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    Clinical Trial Results:
    A 48-week, Open-label, 2-arm, Parallel-group, Randomized Exploratory Study to Assess Liver Iron Concentration Measured by FerriScan® (R2) Magnetic Resonance Imaging in Beta-thalassemia Subjects Administered SPD602 (SSP-004184AQ) or Exjade® (deferasirox) for Treatment of Chronic Transfusional Iron Overload

    Summary
    EudraCT number
    		 2013-000743-33
    Trial protocol
    		 BE   GB   GR   IT  
    Global end of trial date
    15 Jul 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    05 Apr 2019
    First version publication date
    05 Apr 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    SPD602-204
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01927913
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Shire
    Sponsor organisation address
    300 Shire Way, Lexington, United States, MA 02421
    Public contact
    Study Director, Shire, ClinicalTransparency@shire.com
    Scientific contact
    Study Director, Shire, ClinicalTransparency@shire.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    15 Jul 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    15 Jul 2014
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The main objective of this trial was to assess change in liver iron concentration (LIC) from baseline utilizing FerriScan® (R2) magnetic resonance imaging (MRI) in subjects with transfusional iron overload receiving SPD602 (SSP-004184AQ) or deferasirox whose primary diagnosis is beta-thalassemia. Study was withdrawn with 0 participants. Sponsor followed EMA's advice and contacted NCAs to enter comment that no participants were recruited. There is still no EudraCT functionality to inform the public that recruitment never started. '999999' was entered in Population of Trial Subjects section since '0' could not be entered due to EudraCT system constraints.
    Protection of trial subjects
    This study was conducted in accordance with International Conference on Harmonization (ICH) Good Clinical Practice, the principles of the Declaration of Helsinki, as well as other applicable local ethical and legal requirements. Study was withdrawn with 0 participants. Sponsor followed EMA's advice and contacted NCAs to enter comment that no participants were recruited. There is still no EudraCT functionality to inform the public that recruitment never started. '999999' was entered in Population of Trial Subjects section since '0' could not be entered due to EudraCT system constraints.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    15 Jul 2014
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Belgium: 999999
    Worldwide total number of subjects
    999999
    EEA total number of subjects
    999999
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    999999
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Study was withdrawn with 0 participants. Sponsor followed EMA's advice and contacted NCAs to enter comment that no participants were recruited. There is still no EudraCT functionality to inform the public that recruitment never started.

    Period 1
    Period 1 title
    Period 1 (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 SPD602
    Arm description
    		 Study was withdrawn with 0 participants. Sponsor followed EMA's advice and contacted NCAs to enter comment that no participants were recruited. There is still no EudraCT functionality to inform the public that recruitment never started. '99999' was entered since '0' could not be entered due to EudraCT system constraints.
    Arm type
    		 Experimental

    Investigational medicinal product name
    SPD602
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    16-75 mg/kg/day

    Arm title
    		 Deferasirox
    Arm description
    		 Study was withdrawn with 0 participants. Sponsor followed EMA's advice and contacted NCAs to enter comment that no participants were recruited. There is still no EudraCT functionality to inform the public that recruitment never started. '99999' was entered since '0' could not be entered due to EudraCT system constraints.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Deferasirox
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Per approved country specific label

    Number of subjects in period 1 [1]
    		SPD602 Deferasirox
    Started
    99999
    99999
    Completed
    0
    0
    Not completed
    99999
    99999
         Study was withdrawn with 0 participants
    99999
    99999
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: Study was withdrawn with 0 participants. Sponsor followed EMA's advice and contacted NCAs to enter comment that no participants were recruited. There is still no EudraCT functionality to inform the public that recruitment never started. '99999' was entered for Number of Subjects for each arm since '0' could not be entered due to EudraCT system constraints.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    SPD602
    Reporting group description
    		 Study was withdrawn with 0 participants. Sponsor followed EMA's advice and contacted NCAs to enter comment that no participants were recruited. There is still no EudraCT functionality to inform the public that recruitment never started. '99999' was entered since '0' could not be entered due to EudraCT system constraints.

    Reporting group title
    Deferasirox
    Reporting group description
    		 Study was withdrawn with 0 participants. Sponsor followed EMA's advice and contacted NCAs to enter comment that no participants were recruited. There is still no EudraCT functionality to inform the public that recruitment never started. '99999' was entered since '0' could not be entered due to EudraCT system constraints.

