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    Clinical Trial Results:
    A Phase 3, Prospective, Open-label, Randomized Study to Evaluate Safety and Efficacy of Recombinant Activated FVII BI (rFVIIa BI) in the Treatment of Acute Bleeding Episodes per an On-demand Regimen in Patients with Hemophilia A or B with Inhibitors.

    Due to the EudraCT – Results system being out of service between 31 July 2015 and 12 January 2016, these results have been published in compliance with revised timelines.
    Summary
    EudraCT number
    2011-006294-26
    Trial protocol
    ES   BE   PL  
    Global end of trial date
    11 Nov 2014

    Results information
    Results version number
    v1(current)
    This version publication date
    13 Feb 2016
    First version publication date
    13 Feb 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    021101
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01757405
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Baxalta Innovations GmbH
    Sponsor organisation address
    Industriestrasse 67, Vienna, Austria, A-1221
    Public contact
    Clinical Trial Registries and Results Disclosure, Baxalta Innovations GmbH, ClinicalTrialsDisclosure@baxalta.com
    Scientific contact
    Clinical Trial Registries and Results Disclosure, Baxalta Innovations GmbH, ClinicalTrialsDisclosure@baxalta.com
    Sponsor organisation name
    Baxalta US Inc.
    Sponsor organisation address
    One Baxter Way, Westlake Village, CA, United States, 91362
    Public contact
    Clinical Trial Registries and Results Disclosure, Baxalta US Inc., ClinicalTrialsDisclosure@baxalta.com
    Scientific contact
    Clinical Trial Registries and Results Disclosure, Baxalta US Inc., ClinicalTrialsDisclosure@baxalta.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    EMEA-001382-PIP01-12
    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
    17 Mar 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    11 Nov 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    11 Nov 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the safety and efficacy of rFVIIa BI in the treatment of acute bleeding episodes per an on demand regimen in hemophilia A or B patients with inhibitors
    Protection of trial subjects
    This study was conducted in accordance with the clinical protocol, the International Conference on Harmonisation Guideline for Good Clinical Practice E6 (ICH GCP, April 1996), Title 21 of the US Code of Federal Regulations (US CFR), the European Clinical Trial Directive (2001/20/EC and 2005/28/EC), and applicable national and local regulatory requirements.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    20 Feb 2013
    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
    Romania: 2
    Country: Number of subjects enrolled
    Ukraine: 17
    Country: Number of subjects enrolled
    Russian Federation: 7
    Country: Number of subjects enrolled
    United States: 1
    Country: Number of subjects enrolled
    Serbia: 2
    Country: Number of subjects enrolled
    Poland: 4
    Country: Number of subjects enrolled
    Spain: 3
    Country: Number of subjects enrolled
    Japan: 2
    Worldwide total number of subjects
    38
    EEA total number of subjects
    9
    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)
    7
    Adults (18-64 years)
    31
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Subjects were enrolled (signed informed consent) from 16 sites in 9 countries.

    Pre-assignment
    Screening details
    A total of 40 subjects provided informed consent and were screened for study participation, of which there was 1 screen failure. 39 subjects (in pre-assignment period) were randomized where 1 subject withdrew after randomization prior to treatment, therefore 38 subjects were enrolled and treated with rFVIIa BI.

    Pre-assignment period milestones
    Number of subjects started
    39 [1]
    Number of subjects completed
    38

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    subject w/d after randomization prior to treatment: 1
    Notes
    [1] - The number of subjects reported to have started the pre-assignment period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: A total of 40 subjects provided informed consent and were screened for study participation, of which there was 1 screen failure. 39 subjects (in pre-assignment period) were randomized where 1 subject withdrew after randomization prior to treatment, therefore 38 subjects were enrolled and treated with rFVIIa BI.
    Period 1
    Period 1 title
    Overall Trial (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Arm 1: up to 3 x 90 μg/kg rFVIIa BI
    Arm description
    Bleeding episodes treated with up to 3 doses of 90 μg/kg of recombinant activated factor VII BI (rFVIIa BI) every 3 hours as on-demand intravenous bolus infusions.
    Arm type
    Experimental

    Investigational medicinal product name
    rFVIIa BI
    Investigational medicinal product code
    BAX817
    Other name
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Intravenous bolus use
    Dosage and administration details
    either up to 3 x 90 μg/kg rFVIIa BI (ARM 1) OR 1 x 270 μg/kg rFVIIa BI (ARM 2)

    Arm title
    Arm 2: 1 x 270 μg/kg rFVIIa BI
    Arm description
    Bleeding episodes treated with 1 dose of 270 μg/kg of recombinant activated factor VII BI (rFVIIa BI) as on-demand intravenous bolus infusion.
    Arm type
    Experimental

