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    Clinical Trial Results:
    Safety, tolerability, and pharmacokinetics study of single and multiple subcutaneous doses of turoctocog alfa pegol in patients with haemophilia A

    Summary
    EudraCT number
    		 2016-002396-99
    Trial protocol
    		 AT   DE   BG   FR   GB  
    Global end of trial date
    15 Oct 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    26 Apr 2019
    First version publication date
    26 Apr 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    NN7170-4213
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02994407
    WHO universal trial number (UTN)
    		 U1111-1183-5111
    Other trial identifiers
    		 Japanese trial registration: JapicCTI-173683
    Sponsors
    Sponsor organisation name
    Novo Nordisk
    Sponsor organisation address
    Novo Allé, Bagsvaerd, Denmark, 2880
    Public contact
    Clinical Reporting Anchor and Disclosure (1452), Novo Nordisk, clinicaltrials@novonordisk.com
    Scientific contact
    Clinical Reporting Anchor and Disclosure (1452), Novo Nordisk, 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
    02 Apr 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    15 Oct 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    15 Oct 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the safety of s.c. administration of turoctocog alfa pegol (SC N8-GP) in patients with severe haemophilia A
    Protection of trial subjects
    The trial was conducted in accordance with the Declaration of Helsinki (2013) and ICH Good Clinical Practice, including archiving of essential documents (2009) and 21 CFR 312.120.
    Background therapy
    		 Not applicable
    Evidence for comparator
    		 Not applicable
    Actual start date of recruitment
    30 Jan 2017
    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
    Austria: 4
    Country: Number of subjects enrolled
    Bulgaria: 2
    Country: Number of subjects enrolled
    Germany: 5
    Country: Number of subjects enrolled
    France: 1
    Country: Number of subjects enrolled
    United Kingdom: 8
    Country: Number of subjects enrolled
    Japan: 2
    Country: Number of subjects enrolled
    Serbia: 5
    Country: Number of subjects enrolled
    Turkey: 2
    Country: Number of subjects enrolled
    United States: 7
    Worldwide total number of subjects
    36
    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)
    3
    Adults (18-64 years)
    33
    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 25 sites in 9 countries as follows: Austria: 2 sites; Bulgaria: 1 site; France: 1 site; Germany: 3 sites; Japan: 2 sites; Serbia: 5 sites; Turkey: 1 site; United Kingdom: 3 sites; United States: 7 sites.

    Pre-assignment
    Screening details
    		 The study consisted of two parts: one single dose, dose escalation part (part A) and one multiple dose part (part B) with daily administrations of SC N8-GP for a period of 3 months. Subjects having completed part A and who had wanted to continue to part B treated themselves with their regular FVIII product in the period between part A and B.

    Period 1
    Period 1 title
    Part A
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Investigator, Monitor, Carer, Subject
    Blinding implementation details
    Double blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Part A - SC N8-GP (12.5 IU/kg)
    Arm description
    		 Subjects received a single dose (12.5 IU/kg) of SC N8-GP and a single subcutaneous injection of placebo.
    Arm type
    		 Experimental

    Investigational medicinal product name
    SC turoctocog alfa pegol A 2000
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received a single dose of SC N8-GP 12.5 IU/kg and placebo as subcutaneous injection with a syringe. The two treatments (SC N8-GP and placebo) were administered immediately after one another (one in the abdomen above the umbilicus and one below the umbilicus) in a blinded randomised manner.

    Arm title
    		 Part A - SC N8-GP (25 IU/kg)
    Arm description
    		 Subjects received a single dose (25 IU/kg) of SC N8-GP and a single subcutaneous injection of placebo.
    Arm type
    		 Experimental

    Investigational medicinal product name
    SC turoctocog alfa pegol A 2000
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received a single dose of SC N8-GP 25 IU/kg and placebo as subcutaneous injection with a syringe. The two treatments (SC N8-GP and placebo) were administered immediately after one another (one in the abdomen above the umbilicus and one below the umbilicus) in a blinded randomised manner.

