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    Clinical Trial Results:
    A Phase III, randomized, double-blind, multicenter study to assess the efficacy and safety of OCTAPLEX, a four-factor prothrombin complex concentrate (4F-PCC), compared to the 4F-PCC Beriplex® P/N (Kcentra), for the reversal of vitamin K antagonist induced anticoagulation in patients needing urgent surgery with significant bleeding risk.

    Summary
    EudraCT number
    		 2016-002649-41
    Trial protocol
    		 DE   PL   ES   BG   RO  
    Global end of trial date
    08 Nov 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    15 Dec 2022
    First version publication date
    15 Dec 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    LEX-209
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02740335
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Octapharma Pharmazeutika Produktionsges.m.b.H
    Sponsor organisation address
    Oberlaaerstr. 235, Vienna, Austria, 1100
    Public contact
    Clinical Research & Development, Octapharma Pharmazeutika Produktionsges.m.b.H, +43 (1) 610 320 , dmitrii.matveev@octapharma.com
    Scientific contact
    Clinical Research & Development, Octapharma Pharmazeutika Produktionsges.m.b.H, +43 (1) 610 320 , dmitrii.matveev@octapharma.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
    08 Jul 2022
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Nov 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of the study is to demonstrate that the efficacy of OCTAPLEX as a reversal agent in patients under VKA therapy with the need for urgent surgery with significant bleeding risk is clinically non-inferior to Beriplex® P/N (Kcentra).
    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, national regulatory requirements and FDA Code of Federal Regulations. 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 monitoring of AEs, SAEs, concomitant medication and vital status.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    07 Jun 2017
    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: 51
    Country: Number of subjects enrolled
    United States: 1
    Country: Number of subjects enrolled
    Russian Federation: 12
    Country: Number of subjects enrolled
    Georgia: 43
    Country: Number of subjects enrolled
    Belarus: 7
    Country: Number of subjects enrolled
    Ukraine: 94
    Worldwide total number of subjects
    208
    EEA total number of subjects
    51
    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)
    78
    From 65 to 84 years
    121
    85 years and over
    9

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Patients with reversal of anticoagulation due to vitamin K antagonists needing urgent surgery associated with significant bleeding risk 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
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator
    Blinding implementation details
    IP was assigned using IRT and prepared for infusion by unblinded site personnel. Investigational product was prepared and infused in a manner that blinded the investigator and other blinded site personnel to the study treatment.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Octaplex
    Arm description
    		 Patients received 1 Octaplex infusion intravenously
    Arm type
    		 Experimental

    Investigational medicinal product name
    Octaplex
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solution for suspension for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Investigational product was administered by IV infusion at a rate of 0.12 mL/kg/min (~3 units/kg/min), up to a maximum rate of 8.4 mL/min (~210 units/min). The total volume of IP used and time of infusion was recorded. Infusion lines were to be flushed with 0.9% sodium chloride. One single infusion of IP was administered per patient

    Arm title
    		 Kcentra
    Arm description
    		 Patients received 1 Beriplex® P/N (Kcentra) infusion intravenously.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Beriplex® P/N [Kcentra],
    Investigational medicinal product code
    Other name
    Kcentra
    Pharmaceutical forms
    Powder and solvent for solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Investigational product was administered by IV infusion at a rate of 0.12 mL/kg/min (~3 units/kg/min), up to a maximum rate of 8.4 mL/min (~210 units/min). The total volume of IP used and time of infusion was recorded. Infusion lines were to be flushed with 0.9% sodium chloride. One single infusion of IP was administered per patient

    Number of subjects in period 1
    		Octaplex Kcentra
    Started
    105
    103
    Completed
    105
    103

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Octaplex
    Reporting group description
    		 Patients received 1 Octaplex infusion intravenously

    Reporting group title
    Kcentra
    Reporting group description
    		 Patients received 1 Beriplex® P/N (Kcentra) infusion intravenously.

    Reporting group values
    		 Octaplex Kcentra Total
    Number of subjects
    		 105 103 208
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (full range (min-max))
    		 65.6 (31 to 90) 66.8 (32 to 92) -
    Gender categorical
    Units: Subjects
        Female
    		 47 43 90
        Male
    		 58 60 118
    Subject analysis sets

    Subject analysis set title
    Randomized Population (RAND)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The RAND population includes all randomized patients irrespective of whether they received treatment.

    Subject analysis set title
    Safety Analysis Population (SAF)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The SAF population includes all randomized patients who received IP.

    Subject analysis sets values
    		 Randomized Population (RAND) Safety Analysis Population (SAF)
    Number of subjects
    208
    208
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (full range (min-max))
    66.2 (31 to 92)
    Gender categorical
    Units: Subjects
        Female
        Male

    End points

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    End points reporting groups
    Reporting group title
    Octaplex
    Reporting group description
    		 Patients received 1 Octaplex infusion intravenously

    Reporting group title
    Kcentra
    Reporting group description
    		 Patients received 1 Beriplex® P/N (Kcentra) infusion intravenously.

    Subject analysis set title
    Randomized Population (RAND)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The RAND population includes all randomized patients irrespective of whether they received treatment.

    Subject analysis set title
    Safety Analysis Population (SAF)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The SAF population includes all randomized patients who received IP.

    Primary: Global Hemostatic Efficacy Observed

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    End point title
    		 Global Hemostatic Efficacy Observed [1]
    End point description
    The primary efficacy variable is the hemostatic efficacy as assessed by the Independent Endpoint Adjudication Committee (IEAB). The hemostatic efficacy was assessed based on objective criteria in the categories 'excellent', 'good', 'moderate' or 'none'. Ratings of 'excellent' and 'good' are to be considered as 'effective' hemostasis, while a rating of 'moderate' and 'none' are to be considered as 'ineffective'hemostasis.
    End point type
    Primary
    End point timeframe
    At end of the surgery
    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: No statistical analysis for this endpoint.
    End point values
    		 Octaplex Kcentra
    Number of subjects analysed
    105
    103
    Units: number of patients
    number (not applicable)
        Excellent
    41
    50
        Good
    58
    47
        Moderate
    6
    6
        None
    0
    0
    No statistical analyses for this end point

    Primary: Non-inferiority Proportion Difference Octaplex vs Kcentra

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    End point title
    		 Non-inferiority Proportion Difference Octaplex vs Kcentra
    End point description
    The dichotomous 'hemostatic success' variable was used in the analyses to demonstrate that treatment with Octaplex was clinically not inferior to treatment with Beriplex® P/N (Kcentra) with respect to hemostatic success. Effective hemostasis includes Excellent and Good ratings, while Ineffective hemostasis includes Moderate and None ratings from Global hemostatic efficacy observed by IEAB. Imputation for Ineffective was performed for missing rating or additional coagulation after initial IP infusion as None.
    End point type
    Primary
    End point timeframe
    At end of the surgery
    End point values
    		 Octaplex Kcentra
    Number of subjects analysed
    105
    103
    Units: number of patiets
    number (not applicable)
        Effective
    99
    97
        Ineffective
    6
    6
    Statistical analysis title
    		 Non-inferiority Difference Octaplex vs Kcentra....
    Comparison groups
    Octaplex v Kcentra
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.001
    Method
    		 Farrington’s and Manning’s test
    Parameter type
    		 Proportion difference
    Point estimate
    0.001
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.08
         upper limit
    		 0.082

    Secondary: Patients with an INR value of less or equal to 1.5 at 30 (± 15) minutes after the end of infusion

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    End point title
    		 Patients with an INR value of less or equal to 1.5 at 30 (± 15) minutes after the end of infusion
    End point description
    Proportion of patients with an INR value of less or equal to 1.5 at 30 (± 15) minutes after the end of infusion.
    End point type
    Secondary
    End point timeframe
    30 (± 15) minutes after the end of infusion.
    End point values
    		 Octaplex Kcentra
    Number of subjects analysed
    105
    103
    Units: patients
    number (not applicable)
        <= 1.5
    82
    74
        > 1.5
    23
    29
        Missing
    0
    0
    Statistical analysis title
    		 Proportion difference Octaplex VS Kcentra
    Comparison groups
    Octaplex v Kcentra
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    		 other [2]
    Method
    Parameter type
    		 Proportion difference
    Point estimate
    0.063
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.056
         upper limit
    		 0.181
    Notes
    [2] - Farrington's and Manning's test for difference in proportions was performed.

    Secondary: Change in Coagulation Factor FII Level

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    End point title
    		 Change in Coagulation Factor FII Level
    End point description
    Change in coagulation factor FII level from baseline to 30 (± 15) minutes after the end of infusion.
    End point type
    Secondary
    End point timeframe
    30 (± 15) minutes after the end of infusion.
    End point values
    		 Octaplex Kcentra
    Number of subjects analysed
    104
    100 [3]
    Units: FII activity (%)
    arithmetic mean (standard deviation)
        Mean baseline
    33.7 ± 19.8
    34.4 ± 19.6
        Mean change from baseline
    56.5 ± 29.4
    55.6 ± 28.7
    Notes
    [3] - Baseline: 101 patients Change from Baseline: 100 patients
    Statistical analysis title
    		 Median Difference Octaplex vs Kcentra
    Comparison groups
    Octaplex v Kcentra
    Number of subjects included in analysis
    204
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Median difference
    Point estimate
    1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7
         upper limit
    		 9

    Secondary: Change in Coagulation Factor FVII Level

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    End point title
    		 Change in Coagulation Factor FVII Level
    End point description
    Change in coagulation factor FVII level from baseline to 30 (± 15) minutes after the end of infusion.
    End point type
    Secondary
    End point timeframe
    30 (± 15) minutes after the end of infusion.
    End point values
    		 Octaplex Kcentra
    Number of subjects analysed
    105
    102
    Units: FVII activity (%)
    arithmetic mean (standard deviation)
        Mean baseline
    27.6 ± 25.1
    27.3 ± 23.1
        Mean change from baseline
    40.9 ± 32.8
    32.8 ± 34.4
    Statistical analysis title
    		 Median Difference Octaplex vs Kcentra
    Comparison groups
    Kcentra v Octaplex
    Number of subjects included in analysis
    207
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Median difference
    Point estimate
    8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2
         upper limit
    		 15

    Secondary: Change in Coagulation Factor FIX Level

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    End point title
    		 Change in Coagulation Factor FIX Level
    End point description
    Change in coagulation factor FIX level from baseline to 30 (± 15) minutes after the end of infusion.
    End point type
    Secondary
    End point timeframe
    30 (± 15) minutes after the end of infusion.
    End point values
    		 Octaplex Kcentra
    Number of subjects analysed
    105
    102
    Units: FIX activity (%)
    arithmetic mean (standard deviation)
        Mean baseline
    53.0 ± 32.2
    53.6 ± 31.4
        Mean change from baseline
    36.9 ± 37.6
    36.5 ± 33.2
    Statistical analysis title
    		 Median Difference Octaplex vs Kcentra
    Comparison groups
    Octaplex v Kcentra
    Number of subjects included in analysis
    207
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Proportion difference
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7
         upper limit
    		 8

    Secondary: Change in Coagulation Factor FX Level

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    End point title
    		 Change in Coagulation Factor FX Level
    End point description
    Change in coagulation factor FX level from baseline to 30 (± 15) minutes after the end of infusion.
    End point type
    Secondary
    End point timeframe
    30 (± 15) minutes after the end of infusion.
    End point values
    		 Octaplex Kcentra
    Number of subjects analysed
    103
    99 [4]
    Units: FX activity (%)
    arithmetic mean (standard deviation)
        Mean baseline
    24.4 ± 17.6
    24.0 ± 18.6
        Mean change from baseline
    56.0 ± 29.8
    69.0 ± 32.3
    Notes
    [4] - Baseline: 100 patients Change from Baseline: 99 patients
    Statistical analysis title
    		 Median Difference Octaplex vs Kcentra
    Comparison groups
    Octaplex v Kcentra
    Number of subjects included in analysis
    202
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Median difference
    Point estimate
    -13
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -21
         upper limit
    		 4

    Secondary: Red Blood Cells Received During Surgery

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    End point title
    		 Red Blood Cells Received During Surgery
    End point description
    Proportion of patients receiving red blood cells.
    End point type
    Secondary
    End point timeframe
    during surgery
    End point values
    		 Octaplex Kcentra
    Number of subjects analysed
    105
    103
    Units: patients
        number (not applicable)
    4
    3
    Statistical analysis title
    		 Proportion difference Octaplex VS Kcentra
    Comparison groups
    Octaplex v Kcentra
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Proportion difference
    Point estimate
    0.009
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.068
         upper limit
    		 0.086

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Throughout the whole study from baseline up to day 45 (follow up visit)
    Adverse event reporting additional description
    AEs were to be followed-up until Day 4. SAEs were to be followed-up until Day 45. If TEEs were suspected at any time during the study, appropriate examinations according to local standards were performed
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.1
    Reporting groups
    Reporting group title
    Octaplex
    Reporting group description
    		 Patients received 1 Octaplex infusion intravenously

    Reporting group title
    Kcentra
    Reporting group description
    		 Patients received 1 Kcentra infusions intravenously

