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    Clinical Trial Results:
    Efficacy and safety of once-weekly subcutaneous administration of concizumab prophylaxis in patients with haemophilia A and B, with or without inhibitors

    Summary
    EudraCT number
    		 2019-002641-37
    Trial protocol
    		 SE   NL  
    Global end of trial date
    26 Mar 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    27 Aug 2020
    First version publication date
    27 Aug 2020
    Other versions
    Summary report(s)
    		 Cancelled before Active Statement

    Trial information

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    Trial identification
    Sponsor protocol code
    NN7415-4580
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 U1111-1235-5858
    Sponsors
    Sponsor organisation name
    Novo Nordisk A/S
    Sponsor organisation address
    Novo Allé, Bagsvaerd, Denmark, 2880
    Public contact
    Clinical Reporting Anchor and Disclosure (1452), Novo Nordisk A/S, clinicaltrials@novonordisk.com
    Scientific contact
    Clinical Reporting Anchor and Disclosure (1452), Novo Nordisk A/S, clinicaltrials@novonordisk.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
    26 Mar 2020
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    26 Mar 2020
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To evaluate the effect of 1.75 mg/kg concizumab administered once-weekly in maintaining adequate control of bleeding in adult and adolescent patients with haemophilia A or B with or without inhibitors
    Protection of trial subjects
    Not applicable.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    26 Mar 2020
    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
    Netherlands: 99999
    Worldwide total number of subjects
    99999
    EEA total number of subjects
    99999
    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)
    99999
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 99999 is “Not applicable” value or “0 participants”, this trial was discontinued with no participants enrolled in the trial.

    Pre-assignment
    Screening details
    		 Not Applicable

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

    Arms
    Arm title
    		 Concizumab
    Arm description
    		 99999 is “Not applicable” value or “0 participants”, this trial was discontinued with no participants enrolled in the trial.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Concizumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled pen
    Routes of administration
    Not mentioned
    Dosage and administration details
    Not Applicable

    Number of subjects in period 1
    		Concizumab
    Started
    99999
    Completed
    99999

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall Study
    Reporting group description
    		 -

    Reporting group values
    		 Overall Study Total
    Number of subjects
    		 99999 99999
    Age Categorical
    Units: Subjects
        In utero
    		 0 0
        Pre-term newborn - gestational age < 37 wk
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 99999 99999
        From 65-84 years)
    		 0 0
        85 years and over
    		 0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 0 ± 0 -
    Gender Categorical
    Units: Subjects
        Female
    		 99999 99999
        Male
    		 0 0

    End points

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    End points reporting groups
    Reporting group title
    Concizumab
    Reporting group description
    		 99999 is “Not applicable” value or “0 participants”, this trial was discontinued with no participants enrolled in the trial.

    Primary: The number of treated bleeding episodes (spontaneous and traumatic)

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    End point title
    		 The number of treated bleeding episodes (spontaneous and traumatic) [1]
    End point description
    99999 is “Not applicable” value or “0 participants”, this trial was discontinued with no participants enrolled in the trial.
    End point type
    Primary
    End point timeframe
    Not Applicable
    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 subjects were enrolled in the trial, hence results are not available
    End point values
    		 Concizumab
    Number of subjects analysed
    99999
    Units: Not Applicable
    99999
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    99999 is “Not applicable” value or “0 participants”, this trial was discontinued with no participants enrolled in the trial.
    Adverse event reporting additional description
    Not Applicable
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    0
    Reporting groups
    Reporting group title
    Concizumab
    Reporting group description
    		 Concizumab C 100 mg/ml PDS290

    Serious adverse events
    		 Concizumab
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 99999 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Concizumab
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 99999 (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: No subjects were enrolled in the trial, hence results are not available

    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.
    99999 is “Not applicable” value or “0 participants”, this trial was discontinued with no participants enrolled in the trial.
    For support, Contact us.
    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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