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    Clinical Trial Results:
    An Open-Label Study to Explore the Clinical Efficacy of Sofosbuvir With Ribavirin Administered Pre-Transplant in Preventing Hepatitis C Virus (HCV) Recurrence Post-Transplant in HIV-HCV infected patients

    Summary
    EudraCT number
    		 2014-001739-35
    Trial protocol
    		 IT  
    Global end of trial date
    20 Feb 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    01 Feb 2020
    First version publication date
    01 Feb 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    SOFT-preOLT
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01559844
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Università di Modena e Reggio Emilia
    Sponsor organisation address
    via del Pozzo, 71, Modena, Italy,
    Public contact
    Researcher, Università di Modena e ReggioEmilia, +39 0594225318, giovanni.guaraldi@unimore.it
    Scientific contact
    Researcher, Università di Modena e ReggioEmilia, +39 0594225318, giovanni.guaraldi@unimore.it
    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
    30 May 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    20 Feb 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    20 Feb 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To determine if the administration of a combination of sofosbuvir and ribavirin to HIV-HCV co-infected subjects prior to undergoing liver transplantation for up to 48 weeks (or the time of transplant) can prevent post-transplant HCV re-infection as determined by a sustained post-transplant virological response (HCV RNA <LLoQ) at 12 weeks post-transplant
    Protection of trial subjects
    No particular actions
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Jul 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
    Italy: 11
    Worldwide total number of subjects
    11
    EEA total number of subjects
    11
    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)
    11
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 recruitment period 6th Oct 2014-31st Oct-2016

    Pre-assignment
    Screening details
    		 All the screened subjects were enrolled in the trial. No screening-failure

    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
    		 Treatment
    Arm description
    		 sofosbuvir (Sovaldi) and after the approved Amendment sofosbuvir+ledipasvir (Harvoni)
    Arm type
    		 Experimental

    Investigational medicinal product name
    sofosbuvir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    400mg QD

    Investigational medicinal product name
    Harvoni (sofosbuvir+ledipasvir)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    sofosbuvir + ledipasvir= 400 mg/90mg QD

    Number of subjects in period 1
    		Treatment
    Started
    11
    Completed
    11

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    overall trial
    Reporting group description
    		 11

    Reporting group values
    		 overall trial Total
    Number of subjects
    		 11 11
    Age categorical
    >18 years
    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)
    		 11 11
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age continuous
    adults
    Units: years
        median (inter-quartile range (Q1-Q3))
    		 51 (50 to 52) -
    Gender categorical
    Units: Subjects
        Female
    		 3 3
        Male
    		 8 8

    End points

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    End points reporting groups
    Reporting group title
    Treatment
    Reporting group description
    		 sofosbuvir (Sovaldi) and after the approved Amendment sofosbuvir+ledipasvir (Harvoni)

    Primary: sustained post-transplant virological response (HCV RNA <LLoQ)

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    End point title
    		 sustained post-transplant virological response (HCV RNA <LLoQ) [1]
    End point description
    End point type
    Primary
    End point timeframe
    12 week post orthotopic liver transplant
    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: Only descriptive analysis was perfomed. Only one arm.
    End point values
    		 Treatment
    Number of subjects analysed
    11
    Units: copies/ml
        number (not applicable)
    11
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    from consent form signature to last patient last visit
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22
    Frequency threshold for reporting non-serious adverse events: 0%
    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: Considering the particularly complex conditions of patients in waiting list for orthotopic liver transplantation, all reported clinical conditions are considered pre-existing and related to the underlying pathology.

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    16 Feb 2015
    Based on international guidelines replacement of sofosbuvir with sofosbuvir+ledipasvir

    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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