Endocrine Function During Deferasirox Therapy

Completed

• Conditions: Iron Overload; Transfusion-dependent Thalassemia; Endocrine; Complications

• Registration Number: NCT04515680
• Lead Sponsor: University of Campania "Luigi Vanvitelli"

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 population during a longer follow up and improve the quality of previous investigations.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-11-02
• Primary Completion: 2019-01-30
• Study Completion: 2019-01-30
• Status Verified: 2020-08
• Study First Submitted: 2020-08-06
• Study First Submitted QC: 2020-08-13
• Last Update Submitted: 2020-08-13
• Study First Posted: 2020-08-17
• Last Update Posted: 2020-08-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 426

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change from baseline number of endocrine disorders at study completion	baseline through study completion, a minimum of 5 years	Absolute change in number of patients diagnosed with any endocrine disorder at the baseline and at the study completion

Trial Locations

Locations (1)

Università degli Studi della Campania Luigi Vanvitelli; 🇮🇹 Naples, Italy