Endocrine Function During Deferasirox Therapy

Sponsor
University of Campania "Luigi Vanvitelli" (Other)
Overall Status
Completed
CT.gov ID
NCT04515680
Collaborator
(none)
426
1
26.9
15.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    426 participants
    Observational Model:
    Cohort
    Time Perspective:
    Other
    Official Title:
    National Survey on Endocrine Function and Bone Metabolism in Transfusion--dependent Patients Treated With Deferasirox
    Actual Study Start Date :
    Nov 2, 2016
    Actual Primary Completion Date :
    Jan 30, 2019
    Actual Study Completion Date :
    Jan 30, 2019

    Outcome Measures

    Primary Outcome Measures

    1. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    2 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Università degli Studi della Campania Luigi Vanvitelli Naples Italy 80138

    Sponsors and Collaborators

    • University of Campania "Luigi Vanvitelli"

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Silverio Perrotta, Prof., University of Campania "Luigi Vanvitelli"
    ClinicalTrials.gov Identifier:
    NCT04515680
    Other Study ID Numbers:
    • CICL670AIT16T
    First Posted:
    Aug 17, 2020
    Last Update Posted:
    Aug 17, 2020
    Last Verified:
    Aug 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 17, 2020