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NCT01376622 Clinical Trial

Changes in Pituitary Iron and Volume With Deferasirox

Iron Overload Clinical Trial

Official title:
Changes in Pituitary Iron and Volume With Deferasirox in Transfusional Iron Overload

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01376622
Other study ID # CCI-08-00143
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 2008
Est. completion date July 1, 2011

Study information
Verified date October 2023
Source Children's Hospital Los Angeles
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 130
Est. completion date July 1, 2011
Est. primary completion date July 1, 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 2 Years to 25 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Children's Hospital Los Angeles Los Angeles California

Sponsors (2)
Lead Sponsor Collaborator
Children's Hospital Los Angeles Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. doi: 10.1111/j.1749-6632.2010.05545.x. — View Citation

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