    Serious adverse events
    		 Octaplex Kcentra
    Total subjects affected by serious adverse events
         subjects affected / exposed
    13 / 105 (12.38%)
    6 / 103 (5.83%)
         number of deaths (all causes)
    5
    1
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Ovarian cancer stage IV
         subjects affected / exposed
    0 / 105 (0.00%)
    1 / 103 (0.97%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Anastomotic haemorrhage
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Failure to anastomose
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Joint dislocation
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subdural haemorrhage
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postoperative wound complication
         subjects affected / exposed
    0 / 105 (0.00%)
    1 / 103 (0.97%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Shock
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Shock haemorrhagic
         subjects affected / exposed
    0 / 105 (0.00%)
    1 / 103 (0.97%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Angina unstable
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure chronic
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial ischaemia
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure acute
         subjects affected / exposed
    0 / 105 (0.00%)
    1 / 103 (0.97%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebral infarction
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 105 (0.00%)
    1 / 103 (0.97%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhagic Anaemia
         subjects affected / exposed
    0 / 105 (0.00%)
    1 / 103 (0.97%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Death
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Multiple organ dysfunction syndrome
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Gastritis erosive
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mesenteric haematoma
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Proctitis
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastritis haemorrhagic
         subjects affected / exposed
    0 / 105 (0.00%)
    1 / 103 (0.97%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ileus
         subjects affected / exposed
    0 / 105 (0.00%)
    1 / 103 (0.97%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory failure
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary oedema
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Soft tissue haemorrhage
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Orchitis
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 105 (0.00%)
    1 / 103 (0.97%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 Octaplex Kcentra
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    85 / 105 (80.95%)
    80 / 103 (77.67%)
    Investigations
    Blood pressure increased
         subjects affected / exposed
    0 / 105 (0.00%)
    5 / 103 (4.85%)
         occurrences all number
    0
    5
    Body temperature increased
         subjects affected / exposed
    0 / 105 (0.00%)
    4 / 103 (3.88%)
         occurrences all number
    0
    4
    Injury, poisoning and procedural complications
    Procedural pain
         subjects affected / exposed
    50 / 105 (47.62%)
    50 / 103 (48.54%)
         occurrences all number
    51
    50
    Postoperative wound complication
         subjects affected / exposed
    15 / 105 (14.29%)
    14 / 103 (13.59%)
         occurrences all number
    15
    15
    Procedural vomiting
         subjects affected / exposed
    4 / 105 (3.81%)
    0 / 103 (0.00%)
         occurrences all number
    4
    0
    Suture related complication
         subjects affected / exposed
    2 / 105 (1.90%)
    4 / 103 (3.88%)
         occurrences all number
    2
    4
    Vascular disorders
    Hypotension
         subjects affected / exposed
    0 / 105 (0.00%)
    3 / 103 (2.91%)
         occurrences all number
    0
    4
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    6 / 105 (5.71%)
    6 / 103 (5.83%)
         occurrences all number
    6
    6
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    13 / 105 (12.38%)
    18 / 103 (17.48%)
         occurrences all number
    13
    22
    Catheter site related reaction
         subjects affected / exposed
    4 / 105 (3.81%)
    2 / 103 (1.94%)
         occurrences all number
    5
    2
    Hyperthermia
         subjects affected / exposed
    3 / 105 (2.86%)
    2 / 103 (1.94%)
         occurrences all number
    3
    2
    Pyrexia
         subjects affected / exposed
    1 / 105 (0.95%)
    3 / 103 (2.91%)
         occurrences all number
    1
    3
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    3 / 105 (2.86%)
    5 / 103 (4.85%)
         occurrences all number
    3
    5
    Abdominal distension
         subjects affected / exposed
    2 / 105 (1.90%)
    3 / 103 (2.91%)
         occurrences all number
    2
    3
    Dyschezia
         subjects affected / exposed
    1 / 105 (0.95%)
    3 / 103 (2.91%)
         occurrences all number
    1
    3
    Nausea
         subjects affected / exposed
    0 / 105 (0.00%)
    3 / 103 (2.91%)
         occurrences all number
    0
    3
    Renal and urinary disorders
    Dysuria
         subjects affected / exposed
    5 / 105 (4.76%)
    2 / 103 (1.94%)
         occurrences all number
    5
    2
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    1 / 105 (0.95%)
    2 / 103 (1.94%)
         occurrences all number
    1
    2

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    21 Oct 2016
    Protocol version 3.0, 21.10.2016: -Additional changes in response to the FDA advice dated October 6, 2016. -ICF revised to align with revised protocol. -Safety section updated to cover post marketing experience of Octaplex use, align with IB ed.10
    19 Jan 2018
    Protocol version 4.0, 19.01.2018 - Amendment #1 dated 19-Jan-2018 incorporated: Changes to clarify the text based on the investigators questions and feedback (clarification of ex/in criteria, admin. changes).

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    08 Nov 2021
    The study was conducted in 2 stages, with one un-blinded interim analysis after enrollment of 50% of the planned sample size, to allow for an early stopping of the study for demonstrated non-inferiority of OCTAPLEX or to allow for an early stopping due to futility to achieve this. As study success was claimed on the interim results enrollment of additional patients was prematurely discontinued (as agreed by the FDA on 22-Feb-2022), and this report of the final analysis was prepared. All patients enrolled until a decision to stop the study was made were observed until the end of the follow-up period. The interim analysis was performed by a statistical team which was independent from the study team. The decision to prematurely terminate the study was made in consultation with the relevant authorities.
    -

    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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