    Reporting group values
    		 SPD602 Deferasirox Total
    Number of subjects
    		 99999 99999 199998
    Age categorical
    Study was withdrawn with 0 participants. Sponsor followed EMA's advice and contacted NCAs to enter comment that no participants were recruited. There is still no EudraCT functionality to inform the public that recruitment never started. '99999' was entered since '0' could not be entered due to EudraCT system constraints.
    Units: Subjects
        Age Categorical
    		 99999 99999 199998
    Gender categorical
    Study was withdrawn with 0 participants. Sponsor followed EMA's advice and contacted NCAs to enter comment that no participants were recruited. There is still no EudraCT functionality to inform the public that recruitment never started. '99999' was entered since '0' could not be entered due to EudraCT system constraints.
    Units:
        All
    		 99999 99999 199998

    End points

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    End points reporting groups
    Reporting group title
    SPD602
    Reporting group description
    		 Study was withdrawn with 0 participants. Sponsor followed EMA's advice and contacted NCAs to enter comment that no participants were recruited. There is still no EudraCT functionality to inform the public that recruitment never started. '99999' was entered since '0' could not be entered due to EudraCT system constraints.

    Reporting group title
    Deferasirox
    Reporting group description
    		 Study was withdrawn with 0 participants. Sponsor followed EMA's advice and contacted NCAs to enter comment that no participants were recruited. There is still no EudraCT functionality to inform the public that recruitment never started. '99999' was entered since '0' could not be entered due to EudraCT system constraints.

    Primary: Change from baseline in Liver Iron Concentration (LIC) as assessed by FerriScan® R2 at Weeks 12, 24, and 48.

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    End point title
    		 Change from baseline in Liver Iron Concentration (LIC) as assessed by FerriScan® R2 at Weeks 12, 24, and 48. [1]
    End point description
    Study was withdrawn with 0 participants. Sponsor followed EMA's advice and contacted NCAs to enter comment that no participants were recruited. There is still no EudraCT functionality to inform the public that recruitment never started.
    End point type
    Primary
    End point timeframe
    Baseline to Weeks 12, 24, and 48.
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Study was withdrawn with 0 participants. Sponsor followed EMA's advice and contacted NCAs to enter comment that no participants were recruited. There is still no EudraCT functionality to inform the public that recruitment never started.
    End point values
    		 SPD602 Deferasirox
    Number of subjects analysed
    0 [2]
    0 [3]
    Units: mg iron per g
        arithmetic mean (standard deviation)
    ( )
    ( )
    Notes
    [2] - Study was withdrawn with 0 participants.
    [3] - Study was withdrawn with 0 participants.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    All AEs are collected from the time the informed consent is signed until the defined follow-up period.
    Adverse event reporting additional description
    Study was withdrawn with 0 participants. Sponsor followed EMA's advice and contacted NCAs to enter comment that no participants were recruited. There is still no EudraCT functionality to inform the public that recruitment never started.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    NA
    Frequency threshold for reporting non-serious adverse events: 5%
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: Study was withdrawn with 0 participants. Sponsor followed EMA's advice and contacted NCAs to enter comment that no participants were recruited. There is still no EudraCT functionality to inform the public that recruitment never started.

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    03 Oct 2013
    Clarified that total daily dose range will be 16-75 mg/kg/day. Modified starting doses for this study from 32, 50, and 75 mg/kg/day to 16 and 20mg/kg BID. Clarified that total daily doses are divided into 2 daily doses. Removed baseline LIC criterion for determination of starting dose; starting dose is determined by TII. Dose adjustments will be made based on LIC, CIC and/or serum ferritin results. Updated EQ-5D-3L to EQ-5D-5L. Updated information on current treatment options to be consistent with newly available data; updated rationale for SPD602 iron overload indication. Updated Inclusion Criteria 4 & 6 and Exclusion Criteria 5, 6 & 9. Clarified that subjects will be stratified by baseline LIC value and historical transfusion requirement after 2-week washout. Updated Rationale for Twice Daily Dosing text. Updated Rationale for the Dosing Algorithm text. Updated acceptable forms of birth control for women of child-bearing potential. Updated in vitro data for drug-drug interaction potential. Revised information regarding suspension or modification of dosing. Added table showing dose titration increments and BID to total daily dose equivalency. Modified dose increments as well as up and down titrations. Indicated that the investigator will be provided with local prescribing information for deferasirox. Updated safety measurements to include serum creatinine and eGFR. Updated renal function assessments to include eGFR. Added laboratory tests related to sensory disturbances as part of the biochemistry panel at select time points and in the event of a neurological adverse event. Specified that Vitamin D is to be assessed as part of biochemistry panel in the event of neurological averse event requiring follow-up. Added LPI to biochemistry panel. Added NTBI and LPI to the clinical pharmacology assessments discussion. Specified blood sample details for neurology-specific biochemistry testing and updated estimated total mL volume of blood drawn.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    Study was withdrawn with 0 participants. Sponsor followed EMA's advice and contacted NCAs to enter comment that no participants were recruited. There is still no EudraCT functionality to inform the public that recruitment never started.
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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