    Arm title
    		 Part A - SC N8-GP (50 IU/kg)
    Arm description
    		 Subjects received a single dose (50 IU/kg) of SC N8-GP and a single subcutaneous injection of placebo.
    Arm type
    		 Experimental

    Investigational medicinal product name
    SC turoctocog alfa pegol A 2000
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received a single dose of SC N8-GP 50 IU/kg and placebo as subcutaneous injection with a syringe. The two treatments (SC N8-GP and placebo) were administered immediately after one another (one in the abdomen above the umbilicus and one below the umbilicus) in a blinded randomised manner.

    Arm title
    		 Part A - SC N8-GP (100 IU/kg)
    Arm description
    		 Subjects received a single dose (100 IU/kg) of SC N8-GP and a single subcutaneous injection of placebo.
    Arm type
    		 Experimental

    Investigational medicinal product name
    SC turoctocog alfa pegol A 2000
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received a single dose of SC N8-GP 100 IU/kg and placebo as subcutaneous injection with a syringe. The two treatments (SC N8-GP and placebo) were administered immediately after one another (one in the abdomen above the umbilicus and one below the umbilicus) in a blinded randomised manner.

    Number of subjects in period 1 [1]
    		Part A - SC N8-GP (12.5 IU/kg) Part A - SC N8-GP (25 IU/kg) Part A - SC N8-GP (50 IU/kg) Part A - SC N8-GP (100 IU/kg)
    Started
    6
    6
    6
    6
    Completed
    6
    6
    6
    6
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: Only one period can be selected for baseline period. Therefore the baseline characteristics of the second period (part B) is explained by means of subject analysis set.
    Period 2
    Period 2 title
    Part B
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 SC N8-GP
    Arm description
    		 Subjects received daily subcutaneous administrations of SC N8-GP for a period of 3 months (13 weeks). In addition to 12 new subjects, fourteen subjects having completed part A continued to part B and treated himself with his regular FVIII product in the period between part A and B.
    Arm type
    		 Experimental

    Investigational medicinal product name
    SC turoctocog alfa pegol A 2000
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received daily subcutaneous administrations of SC N8-GP for a period of 3 months (13 weeks). The starting dose for all patients depended on their individual body weight. Based on available safety data from part A, SC N8-GP doses of up to 100 IU/kg per day were considered safe also for repeated daily dosing.

    Number of subjects in period 2 [2]
    		SC N8-GP
    Started
    12
    Completed
    12
    Notes
    [2] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: The number of subjects mentioned here (12) are the new subjects enrolled in part B, in addition to the 14 subjects who continued from the previous period.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Part A - SC N8-GP (12.5 IU/kg)
    Reporting group description
    		 Subjects received a single dose (12.5 IU/kg) of SC N8-GP and a single subcutaneous injection of placebo.

    Reporting group title
    Part A - SC N8-GP (25 IU/kg)
    Reporting group description
    		 Subjects received a single dose (25 IU/kg) of SC N8-GP and a single subcutaneous injection of placebo.

    Reporting group title
    Part A - SC N8-GP (50 IU/kg)
    Reporting group description
    		 Subjects received a single dose (50 IU/kg) of SC N8-GP and a single subcutaneous injection of placebo.

    Reporting group title
    Part A - SC N8-GP (100 IU/kg)
    Reporting group description
    		 Subjects received a single dose (100 IU/kg) of SC N8-GP and a single subcutaneous injection of placebo.

    Reporting group values
    		 Part A - SC N8-GP (12.5 IU/kg) Part A - SC N8-GP (25 IU/kg) Part A - SC N8-GP (50 IU/kg) Part A - SC N8-GP (100 IU/kg) Total
    Number of subjects
    		 6 6 6 6 24
    Age Categorical
    Number of subjects in each age category.
    Units: Subjects
        Adolescents (12-17 years)
    		 0 0 0 0 0
        Adults (18-64 years)
    		 6 6 6 6 24
        From 65-84 years
    		 0 0 0 0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 36.0 ( 10.5 ) 37.8 ( 15.8 ) 34.7 ( 16.7 ) 38.7 ( 16.1 ) -
    Gender Categorical
    Units: Subjects
        Female
    		 0 0 0 0 0
        Male
    		 6 6 6 6 24
    Subject analysis sets

    Subject analysis set title
    Part B SC-N8-GP
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subjects received daily subcutaneous administrations of SC N8-GP for a period of 3 months (13 weeks). In addition to 12 new subjects, fourteen subjects having completed part A continued to part B and treated themselves with their regular FVIII product in the period between part A and B. Thus the subject analysis set included 26 subjects.

    Subject analysis sets values
    		 Part B SC-N8-GP
    Number of subjects
    26
    Age Categorical
    Number of subjects in each age category.
    Units: Subjects
        Adolescents (12-17 years)
    3
        Adults (18-64 years)
    22
        From 65-84 years
    1
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    33.9 ( 15.4 )
    Gender Categorical
    Units: Subjects
        Female
    0
        Male
    26

    End points

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    End points reporting groups
    Reporting group title
    Part A - SC N8-GP (12.5 IU/kg)
    Reporting group description
    		 Subjects received a single dose (12.5 IU/kg) of SC N8-GP and a single subcutaneous injection of placebo.

    Reporting group title
    Part A - SC N8-GP (25 IU/kg)
    Reporting group description
    		 Subjects received a single dose (25 IU/kg) of SC N8-GP and a single subcutaneous injection of placebo.

    Reporting group title
    Part A - SC N8-GP (50 IU/kg)
    Reporting group description
    		 Subjects received a single dose (50 IU/kg) of SC N8-GP and a single subcutaneous injection of placebo.

    Reporting group title
    Part A - SC N8-GP (100 IU/kg)
    Reporting group description
    		 Subjects received a single dose (100 IU/kg) of SC N8-GP and a single subcutaneous injection of placebo.
    Reporting group title
    SC N8-GP
    Reporting group description
    		 Subjects received daily subcutaneous administrations of SC N8-GP for a period of 3 months (13 weeks). In addition to 12 new subjects, fourteen subjects having completed part A continued to part B and treated himself with his regular FVIII product in the period between part A and B.

    Subject analysis set title
    Part B SC-N8-GP
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subjects received daily subcutaneous administrations of SC N8-GP for a period of 3 months (13 weeks). In addition to 12 new subjects, fourteen subjects having completed part A continued to part B and treated themselves with their regular FVIII product in the period between part A and B. Thus the subject analysis set included 26 subjects.

    Primary: Number of adverse events reported after exposure to SC N8-GP

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    End point title
    		 Number of adverse events reported after exposure to SC N8-GP [1]
    End point description
    Number of treatment emergent adverse events reported after exposure to SC N8-GP until 7 days after last exposure.The reporting period of adverse events was changed to until 7 days after last exposure due to the half-time of SC N8-GP.
    End point type
    Primary
    End point timeframe
    Until 7 days after last exposure
    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: The primary endpoint investigates safety and is analysed using descriptive statistics, and thus no statistical analysis is performed.
    End point values
    		 Part A - SC N8-GP (12.5 IU/kg) Part A - SC N8-GP (25 IU/kg) Part A - SC N8-GP (50 IU/kg) Part A - SC N8-GP (100 IU/kg) Part B SC-N8-GP
    Number of subjects analysed
    6
    6
    6
    6
    26
    Units: number of events
    7
    4
    1
    3
    40
    No statistical analyses for this end point

    Secondary: Pharmacokinetic parameter Cmax (up to 144 hours after dose)

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    End point title
    		 Pharmacokinetic parameter Cmax (up to 144 hours after dose)
    End point description
    The maximal FVIII activity measured after single dose administration.
    End point type
    Secondary
    End point timeframe
    After single dose administration (part A)
    End point values
    		 Part A - SC N8-GP (12.5 IU/kg) Part A - SC N8-GP (25 IU/kg) Part A - SC N8-GP (50 IU/kg) Part A - SC N8-GP (100 IU/kg)
    Number of subjects analysed
    6
    6
    6
    6
    Units: IU/dL
        arithmetic mean (standard deviation)
    1.3 ( 106.9 )
    2.5 ( 62.8 )
    4.6 ( 32.6 )
    15.2 ( 75.6 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    After the first day of trial product administration until 7 days after last exposure i.e. total duration of visit 2 for part A and from visit 2 to 7 days after visit 8 in part B.
    Adverse event reporting additional description
    Adverse events were reported tor the safety analysis set which included all patients exposed to the trial product. The reporting period of adverse events was changed from 28 days to 'until 7 days after last exposure' due to the half-time of SC N8-GP.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21
    Reporting groups
    Reporting group title
    Part A - SC N8-GP (12.5 IU/kg)
    Reporting group description
    		 Subjects received a single dose (12.5 IU/kg) of SC N8-GP and a single subcutaneous injection of placebo.

    Reporting group title
    Part A - SC N8-GP (25 IU/kg)
    Reporting group description
    		 Subjects received a single dose (25 IU/kg) of SC N8-GP and a single subcutaneous injection of placebo.

    Reporting group title
    Part A - SC N8-GP (50 IU/kg)
    Reporting group description
    		 Subjects received a single dose (50 IU/kg) of SC N8-GP and a single subcutaneous injection of placebo.

    Reporting group title
    Part A - SC N8-GP (100 IU/kg)
    Reporting group description
    		 Subjects received a single dose (100 IU/kg) of SC N8-GP and a single subcutaneous injection of placebo.

    Reporting group title
    Part B - SC-N8-GP (once daily)
    Reporting group description
    		 Subjects received daily subcutaneous administrations of SC N8-GP for a period of 3 months (13 weeks). In addition to 12 new subjects, fourteen subjects having completed part A continued to part B and treated himself with his regular FVIII product in the period between part A and B. Thus the subject analysis set included 26 subjects

    Serious adverse events
    		 Part A - SC N8-GP (12.5 IU/kg) Part A - SC N8-GP (25 IU/kg) Part A - SC N8-GP (50 IU/kg) Part A - SC N8-GP (100 IU/kg) Part B - SC-N8-GP (once daily)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    2 / 26 (7.69%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    Blood and lymphatic system disorders
    Factor VIII inhibition
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 26 (3.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 26 (3.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Part A - SC N8-GP (12.5 IU/kg) Part A - SC N8-GP (25 IU/kg) Part A - SC N8-GP (50 IU/kg) Part A - SC N8-GP (100 IU/kg) Part B - SC-N8-GP (once daily)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    4 / 6 (66.67%)
    2 / 6 (33.33%)
    1 / 6 (16.67%)
    3 / 6 (50.00%)
    7 / 26 (26.92%)
    Injury, poisoning and procedural complications
    Scratch
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    3 / 26 (11.54%)
         occurrences all number
    0
    0
    0
    0
    6
    General disorders and administration site conditions
    Injection site bruising
         subjects affected / exposed
    1 / 6 (16.67%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    1
    1
    0
    0
    1
    Injection site erythema
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    1 / 6 (16.67%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    1
    1
    0
    Injection site haematoma
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    1
    0
    0
    0
    2
    Injection site pain
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Injection site swelling
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 26 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Vessel puncture site bruise
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Gastrointestinal disorders
    Abdominal pain lower
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Skin and subcutaneous tissue disorders
    Erythema
         subjects affected / exposed
    0 / 6 (0.00%)
    2 / 6 (33.33%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 26 (0.00%)
         occurrences all number
    0
    3
    0
    0
    0
    Renal and urinary disorders
    Proteinuria
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 26 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    3 / 26 (11.54%)
         occurrences all number
    0
    0
    0
    0
    3

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    31 Oct 2016
    Text regarding stopping rules and SUSAR reporting have been updated
    27 Dec 2017
    To specify the dose for part B and updates based on authority commitments prior to the start of part B.

    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
    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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