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    Clinical Trial Results:
    Open-label, multi-center study to evaluate the safety, efficacy, and plasma gadolinium concentrations after an intravenous injection of 0.1 mL/kg body weight Eovist/Primovist for enhanced magnetic resonance imaging of the liver in children 0 to 2 months of age

    Summary
    EudraCT number
    2012-000952-32
    Trial protocol
    Outside EU/EEA  
    Global end of trial date
    11 Aug 2015

    Results information
    Results version number
    v2(current)
    This version publication date
    08 Sep 2016
    First version publication date
    06 Jul 2016
    Other versions
    v1
    Version creation reason
    • New data added to full data set
    • Correction of full data set
    Bayer sponsor contact information to be updated

    Trial information

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    Trial identification
    Sponsor protocol code
    BAY86-4873/16078
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02084628
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Bayer AG
    Sponsor organisation address
    Kaiser-Wilhelm-Allee, D-51368 Leverkusen, Germany,
    Public contact
    Therapeutic Area Head, Bayer AG, clinical-trials-contact@bayer.com
    Scientific contact
    Therapeutic Area Head, Bayer AG, clinical-trials-contact@bayer.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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    11 Aug 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    11 Aug 2015
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The objectives of this study were to evaluate the safety, efficacy (imaging data), and plasma gadolinium concentrations after administration of Eovist/Primovist in pediatric subjects 0 to 2 months of age with known or suspected hepatobiliary pathology who were undergoing contrast-enhanced magnetic resonance imaging (MRI) of the liver.
    Protection of trial subjects
    The conduct of this clinical study met all local legal and regulatory requirements. The study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and the International Conference on Harmonization guideline E6: Good Clinical Practice. Before entering the study, the informed consent form was read by and explained to their legally authorized representative. Participating subject's legally authorized representative signed informed consent form and could withdraw from the study at any time without any disadvantage and without having to provide a reason for this decision. Only investigators qualified by training and experience were selected as appropriate experts to investigate the study drug.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    13 Feb 2015
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United States: 1
    Worldwide total number of subjects
    1
    EEA total number of subjects
    0
    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)
    1
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Study was conducted at 9 centres in United States of America (USA) and only one subject was recruited in one centre, between 13 February 2015 (first subject first visit) and 11 August 2015 (Last subject last visit).

    Pre-assignment
    Screening details
    One subject was enrolled in the study.

    Period 1
    Period 1 title
    Overall study (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Not applicable
    Blinding used
    Not blinded

    Arms
    Arm title
    Eovist/Primovist (BAY86-4873)
    Arm description
    Subjects to receive single dose of Eovist/Primovist as a manual injection at a dose of 0.1 milliliter per kilogram (mL/kg) body weight (BW) (0.025 millimole [mmol]/kg BW), followed by a flush of at least 5 mL saline (sodium chloride 0.9 percent [%] solution) manually.
    Arm type
    Experimental

    Investigational medicinal product name
    Eovist
    Investigational medicinal product code
    BAY86-4873
    Other name
    Primovist
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subject recieved Eovist/Primovist injection at a dose of 0.1 mL/kg BW (0.025 mmol/kg BW), followed by a flush of at least 5 mL saline manually.

    Number of subjects in period 1
    Eovist/Primovist (BAY86-4873)
    Started
    1
    Completed
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Eovist/Primovist (BAY86-4873)
    Reporting group description
    Subjects to receive single dose of Eovist/Primovist as a manual injection at a dose of 0.1 milliliter per kilogram (mL/kg) body weight (BW) (0.025 millimole [mmol]/kg BW), followed by a flush of at least 5 mL saline (sodium chloride 0.9 percent [%] solution) manually.

