ClinicalTrials.gg
CompletedNCT01376622Updated Oct 31, 2023

Changes in Pituitary Iron and Volume With Deferasirox

An observational study in Iron Overload, sponsored by Children's Hospital Los Angeles. Completed at 1 site in United States. Open to participants aged 2 Years to 25 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-10-31.

Sponsored by Children's Hospital Los Angeles · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
130
Ages
2 Years to 25 Years
Sex
All
01

Study 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.

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Conditions studied

  • Iron Overload

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03

In context

Iron Overload

156 studies on the registry are indexed under Iron Overload; 6 are open to participants now.

This study's enrollment of 130 is above the median of 94 across 49 observational studies indexed under Iron Overload.

Browse Iron Overload studies →

Lead sponsor

Children's Hospital Los Angeles is the lead sponsor of 152 studies on the registry; 46 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
2 Years to 25 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Transfusion Dependent Anemia

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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.
  • from legal guardian and/or patient.
  • On deferasirox for a minimum of 3 months at start of study.

Exclusion criteria

Exclusion Criteria:

  • Sickle cell disease or sickle-beta zero genotype.
  • Combination of deferasirox and another iron chelator.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
130 participants (actual)

Groups and 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.

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Study locations

1 site
  • Children's Hospital Los Angeles
    Los Angeles, California 90027, United States
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References and documents

Publications

  • 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. PubMed 20712782 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 31, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01376622
Responsible party
John C. Wood (Principal Investigator, Children's Hospital Los Angeles) — Principal investigator
First posted
Jun 20, 2011
Start date
Nov 2008
Primary completion
Jul 1, 2011
Completion
Jul 1, 2011
Last update
Oct 31, 2023

Study contacts

John C Wood, MD, PhD
principal investigator · Children's Hospital Los Angeles

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.

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