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    Clinical Trial Results:
    A Multi-centre, Single-blind Trial Evaluating Safety and Efficacy, including Pharmacokinetics, of NNC-0156-0000-0009 when used for Treatment and Prophylaxis of Bleeding Episodes in Patients with Haemophilia B

    Summary
    EudraCT number
    		 2010-023069-24
    Trial protocol
    		 FR   NL   DE   GB   IT  
    Global end of trial date
    02 Apr 2013

    Results information
    Results version number
    		 v1(current)
    This version publication date
    15 Mar 2016
    First version publication date
    30 Jul 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    NN7999-3747
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01333111
    WHO universal trial number (UTN)
    		 U1111-1119-6415
    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)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-000731-PIP01-09
    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
    18 Sep 2013
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    02 Apr 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    02 Apr 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the immunogenicity of NNC-0156-0000-0009 (nonacog beta pegol)
    Protection of trial subjects
    The trial was conducted in accordance with the Declaration of Helsinki (Seoul, October 2008), the ICH Good Clinical Practice (Geneva, May 1996) and FDA 21 CFR 312.120.
    Background therapy
    		 Not applicable
    Evidence for comparator
    		 Not applicable
    Actual start date of recruitment
    29 Apr 2011
    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
    Japan: 8
    Country: Number of subjects enrolled
    Macedonia, the former Yugoslav Republic of: 4
    Country: Number of subjects enrolled
    Malaysia: 4
    Country: Number of subjects enrolled
    Russian Federation: 5
    Country: Number of subjects enrolled
    South Africa: 4
    Country: Number of subjects enrolled
    Thailand: 4
    Country: Number of subjects enrolled
    Turkey: 4
    Country: Number of subjects enrolled
    United States: 21
    Country: Number of subjects enrolled
    Netherlands: 3
    Country: Number of subjects enrolled
    United Kingdom: 9
    Country: Number of subjects enrolled
    France: 2
    Country: Number of subjects enrolled
    Germany: 4
    Country: Number of subjects enrolled
    Italy: 2
    Worldwide total number of subjects
    74
    EEA total number of subjects
    20
    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)
    18
    Adults (18-64 years)
    55
    From 65 to 84 years
    1
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The trial was conducted at 39 sites in 13 countries, as follows: France: 1 site; Germany: 3 sites; Italy: 2 sites; Japan: 5 sites; Macedonia: 2 sites; Malaysia: 1 site; Netherlands: 1 site; Russia: 2 sites; South Africa: 1 site; Thailand: 2 sites; Turkey: 3 sites; United Kingdom: 4 sites; United States: 12 sites.

    Pre-assignment
    Screening details
    		 Not applicable

    Period 1
    Period 1 title
    Overall study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind
    Roles blinded
    		 Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Prophylaxis 10 IU/kg
    Arm description
    		 The patients were randomised to either prophylaxis 10 IU/kg or 40 IU/kg arm. Patients enrolled in this arm received 10 IU/kg nonacog beta pegol dose once weekly (every 7th day ± 24 hours). Mild and moderate bleeding episodes were treated with 40 IU/kg. Severe bleeding episodes were treated with 80 IU/kg.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Nonacog beta pegol
    Investigational medicinal product code
    Other name
    NNC-0156-0000-0009, N9-GP
    Pharmaceutical forms
    Powder and solvent for solution for injection/skin-prick test
    Routes of administration
    Intravenous use
    Dosage and administration details
    Administration of the appropriate volume of nonacog beta pegol was given as an i.v. bolus injection. The maximum injection rate was 4 mL/min.

    Arm title
    		 Prophylaxis 40 IU/kg
    Arm description
    		 The patients were randomised to either prophylaxis 10 IU/kg or 40 IU/kg arm. Patients enrolled in this arm received 40 IU/kg nonacog beta pegol dose once weekly (every 7th day ± 24 hours). Mild and moderate bleeding episodes were treated with 40 IU/kg. Severe bleeding episodes were treated with 80 IU/kg.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Nonacog beta pegol
    Investigational medicinal product code
    Other name
    NNC-0156-0000-0009, N9-GP
    Pharmaceutical forms
    Powder and solvent for solution for injection/skin-prick test
    Routes of administration
    Intravenous use
    Dosage and administration details
    Administration of the appropriate volume of nonacog beta pegol was given as an i.v. bolus injection. The maximum injection rate was 4 mL/min.

