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    Clinical Trial Results:
    Pharmacokinetics, safety and efficacy of a new gadolinium-based contrast agent, P03277, in pediatric patients from 2 to 17 years of age undergoing central nervous system contrast-enhanced MRI.

    Summary
    EudraCT number
    		 2018-001516-30
    Trial protocol
    		 SK   PL   BG  
    Global end of trial date
    10 Aug 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    24 Jun 2021
    First version publication date
    24 Jun 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    GDX-44-007
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03749252
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 IND: 123673
    Sponsors
    Sponsor organisation name
    GUERBET
    Sponsor organisation address
    BP 57400, Roissy CdG, France, 95943, Villepinte, France,
    Public contact
    Global Head of Medical Affairs & Clinical Development, GUERBET, +33 0145915176, jing.hao@guerbet.com
    Scientific contact
    Global Head of Medical Affairs & Clinical Development, GUERBET, +33 0145915176, jing.hao@guerbet.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-001949-PIP01-16 EMEA-001949-PIP02-18
    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
    16 Apr 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    10 Aug 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Aug 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the pharmacokinetic profile of gadopiclenol (P03277) in plasma following single intravenous injection of 0.05 mmol/kg body weight in pediatric population aged from 2 to 17 years undergoing central nervous system (CNS) contrast-enhanced magnetic resonance imaging (MRI) (CNS cohort).
    Protection of trial subjects
    This trial has been conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki, that are consistent with Good Clinical Practice (GCP) according to International Conference on Harmonisation (ICH) guidelines and with the applicable regional/local regulations of the country in which the trial was conducted. The safety data were monitored during the whole study period.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    06 Nov 2018
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety
    Long term follow-up duration
    		 3 Months
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Bulgaria: 12
    Country: Number of subjects enrolled
    Hungary: 7
    Country: Number of subjects enrolled
    Poland: 37
    Country: Number of subjects enrolled
    Slovakia: 16
    Country: Number of subjects enrolled
    Ukraine: 8
    Worldwide total number of subjects
    80
    EEA total number of subjects
    72
    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)
    49
    Adolescents (12-17 years)
    31
    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
    		 An age-down staggered approach was used. Patients were recruited into 3 predefined age groups. The inclusions started with Adolescents (12-17 years), followed by Preadolescents (7-11 years) and finally Young Children (2-6 years).

    Pre-assignment
    Screening details
    		 -

    Pre-assignment period milestones
    Number of subjects started
    		 80
    Number of subjects completed
    		 80

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 CNS_2-6 years
    Arm description
    		 Patients aged 2-6 years who underwent CNS contrast-enhanced MRI
    Arm type
    		 Experimental

    Investigational medicinal product name
    gadopiclenol
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    0.05 mmol/kg in a single injection

    Arm title
    		 CNS_7-11 years
    Arm description
    		 Patients aged 7-11 years who underwent CNS contrast-enhanced MRI
    Arm type
    		 Experimental

    Investigational medicinal product name
    gadopiclenol
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    0.05 mmol/kg in a single injection

    Arm title
    		 CNS_12-17 years
    Arm description
    		 Patients aged 12-17 years who underwent CNS contrast-enhanced MRI
    Arm type
    		 Experimental

    Investigational medicinal product name
    gadopiclenol
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    0.05 mmol/kg in a single injection

    Arm title
    		 Body_2-17 years
    Arm description
    		 Patients aged 2-17 years who underwent Body contrast-enhanced MRI
    Arm type
    		 Experimental

    Investigational medicinal product name
    gadopiclenol
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    0.05 mmol/kg in a single injection

    Number of subjects in period 1
    		CNS_2-6 years CNS_7-11 years CNS_12-17 years Body_2-17 years
    Started
    20
    20
    20
    20
    Completed
    20
    20
    20
    20

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Period 1
    Reporting group description
    		 -

    Reporting group values
    		 Period 1 Total
    Number of subjects
    		 80 80
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 49 49
        Adolescents (12-17 years)
    		 31 31
        Adults (18-64 years)
    		 0 0
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 9.3 ( 4.7 ) -
    Gender categorical
    Units: Subjects
        Female
    		 39 39
        Male
    		 41 41
    Weight
    Units: kilogram(s)
        arithmetic mean (standard deviation)
    		 39.61 ( 21.02 ) -

    End points

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    End points reporting groups
    Reporting group title
    CNS_2-6 years
    Reporting group description
    		 Patients aged 2-6 years who underwent CNS contrast-enhanced MRI

    Reporting group title
    CNS_7-11 years
    Reporting group description
    		 Patients aged 7-11 years who underwent CNS contrast-enhanced MRI

    Reporting group title
    CNS_12-17 years
    Reporting group description
    		 Patients aged 12-17 years who underwent CNS contrast-enhanced MRI

    Reporting group title
    Body_2-17 years
    Reporting group description
    		 Patients aged 2-17 years who underwent Body contrast-enhanced MRI

    Primary: Clearance

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    End point title
    		 Clearance [1] [2]
    End point description
    End point derived from a PopPK model and assessed only in the CNS cohort
    End point type
    Primary
    End point timeframe
    Four blood samples per patient were collected post-injection of gadopiclenol for PK analysis, one within each window (1-20 min, 30-45 min, 2-3 h, 7-8 h).
    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: No statistical analysis for this endpoint. Descriptive statistics only for PK endpoints
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: End point assessed only in the CNS cohort
    End point values
    		 CNS_2-6 years CNS_7-11 years CNS_12-17 years
    Number of subjects analysed
    20
    20
    19
    Units: L/h/kg
        median (full range (min-max))
    0.12 (0.05 to 0.28)
    0.10 (0.04 to 0.24)
    0.08 (0.04 to 0.20)
    No statistical analyses for this end point

    Primary: Central volume of distribution (V1)

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    End point title
    		 Central volume of distribution (V1) [3] [4]
    End point description
    End point derived from a PopPK model and assessed only in the CNS cohort
    End point type
    Primary
    End point timeframe
    Four blood samples per patient were collected post-injection of gadopiclenol for PK analysis, one within each window (1-20 min, 30-45 min, 2-3 h, 7-8 h).
    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: No statistical analysis for this endpoint. Descriptive statistics only for PK endpoints
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: End point assessed only in the CNS cohort
    End point values
    		 CNS_2-6 years CNS_7-11 years CNS_12-17 years
    Number of subjects analysed
    20
    20
    19
    Units: L/kg
        median (full range (min-max))
    0.12 (0.06 to 0.26)
    0.12 (0.06 to 0.24)
    0.11 (0.05 to 0.24)
    No statistical analyses for this end point

    Primary: Peripheral volume of distribution (V2)

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    End point title
    		 Peripheral volume of distribution (V2) [5] [6]
    End point description
    End point derived from a PopPK model and assessed only in the CNS cohort
    End point type
    Primary
    End point timeframe
    Four blood samples per patient were collected post-injection of gadopiclenol for PK analysis, one within each window (1-20 min, 30-45 min, 2-3 h, 7-8 h).
    Notes
    [5] - 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: No statistical analysis for this endpoint. Descriptive statistics only for PK endpoints
    [6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: End point assessed only in the CNS cohort
    End point values
    		 CNS_2-6 years CNS_7-11 years CNS_12-17 years
    Number of subjects analysed
    20
    20
    19
    Units: L/kg
        median (full range (min-max))
    0.06 (0.06 to 0.06)
    0.06 (0.06 to 0.06)
    0.06 (0.06 to 0.06)
    No statistical analyses for this end point

    Primary: Terminal elimination half-life

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    End point title
    		 Terminal elimination half-life [7] [8]
    End point description
    End point derived from a PopPK model and assessed only in the CNS cohort
    End point type
    Primary
    End point timeframe
    Four blood samples per patient were collected post-injection of gadopiclenol for PK analysis, one within each window (1-20 min, 30-45 min, 2-3 h, 7-8 h).
    Notes
    [7] - 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: No statistical analysis for this endpoint. Descriptive statistics only for PK endpoints
    [8] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: End point assessed only in the CNS cohort
    End point values
    		 CNS_2-6 years CNS_7-11 years CNS_12-17 years
    Number of subjects analysed
    20
    20
    19
    Units: hour
        median (full range (min-max))
    1.29 (0.69 to 3.38)
    1.48 (0.83 to 3.20)
    1.77 (1.00 to 3.57)
    No statistical analyses for this end point

