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    Clinical Trial Results:
    Multiple escalating dose study of BAY 1093884 in adults with hemophilia A or B with or without inhibitors

    Summary
    EudraCT number
    		 2017-003324-67
    Trial protocol
    		 GB   AT   BG   FR   HU   IT  
    Global end of trial date
    15 Oct 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    28 Oct 2020
    First version publication date
    28 Oct 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    BAY1093884/19580
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03597022
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Bayer AG
    Sponsor organisation address
    Bayer AG Kaiser Wilhelm Allee, Leverkusen, Germany, D-51368
    Public contact
    Therapeutic Area Head, Bayer AG, clinical-trials-contact@bayer.com
    Scientific contact
    Therapeutic Area Head, Bayer AG, clinical-trials-contact@bayer.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
    15 Oct 2019
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    15 Oct 2019
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To assess the safety and tolerability of multiple subcutaneous doses of befovacimab in subjects with hemophilia A or B with or without inhibitors
    Protection of trial subjects
    The conduct of this clinical study met all local legal and regulatory requirements. The study was conducted in accordance with ethical principles that have their origin in the Declaration of Helsinki and the International Council for Harmonization guideline E6: Good Clinical Practice. Before entering the study, the informed consent was read by and explained to all the subjects. Participating subjects signed informed consent form and could withdraw from the study at any time without any disadvantage and without having to provide a reason for this decision. Only investigators qualified by training and experience were selected as appropriate experts to investigate the study drug.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    24 Jul 2018
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 4
    Country: Number of subjects enrolled
    Bulgaria: 2
    Country: Number of subjects enrolled
    France: 3
    Country: Number of subjects enrolled
    Australia: 1
    Country: Number of subjects enrolled
    Austria: 3
    Country: Number of subjects enrolled
    Hungary: 1
    Country: Number of subjects enrolled
    Italy: 3
    Country: Number of subjects enrolled
    Japan: 2
    Country: Number of subjects enrolled
    New Zealand: 1
    Country: Number of subjects enrolled
    Korea, Republic of: 3
    Country: Number of subjects enrolled
    Taiwan: 1
    Worldwide total number of subjects
    24
    EEA total number of subjects
    16
    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)
    23
    From 65 to 84 years
    1
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Study was conducted at multiple centers in 11 countries or regions between 24 July 2018 (first subject first visit) and 15 October 2019 (last subject last visit).

    Pre-assignment
    Screening details
    		 Overall, 26 subjects were screened. Of them, 1 subject was screen failure and 1 subject could not start subsequent treatment on schedule; 24 subjects received study treatment.

    Period 1
    Period 1 title
    Overall study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 BAY1093884 100mg
    Arm description
    		 Subjects received BAY1093884 100 mg once a week until premature termination of the study
    Arm type
    		 Experimental

    Investigational medicinal product name
    Befovacimab
    Investigational medicinal product code
    BAY1093884
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    100 mg, once weekly doses until premature termination of the study, subcutaneous injection

    Arm title
    		 BAY1093884 225mg
    Arm description
    		 Subjects received BAY1093884 225 mg once a week until premature termination of the study
    Arm type
    		 Experimental

    Investigational medicinal product name
    Befovacimab
    Investigational medicinal product code
    BAY1093884
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    225 mg, once weekly doses until premature termination of the study, subcutaneous injection

    Arm title
    		 BAY1093884 400mg
    Arm description
    		 Subjects received BAY1093884 400mg once a week until premature termination of the study
    Arm type
    		 Experimental

    Investigational medicinal product name
    Befovacimab
    Investigational medicinal product code
    BAY1093884
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    400 mg, once weekly doses until premature termination of the study, subcutaneous injection

    Number of subjects in period 1
    		BAY1093884 100mg BAY1093884 225mg BAY1093884 400mg
    Started
    8
    8
    8
    Completed
    0
    0
    0
    Not completed
    8
    8
    8
         Premature termination of the study
    7
    7
    8
         Serious adverse event
    1
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    BAY1093884 100mg
    Reporting group description
    		 Subjects received BAY1093884 100 mg once a week until premature termination of the study

    Reporting group title
    BAY1093884 225mg
    Reporting group description
    		 Subjects received BAY1093884 225 mg once a week until premature termination of the study

    Reporting group title
    BAY1093884 400mg
    Reporting group description
    		 Subjects received BAY1093884 400mg once a week until premature termination of the study

