Changes in Pituitary Iron and Volume With Deferasirox

This study has been completed.
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by:
Children's Hospital Los Angeles
ClinicalTrials.gov Identifier:
NCT01376622
First received: June 17, 2011
Last updated: NA
Last verified: July 2010
History: No changes posted

June 17, 2011
June 17, 2011
November 2008
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No Changes Posted
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Changes in Pituitary Iron and Volume With Deferasirox
Changes in Pituitary Iron and Volume With Deferasirox in Transfusional Iron Overload

Despite continuing advances in iron chelation therapy, iron toxicity of endocrine glands, particularly the pituitary gland, remains common in patients with transfusion dependent anemias. We would like to establish accurate population norms of pituitary R2 and volume and understand the progression of pituitary iron in transfused patients on Deferasirox.

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Observational
Time Perspective: Prospective
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Non-Probability Sample

Transfusion Dependent Anemia

Iron Overload
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  • Chronically Transfusion Patients
    Patients with transfusion dependent anemia (excluding sickle cell disease), ages 2-25, on Deferasirox chelation therapy, to be monitored over 2 years.
  • Controls
    Normal controls, ages 2-25, with no known brain abnormality or endocrine dysfunction.
Wood JC, Noetzl L, Hyderi A, Joukar M, Coates T, Mittelman S. Predicting pituitary iron and endocrine dysfunction. Ann N Y Acad Sci. 2010 Aug;1202:123-8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
130
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Inclusion Criteria:

  • Currently on chronic transfusion therapy.
  • Duration of chronic transfusion >1 year.
  • Age 2 to 25 years
  • On deferasirox monotherapy for the duration of the study.
  • Informed consent from legal guardian and/or patient.
  • On deferasirox for a minimum of 3 months at start of study.

Exclusion Criteria:

  • Sickle cell disease or sickle-beta zero genotype.
  • Combination of deferasirox and another iron chelator.
Both
2 Years to 25 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01376622
CICL670AUS29T, CCI-08-00143
No
Dr. John Wood, Children's Hospital Los Angeles
Children's Hospital Los Angeles
Novartis Pharmaceuticals
Principal Investigator: John C Wood, MD, PhD Children's Hospital Los Angeles
Children's Hospital Los Angeles
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP