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    Clinical Trial Results:
    An Open-label, Multicenter, Post-Marketing Requirement (PMR) Study to Investigate the Safety, Tolerability and Efficacy of Octaplas in the Management of Pediatric Patients Who Require Replacement of Multiple Coagulation Factors

    Summary
    EudraCT number
    		 2018-004686-13
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    04 Dec 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    15 Jul 2020
    First version publication date
    15 Jul 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    LAS-212
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02050841
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Octapharma Pharmazeutika Produktionsges.m.b.H.
    Sponsor organisation address
    Oberlaaer Strasse 235, Vienna, Austria, 1100
    Public contact
    Clinical Research Department, Octapharma Pharmazeutika Produktionsges.m.b.H., franz-josef.tarmann@octapharma.com
    Scientific contact
    Clinical Research Department, Octapharma Pharmazeutika Produktionsges.m.b.H., franz-josef.tarmann@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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    11 Jul 2018
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    04 Dec 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of the study is to assess the safety and tolerability of Octaplas in the pediatric population by monitoring serious adverse events (SAEs), adverse drug reactions (ADRs), thrombotic events (TEs), thromboembolic events (TEEs) and hyperfibrinolytic events (HFEs), including laboratory parameters for metabolic derangements, renal function, and hematologic implications.
    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. 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 of monitoring of ADRs, thrombotic events (TEs), thromboembolic events (TEEs), Hyperfibrinolytic event (HFEs) of causality and documentation of concomitant medication.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    09 Jul 2015
    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 States: 50
    Worldwide total number of subjects
    50
    EEA total number of subjects
    0
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    5
    Infants and toddlers (28 days-23 months)
    28
    Children (2-11 years)
    14
    Adolescents (12-17 years)
    3
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Paediatric patients who require replacement of multiple coagulation factors due to liver disease and/or cardiac surgery or liver transplantation.

    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
    		 Octaplas
    Arm description
    		 Octaplas was used per the approved labeling for the product
    Arm type
    		 Experimental

    Investigational medicinal product name
    Octaplas
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Octaplas was used per the approved labeling for the product. The number of infusion episodes and volume of Octaplas administered within the 72-hour treatment period depended on the clinical setting. The infusion rate of Octaplas was not to exceed 0.020-0.025 mmol citrate per kg per minute. The minimum dose of the first infusion was 10 mL/kg or one unit unless a lower dose was medically justified.

    Number of subjects in period 1
    		Octaplas
    Started
    50
    Completed
    49
    Not completed
    1
         Use of prohibited medication
    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
    		 50 50
    Age categorical
    Units: Subjects
        Infants ≤2Years
    		 37 37
        Children>2Years
    		 13 13
    Age continuous
    Units: years
        arithmetic mean (full range (min-max))
    		 2.0 (0 to 16) -
    Gender categorical
    Units: Subjects
        Female
    		 24 24
        Male
    		 26 26

    End points

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    End points reporting groups
    Reporting group title
    Octaplas
    Reporting group description
    		 Octaplas was used per the approved labeling for the product

    Subject analysis set title
    Safety population (SAF)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Patients who received at least one infusion of Octaplas

    Subject analysis set title
    Full analysis set (FAS)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All patients of the safety population with any measurements on the primary endpoint variables

    Subject analysis set title
    Per-protocol population (PP)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All patients who completed the infusion episode(s) and the final examination without major protocol deviations that may have had an impact on the evaluation of the study outcome parameters

    Subject analysis set title
    Children >2 Years
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Children >2 Years

    Subject analysis set title
    Infants ≤2 Years
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Infants ≤2 Years

    Subject analysis set title
    EPL30-TEG
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Number of Participants With Clinically Significant Changes in Hemostatic Parameters as Measured by EPL30-TEG (estimated percent lysis)

    Subject analysis set title
    ML30-ROTEM
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Number of Participants WithClinically Significant Changes in Hemostatic Parameters as Measured byThromboelastometry (ROTEM).

