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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00466063
First received: April 25, 2007
Last updated: October 28, 2013
Last verified: October 2013
  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 4

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Safety - renal and hepatic function monitoring. [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Adverse events [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Longitudinal ferritin levels [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Assessment of auditory and ophthalmologic status [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 200
Study Start Date: May 2007
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)

  Eligibility

Ages Eligible for Study:   2 Years to 5 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00466063     History of Changes
Other Study ID Numbers: CICL670A2411
Study First Received: April 25, 2007
Last Updated: October 28, 2013
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 - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
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

Additional relevant MeSH terms:
Deferasirox
Iron Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 19, 2014