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    Clinical Trial Results:
    Effects of the activation of peroxisome proliferator-activated receptors in patients with primary biliary cirrhosis

    Summary
    EudraCT number
    		 2011-004681-15
    Trial protocol
    		 AT  
    Global end of trial date
    14 Oct 2013

    Results information
    Results version number
    		 v1(current)
    This version publication date
    23 Jun 2021
    First version publication date
    23 Jun 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    KIMCL_TS_2011-09
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Medical University of Graz
    Sponsor organisation address
    Auenbruggerplatz 15, Graz, Austria, 8036
    Public contact
    MUG, Medical University of Graz, +43 316385 80442, tatjana.stojakovic@medunigraz.at
    Scientific contact
    MUG, Medical University of Graz, +43 316385 80442, tatjana.stojakovic@medunigraz.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
    27 Jan 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    14 Oct 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    14 Oct 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Our major hypothesis is that the treatment with bezafibrate will improve levels of AP in early-stage PBC patients with an incomplete biochemical response to UCDA through a combination of metabolic and anti-inflammatory effects.
    Protection of trial subjects
    close follow-up at 3 study visits (baseline, week 4, week 8)
    Background therapy
    		 ursodeoxycholic acid (UDCA)
    Evidence for comparator
    		 -
    Actual start date of recruitment
    09 Jan 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
    Austria: 13
    Worldwide total number of subjects
    13
    EEA total number of subjects
    13
    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)
    12
    From 65 to 84 years
    1
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 January 2012 - June 2013

    Pre-assignment
    Screening details
    		 Patients with PBC and incomplete response to UDCA

    Period 1
    Period 1 title
    baseline
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 bezafibrate
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    bezafibrate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    400 mg once daily

    Number of subjects in period 1
    		bezafibrate
    Started
    13
    Completed
    13
    Period 2
    Period 2 title
    week 8
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 bezafibrate
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    bezafibrate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    400 mg once daily

    Number of subjects in period 2
    		bezafibrate
    Started
    13
    Completed
    12
    Not completed
    1
         Adverse event, non-fatal
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    baseline
    Reporting group description
    		 -

    Reporting group values
    		 baseline Total
    Number of subjects
    		 13 13
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 54 ± 8 -
    Gender categorical
    Units: Subjects
        Female
    		 12 12
        Male
    		 1 1

    End points

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    End points reporting groups
    Reporting group title
    bezafibrate
    Reporting group description
    		 -
    Reporting group title
    bezafibrate
    Reporting group description
    		 -

    Primary: alkaline phosphatase (AP)

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    End point title
    		 alkaline phosphatase (AP)
    End point description
    End point type
    Primary
    End point timeframe
    baseline
    End point values
    		 bezafibrate bezafibrate
    Number of subjects analysed
    13
    12
    Units: U/l
        arithmetic mean (standard deviation)
    217 ± 75
    105 ± 26
    Attachments
    		 Tables
    Statistical analysis title
    		 paired t-test
    Statistical analysis description
    week 8 vs. baseline
    Comparison groups
    bezafibrate v bezafibrate
    Number of subjects included in analysis
    25
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 t-test, 2-sided
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    January 2012 - October 2013
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.0
    Reporting groups
    Reporting group title
    bezafibrate
    Reporting group description
    		 oral administration of bezafibrate for 8 weeks

    Serious adverse events
    		 bezafibrate
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 13 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 bezafibrate
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 13 (7.69%)
    Musculoskeletal and connective tissue disorders
    Myalgia
         subjects affected / exposed
    1 / 13 (7.69%)
         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
    For support, Contact us.
    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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