    Reporting group values
    		 BAY1093884 100mg BAY1093884 225mg BAY1093884 400mg Total
    Number of subjects
    		 8 8 8 24
    Age Categorical
    Units: Subjects
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 44.0 ± 14.5 43.5 ± 15.6 43.1 ± 5.9 -
    Gender Categorical
    Units: Subjects
        Female
    		 0 0 0 0
        Male
    		 8 8 8 24
    Race
    Units: Subjects
        Asian
    		 2 2 2 6
        Black or African American
    		 0 0 1 1
        White
    		 6 6 5 17

    End points

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    End points reporting groups
    Reporting group title
    BAY1093884 100mg
    Reporting group description
    		 Subjects received BAY1093884 100 mg once a week until premature termination of the study

    Reporting group title
    BAY1093884 225mg
    Reporting group description
    		 Subjects received BAY1093884 225 mg once a week until premature termination of the study

    Reporting group title
    BAY1093884 400mg
    Reporting group description
    		 Subjects received BAY1093884 400mg once a week until premature termination of the study

    Subject analysis set title
    Safety analysis set (SAF)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All subjects with at least one intake of study drug

    Primary: Number of subjects with drug-related treatment-emergent adverse events

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    End point title
    		 Number of subjects with drug-related treatment-emergent adverse events [1]
    End point description
    An adverse event (AE) was any untoward medical occurrence (i.e., any unfavorable and unintended sign [including abnormal laboratory findings], symptom or disease) in a subject in the study. Any bleeding event occurring during the study was not documented as an AE because this event was planned to be captured in the assessment of efficacy. AEs occurring after the first administration of study drug and up to and including 30 days after the last administration of study drug were defined as treatment-emergent AEs (TEAEs). Drug-related TEAEs were TEAEs that had "reasonable causal relationship" to the study treatment decided by the investigators.
    End point type
    Primary
    End point timeframe
    After the first administration of study drug and up to and including 30 days after the last administration of study drug
    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: Due to the nature of this trial, only descriptive statistics were performed. Neither confirmatory nor exploratory inferential statistical analyses were pre-specified. Thus those analyses were not performed.
    End point values
    		 BAY1093884 100mg BAY1093884 225mg BAY1093884 400mg
    Number of subjects analysed
    8 [2]
    8 [3]
    8 [4]
    Units: Subjects
    1
    4
    5
    Notes
    [2] - SAF
    [3] - SAF
    [4] - SAF
    No statistical analyses for this end point

    Primary: Number of subjects with serious treatment-emergent adverse events

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    End point title
    		 Number of subjects with serious treatment-emergent adverse events [5]
    End point description
    A serious adverse event (SAE) was any untoward medical occurrence that at any dose was resulting in death, was lifethreatening, requires hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity. SAEs occurring after the first administration of study drug and up to and including 30 days after the last administration of study drug were defined as serious treatment-emergent AEs (TESAEs). Drug-related TESAEs were TESAEs that had "reasonable causal relationship" to the study treatment decided by the investigators.
    End point type
    Primary
    End point timeframe
    After the first administration of study drug and up to and including 30 days after the last administration of study drug
    Notes
    [5] - 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: Due to the nature of this trial, only descriptive statistics were performed. Neither confirmatory nor exploratory inferential statistical analyses were pre-specified. Thus those analyses were not performed.
    End point values
    		 BAY1093884 100mg BAY1093884 225mg BAY1093884 400mg
    Number of subjects analysed
    8 [6]
    8 [7]
    8 [8]
    Units: Subjects
        TESAEs
    1
    2
    1
        Drug-related TESAEs
    0
    2
    1
    Notes
    [6] - SAF
    [7] - SAF
    [8] - SAF
    No statistical analyses for this end point

    Primary: Number of subjects with treatment-emergent adverse events of special interest

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    End point title
    		 Number of subjects with treatment-emergent adverse events of special interest [9]
    End point description
    Any thromboembolic or thrombotic microangiopathic event or any hypersensitivity reaction was an adverse event of special interest (AESI). AESIs occurring after the first administration of study drug and up to and including 30 days after the last administration of study drug were defined as treatment-emergent AESIs.
    End point type
    Primary
    End point timeframe
    After the first administration of study drug and up to and including 30 days after the last administration of study drug
    Notes
    [9] - 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: Due to the nature of this trial, only descriptive statistics were performed. Neither confirmatory nor exploratory inferential statistical analyses were pre-specified. Thus those analyses were not performed.
    End point values
    		 BAY1093884 100mg BAY1093884 225mg BAY1093884 400mg
    Number of subjects analysed
    8 [10]
    8 [11]
    8 [12]
    Units: Subjects
    0
    2
    1
    Notes
    [10] - SAF
    [11] - SAF
    [12] - SAF
    No statistical analyses for this end point

    Primary: Number of subjects with clinically relevant abnormalities in laboratory values

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    End point title
    		 Number of subjects with clinically relevant abnormalities in laboratory values [13]
    End point description
    “Clinically relevant “implied the presence of a clinical sign or symptom that required medical action.
    End point type
    Primary
    End point timeframe
    After the first administration of study drug and up to and including 30 days after the last administration of study drug
    Notes
    [13] - 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: Due to the nature of this trial and due to the premature termination of the study, only descriptive statistics were performed.
    End point values
    		 BAY1093884 100mg BAY1093884 225mg BAY1093884 400mg
    Number of subjects analysed
    8 [14]
    8 [15]
    8 [16]
    Units: Subjects
    0
    0
    0
    Notes
    [14] - SAF
    [15] - SAF
    [16] - SAF
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    After the first administration of study drug and up to and including 30 days after the last administration of study drug
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.1
    Reporting groups
    Reporting group title
    BAY1093884 100mg
    Reporting group description
    		 Subjects received BAY1093884 100 mg once a week until premature termination of the study

    Reporting group title
    BAY1093884 225mg
    Reporting group description
    		 Subjects received BAY1093884 225 mg once a week until premature termination of the study

    Reporting group title
    BAY1093884 400mg
    Reporting group description
    		 Subjects received BAY1093884 400 mg once a week until premature termination of the study

    Serious adverse events
    		 BAY1093884 100mg BAY1093884 225mg BAY1093884 400mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 8 (12.50%)
    2 / 8 (25.00%)
    1 / 8 (12.50%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Paranasal sinus neoplasm
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 8 (0.00%)
    0 / 8 (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
    Nervous system disorders
    Transverse sinus thrombosis
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 8 (12.50%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ischaemic stroke
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 8 (12.50%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Retinal artery thrombosis
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 8 (12.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 BAY1093884 100mg BAY1093884 225mg BAY1093884 400mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    7 / 8 (87.50%)
    6 / 8 (75.00%)
    6 / 8 (75.00%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Lymphoma
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    0
    Paranasal sinus neoplasm
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    0
    Vascular disorders
    Haematoma
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 8 (12.50%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    0
    Surgical and medical procedures
    Tooth extraction
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    0
    General disorders and administration site conditions
    Influenza like illness
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    0
    Injection site bruising
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 8 (12.50%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    0
    Injection site erythema
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    2 / 8 (25.00%)
         occurrences all number
    0
    0
    19
    Injection site inflammation
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 8 (12.50%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    0
    Injection site pruritus
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    2 / 8 (25.00%)
         occurrences all number
    0
    0
    9
    Injection site reaction
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 8 (12.50%)
    0 / 8 (0.00%)
         occurrences all number
    0
    26
    0
    Application site inflammation
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 8 (12.50%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    0
    Injection site swelling
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 8 (12.50%)
    1 / 8 (12.50%)
    0 / 8 (0.00%)
         occurrences all number
    1
    1
    0
    Pharyngeal hypoaesthesia
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 8 (12.50%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    0
    Oropharyngeal pain
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    0
    1
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    0
    Investigations
    Fibrin D dimer increased
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    0
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    2
    0
    0
    Muscle strain
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    0
    Contusion
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 8 (12.50%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    0
    Procedural pain
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    0
    Bone contusion
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    0
    Cardiac disorders
    Cardiovascular disorder
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    0
    1
    Palpitations
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 8 (12.50%)
    0 / 8 (0.00%)
         occurrences all number
    0
    2
    0
    Tachycardia
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    2 / 8 (25.00%)
         occurrences all number
    0
    0
    2
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 8 (12.50%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    0
    Headache
         subjects affected / exposed
    0 / 8 (0.00%)
    2 / 8 (25.00%)
    2 / 8 (25.00%)
         occurrences all number
    0
    3
    3
    Paraesthesia
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    0
    1
    Blood and lymphatic system disorders
    Hypofibrinogenaemia
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    0
    1
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    0
    2
    Eye disorders
    Photopsia
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    0
    1
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    0
    Diarrhoea
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    0
    1
    Nausea
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 8 (12.50%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    0
    Proctalgia
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    0
    1
    Tooth development disorder
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 8 (12.50%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    0
    Vomiting
         subjects affected / exposed
    1 / 8 (12.50%)
    1 / 8 (12.50%)
    0 / 8 (0.00%)
         occurrences all number
    1
    1
    0
    Perianal erythema
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    0
    1
    Hypoaesthesia oral
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 8 (12.50%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    0
    Anal pruritus
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    0
    2
    Skin and subcutaneous tissue disorders
    Actinic keratosis
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    0
    Erythema
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 8 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    1
    0
    2
    Pruritus
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    0
    Rash
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 8 (12.50%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    0
    Skin haemorrhage
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 8 (12.50%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    0
    Renal and urinary disorders
    Nephrolithiasis
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 8 (12.50%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 8 (0.00%)
    2 / 8 (25.00%)
         occurrences all number
    2
    0
    2
    Haemarthrosis
         subjects affected / exposed
    2 / 8 (25.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    4
    0
    0
    Joint swelling
         subjects affected / exposed
    2 / 8 (25.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    3
    0
    0
    Muscle haemorrhage
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 8 (12.50%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    0
    Musculoskeletal pain
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    0
    Osteoarthritis
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    0
    1
    Pain in extremity
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 8 (12.50%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    0
    Infections and infestations
    Cellulitis
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    0
    Ear infection
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    0
    Labyrinthitis
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    0
    Nasopharyngitis
         subjects affected / exposed
    5 / 8 (62.50%)
    1 / 8 (12.50%)
    0 / 8 (0.00%)
         occurrences all number
    5
    1
    0

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    26 Jun 2018
    Integrated protocol version 2.0 introduced the following changes: 1. Text describing the product updated to include most recent data from the ongoing First in Man Phase 1 study; 2. Dose escalation criteria and safety rules between cohorts added in addition to those already described within cohorts/subjects; 3. Text added providing further detail on the role and responsibilities of the DMC; 4. Text added describing the rationale for fixed doses; 5. Communication plan added; 6. Text added stating that subjects may be replaced only if they have not withdrawn from the study for drug-related safety concerns; 7. Guidance added for use of bypassing agents to treat bleeds during treatment with BAY1093884; 8. Every 24-week visit changed to frequency of every 12 weeks; 9. Dose strength changed from “100 mg/mL” to “either 100 mg/mL or 150 mg/mL”; 10. Additional detail provided on the amount and type of safety, PK and PD data collected; 11. Local ECG added at Visits 3 – 7 and every 12 week visits; 12. LDL added to blood samples collected at Visit 2; 13. AE intensity should be graded according to NCI CTCAE version 5.0; 14. Section added describing reporting of non-approved medical device failures; 15. Section added to define DLTs for the study; 16. Lactate dehydrogenase and fibrinogen added to standard safety laboratory analyses; 17. Immunoglobulins would be collected for hypersensitivity reactions; 18. LDH added to central laboratory tests for thromboembolic and thrombotic microangiopathic events; 19. Section added to note that ECGs would be performed at PK visits; 20. Injection site reactions removed as separate endpoint, as these would be collected as part of regular AE reporting; 21. Note pertaining to DMC review of thromboembolic or thrombotic icroangiopathic events removed, as this was now described in new section.
    12 Feb 2019
    Integrated protocol version 3.0 introduced the following changes: 1. The visit schedule was updated to include an additional safety visit 6 weeks (± 1 day) after dose escalation; 2. Inclusion criterion 1 was modified to specify that subjects with inhibitors against FVIII or FIX also have undetectable FVIII or FIX levels; 3. Exclusion criterion 10 was modified to more accurately describe advanced liver disease.
    05 Apr 2019
    Integrated protocol version 4.0 introduced the following changes: Inclusion criterion 1 was modified to further specify that only subjects diagnosed with severe hemophilia, with or without inhibitors, are eligible.

    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.
    Acceptable safety and tolerability of multiple subcutaneous doses of befovacimab in subjects with hemophilia A or B with or without inhibitors was not demonstrated, prompting early termination of the study.
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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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