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    Clinical Trial Results:
    Clinical Study to Investigate the Pharmacokinetics, Efficacy, Safety, and Immunogenicity of Wilate in Previously Treated Patients with Severe Hemophilia A

    Summary
    EudraCT number
    		 2016-003681-34
    Trial protocol
    		 HU   BG   PL  
    Global end of trial date
    29 Mar 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    02 May 2019
    First version publication date
    02 May 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    WIL-27
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02954575
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Octapharma AG
    Sponsor organisation address
    Seidenstrasse 2, Lachen, Switzerland, CH-8853
    Public contact
    Clinical Trial Manager, Octapharma AG, +41 554512180, Cristina.Solomon@octapharma.ch
    Scientific contact
    Clinical Trial Manager, Octapharma AG, +41 554512180, Cristina.Solomon@octapharma.ch
    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
    22 Aug 2018
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    29 Mar 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study is to determine the efficacy of Wilate in the prophylactic treatment of previously treated patients (PTP) with severe hemophilia A.
    Protection of trial subjects
    This trial was conducted in accordance to the principles of ICH- GCP, ensuring that the rights, safety and well-being of patients are protected and in consistency with the Declaration of Helsinki and national regulatory requirements. Inclusion and exclusion criteria were carefully defined in order to protect subjects from contraindications, interactions with other medication and risk factors associated with the investigational medicinal product. Throughout the study safety was assessed, such as occurrence of AEs and concomitant medications.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    21 Dec 2016
    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
    Russian Federation: 7
    Country: Number of subjects enrolled
    Poland: 17
    Country: Number of subjects enrolled
    Bulgaria: 27
    Country: Number of subjects enrolled
    Hungary: 4
    Worldwide total number of subjects
    55
    EEA total number of subjects
    48
    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)
    5
    Adults (18-64 years)
    50
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Patients with documented severe hemophilia A, who had previous treatment with a FVIII concentrate for at least 150 exposure days (EDs) were screened according to predefined in- and exclusion criteria.

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

    Arms
    Arm title
    		 Wilate
    Arm description
    		 All patients will received Wilate for prophylactic treatment according to the guidelines given in the clinical study protocol and the patient’s clinical condition.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Wilate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Dose and frequency of Wilate was determined according to detailed guidelines given in the clinical study protocol and to the patient’s clinical condition. The dose used for PK assessment, i.e., 50 ± 5 IU/kg, was in line with the current recommendations of the EMA ,which recommends a dose of 25–50 IU/kg. The doses for prophylaxis (20–40 IU/kg Wilate/kg BW given at intervals of 2 to 3 days), the treatment of bleeding episodes and perioperative prophylaxis, were given as indicated in the European Summary of Product Characteristics. The body weight measurement obtained at the visit prior to the prophylactic treatments was used in the calculations of dose.

    Number of subjects in period 1
    		Wilate
    Started
    55
    Completed
    54
    Not completed
    1
         Adverse event, non-fatal
    1

    Baseline characteristics

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

    Reporting group values
    		 Overall Trial Total
    Number of subjects
    		 55 55
    Age categorical
    Units: Subjects
        < 16 years
    		 5 5
        >= 16 years
    		 50 50
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 35.0 ( 12.3 ) -
    Gender categorical
    Units: Subjects
        Female
    		 0 0
        Male
    		 55 55

    End points

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    End points reporting groups
    Reporting group title
    Wilate
    Reporting group description
    		 All patients will received Wilate for prophylactic treatment according to the guidelines given in the clinical study protocol and the patient’s clinical condition.

    Subject analysis set title
    Per-protocol population (PP)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The per-protocol (PP) set, i.e. a subset of the full analysis set excludes subjects with major protocol deviations which may have an impact on the evaluation of the primary study outcome parameter (major protocol deviations as defined during the data review meeting.

