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An Epidemiological Study to Assess Iron Overload Using MRI in Patients With Transfusional Siderosis (TIMES Study)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01736540
First received: November 26, 2012
Last updated: July 29, 2016
Last verified: July 2016
Results First Received: May 28, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label
Condition: Thalassemia, Non-transfusional-dependent Thalassemia (NTDT), Myeloplastic Dysplasia (MDS), Other Anemia
Intervention: Device: MRI scan

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Magnetic Resonance Imaging (MRI) All participants were subjected to a non-invasive hepatic and cardiac MRI within 60 days of enrollment to measure iron overload.

Participant Flow:   Overall Study
    Magnetic Resonance Imaging (MRI)  
STARTED     243  
COMPLETED     228  
NOT COMPLETED     15  
Did not complete scan within 45 days                 2  
Death                 1  
Abnormal test procedure                 1  
Withdrawal by Subject                 5  
Protocol Violation                 1  
Unable to tolerate MRI; claustrophobic                 1  
No show for MRI appointment                 1  
Unable to make MRI appointment                 3  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Magnetic Resonance Imaging (MRI) All participants were subjected to a non-invasive hepatic and cardiac MRI within 60 days of enrollment to measure iron overload.

Baseline Measures
    Magnetic Resonance Imaging (MRI)  
Number of Participants  
[units: participants]
  243  
Age  
[units: Years]
Mean (Standard Deviation)
  52.8  (20.92)  
Gender  
[units: Participants]
 
Female     109  
Male     134  



  Outcome Measures
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1.  Primary:   Percentage of Participants With Cardiac and Liver Iron Overload.   [ Time Frame: 2 months ]

2.  Primary:   Cardiac Siderosis Severity   [ Time Frame: 2 months ]

3.  Secondary:   Comparison of T2* Levels to Evaluate the Severity of Iron Overload Due to Transfusion Therapy in Chelation-naïve and Chelation-treated Participant Subgroups   [ Time Frame: 2 months ]

4.  Secondary:   Comparison of Liver Iron Concentration (LIC) Levels to Evaluate Iron Overload Due to Transfusion Therapy in Chelation-naïve and Chelation-treated Participant Subgroups   [ Time Frame: 2 months ]

5.  Secondary:   Mean Serum Ferritin According to the Presence or Absence of Retrospective Cardiac Events   [ Time Frame: 12 months - retrospective ]

6.  Secondary:   Mean Serum Ferritin According to the Presence or Absence of Retrospective Hepatic Events   [ Time Frame: 12 months - retrospective ]

7.  Secondary:   Mean Cardiac T2* According to the Presence or Absence of Retrospective Cardiac Events   [ Time Frame: 12 months - retrospective ]

8.  Secondary:   Mean LIC According to the Presence or Absence of Retrospective Hepatic Events   [ Time Frame: 12 months - retrospective ]

9.  Secondary:   Percentage of Participants Transfused With Erythrocytes   [ Time Frame: 12 months - retrospective ]

10.  Secondary:   Percentage of Participants With Time Since Most Recent Transfuison of <7 Days, 7 to < 14 Days, 14 to < 30 Days, 30 to < 60 Days or >= 60 Days   [ Time Frame: 12 months - retrospective ]

11.  Secondary:   Mean Number of Erythrocyte Units Transfused in Last 12 Months   [ Time Frame: 12 months - retrospective ]

12.  Secondary:   Mean Quality of Life (QOL) Scores   [ Time Frame: 1 month ]

13.  Secondary:   Percentage of Participants With Low Medium or High Adherence to Iron Chelator Therapy   [ Time Frame: 1 month ]

14.  Secondary:   Investigator Treatment Decisions Based on MRI Results   [ Time Frame: 2 months ]

15.  Secondary:   Mean Blood Magnetic Susceptibility (BMS)   [ Time Frame: 1 month ]
Results not yet reported.   Anticipated Reporting Date:   12/2016   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Study Director
Organization: Novartis
phone: 862-778-8300



Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01736540     History of Changes
Other Study ID Numbers: CICL670AAU05
Study First Received: November 26, 2012
Results First Received: May 28, 2016
Last Updated: July 29, 2016
Health Authority: Australia: Human Research Ethics Committee
United States: Food and Drug Administration