    Primary: Simulated gadopiclenol concentrations 10 min post-injection

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    End point title
    		 Simulated gadopiclenol concentrations 10 min post-injection [9] [10]
    End point description
    End point derived from a PopPK model and assessed only in the CNS cohort
    End point type
    Primary
    End point timeframe
    Four blood samples per patient were collected post-injection of gadopiclenol for PK analysis, one within each window (1-20 min, 30-45 min, 2-3 h, 7-8 h).
    Notes
    [9] - 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: No statistical analysis for this endpoint. Descriptive statistics only for PK endpoints
    [10] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: End point assessed only in the CNS cohort
    End point values
    		 CNS_2-6 years CNS_7-11 years CNS_12-17 years
    Number of subjects analysed
    20
    20
    19
    Units: mg/L
        arithmetic mean (standard deviation)
    302.11 ( 44.68 )
    327.20 ( 47.95 )
    349.15 ( 52.59 )
    No statistical analyses for this end point

    Primary: Simulated gadopiclenol concentrations 20 min post-injection

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    End point title
    		 Simulated gadopiclenol concentrations 20 min post-injection [11] [12]
    End point description
    End point derived from a PopPK model and assessed only in the CNS cohort
    End point type
    Primary
    End point timeframe
    Four blood samples per patient were collected post-injection of gadopiclenol for PK analysis, one within each window (1-20 min, 30-45 min, 2-3 h, 7-8 h).
    Notes
    [11] - 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: No statistical analysis for this endpoint. Descriptive statistics only for PK endpoints
    [12] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: End point assessed only in the CNS cohort
    End point values
    		 CNS_2-6 years CNS_7-11 years CNS_12-17 years
    Number of subjects analysed
    20
    20
    19
    Units: mg/L
        arithmetic mean (standard deviation)
    234.88 ( 30.18 )
    259.67 ( 32.02 )
    285.16 ( 35.35 )
    No statistical analyses for this end point

    Primary: Simulated gadopiclenol concentrations 30 min post-injection

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    End point title
    		 Simulated gadopiclenol concentrations 30 min post-injection [13] [14]
    End point description
    End point derived from a PopPK model and assessed only in the CNS cohort
    End point type
    Primary
    End point timeframe
    Four blood samples per patient were collected post-injection of gadopiclenol for PK analysis, one within each window (1-20 min, 30-45 min, 2-3 h, 7-8 h).
    Notes
    [13] - 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: No statistical analysis for this endpoint. Descriptive statistics only for PK endpoints
    [14] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: End point assessed only in the CNS cohort
    End point values
    		 CNS_2-6 years CNS_7-11 years CNS_12-17 years
    Number of subjects analysed
    20
    20
    19
    Units: mg/L
        arithmetic mean (standard error)
    188.26 ( 25.10 )
    211.20 ( 25.82 )
    237.25 ( 26.97 )
    No statistical analyses for this end point

    Primary: Simulated area under the curve (AUCinf)

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    End point title
    		 Simulated area under the curve (AUCinf) [15] [16]
    End point description
    End point derived from a PopPK model and assessed only in the CNS cohort
    End point type
    Primary
    End point timeframe
    Four blood samples per patient were collected post-injection of gadopiclenol for PK analysis, one within each window (1-20 min, 30-45 min, 2-3 h, 7-8 h).
    Notes
    [15] - 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: No statistical analysis for this endpoint. Descriptive statistics only for PK endpoints
    [16] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: End point assessed only in the CNS cohort
    End point values
    		 CNS_2-6 years CNS_7-11 years CNS_12-17 years
    Number of subjects analysed
    20
    20
    19
    Units: mg.h/L
        arithmetic mean (standard deviation)
    403.16 ( 93.35 )
    477.25 ( 105.71 )
    582.30 ( 122.08 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From informed consent signature untill the end of the study (up to 120 days after gadopiclenol administration).
    Adverse event reporting additional description
    Adverse events occuring during or after gadopiclenol administration are listed below.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.0
    Reporting groups
    Reporting group title
    Safety Set
    Reporting group description
    		 All patients administered gadopiclenol

