Overview

Effect of Deferasirox on Patients With Cardiac MRI T2* < 20 Msec

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
Summary
This study will assess the safety and efficacy of deferasirox in patients with cardiac MRI T2* < 20 msec.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Novartis Pharmaceuticals
Treatments:
Deferasirox
Criteria
Inclusion Criteria:

- β-thalassemic patients receiving regular transfusions with an history of at least 20
transfusional events

- Patients naïve for deferasirox

- Serum ferritin levels ≥1000ng/ml (average of the last 6 months assays);

- Cardiac MRI T2* >5 and <20 msec.

- LVEF at MRI ≥56%

Exclusion Criteria:

- Patients that have already started deferasirox therapy

- Existing contraindications to the performance of MRI procedure, including presence of
metallic prostheses not compatible with the MRI procedure other than those approved as
safe for use in MRI scanners (e.g., some types of aneurysm clips, shrapnel in
proximity to vital organs such as the retina), pacemaker, intractable claustrophobia
and incapability to follow the instruction for the correct performance of the MRI
(e.g. to maintain a supine position, to hold breath, etc.)

- Clinical conditions requiring intensive chelating therapy on the basis of
Investigator's judgment

- Stable average ALT levels >300 U/L in the preceding 12 months

- Uncontrolled systemic hypertension

- Estimated creatinine clearance <60 ml/min

- History of nephrotic syndrome

- History of clinically significant ocular toxicity related to the chelating therapy

- Psychiatric disorders or drug dependence that might impair the capability of the
patient to provide their Informed Consent or to be administered the study treatment

- Known sensitivity to study drug(s) or class of study drug(s)

- Patients with severe medical condition(s) that in the view of the investigator
prohibits participation in the study

- Use of any other investigational agent in the last 30 days.

Other protocol-defined inclusion/exclusion criteria may apply.