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    Clinical Trial Results:
    Ten03: A Phase III Open, Multicentre Study to Investigate the Safety and Efficacy of BPL’s High Purity Factor X in the treatment of the Factor X Deficient Subjects Undergoing Surgery

    Summary
    EudraCT number
    		 2009-015086-31
    Trial protocol
    		 GB   ES  
    Global end of trial date
    08 Jan 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    18 Jul 2016
    First version publication date
    20 Jun 2014
    Other versions
    Summary report(s)
    		 Final CSR Ten03

    Trial information

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    Trial identification
    Sponsor protocol code
    Ten03
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01086852
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Bio Products Laboratory Limited
    Sponsor organisation address
    Dagger Lane, Elstree, United Kingdom, WD6 3BX
    Public contact
    Miranda Norton, Bio Products Laboratory Ltd, 44 208 957 2661, miranda.norton@bpl.co.uk
    Scientific contact
    Miranda Norton, Bio Products Laboratory Ltd, 44 208 957 2661, miranda.norton@bpl.co.uk
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-000971-PIP01-10
    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 Jan 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    08 Jan 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Jan 2014
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To investigate the safety and efficacy of FACTOR X administered by bolus infusion to prevent bleeding and achieve haemostasis in factor X deficient subjects undergoing surgery.
    Protection of trial subjects
    The following potential risks were monitored: Infusion site reactions Virology samples were taken at the prior to the first infusion and at the end of the study factor X inhibitor samples were taken prior to the first infusion and throughout until the end of the study. factor X levels were monitored at a local laboratory prior to and whilst during the treatment period.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    29 Jun 2012
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 2
    Country: Number of subjects enrolled
    United States: 2
    Worldwide total number of subjects
    4
    EEA total number of subjects
    2
    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)
    4
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 4 subjects were screened and enrolled into the study, all 4 subjects completed the study.

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

    Arms
    Arm title
    		 ACTIVE TREATMENT
    Arm description
    		 Raise plasma factor X to 70-90 IU/dL pre-surgery and maintain >50 IU/dL post-surgery until no longer at risk of bleeding due to surgery.
    Arm type
    		 Experimental

    Investigational medicinal product name
    FACTOR X
    Investigational medicinal product code
    Other name
    Human coagulation factor X
    Pharmaceutical forms
    Powder and solvent for solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Raise plasma factor X to 70-90 IU/dL pre-surgery and maintain >50 IU/dL post-surgery until no longer at risk of bleeding due to surgery.

    Number of subjects in period 1
    		ACTIVE TREATMENT
    Started
    4
    Completed
    4

    Baseline characteristics

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

    Reporting group values
    		 Overall Trial Period Total
    Number of subjects
    		 4 4
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 4 4
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 0 0
        Male
    		 4 4
    Factor X severity
    Mild = plasma FX:C 5 to <20 IU/dL Moderate to severe = plasma FX:C <5 IU/dL
    Units: Subjects
        Mild
    		 4 4
        Moderate - Severe
    		 0 0
    Major or Minor Surgery
    Surgical procedures requiring day case or overnight stay, such as laparoscopic or arthroscopic procedures, will be defined as minor procedures. Procedures typically requiring full anaesthesia and involving opening of the major cavities, such as thoracic, abdominal, orthopaedic or open heart surgery, will be defined as major procedures. A Data Review Committee made the final decision with respect to assignment of severity (major or minor) of the surgeries.
    Units: Subjects
        Major
    		 4 4
        Minor
    		 0 0

    End points

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    End points reporting groups
    Reporting group title
    ACTIVE TREATMENT
    Reporting group description
    		 Raise plasma factor X to 70-90 IU/dL pre-surgery and maintain >50 IU/dL post-surgery until no longer at risk of bleeding due to surgery.

    Subject analysis set title
    ITT Population
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The ITT population will be defined as all surgical procedures in which subjects were treated with at least one dose of FACTOR X and have undergone surgery.

    Subject analysis set title
    Safety Population
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The safety population will be defined as all surgical procedures in which subjects receive at least part of one dose of study medication. For subjects who withdraw, safety data will be analysed up to the point of withdrawal, if the available data is adequate to allow a scientific analysis.

