Endocrine Function During Deferasirox Therapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

426 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-11-02

Study Completion Date

2019-01-30

Brief Summary

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A national survey on the prevalence and natural history of endocrine complications in thalassemia transfusion--dependent patients treated with deferasirox was designed, in order to assess a larger population during a longer follow up and improve the quality of previous investigations.

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Detailed Description

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Conditions

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Iron Overload Transfusion-dependent Thalassemia Endocrine; Complications

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Eligibility Criteria

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Inclusion Criteria

* Adult and pediatric patients with transfusion---dependent thalassemia;
* Chelation with deferasirox as assigned chelation therapy;
* Available medical history including relevant clinical data (age at start of transfusion regimen, age at start of chelation therapy, prior chelation therapy, concomitant diseases and concomitant treatments, including hormonal replacement treatments if appropriate) and laboratory data (e.g TSH, FT3 and FT4, fasting serum glucose, OGTT serum glucose, bone mineral density z---score, T---score, g/cm2, PTH, FSH, LH, testosterone and estradiol, serum ferritin, liver function tests,renal function tests, MRI T2\* value) at baseline and at the end of study

Exclusion Criteria

* Non transfusion- dependent patients;
* Other chelation therapy than deferasirox or combination with other chelators during the observation;
* Absence of complete medical history as above specified

Minimum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No