Endocrine Function During Deferasirox Therapy

Iron Overload Clinical Trial

Official title:

National Survey on Endocrine Function and Bone Metabolism in Transfusion--dependent Patients Treated With Deferasirox

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04515680
• Other study ID #: CICL670AIT16T
• Status: Completed
• Start date: November 2, 2016
• Est. completion date: January 30, 2019

Study information

• Verified date: August 2020
• Source: University of Campania "Luigi Vanvitelli"
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 426
• Est. completion date: January 30, 2019
• Est. primary completion date: January 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Italy	Università degli Studi della Campania Luigi Vanvitelli	Naples

Sponsors (1)

Lead Sponsor	Collaborator
University of Campania "Luigi Vanvitelli"

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline number of endocrine disorders at study completion	Absolute change in number of patients diagnosed with any endocrine disorder at the baseline and at the study completion	baseline through study completion, a minimum of 5 years