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Changes in Pituitary Iron and Volume With Deferasirox

Sponsor
Children's Hospital Los Angeles (Other)
Overall Status
Completed
CT.gov ID
NCT01376622
Collaborator
Novartis Pharmaceuticals (Industry)
130
Enrollment
1
Location

Study Details

Study Description

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 Intervention/Treatment Phase

    Study Design

    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 :
    Nov 1, 2008

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      2 Years to 25 Years
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      Yes
      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

      Locations

      Site City State Country Postal Code
      1 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

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      , ,
      ClinicalTrials.gov Identifier:
      NCT01376622
      Other Study ID Numbers:
      • CICL670AUS29T
      • CCI-08-00143
      First Posted:
      Jun 20, 2011
      Last Update Posted:
      Jun 20, 2011
      Last Verified:
      Jul 1, 2010
      Additional relevant MeSH terms:
      Iron Overload

      Study Results

      No Results Posted as of Jun 20, 2011