Retrospective Evaluation of Adult and Pediatric Transfusion-dependent Patients Treated With Deferasirox Therapy

University of Campania "Luigi Vanvitelli"

Status: Completed

Conditions: Iron Overload

Study type: Observational

Funder types: Other

Identifiers

NCT01874405

DIPEDNA-2013-1

Details and patient eligibility

About

Iron overload is a leading cause of morbidity and mortality in transfusion-dependent patients. Deferasirox is the most promising iron chelator agent in several clinical scenarios. The investigators propose a retrospective study (chart review) to evaluate comprehensive iron overload management in transfusion-dependent patients treated with deferasirox for up to 5-10 years in a real clinical practice setting.

Enrollment: 80 patients

Sex: All

Ages: 2+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Transfusion- dependent patients (> 2 years);
• Ongoing deferasirox therapy during the study period;
• ≥ 2 Magnetic Resonance scans (one at baseline and at least one post baseline - as per clinical need) during study period (this criteria is not mandatory for patients undergoing only the endocrine subanalysis and participating only to the cardiac analysis);
• Available medical history including relevant clinical and laboratory data (e.g serum ferritin, liver function tests, renal function tests, endocrine parameters ) at baseline before starting deferasirox treatment

Exclusion criteria

• Non transfusion- dependent patients;
• Other chelation therapy than deferasirox;
• Absence of complete medical history as above specified