    Subject analysis set title
    Octaplas - Pre-Infusion
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Pre-Infusion Vital Signs

    Subject analysis set title
    Octaplas - Post-Infusion
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Post-Infusion Vital Signs

    Subject analysis set title
    N (ratings)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Number of Patients

    Subject analysis set title
    percentage (%)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Percentage

    Subject analysis set title
    CHANGE FROM PRE-INFUSION 1
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    VITAL SIGNS DURING THE STUDY AND CHANGE FROM PRE-INFUSION TO POST-INFUSION

    Primary: Number of Participants With Adverse Drug Reactions

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    End point title
    		 Number of Participants With Adverse Drug Reactions [1]
    End point description
    Number of Participants With Adverse Drug Reactions (e.g., Allergic Reactions, TEs, TEEs (Thromboembolic Events) and Hyperfibrinolytic Events)
    End point type
    Primary
    End point timeframe
    up to 6 days
    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 statistical analysis at least 2 arms are required, so no statistical analysis can be provided. Therefore, only results for this endpoint are provided
    End point values
    		 Safety population (SAF)
    Number of subjects analysed
    50
    Units: Number of patients
        Any SAE
    5
        Any SAE related to Octaplas
    0
        Any ADR
    0
        Any ADR, SAE, HFE TEE, or TE leading to withdrawal
    0
        Any ADR, SAE, HFE, TEE, or TE leading to death
    1
        Any study death related to Octaplas
    0
    No statistical analyses for this end point

    Primary: Clinically Significant Changes in White Blood Cells

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    End point title
    		 Clinically Significant Changes in White Blood Cells [2]
    End point description
    Assesses Pre- and Post-infusion for Infusion Episode 1
    End point type
    Primary
    End point timeframe
    up to 6 days
    Notes
    [2] - 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 statistical analysis at least 2 arms are required, so no statistical analysis can be provided. Therefore, only results for this endpoint are provided
    End point values
    		 Children >2 Years Infants ≤2 Years
    Number of subjects analysed
    13
    37
    Units: 10^3/µL
        median (full range (min-max))
    5.3 (-4.7 to 28.3)
    2.05 (-12.3 to 9.3)
    No statistical analyses for this end point

    Primary: Clinically Significant Changes in Red Blood Cells

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    End point title
    		 Clinically Significant Changes in Red Blood Cells [3]
    End point description
    Assesses Pre- and Post-infusion for Infusion Episode 1
    End point type
    Primary
    End point timeframe
    up to 6 days
    Notes
    [3] - 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 statistical analysis at least 2 arms are required, so no statistical analysis can be provided. Therefore, only results for this endpoint are provided
    End point values
    		 Children >2 Years Infants ≤2 Years
    Number of subjects analysed
    13
    37
    Units: 10^6/µL
        median (full range (min-max))
    -0.34 (-1.4 to 0.6)
    -0.06 (-1.8 to 1.8)
    No statistical analyses for this end point

    Primary: Clinically Significant Changes in Hemoglobin

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    End point title
    		 Clinically Significant Changes in Hemoglobin [4]
    End point description
    Assesses Pre- and Post-infusion for Infusion Episode 1
    End point type
    Primary
    End point timeframe
    up to 6 days
    Notes
    [4] - 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 statistical analysis at least 2 arms are required, so no statistical analysis can be provided. Therefore, only results for this endpoint are provided
    End point values
    		 Children >2 Years Infants ≤2 Years
    Number of subjects analysed
    13
    37
    Units: g/dL
        median (full range (min-max))
    -0.70 (-3.9 to 2.7)
    0.8 (-4.6 to 5.2)
    No statistical analyses for this end point