    Reporting group values
    Eovist/Primovist (BAY86-4873) Total
    Number of subjects
    1 1
    Age categorical
    Age categorical included the age 0 to 2 months (gestational age 37 to 41 weeks inclusive) as well.
    Units: Subjects
        Infants and toddlers (28 days-23 months)
    1 1
    Gender categorical
    Units: Subjects
        Female
    1 1
        Male
    0 0

    End points

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    End points reporting groups
    Reporting group title
    Eovist/Primovist (BAY86-4873)
    Reporting group description
    Subjects to receive single dose of Eovist/Primovist as a manual injection at a dose of 0.1 milliliter per kilogram (mL/kg) body weight (BW) (0.025 millimole [mmol]/kg BW), followed by a flush of at least 5 mL saline (sodium chloride 0.9 percent [%] solution) manually.

    Primary: Number of Subjects With Additional Diagnostic Information From Combined (Pre-contrast And Post-contrast) Images Compared With Pre-contrast Images

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    End point title
    Number of Subjects With Additional Diagnostic Information From Combined (Pre-contrast And Post-contrast) Images Compared With Pre-contrast Images [1]
    End point description
    Additional diagnostic information such as better delineation of the border of the lesion, better definition of the internal morphology of the lesion, better characterization of the lesion, better definition of the location of the lesion, better assessment of the communication of the lesion with respect to the biliary system obtained from the combined magnetic resonance (MR) images compared with pre-contrast MR images. Number of subjects with additional diagnostic information were recorded and analyzed.
    End point type
    Primary
    End point timeframe
    Images were taken pre-injection and post-injection (within about 15 minutes)
    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: In this study only one subject was enrolled and hence, inferential statistical analysis was not performed.
    End point values
    Eovist/Primovist (BAY86-4873)
    Number of subjects analysed
    1
    Units: subjects
    0
    No statistical analyses for this end point

    Primary: Number of Subjects With Adverse Events

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    End point title
    Number of Subjects With Adverse Events [2]
    End point description
    An adverse event (AE) was any untoward medical occurrence that is, any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease in a subject or clinical investigation subject after providing written informed consent for participation in the study.
    End point type
    Primary
    End point timeframe
    From the signing of the informed consent form until the 6 month post MRI follow-up
    Notes
    [2] - 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: In this study only one subject was enrolled and hence, inferential statistical analysis was not performed.
    End point values
    Eovist/Primovist (BAY86-4873)
    Number of subjects analysed
    1
    Units: subjects
    0
    No statistical analyses for this end point

    Primary: Number of Subjects With Serious Adverse Events

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    End point title
    Number of Subjects With Serious Adverse Events [3]
    End point description
    An serious adverse events (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
    End point type
    Primary
    End point timeframe
    From the signing of the informed consent form until the 6 month post MRI follow-up
    Notes
    [3] - 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: In this study only one subject was enrolled and hence, inferential statistical analysis was not performed.
    End point values
    Eovist/Primovist (BAY86-4873)
    Number of subjects analysed
    1
    Units: subjects
    0
    No statistical analyses for this end point

    Secondary: Number of Lesions Detected for the Pre-contrast Images

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    End point title
    Number of Lesions Detected for the Pre-contrast Images
    End point description
    End point type
    Secondary
    End point timeframe
    Images were taken pre-injection
    End point values
    Eovist/Primovist (BAY86-4873)
    Number of subjects analysed
    1
    Units: number of lesions
    0
    No statistical analyses for this end point

    Secondary: Number of Lesions Detected for the Combined Images

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    End point title
    Number of Lesions Detected for the Combined Images
    End point description
    End point type
    Secondary
    End point timeframe
    Images were taken pre-injection and post-injection (within about 15 minutes)
    End point values
    Eovist/Primovist (BAY86-4873)
    Number of subjects analysed
    1
    Units: number of lesions
    0
    No statistical analyses for this end point

    Secondary: Contrast Enhancement of the Liver for the Combined Images Assessed by yes or no Question

