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    Clinical Trial Results:
    The effects of PXR activation on hepatic fat content

    Summary
    EudraCT number
    		 2014-003422-41
    Trial protocol
    		 FI  
    Global end of trial date
    01 Feb 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    08 Mar 2022
    First version publication date
    08 Mar 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    Rifa-Stea
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02329405
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Oulu University Hospital
    Sponsor organisation address
    Kajaanintie 50, Oulu, Finland,
    Public contact
    janne.hukkanen@oulu.fi, Oulu University Hospital, Department of Internal Medicine, 358 83156212, janne.hukkanen@oulu.fi
    Scientific contact
    janne.hukkanen@oulu.fi, Oulu University Hospital, Department of Internal Medicine, 358 83156212, janne.hukkanen@oulu.fi
    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
    Interim
    Date of interim/final analysis
    15 Feb 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 Feb 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Feb 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To study how PXR activation by rifampicin affects hepatic fat content
    Protection of trial subjects
    Basic laboratory measures controlled to ensure safety of using rifampicin.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    03 Nov 2014
    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
    Finland: 17
    Worldwide total number of subjects
    17
    EEA total number of subjects
    17
    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)
    17
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Healthy volunteers responding to recruitment add in email list.

    Pre-assignment
    Screening details
    		 Healthy volunteers responding to recruitment add in email list. Screened and randomized to two-arm crossover study.

    Period 1
    Period 1 title
    Screening and randomization (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Rifampicin arm
    Arm description
    		 Rifampicin 600 mg daily for one week
    Arm type
    		 Experimental

    Investigational medicinal product name
    Rifampicin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    600 mg daily for a week

    Arm title
    		 Placebo arm
    Arm description
    		 Placebo daily for a week.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo (contains magnesium stearate, microcrystalline cellulose)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Tablet once daily for a week.

    Number of subjects in period 1
    		Rifampicin arm Placebo arm
    Started
    16
    17
    Completed
    16
    16
    Not completed
    0
    1
         Adverse event, non-fatal
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Screening and randomization
    Reporting group description
    		 -

    Reporting group values
    		 Screening and randomization Total
    Number of subjects
    		 17 17
    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)
    		 17 17
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 23 ( 3 ) -
    Gender categorical
    Units: Subjects
        Female
    		 6 6
        Male
    		 11 11

    End points

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    End points reporting groups
    Reporting group title
    Rifampicin arm
    Reporting group description
    		 Rifampicin 600 mg daily for one week

    Reporting group title
    Placebo arm
    Reporting group description
    		 Placebo daily for a week.

    Primary: Hepatic fat

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    End point title
    		 Hepatic fat
    End point description
    End point type
    Primary
    End point timeframe
    After one-week of rifampicin/placebo
    End point values
    		 Rifampicin arm Placebo arm
    Number of subjects analysed
    16
    16
    Units: Arbitary unit
        arithmetic mean (standard deviation)
    2.45 ( 1.7 )
    2.53 ( 2.4 )
    Statistical analysis title
    		 Student t-test
    Comparison groups
    Placebo arm v Rifampicin arm
    Number of subjects included in analysis
    32
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [1]
    P-value
    		 > 0.05
    Method
    		 t-test, 2-sided
    Confidence interval
    Notes
    [1] - EudraCT system does not understand crossover analysis, thus, there is only 16 subjects.

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    One-week study arms
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10.0
    Reporting groups
    Reporting group title
    Rifampicin arm
    Reporting group description
    		 -

    Reporting group title
    Placebo arm
    Reporting group description
    		 -

    Serious adverse events
    		 Rifampicin arm Placebo arm
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 17 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Reproductive system and breast disorders
    Ovarian cyst
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 17 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Rifampicin arm Placebo arm
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    7 / 16 (43.75%)
    3 / 17 (17.65%)
    General disorders and administration site conditions
    Bad taste in mount
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    2 / 16 (12.50%)
    1 / 17 (5.88%)
         occurrences all number
    2
    1
    Appetite disorder
    Additional description: Lack of appetite
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    Constipation
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    Liver function test increased
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Upper respiratory tract infection
         subjects affected / exposed
    2 / 16 (12.50%)
    1 / 17 (5.88%)
         occurrences all number
    2
    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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