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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
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Tracking Information
First Submitted Date  ICMJE April 8, 2009
First Posted Date  ICMJE April 9, 2009
Last Update Posted Date December 12, 2016
Study Start Date  ICMJE February 2009
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 14, 2011)
Change from baseline in cardiac T2* value [ Time Frame: 52 weeks ]
Unsatisfactory response is a monthly MRI T2* improvement lower than 3% versus baseline.
Original Primary Outcome Measures  ICMJE
 (submitted: April 8, 2009)
Change from baseline in cardiac T2* value [ Time Frame: 52 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 8, 2009)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Effect of Deferasirox on Patients With Cardiac MRI T2* < 20 Msec
Official Title  ICMJE 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
Brief Summary This study will assess the safety and efficacy of deferasirox in patients with cardiac MRI T2* < 20 msec.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Beta Thalassemia Transfusion Dependent
Intervention  ICMJE Drug: Deferasirox
Dispersible tables of 125, 250 and 500 mg at the dose of 30 mg/kg/day, oral administration.
Study Arms  ICMJE Experimental: Deferasirox
30 mg/kg/day. The daily dose can be increased to 40 mg/kg in case of unsatisfactory response after 12 weeks of treatment.
Intervention: Drug: Deferasirox
Publications * Piga A, Longo F, Origa R, Roggero S, Pinna F, Zappu A, Castiglioni C, Cappellini MD. Deferasirox for cardiac siderosis in beta-thalassaemia major: a multicentre, open label, prospective study. Br J Haematol. 2014 Nov;167(3):423-6. doi: 10.1111/bjh.12987. Epub 2014 Jun 30. No abstract available.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 14, 2011)
Original Estimated Enrollment  ICMJE
 (submitted: April 8, 2009)
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 10 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00879242
Other Study ID Numbers  ICMJE CICL670AIT07
EUDRACT Code :2008-003230-22
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Novartis ( Novartis Pharmaceuticals )
Original Responsible Party External Affairs, Novartis Pharmaceuticals
Current Study Sponsor  ICMJE Novartis Pharmaceuticals
Original Study Sponsor  ICMJE Novartis
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
PRS Account Novartis
Verification Date November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP