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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00879242
Recruitment Status : Completed
First Posted : April 9, 2009
Last Update Posted : December 12, 2016
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
This study will assess the safety and efficacy of deferasirox in patients with cardiac MRI T2* < 20 msec.

Condition or disease Intervention/treatment Phase
Beta Thalassemia Transfusion Dependent Drug: Deferasirox Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Thalassemia
Drug Information available for: Deferasirox

Arm Intervention/treatment
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.
Drug: Deferasirox
Dispersible tables of 125, 250 and 500 mg at the dose of 30 mg/kg/day, oral administration.

Primary Outcome Measures :
  1. Change from baseline in cardiac T2* value [ Time Frame: 52 weeks ]
    Unsatisfactory response is a monthly MRI T2* improvement lower than 3% versus baseline.

Secondary Outcome Measures :
  1. Change from baseline in cardiac functions parameters (LVEF, LVESV and LVEDV) [ Time Frame: 52 weeks ]
  2. Change from baseline liver T2* value [ Time Frame: 52 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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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

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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT00879242

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Novartis Investigative Site
Cagliari, Italy
Novartis Investigative Site
Orbassano, Italy
Sponsors and Collaborators
Novartis Pharmaceuticals
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Publications of Results:
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Responsible Party: Novartis Pharmaceuticals Identifier: NCT00879242    
Other Study ID Numbers: CICL670AIT07
EUDRACT Code :2008-003230-22
First Posted: April 9, 2009    Key Record Dates
Last Update Posted: December 12, 2016
Last Verified: November 2011
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
cardiac MRI T2*
Additional relevant MeSH terms:
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Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Hematologic Diseases
Genetic Diseases, Inborn
Iron Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action