    Primary: Blood loss during and after surgery

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    End point title
    		 Blood loss during and after surgery [1]
    End point description
    Blood loss will be assessed by the following: Clinical estimation of volume of blood loss during surgery Requirement for blood transfusion or infusion of autologous red cells during and after surgery Number and duration of post-operative bleeding episodes Measurements of haemoglobin pre-opeartively, post-operatively and at discharge.
    End point type
    Primary
    End point timeframe
    Blood loss is measured during and after surgery, the overall assessment is made after the last dose of FACTOR X.
    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 formal statistical analysis was performed. This was a non-comparative study; efficacy endpoints related to bleeding during and after surgery,but no statistical hypothesis test was performed.
    End point values
    		 ACTIVE TREATMENT ITT Population Safety Population
    Number of subjects analysed
    4
    4
    4
    Units: Excellent/Good/Poor
    number (not applicable)
        Excellent
    4
    4
    4
        Good
    0
    0
    0
        Poor
    0
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Consent to 28 days after the last dose of IMP
    Adverse event reporting additional description
    All subjects receiving FACTOR X
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    13.0
    Reporting groups
    Reporting group title
    All subjects receiving FACTOR X
    Reporting group description
    		 -

    Serious adverse events
    		 All subjects receiving FACTOR X
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 4 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 All subjects receiving FACTOR X
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    4 / 4 (100.00%)
    Investigations
    Haemoglobin decreased
         subjects affected / exposed
    1 / 4 (25.00%)
         occurrences all number
    1
    Injury, poisoning and procedural complications
    Post procedural discomfort
    Additional description: Surgical wound site discomfort
         subjects affected / exposed
    1 / 4 (25.00%)
         occurrences all number
    2
    Contusion
    Additional description: Right calf with bruising
         subjects affected / exposed
    1 / 4 (25.00%)
         occurrences all number
    1
    Incision site complication
    Additional description: 2 small vesicles around surgical site incision
         subjects affected / exposed
    1 / 4 (25.00%)
         occurrences all number
    1
    Vascular disorders
    Haematoma
    Additional description: Right lower extremety haematoma, inner thigh
         subjects affected / exposed
    1 / 4 (25.00%)
         occurrences all number
    1
    General disorders and administration site conditions
    Pyrexia
    Additional description: Fever
         subjects affected / exposed
    1 / 4 (25.00%)
         occurrences all number
    1
    Procedural pain
    Additional description: Surgical Site Pain
         subjects affected / exposed
    2 / 4 (50.00%)
         occurrences all number
    2
    Oedema peripheral
         subjects affected / exposed
    2 / 4 (50.00%)
         occurrences all number
    2
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 4 (25.00%)
         occurrences all number
    1
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    3 / 4 (75.00%)
         occurrences all number
    3
    Dyspepsia
    Additional description: Indigestion
         subjects affected / exposed
    3 / 4 (75.00%)
         occurrences all number
    3
    Nausea
         subjects affected / exposed
    2 / 4 (50.00%)
         occurrences all number
    2
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
    Additional description: Sore throat
         subjects affected / exposed
    1 / 4 (25.00%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Ecchymosis
    Additional description: Ecchymosis on left thigh
         subjects affected / exposed
    1 / 4 (25.00%)
         occurrences all number
    1
    Pruritus
    Additional description: Pruritus on back
         subjects affected / exposed
    1 / 4 (25.00%)
         occurrences all number
    1
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    1 / 4 (25.00%)
         occurrences all number
    1
    Infections and infestations
    Herpes zoster
    Additional description: Nerve Pain, Shingles
         subjects affected / exposed
    1 / 4 (25.00%)
         occurrences all number
    1
    Metabolism and nutrition disorders
    Hyperglycaemia
         subjects affected / exposed
    1 / 4 (25.00%)
         occurrences all number
    1
    Hypokalaemia
         subjects affected / exposed
    1 / 4 (25.00%)
         occurrences all number
    1
    Hypomagnesaemia
         subjects affected / exposed
    1 / 4 (25.00%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    22 May 2012
    Changes to the primary endpoints Changes to the secondary endpoints, as a consequence of changes to the primary endpoints Update to definitions of efficacy populations Addition of analysis to take into account effect of the severity of factor X deficiency on the efficacy of FACTOR X Update to the definition of major and minor surgery Clarification of treatment after the end of study Administrative changes
    21 Aug 2012
    Update to the surgeons' estimation of blood loss in line with updated primary efficacy analysis Administrative changes
    03 Jan 2013
    Revised study personnel to reflect new contract research organisation, INC Research. Revised the contact details for reporting SAEs to remove CROfessionals LLC. Details for contacting the sponsor to report SAEs were clarified
    01 Feb 2013
    Update to the dose calculation in line with pharmacokinetic data from study Ten01 (assumed incremental recovery of 2.0 IU/dL per IU/kg) Update to the half life in with pharmacokinetic data from study Ten01. Clarify that the FX level achieved should be checked before surgery. Update to arrangements for early discharge Administrative changes

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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