Status:
COMPLETED
Endocrine Function During Deferasirox Therapy
Lead Sponsor:
University of Campania Luigi Vanvitelli
Conditions:
Iron Overload
Transfusion-dependent Thalassemia
Eligibility:
All Genders
2+ years
Brief Summary
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 pop...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 2 2016
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 30 2019
Estimated Enrollment :
426 Patients enrolled
Trial Details
Trial ID
NCT04515680
Start Date
November 2 2016
End Date
January 30 2019
Last Update
August 17 2020
Active Locations (1)
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1
Università degli Studi della Campania Luigi Vanvitelli
Naples, Italy, 80138