Endocrine Function During Deferasirox Therapy

NCT04515680 | Completed DMC

• 1 other identifier: CICL670AIT16T
• Study Type: observational
• Target: 426
• Locations: 1 country
• Sites: 1

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.

Conditions

Iron Overload; Transfusion-dependent Thalassemia; Endocrine; Complications

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

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability 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;
• 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

Sponsors & Collaborators

• University of Campania Luigi Vanvitelli: lead

Study Sites (1)

Università degli Studi della Campania Luigi Vanvitelli

Naples, 80138, Italy

Location

MeSH Terms

Conditions

Iron Overload

Condition Hierarchy (Ancestors)

Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

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
• Primary Completion: January 30, 2019
• Study Completion: January 30, 2019
• Last Updated: August 17, 2020

Record last verified: 2020-08

Locations

IT (1)