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    End point title
    Contrast Enhancement of the Liver for the Combined Images Assessed by yes or no Question
    End point description
    End point type
    Secondary
    End point timeframe
    Images were taken pre-injection and post-injection (within about 15 minutes)
    End point values
    Eovist/Primovist (BAY86-4873)
    Number of subjects analysed
    1
    Units: number of responses
        Yes
    1
        No
    0
    No statistical analyses for this end point

    Secondary: Contrast Enhancement of the Biliary System for the Combined Images Assessed by yes or no Question

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    End point title
    Contrast Enhancement of the Biliary System for the Combined Images Assessed by yes or no Question
    End point description
    Biliary system included a. Gall bladder b. Cystic duct c. Common bile duct d. Right main bile duct e. Left main bile duct
    End point type
    Secondary
    End point timeframe
    Images were taken pre-injection and post-injection (within about 15 minutes)
    End point values
    Eovist/Primovist (BAY86-4873)
    Number of subjects analysed
    1
    Units: number of responses
        Yes
    1
        No
    0
    No statistical analyses for this end point

    Secondary: Visualization of the Biliary System for the Pre-contrast and Combined Images Assessed by yes or no Question

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    End point title
    Visualization of the Biliary System for the Pre-contrast and Combined Images Assessed by yes or no Question
    End point description
    End point type
    Secondary
    End point timeframe
    Images were taken pre-injection and post-injection (within about 15 minutes)
    End point values
    Eovist/Primovist (BAY86-4873)
    Number of subjects analysed
    1
    Units: subjects
        Pre-contrast Images: Yes
    0
        Pre-contrast Images: No
    1
        Combined Images: Yes
    0
        Combined Images: No
    1
    No statistical analyses for this end point

    Secondary: Change in Diagnosis for the Combined Images Compared With Pre-contrast Images

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    End point title
    Change in Diagnosis for the Combined Images Compared With Pre-contrast Images
    End point description
    Diagnosis based on the pre-contrast images will be indicated. If there is a change in the diagnosis based on the combined images, then the combined images diagnosis will be recorded.
    End point type
    Secondary
    End point timeframe
    Images were taken pre-injection and post-injection (within about 15 minutes)
    End point values
    Eovist/Primovist (BAY86-4873)
    Number of subjects analysed
    1
    Units: subjects
    0
    No statistical analyses for this end point

    Secondary: Diagnostic Confidence for the Pre-contrast and Combined Images Assessed by yes or no Question

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    End point title
    Diagnostic Confidence for the Pre-contrast and Combined Images Assessed by yes or no Question
    End point description
    Diagnostic confidence was classified as not confident (No), confident (Yes), very confident (Yes).
    End point type
    Secondary
    End point timeframe
    Images were taken pre-injection and post-injection (within about 15 minutes)
    End point values
    Eovist/Primovist (BAY86-4873)
    Number of subjects analysed
    1
    Units: number of responses
        Pre-contrast Images: Very Confident – Yes
    0
        Pre-contrast Images: Confident – Yes
    0
        Pre-contrast Images: Not Confident – No
    1
        Combined Images: Very Confident – Yes
    1
        Combined Images: Confident – Yes
    0
        Combined Images: Not Confident - No
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    From the signing of the informed consent form until the 6 month post MRI follow-up
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    18.1
    Reporting groups
    Reporting group title
    Eovist/Primovist (BAY86-4873)
    Reporting group description
    Subject recieved Eovist/Primovist injection at a dose of 0.1 mL/kg BW (0.025 mmol/kg BW), followed by a flush of at least 5 mL saline manually.

    Serious adverse events
    Eovist/Primovist (BAY86-4873)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 1 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    Eovist/Primovist (BAY86-4873)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 1 (0.00%)
    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: In this study only one subject was enrolled, received treatment and completed the study. There were no non-serious adverse event reported for this subject during the study.

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? No

    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.
    Primarily based on study 13729 along with supporting data the FDA revised Eovist labeling to remove any age restriction from indication and decided that there are no further pediatric data requested. Consequently, study was discontinued.
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