    Arm title
    		 On-demand
    Arm description
    		 Mild and moderate bleeding episodes were treated with 40 IU/kg. Severe bleeding episodes were treated with 80 IU/kg.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Nonacog beta pegol
    Investigational medicinal product code
    Other name
    NNC-0156-0000-0009, N9-GP
    Pharmaceutical forms
    Powder and solvent for solution for injection/skin-prick test
    Routes of administration
    Intravenous use
    Dosage and administration details
    Administration of the appropriate volume of nonacog beta pegol was given as an i.v. bolus injection. The maximum injection rate was 4 mL/min.

    Number of subjects in period 1
    		Prophylaxis 10 IU/kg Prophylaxis 40 IU/kg On-demand
    Started
    30
    29
    15
    Completed
    28
    26
    13
    Not completed
    2
    3
    2
         Withdrawal criteria
    -
    1
    -
         Patient undergoing major surgery
    -
    2
    -
         Unclassified
    1
    -
    1
         Protocol deviation
    1
    -
    -
         Lack of efficacy
    -
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Prophylaxis 10 IU/kg
    Reporting group description
    		 The patients were randomised to either prophylaxis 10 IU/kg or 40 IU/kg arm. Patients enrolled in this arm received 10 IU/kg nonacog beta pegol dose once weekly (every 7th day ± 24 hours). Mild and moderate bleeding episodes were treated with 40 IU/kg. Severe bleeding episodes were treated with 80 IU/kg.

    Reporting group title
    Prophylaxis 40 IU/kg
    Reporting group description
    		 The patients were randomised to either prophylaxis 10 IU/kg or 40 IU/kg arm. Patients enrolled in this arm received 40 IU/kg nonacog beta pegol dose once weekly (every 7th day ± 24 hours). Mild and moderate bleeding episodes were treated with 40 IU/kg. Severe bleeding episodes were treated with 80 IU/kg.

    Reporting group title
    On-demand
    Reporting group description
    		 Mild and moderate bleeding episodes were treated with 40 IU/kg. Severe bleeding episodes were treated with 80 IU/kg.

    Reporting group values
    		 Prophylaxis 10 IU/kg Prophylaxis 40 IU/kg On-demand Total
    Number of subjects
    		 30 29 15 74
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0
        Adolescents (12-17 years)
    		 7 9 2 18
        Adults (18-64 years)
    		 23 19 13 55
        From 65-84 years
    		 0 1 0 1
        85 years and over
    		 0 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 32.4 ( 13.9 ) 30 ( 15.8 ) 32.4 ( 12 ) -
    Gender categorical
    Units: Subjects
        Female
    		 0 0 0 0
        Male
    		 30 29 15 74

    End points

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    End points reporting groups
    Reporting group title
    Prophylaxis 10 IU/kg
    Reporting group description
    		 The patients were randomised to either prophylaxis 10 IU/kg or 40 IU/kg arm. Patients enrolled in this arm received 10 IU/kg nonacog beta pegol dose once weekly (every 7th day ± 24 hours). Mild and moderate bleeding episodes were treated with 40 IU/kg. Severe bleeding episodes were treated with 80 IU/kg.

    Reporting group title
    Prophylaxis 40 IU/kg
    Reporting group description
    		 The patients were randomised to either prophylaxis 10 IU/kg or 40 IU/kg arm. Patients enrolled in this arm received 40 IU/kg nonacog beta pegol dose once weekly (every 7th day ± 24 hours). Mild and moderate bleeding episodes were treated with 40 IU/kg. Severe bleeding episodes were treated with 80 IU/kg.

    Reporting group title
    On-demand
    Reporting group description
    		 Mild and moderate bleeding episodes were treated with 40 IU/kg. Severe bleeding episodes were treated with 80 IU/kg.

