NCT04515680

Completed

Endocrine Function During Deferasirox Therapy

University of Campania Luigi Vanvitelli Source

Compare

Other study identifiers

Sponsor study identifier

CICL670AIT16T

Study Type

observational

Actual enrollment (reported)

426

Locations

1 country

Sites

1

Timeline

Study Start

November 2, 2016

Actual (reported)

Primary Completion

January 30, 2019

Actual (reported)

Study Completion

January 30, 2019

Actual (reported)

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 426 participants
Study completion date: January 30, 2019
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
November 2, 2016
Actual (reported)
Primary Completion
January 30, 2019
Actual (reported)
Study Completion
January 30, 2019
Actual (reported)
First Submitted
August 6, 2020
Actual (reported)
First Posted
August 17, 2020
Actual (reported)

Last Updated: August 17, 2020
Status Verified: August 2020
Last Update Submitted: August 13, 2020

Conditions

Endocrine; Complications Iron Overload Transfusion-dependent Thalassemia

Outcome Measures

Primary Outcomes (1)

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

Eligibility Criteria

Age2 Years+

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

Sampling MethodProbability Sample

Study Population

All consecutive patients visited at the participating sites since September 2009 were recruited into the cohort provided the inclusion criteria were met: affected by TDT and on deferasirox monotherapy during the study period.

You may qualify if:

Adult and pediatric patients with transfusion---dependent thalassemia;

Sponsors & Collaborators

University of Campania Luigi Vanvitelli
Otherlead

Study Sites (1)

Università degli Studi della Campania Luigi Vanvitelli

Naples, 80138, Italy

MeSH Terms

Conditions

Iron Overload

Condition Hierarchy (Ancestors)

Iron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Enrollment

426 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: OTHER
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Prof.

Study Record Dates

First Submitted

August 6, 2020

First Posted

August 17, 2020

Study Start

November 2, 2016

Actual (reported)

NCT00447694

Cardiac T2* in Beta-thalassemia Patients on Deferasirox Treatment

Phase 2Completed

NCT01376622

Changes in Pituitary Iron and Volume With Deferasirox

Completed

NCT02425956

Non-invasive Quantification of Liver Iron With MRI

Not ApplicableCompleted

NCT02474420

Amlodipine as Adjuvant Treatment to Iron Chelation for Prevention of Cardiac Iron Overload in Thalassemia Patients

Not ApplicableUnknown

NCT06137079

"Iron Overload and Endocrinological Diseases"

Unknown

NCT00654589

Efficacy and Safety of Oral Deferasirox (20 mg/kg/d) in Pts 3 to 6 Months After Allogeneic Hematopoietic Cell Transplantation Who Present With Iron Overload

Phase 4Completed

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Primary Completion

January 30, 2019

Actual (reported)

Study Completion

January 30, 2019

Actual (reported)

Last Updated

August 17, 2020

Record last verified: 2020-08

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT04515680
Data provider: ClinicalTrials.gov
Source updated: 2020-08-17
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:29:26 UTC

Locations

IT(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations