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
  Purpose

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
Iron Overload

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Changes in Pituitary Iron and Volume With Deferasirox in Transfusional Iron Overload

Resource links provided by NLM:


Further study details as provided by Children's Hospital Los Angeles:

Enrollment: 130
Study Start Date: November 2008
Groups/Cohorts
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.

  Eligibility

Ages Eligible for Study:   2 Years to 25 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Transfusion Dependent Anemia

Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01376622

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

Publications:
Responsible Party: Dr. John Wood, Children's Hospital Los Angeles
ClinicalTrials.gov Identifier: NCT01376622     History of Changes
Other Study ID Numbers: CICL670AUS29T, CCI-08-00143
Study First Received: June 17, 2011
Last Updated: June 17, 2011
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 16, 2014