    Primary: Incidence of inhibitory antibodies against FIX defined as titre ≥0.6 BU

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    End point title
    		 Incidence of inhibitory antibodies against FIX defined as titre ≥0.6 BU [1]
    End point description
    End point type
    Primary
    End point timeframe
    For the subjects treated with prophylaxis, inhibitory antibodies were assessed for 52 weeks + 4 weeks. For the subjects treated on-demand, inhibitory antibodies were assessed for 28 weeks + 4 weeks.
    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: Rate of inhibitory antibodies estimates were based on exact calculations for a binomial distribution. Adequate safety in the total population with regard to inhibitory antibodies was concluded if the observed rate was <= 2% and the upper 1-sided 97.5% confidence limit was <= 10.7%. Result: No inhibitory antibodies were detected and the 1-sided 97.5% upper confidence limit for the inhibitor incidence rate of 0 was 6%, thus the primary test succeeded as the upper confidence limit was below 10.7%.
    End point values
    		 Prophylaxis 10 IU/kg Prophylaxis 40 IU/kg On-demand
    Number of subjects analysed
    30 [2]
    28 [3]
    9 [4]
    Units: Patients with inhibitory antibodies
    0
    0
    0
    Notes
    [2] - Any patient with a minimum 10 exposure days plus any patient with inhibitory antibodies is included.
    [3] - Any patient with a minimum 10 exposure days plus any patient with inhibitory antibodies is included.
    [4] - Any patient with a minimum 10 exposure days plus any patient with inhibitory antibodies is included.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    For the subjects treated with prophylaxis, adverse events were assessed for 52 weeks + 4 weeks. For the subjects treated on-demand, adverse events were assessed for 28 weeks + 4 weeks.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17
    Reporting groups
    Reporting group title
    Prophylaxis 10 IU/kg
    Reporting group description
    		 The patients were randomised to either prophylaxis 10 IU/kg or 40 IU/kg arm. Patients enrolled in this arm received 10 IU/kg nonacog beta pegol dose once weekly (every 7th day ± 24 hours). Mild and moderate bleeding episodes were treated with 40 IU/kg. Severe bleeding episodes were treated with 80 IU/kg.

    Reporting group title
    Prophylaxis 40 IU/kg
    Reporting group description
    		 The patients were randomised to either prophylaxis 10 IU/kg or 40 IU/kg arm. Patients enrolled in this arm received 40 IU/kg nonacog beta pegol dose once weekly (every 7th day ± 24 hours). Mild and moderate bleeding episodes were treated with 40 IU/kg. Severe bleeding episodes were treated with 80 IU/kg.

    Reporting group title
    On-demand
    Reporting group description
    		 Mild and moderate bleeding episodes were treated with 40 IU/kg. Severe bleeding episodes were treated with 80 IU/kg.