    Serious adverse events
    		 Safety Set
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 80 (3.75%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    Injury, poisoning and procedural complications
    Head injury
    Additional description: Not related to contrast
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Epilepsy
    Additional description: Not related to contrast
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Coma
    Additional description: Not related to contrast
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Condition aggravated
    Additional description: Not related to contrast
         subjects affected / exposed
    2 / 80 (2.50%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Renal and urinary disorders
    Hydronephrosis
    Additional description: Not related to contrast
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Tonsillitis
    Additional description: Not related to contrast
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Safety Set
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    13 / 80 (16.25%)
    Investigations
    Blood pressure increased
    Additional description: Not related to contrast
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences all number
    1
    Electrocardiogram QT prolonged
    Additional description: Related to contrast
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences all number
    1
    Eosinophil count increased
    Additional description: Not related to contrast
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences all number
    1
    Neutrophil count decreased
    Additional description: Not related to contrast
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences all number
    1
    Cardiac disorders
    Long QT syndrome
    Additional description: Not related to contrast
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences all number
    2
    Nervous system disorders
    Epilepsy
    Additional description: Not related to contrast
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences all number
    1
    General disorders and administration site conditions
    Condition aggravated
    Additional description: Not related to contrast
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences all number
    1
    Application site erythema
    Additional description: Not related to contrast
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences all number
    2
    Gastrointestinal disorders
    Abdominal pain
    Additional description: Not related to contrast
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences all number
    1
    Nausea
    Additional description: Not related to contrast
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences all number
    1
    Vomiting
    Additional description: Not related to contrast
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
    Additional description: Not related to contrast
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences all number
    1
    Rhinorrhoea
    Additional description: Not related to contrast
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Pruritus
    Additional description: Not related to contrast
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences all number
    1
    Rash maculo-papular
    Additional description: Related to contrast
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences all number
    1
    Infections and infestations
    Herpes virus infection
    Additional description: Not related to contrast
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences all number
    1
    Nasopharyngitis
    Additional description: Not related to contrast
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences all number
    1
    Pharyngitis
    Additional description: Not related to contrast
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences all number
    1
    Respiratory tract infection viral
    Additional description: Not related to contrast
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences all number
    1
    Tracheobronchitis mycoplasmal
    Additional description: Not related to contrast
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences all number
    1
    Upper respiratory tract infection
    Additional description: Not related to contrast
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences all number
    1
    Urinary tract infection
    Additional description: Not related to contrast
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    12 Oct 2018
    Total urine collection from 0 to 8 hours for PK assessment in patients capable to control urination was added in appropriate sections, while the spot urine sample at 1 day after the injection was finally not collected. In addition, the collection of serious AEs was prolonged up to the last follow-up visit at day 90.
    19 Mar 2019
    An additional cohort of 20 patients, receiving 0.05 mmol/kg of gadopiclenol, was included in order to assess the safety and urinary excretion of gadopiclenol and efficacy of gadopiclenol-enhanced MRI in children with pathologies of various body organs. This amendment was approved in Ukraine under the condition that no patients would be enrolled in the Body cohort in this country.
    24 Apr 2020
    The main changes implemented in this amendment were the possibility to perform visits V3 and V4 remotely and additional on-site visits were scheduled at the latest 30 days and 120 days after gadopiclenol administration. Regarding the Body cohort, it was possible to shorten the 8-hour confinement period if it could not be respected and it was possible to perform the day 2 visit at patient’s home and remotely at the very least. This amendment was not submitted in Ukraine.

    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.
    None reported
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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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