Magnetic Resonance Imaging (MRI) Assessments of the Heart and Liver Iron Load in Patients With Transfusion Induced Iron Overload

Phase 4

Completed

• Conditions: Hemoglobinopathies; Myelodysplastic Syndromes; Other Inherited or Acquired Anaemia; MPD Syndrome; Diamond-Blackfan Anemia; Other Rare Anaemias; Transfusional Iron Overload
• Interventions: Drug: deferasirox

• Registration Number: NCT00673608
• Lead Sponsor: Novartis

Brief Summary

This study will evaluate the change in cardiac iron load over a 53 week period measured by MRI in 2 cohorts of patients

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11
• Study First Submitted: 2008-05-05
• Study First Submitted QC: 2008-05-06
• Study First Posted: 2008-05-07
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-20
• Last Update Posted: 2017-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 118

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Deferasirox	deferasirox	-

Primary Outcome Measures

Name	Time	Method
Change in cardiac iron load and cardiac ejection fraction by MRI recorded at baseline and after 53 weeks.	12 months

Secondary Outcome Measures

Name	Time	Method
Change in cardiac T2* from baseline to 53 weeks in the MDS and other anaemias subgroup, compared to the thalassaemia subgroup.	12 months
Changes in serum ferritin from baseline values to 53 weeks.	12 months
Changes in Liver Iron Content (LIC) by MRI from baseline values to 53 weeks	12 months
The relationship between the dosing regimen of Exjade® and changes in cardiac T2* and LIC R2 MRI	12 months
Changes in markers of iron load levels between baseline and 53 weeks.	12 months
The safety and tolerability of deferasirox therapy from baseline to 53 weeks	12 months
Change in ventricular ejection fraction values, ventricular volumes and masses from baseline values after 53 weeks.	12 months

Trial Locations

Locations (1)

Novarts Investigative Site; 🇦🇺 Sydney, Australia