    Primary: Clinically Significant Changes in Hematocrit

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    End point title
    		 Clinically Significant Changes in Hematocrit [5]
    End point description
    Assesses Pre- and Post-infusion for Infusion Episode 1
    End point type
    Primary
    End point timeframe
    up to 6 days
    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: Trial includes one arm only. For statistical analysis at least 2 arms are required, so no statistical analysis can be provided. Therefore, only results for this endpoint are provided
    End point values
    		 Children >2 Years Infants ≤2 Years
    Number of subjects analysed
    13
    37
    Units: percentage
        median (full range (min-max))
    -2.35 (-10.8 to 6.5)
    1.35 (-14.6 to 16.2)
    No statistical analyses for this end point

    Primary: Clinically Significant Changes in Mean Corpuscular Volume (MCV)

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    End point title
    		 Clinically Significant Changes in Mean Corpuscular Volume (MCV) [6]
    End point description
    Assesses Pre- and Post-infusion for Infusion Episode 1
    End point type
    Primary
    End point timeframe
    up to 6 days
    Notes
    [6] - 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 statistical analysis at least 2 arms are required, so no statistical analysis can be provided. Therefore, only results for this endpoint are provided
    End point values
    		 Children >2 Years Infants ≤2 Years
    Number of subjects analysed
    13
    37
    Units: fL
        median (full range (min-max))
    1.6 (-5.4 to 6.3)
    1.85 (-22.8 to 9.1)
    No statistical analyses for this end point

    Primary: Clinically Significant Changes in Mean Corpuscular Hemoglobin (MCH)

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    End point title
    		 Clinically Significant Changes in Mean Corpuscular Hemoglobin (MCH) [7]
    End point description
    Assesses Pre- and Post-infusion for Infusion Episode 1
    End point type
    Primary
    End point timeframe
    up to 6 days
    Notes
    [7] - 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 statistical analysis at least 2 arms are required, so no statistical analysis can be provided. Therefore, only results for this endpoint are provided
    End point values
    		 Children >2 Years Infants ≤2 Years
    Number of subjects analysed
    13
    37
    Units: pg
        median (full range (min-max))
    0.85 (-1.8 to 2.9)
    1.00 (-8.3 to 5.6)
    No statistical analyses for this end point

    Primary: Clinically Significant Changes in Mean Corpuscular Hemoglobin Concentration (MCHC)

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    End point title
    		 Clinically Significant Changes in Mean Corpuscular Hemoglobin Concentration (MCHC) [8]
    End point description
    Assesses Pre- and Post-infusion for Infusion Episode 1
    End point type
    Primary
    End point timeframe
    up to 6 days
    Notes
    [8] - 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 statistical analysis at least 2 arms are required, so no statistical analysis can be provided. Therefore, only results for this endpoint are provided
    End point values
    		 Children >2 Years Infants ≤2 Years
    Number of subjects analysed
    13
    37
    Units: g/dL
        median (full range (min-max))
    -0.15 (-0.9 to 4.2)
    0.20 (-1.2 to 2.8)
    No statistical analyses for this end point

    Primary: Clinically Significant Changes in Red Cell Distribution Width (RDW)

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    End point title
    		 Clinically Significant Changes in Red Cell Distribution Width (RDW) [9]
    End point description
    Assesses Pre- and Post-infusion for Infusion Episode 1
    End point type
    Primary
    End point timeframe
    up to 6 days
    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: Trial includes one arm only. For statistical analysis at least 2 arms are required, so no statistical analysis can be provided. Therefore, only results for this endpoint are provided
    End point values
    		 Children >2 Years Infants ≤2 Years
    Number of subjects analysed
    13
    37
    Units: percentage
        median (full range (min-max))
    0.10 (-3.9 to 3.0)
    0.40 (-2.1 to 4.2)
    No statistical analyses for this end point

    Primary: Clinically Significant Changes in Platelets

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    End point title
    		 Clinically Significant Changes in Platelets [10]
    End point description
    Assesses Pre- and Post-infusion for Infusion Episode 1
    End point type
    Primary
    End point timeframe
    up to 6 days
    Notes
    [10] - 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 statistical analysis at least 2 arms are required, so no statistical analysis can be provided. Therefore, only results for this endpoint are provided
    End point values
    		 Children >2 Years Infants ≤2 Years
    Number of subjects analysed
    13
    37
    Units: 10^3/µL
        median (full range (min-max))
    -105.5 (-210.0 to 15.0)
    -167.00 (-410 to 215.0)
    No statistical analyses for this end point

    Secondary: Number of Participants With Clinically Significant Changes in Hemostatic Parameters as Measured by the Following: International Normalized Ratio (INR)

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    End point title
    		 Number of Participants With Clinically Significant Changes in Hemostatic Parameters as Measured by the Following: International Normalized Ratio (INR)
    End point description
    This hemostatic parameter is figured out in the lab and helps to diagnose a bleeding disorder or excessive clotting disorder. The change of INR before and after 1st Octaplas infusion was scrutinized by analyzing the shifts between the classifications given below.
    End point type
    Secondary
    End point timeframe
    up to 6 days
    End point values
    		 Full analysis set (FAS)
    Number of subjects analysed
    50
    Units: Patients
        Shift from Not Clinically Significant to Normal
    1
        Remained Normal
    8
        Remained Not Clinically Significant
    11
        Shift from Normal to Not Clinically Significant
    25
        Shift to or from Clinically Significant
    1
    No statistical analyses for this end point

    Secondary: Clinically Significant Changes in Hemostatic Parameters as Measured by the Following: Prothrombin Time (PT)

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    End point title
    		 Clinically Significant Changes in Hemostatic Parameters as Measured by the Following: Prothrombin Time (PT)
    End point description
    This hemostatic parameter is figured out in the lab and measures the time it takes for your blood to clot (the higher the PT the longer it takes your blood to clot). The change of PT before and after 1st Octaplas infusion was scrutinized by analyzing the shifts between the classifications given below.
    End point type
    Secondary
    End point timeframe
    up to 6 days
    End point values
    		 Full analysis set (FAS)
    Number of subjects analysed
    50
    Units: Patients
        Shift from Not Clinically Significant to Normal
    1
        Remained Normal
    8
        Remained Not Clinically Significant
    18
        Shift from Normal to Not Clinically Significant
    19
        Shift to or from Clinically Significant
    0
    No statistical analyses for this end point

    Secondary: Number of Participants With Clinically Significant Changes in Hemostatic Parameters as Measured by the Following: Thromboelastography (TEG) or Thromboelastometry (ROTEM).

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    End point title
    		 Number of Participants With Clinically Significant Changes in Hemostatic Parameters as Measured by the Following: Thromboelastography (TEG) or Thromboelastometry (ROTEM).
    End point description
    TEG and ROTEM are methods of testing the efficiency of blood coagulation. The results were compared by looking at potential trends from TEG and ROTEM between pre-infusion vs post-infusion time points.
    End point type
    Secondary
    End point timeframe
    up to 6 days
    End point values
    		 EPL30-TEG ML30-ROTEM
    Number of subjects analysed
    50
    50
    Units: Patients
        Shift from Not Clinically Significant to Normal
    1
    0
        Remained Normal
    40
    0
        Remained Not Clinically Significant
    0
    0
        Shift from Normal to Not Clinically Significant
    0
    0
        Shift to or from Clinically Significant
    0
    0
    No statistical analyses for this end point

    Secondary: Number of Participants With Clinically Significant Changes in Hemostatic Parameters as Measured by the Following: Activated Partial Thromboplastin Time (aPTT)

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    End point title
    		 Number of Participants With Clinically Significant Changes in Hemostatic Parameters as Measured by the Following: Activated Partial Thromboplastin Time (aPTT)
    End point description
    aPTT measures the length of time (in seconds) that it takes for clotting to occur in a test cube. The higher the number of seconds the longer it takes the blood to clot. The changes between pre - and post infusion were analyzed.
    End point type
    Secondary
    End point timeframe
    up to 6 days
    End point values
    		 Full analysis set (FAS)
    Number of subjects analysed
    50
    Units: Patients
        Shift from Not Clinically Significant to Normal
    5
        Remained Normal
    18
        Remained Not Clinically Significant
    12
        Shift from Normal to Not Clinically Significant
    9
        Shift to or from Clinically Significant
    1
    No statistical analyses for this end point

    Secondary: Volume (Dose in mL/kg) of Octaplas Used Per Infusion Episode for Each Patient.

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    End point title
    		 Volume (Dose in mL/kg) of Octaplas Used Per Infusion Episode for Each Patient.
    End point description
    Normal infusion: Replacement of multiple clotting factors Bypass priming: Limit hemodilution and reduce transfusion requirements Bypass warming up: Rewarm patients suffering from hypothermia during the surgery process
    End point type
    Secondary
    End point timeframe
    up to 6 days
    End point values
    		 Safety population (SAF)
    Number of subjects analysed
    50
    Units: mL/kg
    arithmetic mean (standard deviation)
        Normal Infusion
    15.0 ( 14.17 )
        Bypass Priming
    20.2 ( 7.82 )
        Bypass Warming Up
    15.9 ( 5.88 )
    No statistical analyses for this end point

    Secondary: Medically Significant Changes in Blood Pressure

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    End point title
    		 Medically Significant Changes in Blood Pressure
    End point description
    End point type
    Secondary
    End point timeframe
    up to 6 days
    End point values
    		 Octaplas - Pre-Infusion Octaplas - Post-Infusion CHANGE FROM PRE-INFUSION 1
    Number of subjects analysed
    50
    50
    50
    Units: mmHg
    arithmetic mean (standard deviation)
        Systolic Blood Pressure
    75.66 ( 16.901 )
    79.96 ( 16.437 )
    4.30 ( 17.619 )
        Diastolic Blood Pressure
    46.28 ( 10.031 )
    50.00 ( 11.648 )
    3.72 ( 10.385 )
    No statistical analyses for this end point

    Secondary: Medically Significant Changes in Respiratory Rate

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    End point title
    		 Medically Significant Changes in Respiratory Rate
    End point description
    End point type
    Secondary
    End point timeframe
    up to 6 days
    End point values
    		 Octaplas - Pre-Infusion Octaplas - Post-Infusion CHANGE FROM PRE-INFUSION 1
    Number of subjects analysed
    50
    50
    50
    Units: breaths/minute
        arithmetic mean (standard deviation)
    21.17 ( 7.335 )
    23.79 ( 6.702 )
    1.17 ( 4.706 )
    No statistical analyses for this end point

    Secondary: Medically Significant Changes in Oxygen Saturation

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    End point title
    		 Medically Significant Changes in Oxygen Saturation
    End point description
    End point type
    Secondary
    End point timeframe
    up to 6 days
    End point values
    		 Octaplas - Pre-Infusion Octaplas - Post-Infusion CHANGE FROM PRE-INFUSION 1
    Number of subjects analysed
    50
    50
    50
    Units: percentage in blood
        arithmetic mean (standard deviation)
    96.86 ( 5.564 )
    98.33 ( 3.204 )
    1.50 ( 4.868 )
    No statistical analyses for this end point

    Secondary: Medically Significant Changes in Body Temperature

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    End point title
    		 Medically Significant Changes in Body Temperature
    End point description
    End point type
    Secondary
    End point timeframe
    up to 6 days
    End point values
    		 Octaplas - Pre-Infusion Octaplas - Post-Infusion CHANGE FROM PRE-INFUSION 1
    Number of subjects analysed
    50
    50
    50
    Units: Celsius
        arithmetic mean (standard deviation)
    35.60 ( 2.023 )
    36.50 ( 1.597 )
    0.89 ( 1.425 )
    No statistical analyses for this end point

