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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00466063
Recruitment Status : Completed
First Posted : April 27, 2007
Last Update Posted : December 29, 2015
Sponsor:
Information provided by (Responsible Party):

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 Phase 4

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 2007
Primary Completion Date : July 2015
Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Iron
Drug Information available for: Deferasirox
U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
ICL670
ICL670
Drug: Deferasirox


Outcome Measures

Primary Outcome Measures :
  1. Safety - renal and hepatic function monitoring. [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. Adverse events [ Time Frame: 5 years ]
  2. Longitudinal ferritin levels [ Time Frame: 5 years ]
  3. Assessment of auditory and ophthalmologic status [ Time Frame: 5 years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.
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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00466063


  Show 23 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
More Information

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00466063     History of Changes
Other Study ID Numbers: CICL670A2411
First Posted: April 27, 2007    Key Record Dates
Last Update Posted: December 29, 2015
Last Verified: December 2015

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Iron overload
children
deferasirox
Transfusion-dependent anemia

Additional relevant MeSH terms:
Iron Overload
Iron Metabolism Disorders
Metabolic Diseases
Deferasirox
Iron Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action