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    Clinical Trial Results:
    Pharmacogenetic testing of saliva samples from patients with ≥5 exposure days to rFVIIa analogue in the adept™2 trial.

    Summary
    EudraCT number
    		 2015-001919-13
    Trial protocol
    		 RO  
    Global end of trial date
    15 Apr 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    30 Oct 2016
    First version publication date
    30 Oct 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    NN1731-4214
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02541942
    WHO universal trial number (UTN)
    		 U1111-1169-6103
    Sponsors
    Sponsor organisation name
    Novo Nordisk A/S
    Sponsor organisation address
    Novo Allé, Bagsvaerd, Denmark, 2880
    Public contact
    Global Clinical Registry (GCR, 1452), Novo Nordisk A/S, clinicaltrials@novonordisk.com
    Scientific contact
    Global Clinical Registry (GCR, 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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    28 Sep 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    15 Apr 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    15 Apr 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To determine the HLA type and polymorphisms in the FVII gene in patients previously exposed to rFVIIa analogue in the adeptTM2 trial.
    Protection of trial subjects
    The trial was approved by local IRBs/IECs before collection of saliva samples. Health authority approval was only requested in Romania.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    03 Apr 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: 5
    Country: Number of subjects enrolled
    Greece: 4
    Country: Number of subjects enrolled
    Serbia: 2
    Country: Number of subjects enrolled
    Romania: 1
    Country: Number of subjects enrolled
    Malaysia: 1
    Country: Number of subjects enrolled
    Thailand: 3
    Country: Number of subjects enrolled
    Japan: 3
    Worldwide total number of subjects
    19
    EEA total number of subjects
    5
    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)
    4
    Adults (18-64 years)
    15
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The trial was conducted at 16 sites in 7 countries, as follows: Greece: 2 sites; Japan: 3 sites; Malaysia: 1 site, Romania 1 site, Serbia: 2 sites; Thailand: 2 sites; United States: 5 sites.

    Pre-assignment
    Screening details
    		 This trial describes pharmacogenetic testing of saliva samples from patients who participated in the completed NN1731-3562 (adeptTM2) phase 3 trial, with 5 or more exposure days to trial product rFVIIa analogue.

    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
    		 Subjects for analysis
    Arm description
    		 Patients who participated in the completed NN1731-3562 (adeptTM2) phase 3 trial, with 5 or more exposure days to trial product rFVIIa analogue and/or rFVIIa, were included in this arm.
    Arm type
    		 No treatment given

    Investigational medicinal product name
    No treatment given
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for solution for injection
    Routes of administration
    Not mentioned
    Dosage and administration details
    No treatment given

    Number of subjects in period 1
    		Subjects for analysis
    Started
    19
    Completed
    19

    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
    		 19 19
    Age Categorical
    This table reflects the age of the patients when entering the preceding main trail NN1731-3562.
    Units: Subjects
        Adolescents (12-17 years)
    		 4 4
        Adults (18-64 years)
    		 15 15
    Age Continuous
    This table reflects the age of the patients when entering the preceding main trail NN1731-3562.
    Units: years
        arithmetic mean (standard deviation)
    		 25.26 ( 11.69 ) -
    Gender Categorical
    Units: Subjects
        Female
    		 0 0
        Male
    		 19 19

    End points

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    End points reporting groups
    Reporting group title
    Subjects for analysis
    Reporting group description
    		 Patients who participated in the completed NN1731-3562 (adeptTM2) phase 3 trial, with 5 or more exposure days to trial product rFVIIa analogue and/or rFVIIa, were included in this arm.

    Primary: To determine the HLA type in patients previously exposed to rFVIIa analogue in the adeptTM2 trial.

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    End point title
    		 To determine the HLA type in patients previously exposed to rFVIIa analogue in the adeptTM2 trial. [1]
    End point description
    Determination of HLA type in patients who participated in the completed NN1731-3562 (adeptTM2) phase 3 trial, with 5 or more exposure days to trial product rFVIIa analogue and/or rFVIIa.
    End point type
    Primary
    End point timeframe
    Up to 12 months
    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: There was no statistical analysis planned in the protocol for this trial.
    End point values
    		 Subjects for analysis
    Number of subjects analysed
    19 [2]
    Units: HLA typing
    0
    Notes
    [2] - Results from this trial is communicated in conjunction with the NN1731-3562 trial.
    No statistical analyses for this end point

    Primary: To determine the polymorphisms in the FVII gene in patients previously exposed to rFVIIa analogue in the adeptTM2 trial.

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    End point title
    		 To determine the polymorphisms in the FVII gene in patients previously exposed to rFVIIa analogue in the adeptTM2 trial. [3]
    End point description
    Determination of polymorphisms in the FVII gene in patients who participated in the completed NN1731-3562 (adeptTM2) phase 3 trial, with 5 or more exposure days to trial product rFVIIa analogue and/or rFVIIa.
    End point type
    Primary
    End point timeframe
    Up to 12 months
    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: There was no statistical analysis planned in the protocol for this trial.
    End point values
    		 Subjects for analysis
    Number of subjects analysed
    19 [4]
    Units: Number
    0
    Notes
    [4] - No FVII variation/mutation was found in any of the 19 subjects.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    This is a bio-specimen research study. There is no safety analysis done in this trial.
    Adverse event reporting additional description
    Not Applicable.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 Not Applicable (NA).
    Dictionary version
    NA
    Frequency threshold for reporting non-serious adverse events: 0%
    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: This is a bio-specimen research study. There is no safety analysis done in this trial.

    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.
    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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