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    Clinical Trial Results:
    Two treatment strategies with Ribavirin for Chronic Hepatitis E and severe acute forms randomized study

    Summary
    EudraCT number
    		 2015-000699-91
    Trial protocol
    		 ES  
    Global end of trial date
    07 Nov 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    30 Jan 2022
    First version publication date
    30 Jan 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    RACHE
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    VHIR
    Sponsor organisation address
    Passeig Vall Hebron 119-129, Barcelona, Spain, 08035
    Public contact
    Joaquin Lopez-Soriano, Fundación Hospital Vall Hebron Institut de Recerca, 0034 934894779, joaquin.lopez.soriano@vhir.org
    Scientific contact
    Servicio Hepatología, Fundación Hospital Vall Hebron Institut de Recerca, 0034 934893000, resteban@vhebron.net
    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
    07 Nov 2018
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    07 Nov 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Efficacy assessment (sustained virologic response rate) with Ribavirin in two therapeutic strategies with ribavirin, in patients with chronic and severe acute hepatitis E.
    Protection of trial subjects
    No specific measures were necessary
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Sep 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
    Spain: 5
    Worldwide total number of subjects
    5
    EEA total number of subjects
    5
    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
    1
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients were recruited at Vall Hebron Hospital (Barcelona, Spain)

    Pre-assignment
    Screening details
    		 Patients were selected form the CHES (Chronic Hepatitis E Screening) multicenter study including patients with immune impairment and increased transaminases levels. 381 patients in total were included in that study, from which patients were selected.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 12 weeks
    Arm description
    		 12 weeks treatment with ribavarin
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ribavirin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    600mg daily dose for 12 weeks

    Arm title
    		 24 weeks
    Arm description
    		 24 weeks treatment if RNA detectable at 4 weeks after starting treatment, or else treatment only 12 weeks if RNA undetectable at 4 weeks
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ribavirin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    600mg daily dose for: 12 weeks if RNA not detectable at week 4; or 24 weeks if RNA detectable at 4 weeks, adjusted to renal function

    Number of subjects in period 1
    		12 weeks 24 weeks
    Started
    2
    3
    Completed
    2
    3

    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
    		 5 5
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 5 5
    Gender categorical
    Units: Subjects
        Female
    		 1 1
        Male
    		 4 4

    End points

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    End points reporting groups
    Reporting group title
    12 weeks
    Reporting group description
    		 12 weeks treatment with ribavarin

    Reporting group title
    24 weeks
    Reporting group description
    		 24 weeks treatment if RNA detectable at 4 weeks after starting treatment, or else treatment only 12 weeks if RNA undetectable at 4 weeks

    Primary: RNA not detectable

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    End point title
    		 RNA not detectable [1]
    End point description
    Hepatatis E Virus RNA levels were assessed 48 weeks after ending of treatment
    End point type
    Primary
    End point timeframe
    48 weeks after finishing treatment
    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: The small sample size makes impossible a statistical analysis
    End point values
    		 12 weeks 24 weeks
    Number of subjects analysed
    2
    3
    Units: Patients
        number (not applicable)
    1
    1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    48 weeks after tretament
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.1
    Frequency threshold for reporting non-serious adverse events: 5%
    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: None adverse events were reported in the study

    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.
    Small sample size makes desirable further studies with larger groups
    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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