    Investigational medicinal product name
    rFVIIa BI
    Investigational medicinal product code
    BAX817
    Other name
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Intravenous bolus use
    Dosage and administration details
    either up to 3 x 90 μg/kg rFVIIa BI (ARM 1) OR 1 x 270 μg/kg rFVIIa BI (ARM 2)

    Number of subjects in period 1
    Arm 1: up to 3 x 90 μg/kg rFVIIa BI Arm 2: 1 x 270 μg/kg rFVIIa BI
    Started
    18
    20
    Completed
    17
    18
    Not completed
    1
    2
         Consent withdrawn by subject
             -
             1
         Lost to follow-up
             1
             1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Arm 1: up to 3 x 90 μg/kg rFVIIa BI
    Reporting group description
    Bleeding episodes treated with up to 3 doses of 90 μg/kg of recombinant activated factor VII BI (rFVIIa BI) every 3 hours as on-demand intravenous bolus infusions.

    Reporting group title
    Arm 2: 1 x 270 μg/kg rFVIIa BI
    Reporting group description
    Bleeding episodes treated with 1 dose of 270 μg/kg of recombinant activated factor VII BI (rFVIIa BI) as on-demand intravenous bolus infusion.

    Reporting group values
    Arm 1: up to 3 x 90 μg/kg rFVIIa BI Arm 2: 1 x 270 μg/kg rFVIIa BI Total
    Number of subjects
    18 20 38
    Age categorical
    Units: Subjects
        In utero
    0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0 0
        Newborns (0-27 days)
    0 0 0
        Infants and toddlers (28 days-23 months)
    0 0 0
        Children (2-11 years)
    0 0 0
        Adolescents (12-17 years)
    3 4 7
        Adults (18-64 years)
    15 16 31
        From 65-84 years
    0 0 0
        85 years and over
    0 0 0
    Age continuous
    Units: years
        median (full range (min-max))
    28 (12 to 53) 28 (12 to 54) -
    Gender categorical
    Units: Subjects
        Female
    0 0 0
        Male
    18 20 38

    End points

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    End points reporting groups
    Reporting group title
    Arm 1: up to 3 x 90 μg/kg rFVIIa BI
    Reporting group description
    Bleeding episodes treated with up to 3 doses of 90 μg/kg of recombinant activated factor VII BI (rFVIIa BI) every 3 hours as on-demand intravenous bolus infusions.

    Reporting group title
    Arm 2: 1 x 270 μg/kg rFVIIa BI
    Reporting group description
    Bleeding episodes treated with 1 dose of 270 μg/kg of recombinant activated factor VII BI (rFVIIa BI) as on-demand intravenous bolus infusion.

    Primary: Percentage of bleeding episodes with "Treatment Success".

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    End point title
    Percentage of bleeding episodes with "Treatment Success".
    End point description
    "Treatment Success" defined as no additional haemostatic product required within 12 hours of the first dose of rFVIIa BI per bleeding episode, other than the prescribed dosing regimen (either up to 3 x 90 μg/kg doses of rFVIIa B [Arm 1] OR - 1 x 270 μg/kg dose rFVIIa BI [Arm 2]). There were a total of 289 bleeding episodes in Arm 1 and 256 bleeding episodes in Arm 2. The analysis was conducted on subjects in the Full Analysis Dataset.
    End point type
    Primary
    End point timeframe
    From first exposure to rFVIIa BI until the end of the study, up to 6 months (day 180) per subject.
    End point values
    Arm 1: up to 3 x 90 μg/kg rFVIIa BI Arm 2: 1 x 270 μg/kg rFVIIa BI
    Number of subjects analysed
    18
    20
    Units: Percent of bleeding episodes
        number (confidence interval 95%)
    96.19 (93.31 to 97.86)
    79.3 (73.92 to 83.81)
    Statistical analysis title
    Equivalence test of successfully treated BEs
    Statistical analysis description
    Equivalence test of successfully treated bleeding episodes (BEs) between or within treatment arms. Denoting the success rates in the two treatment groups by p1 and p2 , the null hypotheses of H01 : p1/p2 < 0.83 and H02 : p1/p2 > 1.20 was implicitly tested against the one-sided alternatives Ha1: 0.83 ≤ p1/p2 and Ha2 : p1/p2 ≤ 1.20, by comparing the 90% two-sided confidence interval (CI) of the ratio of success proportions to the equivalence region defined as [0.83, 1.20].
    Comparison groups
    Arm 2: 1 x 270 μg/kg rFVIIa BI v Arm 1: up to 3 x 90 μg/kg rFVIIa BI
    Number of subjects included in analysis
    38
    Analysis specification
    Pre-specified
    Analysis type
    equivalence [1]
    Method
    Parameter type
    Ratio of success proportion
    Point estimate
    1.21
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    1.15
         upper limit
    1.28
    Notes
    [1] - Equivalence of treatment success proportions in all bleeding episodes for the two treatment groups was determined by comparing the 90% two-sided CI of the ratio of success proportions to the equivalence region defined as [0.83, 1.20].

    Secondary: Treatment Response based on a four-point scale.

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    End point title
    Treatment Response based on a four-point scale.
    End point description
    Subject or investigator used a four point rating scale:- EXCELLENT - full relief of pain and cessation of objective signs of bleeding (swelling, tenderness, decrease in range of motion [for muscle bleeds]) within 9 hours of treatment initiation. No additional infusion required to control bleeding, other than prescribed dosing regimen. GOOD - Substantial relief of pain and/or cessation of objective signs of bleeding within 9 hours of treatment initiation. No additional infusion required to control bleeding, other than prescribed dosing regimen. MODERATE - slight relief of pain and slight improvement of signs of bleeding within 9 hours of treatment initiation. Requires additional infusion beyond treatment regimen. NONE - No improvement or condition worsens. SUCCESSFUL = EXCELLENT or GOOD. There were 289 bleeding episodes in Arm 1 ( up to 3 x 90 μg/kg rFVIIa BI) and 256 bleeding episodes in Arm 2 (1 x 270 μg/kg rFVIIa BI). Analysis conducted on subjects in Full Analysis Dataset.
    End point type
    Secondary
    End point timeframe
    From first exposure to rFVIIa BI until the end of the study, up to 6 months (day 180) per subject.
    End point values
    Arm 1: up to 3 x 90 μg/kg rFVIIa BI Arm 2: 1 x 270 μg/kg rFVIIa BI
    Number of subjects analysed
    18
    20
    Units: Percent of bleeding episodes
    number (confidence interval 95%)
        Successful
    87.89 (83.62 to 91.16)
    79.3 (73.92 to 83.31)
        Excellent
    34.6 (29.35 to 40.26)
    36.72 (31.05 to 42.78)
        Good
    53.29 (47.53 to 58.96)
    42.58 (36.67 to 48.7)
        Moderate
    9.69 (6.79 to 13.65)
    18.36 (14.1 to 23.56)
        No Assessment Available
    0 (0 to 0)
    0.39 (0.07 to 2.18)
        None
    2.42 (1.18 to 4.91)
    1.95 (0.84 to 4.49)
    No statistical analyses for this end point

    Secondary: Percentage of clinical responders for all acute bleeding episodes at 24 hours after rFVIIa BI infusion

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    End point title
    Percentage of clinical responders for all acute bleeding episodes at 24 hours after rFVIIa BI infusion
    End point description
    Clinical responders defined as sustained bleeding control, (no additional hemostatic medication including rFVIIa BI required between 12 and 24 hours after first infusion of the successfully treated bleeding episode). There were a total of 289 bleeding episodes in Arm 1 (up to 3 x 3 x 90 μg/kg rFVIIa BI) and 256 bleeding episodes in Arm 2 (1 x 270 μg/kg rFVIIa BI). The analysis was conducted on subjects in the Full Analysis Dataset.
    End point type
    Secondary
    End point timeframe
    From first exposure to rFVIIa BI until the end of the study, up to 6 months (day 180) per subject.
    End point values
    Arm 1: up to 3 x 90 μg/kg rFVIIa BI Arm 2: 1 x 270 μg/kg rFVIIa BI
    Number of subjects analysed
    18
    20
    Units: Percent of bleeding episodes
        number (confidence interval 95%)
    93.43 (89.96 to 95.75)
    76.17 (70.59 to 80.98)
    No statistical analyses for this end point

    Secondary: Safety and Tolerability of Treatment Regimens by Clinical Assessment of Adverse Events (AEs) per Subject

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    End point title
    Safety and Tolerability of Treatment Regimens by Clinical Assessment of Adverse Events (AEs) per Subject
    End point description
    Safety was determined by the number of AEs (both serious AEs [SAEs] and non-serious AEs [nsAE]). Tolerability was determined by the number of AEs related to rFVIIa BI (both SAEs and nsAEs) as determined by causality assessment of the AEs by the investigator. An AE was deemed Related if the investigator judged the AE to be "possibly related" or "probably related" to rFVIIa BI. The percentage of subjects with AEs were presented by seriousness (SAE, nsAE), severity (Mild, Moderate or Severe) and causality (Related or Not Related to rFVIIa BI). The analysis was conducted on subjects in the Safety Analysis Dataset.
    End point type
    Secondary
    End point timeframe
    From first exposure to rFVIIa BI until the end of the study, up to 6 months (day 180) per subject.
    End point values
    Arm 1: up to 3 x 90 μg/kg rFVIIa BI Arm 2: 1 x 270 μg/kg rFVIIa BI
    Number of subjects analysed
    18
    20
    Units: Percent of subjects with AEs
    number (not applicable)
        SAE-Moderate-Unrelated
    5.6
    5
        SAE-Severe-Unrelated
    11.1
    0
        SAE-Severe-Related
    0
    5
        nsAE-Mild-Unrelated
    22.2
    30
        nsAE-Moderate-Unrelated
    0
    15
    No statistical analyses for this end point

    Secondary: Safety and Tolerability of Treatment Regimens by Clinical Assessment of Adverse Events (AEs)

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    End point title
    Safety and Tolerability of Treatment Regimens by Clinical Assessment of Adverse Events (AEs)
    End point description
    Safety was determined by the number of AEs (both serious AEs [SAEs] and non-serious AEs [nsAE]). Tolerability was determined by the number of AEs related to rFVIIa BI (both SAEs and nsAEs) as determined by causality assessment of the AEs by the investigator. An AE was deemed Related if the investigator judges the AE to be "possibly related" or "probably related" to rFVIIa BI. The percentage of AEs were presented by seriousness (SAE, nsAE), severity (Mild, Moderate or Severe) and causality (Related or Not Related [to rFVIIa BI]). The analysis was conducted on subjects in the Safety Analysis Dataset.
    End point type
    Secondary
    End point timeframe
    From first exposure to rFVIIa BI until the end of the study, up to 6 months (day 180) per subject.
    End point values
    Arm 1: up to 3 x 90 μg/kg rFVIIa BI Arm 2: 1 x 270 μg/kg rFVIIa BI
    Number of subjects analysed
    18
    20
    Units: Percent of AEs
    number (not applicable)
        SAE-Moderate-Unrelated
    6.7
    6.3
        SAE-Severe-Unrelated
    20
    0
        SAE-Severe-Related
    0
    12.5
        nsAE-Mild-Unrelated
    73.3
    62.5
        nsAE-Moderate-Unrelated
    0
    18.8
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with Inhibitor Development to FVII

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    End point title
    Percentage of Subjects with Inhibitor Development to FVII
    End point description
    Development of rFVII inhibitors or FVIIa binding antibodies during the study. The analysis was conducted on subjects in the Safety Analysis Dataset.
    End point type
    Secondary
    End point timeframe
    From first exposure to rFVIIa BI until the end of the study, up to 6 months (day 180) per subject.
    End point values
    Arm 1: up to 3 x 90 μg/kg rFVIIa BI Arm 2: 1 x 270 μg/kg rFVIIa BI
    Number of subjects analysed
    18
    20
    Units: Percent of subjects
        number (not applicable)
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From first exposure of rFVIIa BI until the end of the study, up to 6 months (day 180) per subject.
    Adverse event reporting additional description
    The population consisted of subjects who received at least one dose of rFVIIa BI during the study.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    Arm 1: up to 3 x 90 μg/kg rFVIIa BI
    Reporting group description
    Subjects who received at least 1 dose of 90 μg/kg of rFVIIa BI as on-demand intravenous bolus infusion during the study.

    Reporting group title
    Arm 2: 1 x 270 μg/kg rFVIIa BI
    Reporting group description
    Subjects who received at least 1 dose of 270 ug/kg of rFVIIa BI as on-demand intravenous bolus infusion during the study.

    Serious adverse events
    Arm 1: up to 3 x 90 μg/kg rFVIIa BI Arm 2: 1 x 270 μg/kg rFVIIa BI
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 18 (11.11%)
    2 / 20 (10.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Injury, poisoning and procedural complications
    Craniocerebral injury
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Joint injury
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Head injury
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Limb injury
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Drug ineffective
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Muscle haemorrhage
         subjects affected / exposed
    0 / 18 (0.00%)
    2 / 20 (10.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Arm 1: up to 3 x 90 μg/kg rFVIIa BI Arm 2: 1 x 270 μg/kg rFVIIa BI
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    4 / 18 (22.22%)
    2 / 20 (10.00%)
    Injury, poisoning and procedural complications
    Laceration
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Investigations
    Hepatic enzyme increased
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Nasal congestion
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Oropharyngeal pain
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 20 (0.00%)
         occurrences all number
    2
    0
    Immune system disorders
    Drug hypersensitivity
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Sinus headache
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    Influenza
         subjects affected / exposed
    0 / 18 (0.00%)
    2 / 20 (10.00%)
         occurrences all number
    0
    2
    Nasopharyngitis
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Tinea versicolour
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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