Changes in Pituitary Iron and Volume 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. Identifier: NCT01376622
Recruitment Status : Completed
First Posted : June 20, 2011
Last Update Posted : June 20, 2011
Novartis Pharmaceuticals
Information provided by:
Children's Hospital Los Angeles

Brief Summary:
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.

Condition or disease
Iron Overload

Study Type : Observational
Actual Enrollment : 130 participants
Time Perspective: Prospective
Official Title: Changes in Pituitary Iron and Volume With Deferasirox in Transfusional Iron Overload
Study Start Date : November 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Deferasirox
U.S. FDA Resources

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.
Normal controls, ages 2-25, with no known brain abnormality or endocrine dysfunction.

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   2 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Transfusion Dependent Anemia

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.

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 identifier (NCT number): NCT01376622

United States, California
Children's Hospital Los Angeles
Los Angeles, California, United States, 90027
Sponsors and Collaborators
Children's Hospital Los Angeles
Novartis Pharmaceuticals
Principal Investigator: John C Wood, MD, PhD Children's Hospital Los Angeles

Publications of Results:
Responsible Party: Dr. John Wood, Children's Hospital Los Angeles Identifier: NCT01376622     History of Changes
Other Study ID Numbers: CICL670AUS29T
CCI-08-00143 ( Other Identifier: Committee on Clinical Investigations )
First Posted: June 20, 2011    Key Record Dates
Last Update Posted: June 20, 2011
Last Verified: July 2010

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