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    Clinical Trial Results:
    The role of paroxetine in patients taking telaprevir-based HCV therapy: lack of a drug-drug interaction? (ROLEX)

    Summary
    EudraCT number
    		 2012-005372-34
    Trial protocol
    		 NL  
    Global end of trial date
    15 Sep 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    21 Sep 2019
    First version publication date
    21 Sep 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    UMCN-AKF12.02
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Radboudumc
    Sponsor organisation address
    Geert Grooteplein Zuid 10, Nijmegen, Netherlands,
    Public contact
    David Burger, Radboud University Medical Centre, 31 243616405,
    Scientific contact
    David Burger, Radboud University Medical Centre, 31 243616405,
    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
    15 Sep 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    15 Sep 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    15 Sep 2014
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To show that concomitant use of telaprevir (1125 mg BID) does not lead to a relevant decrease (> 20%) in the paroxetine parameter AUC0-24h compared to paroxetine alone.
    Protection of trial subjects
    The study will be performed in HCV infected patients who will be treated with telaprevir containing HCV treatment. Patients are already on antidepressant therapy with paroxetine. We chose to conduct this study in this population because these patients will be treated with telaprevir and paroxetine anyway and will be exposed to these drugs in regular care. The burden of participation in the trial is limited. We only perform a minimal change in the standard treatment regimen, since included patients are already on antidepressant thera-py with paroxetine and are eligible for start of a TVR-containing regimen for treatment of their HCV infection. To further limit the burden, study visits are mostly planned in accord-ance with the regular visiting scheme for HCV treatment.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Apr 2013
    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
    Netherlands: 3
    Worldwide total number of subjects
    3
    EEA total number of subjects
    3
    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)
    3
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 At least 18 and not older than 65 years at screening, able and willing to sign the Informed Consent Form prior to screening evaluations, subject has a chronic HCV infection with genotype 1, subject is eligible for telaprevir containing HCV treatment, subject is on a stable dose of 20 mg paroxetine QD for at least 4 weeks.

    Period 1
    Period 1 title
    paroxetine alone
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 paroxetine
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    paroxetine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    20 mg once daily

    Number of subjects in period 1
    		paroxetine
    Started
    3
    Completed
    2
    Not completed
    1
         Physician decision
    1
    Period 2
    Period 2 title
    paroxetine + telaprevir
    Is this the baseline period?
    		 No
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 interaction arm
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    paroxetine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    20 mg once daily

    Investigational medicinal product name
    telaprevir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1125 mg twice daily

    Number of subjects in period 2
    		interaction arm
    Started
    2
    Completed
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    paroxetine alone
    Reporting group description
    		 -

    Reporting group values
    		 paroxetine alone Total
    Number of subjects
    		 3 3
    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
        median (full range (min-max))
    		 44 (34 to 53) -
    Gender categorical
    Units: Subjects
        Female
    		 1 1
        Male
    		 2 2

    End points

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    End points reporting groups
    Reporting group title
    paroxetine
    Reporting group description
    		 -
    Reporting group title
    interaction arm
    Reporting group description
    		 -

    Primary: paroxetine AUC0-24h decrease

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    End point title
    		 paroxetine AUC0-24h decrease
    End point description
    To show that concomitant use of telaprevir (1125 mg BID) does not lead to a relevant decrease (> 20%) in the paroxetine parameter AUC0-24h compared to paroxetine alone.
    End point type
    Primary
    End point timeframe
    Interaction versus paroxetine alone
    End point values
    		 paroxetine interaction arm
    Number of subjects analysed
    2
    2
    Units: %
    0
    100
    Statistical analysis title
    		 descriptive
    Statistical analysis description
    Individual analysis
    Comparison groups
    paroxetine v interaction arm
    Number of subjects included in analysis
    4
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    P-value
    		 < 0.05
    Method
    		 ANOVA
    Parameter type
    		 geometric mean ratio
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.8
         upper limit
    		 2
    Variability estimate
    Standard error of the mean
    Notes
    [1] - explorative

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    entire study
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 none
    Dictionary version
    1
    Frequency threshold for reporting non-serious adverse events: 1%
    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: No (serious)adverse events were reported

    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? Yes
    Date
    Interruption
    Restart date
    15 Sep 2014
    Telaprevir was not being used anymore end 2014, therefore no further inclusions were expected.
    -

    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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