    Subject analysis set title
    Safety population (SAF)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The safety (SAF) set includes all subjects who received at least one infusion of IMP

    Subject analysis set title
    Full analysis set (FAS)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The full analysis set (FAS) defined according to the intention-to-treat (ITT) principle will include all enrolled subjects who received at least one infusion of IMP after the initial PK or at Non-PK Visit.

    Subject analysis set title
    Pharmacokinetic population (PK)
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    The pharmacokinetic (PK) set will include all subjects for which at least one valid Wilate PK profile has been obtained.

    Subject analysis set title
    N (BE)
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Number of bleeding events (PP -data set )

    Subject analysis set title
    % (BE)
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Percentage of bleeding events (PP -data set )

    Subject analysis set title
    Initial PK
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Initial PK Assessment of FVIII:C

    Subject analysis set title
    PK completion 6 months
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    PK Assessment of FVIII:C at 6 months

    Subject analysis set title
    Number of patients
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Number of patients

    Subject analysis set title
    % of patients
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    percentage of patients

    Subject analysis set title
    Overall efficacy assessment (n)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Result of overall efficacy assessment (n)

    Subject analysis set title
    Overall efficacy assessment (%)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Overall efficacy assessment (%)

    Subject analysis set title
    ABRs during Wilate Prophylaxis
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    ABRs during Wilate Prophylyxis

    Subject analysis set title
    Incremental IVR (kg/dL) over time
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    IVR from FVIII:C plasma levels from all patients at each visit

    Subject analysis set title
    ANOVA assessed association between blood group &IMP half-life
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    ANOVA assessed association between blood group and Wilate half-life

    Subject analysis set title
    ANOVA assessed association between VWF:Ag and IMP half-life
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    ANOVA assessed association between VWF:Ag and Wilate half-life

    Subject analysis set title
    Number of patients Pearson Clopper CI (2-sided) 95%
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    95% Pearson Clopper interval

    Primary: Reduction of total annualized bleeding rate (TABR) under Prophylaxis

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    End point title
    		 Reduction of total annualized bleeding rate (TABR) under Prophylaxis [1]
    End point description
    The efficacy of prophylactic treatment with Wilate was statistically evaluated by comparing the primary endpoint, i.e., TABR under prophylaxis, with a predefined threshold of 29 BEs per patient per year. This threshold corresponds to 50% of the TABR reported in GENA-01 study which had a TABR of 58.1 per patient per year. A confirmative one-sided, one-sample Poisson test was used to test whether the mean annualised bleeding rate (ABR) in patients treated prophylactically with Wilate was below the threshold of 29 BEs per patient year (alpha = 2.5%). A corresponding two-sided 95% CI for the TABR was also provided. In the per-protocol population (N=52) the one-sample Poisson test estimate was 2.13 (95% CI 1.64, 2.76) p<0.0001 vs mean TABR >29
    End point type
    Primary
    End point timeframe
    6 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: Trial includes one arm only. For specifying statistical analysis in the system at least 2 arms are required, so no statistical analysis can be entered. Therefore only results for this endpoint are provided. 84.2% of all BEs were treated successfully (95% CI 72.13%, 92.52%; p=0.0096 for proportion of success ≤70%)
    End point values
    		 ABRs during Wilate Prophylaxis
    Number of subjects analysed
    52
    Units: bleeding events
    arithmetic mean (confidence interval 95%)
        Bleeding Rate
    2.13 (1.64 to 2.76)
    No statistical analyses for this end point

    Secondary: Spontaneous annualized bleeding rate (SABR)

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    End point title
    		 Spontaneous annualized bleeding rate (SABR)
    End point description
    SABR was analysed in the same way as TABR, the only exception being that, for the comparison of mean SABRs, a predefined threshold of 19.1 per patient per year was chosen; this threshold corresponds to 50% of the SABR in GENA-01. For the spontaneous BEs in the PP population, the one-sample Poisson test estimate was 1.53 (95% CI 1.13, 2.08; p<0.0001 vs mean SABR >19.1).
    End point type
    Secondary
    End point timeframe
    6 months
    End point values
    		 ABRs during Wilate Prophylaxis
    Number of subjects analysed
    52
    Units: Bleeding Events
    geometric mean (confidence interval 95%)
        Bleeding Rate
    1.53 (1.13 to 2.08)
    No statistical analyses for this end point

