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    Clinical Trial Results:
    Acute Effects of Benzbromaron on the pulmonary circulation

    Summary
    EudraCT number
    		 2015-000709-38
    Trial protocol
    		 AT  
    Global end of trial date
    23 Jun 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    28 Mar 2019
    First version publication date
    28 Mar 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    BBR
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02790450
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Medical University of Graz
    Sponsor organisation address
    AUenbruggerplatz 20, Graz, Austria, 8036
    Public contact
    Department for Pulmonology, Medical University of Graz, 43 31638512183, gabor.kovacs@klinikum-graz.at
    Scientific contact
    Department for Pulmonology, Medical University of Graz, 43 31638512183, gabor.kovacs@klinikum-graz.at
    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
    23 Jun 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    23 Jun 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    23 Jun 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    to assess the change of pulmonary vascular resistance 2 hours after the application of 200mg benzbromaron
    Protection of trial subjects
    only patients with clinically indicated right heart catheterization were included in order to minimise study-related complications
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Aug 2015
    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
    Austria: 10
    Worldwide total number of subjects
    10
    EEA total number of subjects
    10
    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
    6
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients of the Medical University of Graz with known pulmonary arterial hypertension and clinically indicated right heart catheterization were recruited between November 2015 and June 2016.

    Pre-assignment
    Screening details
    		 We identified n=10 patients with known PAH and clinically indicated right heart catheterization in the recruitment period. N=2 patients were excluded - one due to elevated pulmonary arterial wedge pressure (>15mmHg) and another due to elevated serum bilirubin (>1.6 mg/dl) and impaired GFR. N=8 patients completed the study.

    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
    		 all patients
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Benzbromaron
    Investigational medicinal product code
    PR1
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    200 mg single dose

    Number of subjects in period 1
    		all patients
    Started
    10
    Completed
    8
    Not completed
    2
         elevated bilirubin and impaired GFR at baseline
    1
         Adverse event, non-fatal
    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
    		 10 10
    Age categorical
    Units: Subjects
        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
        Adults (18-64 years)
    		 4 4
        From 65-84 years
    		 6 6
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 9 9
        Male
    		 1 1

    End points

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    End points reporting groups
    Reporting group title
    all patients
    Reporting group description
    		 -

    Primary: change in pulmonary vascular resistance 120 minutes after benzbromarone application as compared to baseline

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    End point title
    		 change in pulmonary vascular resistance 120 minutes after benzbromarone application as compared to baseline [1]
    End point description
    End point type
    Primary
    End point timeframe
    120 minutes
    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: This is a pilot study. An explorative analysis for the primary and secondary end-points has been performed. This compared the pulmonary vascular resistance (primary end-point) and other values at baseline and 120 minutes after administration of Benzbromaron.
    End point values
    		 all patients
    Number of subjects analysed
    8
    Units: pulmonary vascular resistance
        number (not applicable)
    8
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    120 minutes
    Adverse event reporting additional description
    N=2 patients did not complete the study. Both of them were excluded from the study before the administration of Benzbromaron, so they did not receive the single dose of the study drug. The reasons for discontinuation were 1. non-serious adverse event (elevated pulmonary arterial wedge pressure) and 2. impaired renal and hepatic function.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18
    Reporting groups
    Reporting group title
    all patients
    Reporting group description
    		 -

    Serious adverse events
    		 all patients
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 8 (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 patients
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 8 (12.50%)
    Cardiac disorders
    increased pulmonary arterial wedge pressure
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1

    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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    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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