    Serious adverse events
    		 Prophylaxis 10 IU/kg Prophylaxis 40 IU/kg On-demand
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 30 (3.33%)
    3 / 29 (10.34%)
    0 / 15 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Injury, poisoning and procedural complications
    Hip fracture
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 29 (3.45%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 29 (3.45%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Retroperitoneal haematoma
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 29 (0.00%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Skin ulcer
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 29 (3.45%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Prophylaxis 10 IU/kg Prophylaxis 40 IU/kg On-demand
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    21 / 30 (70.00%)
    19 / 29 (65.52%)
    11 / 15 (73.33%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Lipoma
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 29 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    1
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    3 / 30 (10.00%)
    2 / 29 (6.90%)
    1 / 15 (6.67%)
         occurrences all number
    3
    2
    1
    Pyrexia
         subjects affected / exposed
    1 / 30 (3.33%)
    2 / 29 (6.90%)
    1 / 15 (6.67%)
         occurrences all number
    2
    4
    1
    Reproductive system and breast disorders
    Erectile dysfunction
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 29 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    0 / 30 (0.00%)
    2 / 29 (6.90%)
    0 / 15 (0.00%)
         occurrences all number
    0
    3
    0
    Epistaxis
         subjects affected / exposed
    0 / 30 (0.00%)
    2 / 29 (6.90%)
    0 / 15 (0.00%)
         occurrences all number
    0
    6
    0
    Oropharyngeal pain
         subjects affected / exposed
    0 / 30 (0.00%)
    3 / 29 (10.34%)
    1 / 15 (6.67%)
         occurrences all number
    0
    3
    1
    Rhinorrhoea
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 29 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    1
    Psychiatric disorders
    Attention deficit/hyperactivity disorder
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 29 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    1
    Investigations
    C-reactive protein increased
         subjects affected / exposed
    4 / 30 (13.33%)
    0 / 29 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    4
    0
    0
    Prothrombin level increased
         subjects affected / exposed
    0 / 30 (0.00%)
    2 / 29 (6.90%)
    0 / 15 (0.00%)
         occurrences all number
    0
    4
    0
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    2 / 30 (6.67%)
    2 / 29 (6.90%)
    1 / 15 (6.67%)
         occurrences all number
    2
    2
    1
    Fall
         subjects affected / exposed
    1 / 30 (3.33%)
    3 / 29 (10.34%)
    0 / 15 (0.00%)
         occurrences all number
    1
    4
    0
    Laceration
         subjects affected / exposed
    1 / 30 (3.33%)
    1 / 29 (3.45%)
    1 / 15 (6.67%)
         occurrences all number
    2
    1
    1
    Overdose
         subjects affected / exposed
    0 / 30 (0.00%)
    2 / 29 (6.90%)
    0 / 15 (0.00%)
         occurrences all number
    0
    2
    0
    Thermal burn
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 29 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    2 / 30 (6.67%)
    3 / 29 (10.34%)
    2 / 15 (13.33%)
         occurrences all number
    2
    7
    3
    Speech disorder developmental
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 29 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    2
    Blood and lymphatic system disorders
    Eosinophilia
         subjects affected / exposed
    1 / 30 (3.33%)
    2 / 29 (6.90%)
    0 / 15 (0.00%)
         occurrences all number
    1
    2
    0
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 29 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    1
    Nausea
         subjects affected / exposed
    1 / 30 (3.33%)
    1 / 29 (3.45%)
    1 / 15 (6.67%)
         occurrences all number
    1
    2
    1
    Mouth ulceration
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 29 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    1
    Skin and subcutaneous tissue disorders
    Dermatitis
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 29 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    2 / 30 (6.67%)
    1 / 29 (3.45%)
    1 / 15 (6.67%)
         occurrences all number
    2
    2
    2
    Back pain
         subjects affected / exposed
    2 / 30 (6.67%)
    0 / 29 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    2
    0
    0
    Groin pain
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 29 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    1
    Myalgia
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 29 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    1
    Musculoskeletal pain
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 29 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    1
    Neck pain
         subjects affected / exposed
    0 / 30 (0.00%)
    3 / 29 (10.34%)
    0 / 15 (0.00%)
         occurrences all number
    0
    3
    0
    Pain in extremity
         subjects affected / exposed
    1 / 30 (3.33%)
    3 / 29 (10.34%)
    1 / 15 (6.67%)
         occurrences all number
    1
    3
    1
    Tendonitis
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 29 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    1
    Synovitis
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 29 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    1
    Infections and infestations
    Influenza
         subjects affected / exposed
    4 / 30 (13.33%)
    3 / 29 (10.34%)
    1 / 15 (6.67%)
         occurrences all number
    4
    5
    1
    Lower respiratory tract infection
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 29 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    1
    Nasopharyngitis
         subjects affected / exposed
    7 / 30 (23.33%)
    3 / 29 (10.34%)
    0 / 15 (0.00%)
         occurrences all number
    9
    4
    0
    Paronychia
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 29 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    1
    Pharyngotonsillitis
         subjects affected / exposed
    0 / 30 (0.00%)
    2 / 29 (6.90%)
    0 / 15 (0.00%)
         occurrences all number
    0
    2
    0
    Upper respiratory tract infection
         subjects affected / exposed
    3 / 30 (10.00%)
    3 / 29 (10.34%)
    2 / 15 (13.33%)
         occurrences all number
    4
    4
    2

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    30 Dec 2011
    Reduced number of physical examinations. Blood samples and tests that were to be taken in case a patient developed a severe allergic reaction related to nonacog beta pegol. All post-dose vital signs assessments were deleted from the flow charts in order to align with the visit descriptions in the protocol. It was specified that unused vials of trial product dispensed to the patient for treatment of bleeding episodes did not need to be returned to the site at each visit. The patient information and consent form were updated based on the changes to the protocol.
    11 May 2012
    Information on stop time of bleeding episode, on number of months on on-demand treatment and on screening of antibodies was updated.

    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.
    Not applicable
    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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