Status:
COMPLETED
Effect of Deferasirox on Patients With Cardiac MRI T2* < 20 Msec
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Beta Thalassemia Transfusion Dependent
Eligibility:
All Genders
10+ years
Phase:
PHASE2
Brief Summary
This study will assess the safety and efficacy of deferasirox in patients with cardiac MRI T2\* \< 20 msec.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00879242
Start Date
February 1 2009
Last Update
December 12 2016
Active Locations (2)
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1
Novartis Investigative Site
Cagliari, Italy
2
Novartis Investigative Site
Orbassano, Italy