    Secondary: Medically Significant Changes in Heart Rate

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    End point title
    		 Medically Significant Changes in Heart Rate
    End point description
    End point type
    Secondary
    End point timeframe
    up to 6 days
    End point values
    		 Octaplas - Pre-Infusion Octaplas - Post-Infusion CHANGE FROM PRE-INFUSION 1
    Number of subjects analysed
    50
    50
    50
    Units: beats per minut
        arithmetic mean (standard deviation)
    122.86 ( 30.528 )
    132.80 ( 26.439 )
    9.94 ( 26.282 )
    No statistical analyses for this end point

    Secondary: Count of Investigator's Assessment of Overall Safety Observed for Patients by Category

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    End point title
    		 Count of Investigator's Assessment of Overall Safety Observed for Patients by Category
    End point description
    Categories: (Assessed to Have Overall Safety of 'Excellent', Assessed to Have Overall Safety of 'Moderate', Assessed to Have Overall Safety of 'Poor')
    End point type
    Secondary
    End point timeframe
    up to 6 days
    End point values
    		 N (ratings) percentage (%)
    Number of subjects analysed
    50
    50
    Units: Patients
        Excellent
    50
    100
        Moderate
    0
    0
        Poor
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Throughout the whole 72-hour study treatment period until final examination 72 hours after end of last study infusion episode
    Adverse event reporting additional description
    Unrelated, non-serious AEs observed during the study were not captured in the eCRF. Only ADRs, TEs, TEEs, and HFEs were to be recorded.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.0
    Reporting groups
    Reporting group title
    Octaplas
    Reporting group description
    		 Octaplas was used per the approved labeling for the product

    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: Only ADRs were to be reported. Unrelated, non-serious AEs observed during the study were not captured . No ADRs were reported during the study .
    Serious adverse events
    		 Octaplas
    Total subjects affected by serious adverse events
         subjects affected / exposed
    5 / 50 (10.00%)
         number of deaths (all causes)
    1
         number of deaths resulting from adverse events
    0
    Injury, poisoning and procedural complications
    Iatrogenic injury
         subjects affected / exposed
    1 / 50 (2.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Vascular disorders
    Haemorrhage
         subjects affected / exposed
    1 / 50 (2.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Shock haemorrhagic
         subjects affected / exposed
    1 / 50 (2.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hypotension
         subjects affected / exposed
    1 / 50 (2.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Haemorrhage coronary artery
         subjects affected / exposed
    1 / 50 (2.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Intracardiac thrombus
         subjects affected / exposed
    1 / 50 (2.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Supraventricular tachycardia
         subjects affected / exposed
    1 / 50 (2.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hepatobiliary disorders
    Portal vein thrombosis
         subjects affected / exposed
    1 / 50 (2.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Respiratory failure
         subjects affected / exposed
    1 / 50 (2.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Octaplas
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 50 (0.00%)

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    17 Mar 2015
    Amendment #4 was issued to primarily update conditions for storage and use, since new stability data had been approved by FDA.
    18 Mar 2015
    Amendment #3 was issued to primarily apply several enhancements.
    03 Feb 2016
    Amendment #5 was issued to primarily apply several enhancements.
    09 Sep 2016
    Amendment#7: - Use of Octaplas to Prime Cardiopulmonary Bypass (CPB):Language was added into the protocol in order to explain that patients who undergo cardiac surgery and receive Octaplas solely for the priming of the CPB circuit are qualified for enrollment and will be part of the full analysis set - Reduction of Age Categories -The end of study timeline has been revised
    19 Nov 2016
    Amendment#8: The timing of the pre-and post-infusion samples for patients on cardiopulmonary-bypass was clarified in the protocol.
    29 Nov 2017
    Amendment#9: Given that there have been no safety concerns thus far in all age groups and since most patients meeting the eligibility criteria have the required surgery at an early stage in their life, i.e. 0-2 years, the planned enrollment for the 2-16 year age category was changed from a minimum of 17 patients to a minimum of 13 patients.

    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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