    Secondary: Efficacy of Wilate in the treatment of breakthrough bleeding events

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    End point title
    		 Efficacy of Wilate in the treatment of breakthrough bleeding events
    End point description
    The proportion of bleeding events (BEs) successfully treated with Wilate were documented by the patient (together with the investigator in case of on-site treatments) in the patient diary for all BEs according to a 4 point hemostatic efficacy scales including the four items: 'excellent,' 'good,' moderate,' and 'none'. All efficacy ratings assessed as either ‘excellent’ or ‘good’ were considered ‘successfully treated.’
    End point type
    Secondary
    End point timeframe
    6 months
    End point values
    		 N (BE) % (BE)
    Number of subjects analysed
    25 [2]
    25 [3]
    Units: Bleeding Events
    number (not applicable)
        Excellent
    16
    28.1
        Good
    32
    56.1
        Moderate
    9
    15.8
        Treated sucessfully (all BEs)
    48
    84.2
    Notes
    [2] - Number of patients with BEs
    [3] - Number of patients with BEs
    No statistical analyses for this end point

    Secondary: Wilate consumption for prophylaxis

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    End point title
    		 Wilate consumption for prophylaxis
    End point description
    The total consumption of Wilate for all patients receiving prophylaxis (IU/kg)
    End point type
    Secondary
    End point timeframe
    6 months
    End point values
    		 Per-protocol population (PP)
    Number of subjects analysed
    52
    Units: Total Dose IU/kg
    number (not applicable)
        Prophylaxis
    1300017.1
    No statistical analyses for this end point

    Secondary: Pharmacokinetic (PK) assessment area under the curve [AUCnorm] of FVIII:C

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    End point title
    		 Pharmacokinetic (PK) assessment area under the curve [AUCnorm] of FVIII:C
    End point description
    PK assessments of FVIII:C were conducted using the one-stage (OS) assay. The value of the area under the curve [AUC]) of FVIII:C was calculated based on the FVIII:C values measured in the patients participating in the PK study.
    End point type
    Secondary
    End point timeframe
    at baseline and 6 months
    End point values
    		 Initial PK PK completion 6 months
    Number of subjects analysed
    21
    21
    Units: AUCnorm (h*kg*IU/dL/IU)
    geometric mean (standard deviation)
        AUCnorm
    28.61 ( 9.31 )
    30.75 ( 11.32 )
    No statistical analyses for this end point

    Secondary: PK OS assay assessment (in vivo half-life) of FVIII:C

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    End point title
    		 PK OS assay assessment (in vivo half-life) of FVIII:C
    End point description
    PK assessments of FVIII:C were conducted using the OS assay. The in vivo half-life of FVIII:C was calculated based on the FVIII:C values measured in the patients participating in the PK study
    End point type
    Secondary
    End point timeframe
    at baseline and 6 months
    End point values
    		 Initial PK PK completion 6 months
    Number of subjects analysed
    21
    21
    Units: Half-life (h)
    geometric mean (standard deviation)
        Half-life (h)
    10.82 ( 2.5 )
    11.5 ( 2.3 )
    No statistical analyses for this end point

    Secondary: PK assessment (Maximum plasma concentration [Cmax]) of FVIII:C

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    End point title
    		 PK assessment (Maximum plasma concentration [Cmax]) of FVIII:C
    End point description
    PK assessments of FVIII:C were conducted using the one-stage (OS) assay. The Maximum plasma concentration of FVIII:C was calculated based on the FVIII:C values measured in the patients participating in the PK study.
    End point type
    Secondary
    End point timeframe
    at baseline and 6 months
    End point values
    		 Initial PK PK completion 6 months
    Number of subjects analysed
    21
    21
    Units: Cmax (IU/dL)
    geometric mean (standard deviation)
        Cmax (IU/dL)
    106.7 ( 22.45 )
    103.49 ( 26.53 )
    No statistical analyses for this end point

