Skip to main content
OpenTrials
Completed

NCT Number: NCT04515680

Endocrine Function During Deferasirox Therapy

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

2 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Università degli Studi della Campania Luigi Vanvitelli

Naples, 80138, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Change from baseline number of endocrine disorders at study completion

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Campania Luigi Vanvitelli

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Aug 17, 2020
Registry last updated
Aug 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.