Effect of Deferasirox on Patients With Cardiac MRI T2* < 20 Msec
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|ClinicalTrials.gov Identifier: NCT00879242|
Recruitment Status : Completed
First Posted : April 9, 2009
Last Update Posted : December 12, 2016
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|Condition or disease||Intervention/treatment||Phase|
|Beta Thalassemia Transfusion Dependent||Drug: Deferasirox||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Multicenter, Open Label, Prospective Study to Evaluate the Efficacy and Safety of Deferasirox 30 mg/kg/Day for 52 Weeks, in Transfusion-dependent Beta-thalassemic Patients With Cardiac MRI T2* < 20 Msec|
|Study Start Date :||February 2009|
|Actual Primary Completion Date :||May 2011|
30 mg/kg/day. The daily dose can be increased to 40 mg/kg in case of unsatisfactory response after 12 weeks of treatment.
Dispersible tables of 125, 250 and 500 mg at the dose of 30 mg/kg/day, oral administration.
- Change from baseline in cardiac T2* value [ Time Frame: 52 weeks ]Unsatisfactory response is a monthly MRI T2* improvement lower than 3% versus baseline.
- Change from baseline in cardiac functions parameters (LVEF, LVESV and LVEDV) [ Time Frame: 52 weeks ]
- Change from baseline liver T2* value [ Time Frame: 52 weeks ]
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|Ages Eligible for Study:||10 Years and older (Child, Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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%
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00879242
|Novartis Investigative Site|
|Novartis Investigative Site|
|Study Director:||Novartis Pharmaceuticals||Novartis Pharmaceuticals|
|Responsible Party:||Novartis Pharmaceuticals|
|Other Study ID Numbers:||
EUDRACT Code :2008-003230-22
|First Posted:||April 9, 2009 Key Record Dates|
|Last Update Posted:||December 12, 2016|
|Last Verified:||November 2011|
cardiac MRI T2*
Anemia, Hemolytic, Congenital
Genetic Diseases, Inborn
Iron Chelating Agents
Molecular Mechanisms of Pharmacological Action