    Secondary: Incremental in vivo recovery (IVR) of Wilate over time

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    End point title
    		 Incremental in vivo recovery (IVR) of Wilate over time
    End point description
    IVR was determined from FVIII:C plasma levels from all patients at each visit using OS assay
    End point type
    Secondary
    End point timeframe
    At baseline, and at 3 and 6 months of treatment
    End point values
    		 Incremental IVR (kg/dL) over time
    Number of subjects analysed
    55
    Units: kg/dL
    geometric mean (standard deviation)
        First PK/non-PK visit
    2.14 ( 0.51 )
        3 months
    2.14 ( 0.49 )
        PK/non-PK completion 6 months
    1.97 ( 0.64 )
    No statistical analyses for this end point

    Secondary: Association between ABO blood type and the FVIII:C half-life of Wilate

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    End point title
    		 Association between ABO blood type and the FVIII:C half-life of Wilate
    End point description
    Analysis of variance (ANOVA) was used in an exploratory sense to assess an association between AB0 blood type and the FVIII:C half-life of Wilate.
    End point type
    Secondary
    End point timeframe
    6 months
    End point values
    		 ANOVA assessed association between blood group &IMP half-life
    Number of subjects analysed
    21
    Units: p-value
    number (not applicable)
        One-Stage Assay ( OS assay)
    0.0346
    No statistical analyses for this end point

    Secondary: Association between VWF:Ag concentration and the FVIII:C half-life of Wilate

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    End point title
    		 Association between VWF:Ag concentration and the FVIII:C half-life of Wilate
    End point description
    ANOVA was used in an exploratory sense to assess an association between VWF:Ag with the FVIII:C half-life of Wilate.
    End point type
    Secondary
    End point timeframe
    6 months
    End point values
    		 ANOVA assessed association between VWF:Ag and IMP half-life
    Number of subjects analysed
    21
    Units: p-value
    number (not applicable)
        One-Stage Assay ( OS assay)
    0.4244
    No statistical analyses for this end point

    Secondary: Immunogenicity of Wilate by testing for FVIII inhibitors

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    End point title
    		 Immunogenicity of Wilate by testing for FVIII inhibitors
    End point description
    FVIII inhibitor activity was determined at each study visit before the injection of Wilate using the modified Bethesda assay (Nijmegen modification).
    End point type
    Secondary
    End point timeframe
    6 months
    End point values
    		 Number of patients Pearson Clopper CI (2-sided) 95%
    Number of subjects analysed
    55
    Units: patients
    number (confidence interval 95%)
        FVIII inhibitors developed
    0 (0 to 16.11)
    No statistical analyses for this end point

    Secondary: Virus safety to be measured by the incidence of parvovirus B19 seroconversions between baseline (BL) and end of study

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    End point title
    		 Virus safety to be measured by the incidence of parvovirus B19 seroconversions between baseline (BL) and end of study
    End point description
    Virus safety was evaluated by taking a plasma sample for parvovirus B19 antibody testing before the first injection of Wilate. All patients negative at screening were tested again at the study completion visit.
    End point type
    Secondary
    End point timeframe
    6 months
    End point values
    		 Number of patients % of patients
    Number of subjects analysed
    55 [4]
    55 [5]
    Units: % of patients
    number (not applicable)
        Positive for parvovirus B19 IgG antibodies at BL
    53
    96.4
        Positive for parvovirus B19 IgM antibodies at BL
    1
    1.82
        Negative for B19 IgM&IgG at BL and end of study
    2
    3.64
    Notes
    [4] - refers to percentage from the total 55 subjects in SAF
    [5] - refers to percentage from the total 55 subjects in SAF
    No statistical analyses for this end point

    Secondary: Efficacy of Wilate in surgical prophylaxis assessed by surgeon and hematologist using predefined assessment criteria

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    End point title
    		 Efficacy of Wilate in surgical prophylaxis assessed by surgeon and hematologist using predefined assessment criteria
    End point description
    Hemostatic efficacy was assessed at the end of surgery by the surgeon and at end of the postoperative period by the haematologist, using 4 point hemostatic efficacy scales including the four items: 'excellent,' 'good,' moderate,' and 'none'. Overall efficacy was assessed by the investigator, taking both the intra and postoperative assessments into account, and using the ‘excellent,’ ‘good,’ moderate,’ and ‘none’ scale.
    End point type
    Secondary
    End point timeframe
    6 months
    End point values
    		 Overall efficacy assessment (n) Overall efficacy assessment (%)
    Number of subjects analysed
    55
    55
    Units: Efficacy Rating
    number (not applicable)
        Excellent
    0
    0
        Good
    1
    100
        Moderate
    0
    0
        None
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Throughout the observation period until study completion.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.0
    Reporting groups
    Reporting group title
    SAF Population
    Reporting group description
    		 -

    Serious adverse events
    		 SAF Population
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 55 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 SAF Population
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    12 / 55 (21.82%)
    Injury, poisoning and procedural complications
    Limb injury
         subjects affected / exposed
    1 / 55 (1.82%)
         occurrences all number
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 55 (1.82%)
         occurrences all number
    1
    Blood and lymphatic system disorders
    Thrombocytosis
         subjects affected / exposed
    2 / 55 (3.64%)
         occurrences all number
    2
    General disorders and administration site conditions
    Pain
         subjects affected / exposed
    1 / 55 (1.82%)
         occurrences all number
    1
    Immune system disorders
    Seasonal allergy
         subjects affected / exposed
    2 / 55 (3.64%)
         occurrences all number
    2
    Skin and subcutaneous tissue disorders
    Eczema
         subjects affected / exposed
    1 / 55 (1.82%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    2 / 55 (3.64%)
         occurrences all number
    5
    Infections and infestations
    Erysipelas
         subjects affected / exposed
    1 / 55 (1.82%)
         occurrences all number
    1
    Nasopharyngitis
         subjects affected / exposed
    1 / 55 (1.82%)
         occurrences all number
    1
    Viral upper respiratory tract infection
         subjects affected / exposed
    1 / 55 (1.82%)
         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
    16 Jan 2017
    Protocol amendment has been prepared in response to the FDA information request: - a second PK Assessment Phase after 6 months of prophylactic treatment which is included in the PK Study Completion Visit has been added - study duration for patients undergoing PK assessment has been corrected from 1 week to 2 days per PK Assessment Phase. - thromboembolic events have been defined as events subject to expedited reporting throughout the duration of the study. Also, to actively monitor patients for signs and symptoms of thromboembolic events after the end of study treatment, a Follow-up Contact 30 days after the end of study treatment has been included. - specification that, of the 20 patients undergoing PK assessment, 4 patients should be between ≥12 and <17 years of age has been added - the time period for recording bleeding events that will count towards the primary and relevant secondary endpoint has been more clearly defined. - determination of VWF:Ag and VWF:Ac has been dropped from the Screening Visit - further instruction whow to proceed in case the interval between screening and treatment initiation is longer than 30 days have been added - information on how to deal with patients who develop FVIII inhibitors have been specified - details which bleeding frequency during prophylactic treatment should be considered ‘unacceptable’ for a dose adjustment to be triggered have been added - a retention sample being taken for possible virus marker testing in addition to parvovirus B19 antibody testing - the use of Wilate in surgical prophylaxis has been defined as additional (i.e., exploratory) rather than a secondary endpoint. - continuous infusion of Wilate during surgical prophylaxis has been disallowed - The possibility of ‘severe hemorrhage’ during surgery was deleted as a defining criterion for major surgeries

    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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