Derivatives
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D014230	Triazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds