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    Clinical Trial Results:
    3-Year, Observational Study to Evaluate the Durability of Sustained Viral Response and the Kinetics of Antiviral-Resistant HCV in Subjects Who Participated in Studies of Idenix Anti-HCV, Direct Acting Antivirals

    Summary
    EudraCT number
    		 2012-005636-29
    Trial protocol
    		 BG  
    Global end of trial date
    20 Mar 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    31 Mar 2016
    First version publication date
    31 Mar 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    MK-1894-009
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01721265
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Idenix Protocol Number: IDX-03YF
    Sponsors
    Sponsor organisation name
    Merck Sharp & Dohme Corp.
    Sponsor organisation address
    2000 Galloping Hill Road, Kenilworth, NJ, United States, 07033
    Public contact
    Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.com
    Scientific contact
    Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.com
    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
    20 Mar 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    20 Mar 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    20 Mar 2015
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    All participants in this study have previously been in an Idenix hepatitis C virus (HCV) study and received study drug for 3 consecutive days. Participants who had received placebo in a previous Idenix study will not be enrolled in this study. In this study, researchers will try to find answers to these questions: •How much (if any) HCV is in your blood after stopping your Idenix study drug? •Is your HCV possibly resistant to treatment with the Idenix study drug or similar drugs?
    Protection of trial subjects
    This study was conducted in conformance with Good Clinical Practice standards and applicable country and/or local statutes and regulations regarding ethical committee review, informed consent, and the protection of human subjects participating in biomedical research.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    14 Sep 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
    Bulgaria: 1
    Country: Number of subjects enrolled
    Israel: 6
    Country: Number of subjects enrolled
    United States: 138
    Worldwide total number of subjects
    145
    EEA total number of subjects
    1
    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)
    138
    From 65 to 84 years
    7
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Adult male and female participants who participated in an Idenix study and received ≥3 doses of a direct-acting antiviral (DAA) were recruited for this 3-year observational follow-up study.

    Pre-assignment
    Screening details
    		 A total of 145 participants were drawn from Idenix studies IDX-06A-001 (n=17), IDX-06A-005 (n=78), IDX-08C-004 (n=16), and IDX-08C-005 (n=34).

    Period 1
    Period 1 title
    3-Year Observational Period (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    This was an unblinded observational follow-up study.

    Arms
    Arm title
    		 Prior Idenix DAA Treatment
    Arm description
    		 Adult male and female participants who had previously participated in an Idenix HCV study in which they had previously received ≥3 doses of a DAA.
    Arm type
    		 Experimental

    Investigational medicinal product name
    MK-2355
    Investigational medicinal product code
    Other name
    IDX184
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Participants who took ≥3 consecutive daily doses of MK-2355 in an earlier study were followed in the current study.

    Investigational medicinal product name
    MK-1894
    Investigational medicinal product code
    Other name
    IDX719
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants who took ≥3 consecutive daily doses of MK-1894 in an earlier study were followed in the current study.

    Number of subjects in period 1
    		Prior Idenix DAA Treatment
    Started
    145
    Completed
    0
    Not completed
    145
         Consent withdrawn by subject
    12
         Active at time of study discontinuation
    126
         Lost to follow-up
    4
         Initiated other treatment
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Prior Idenix DAA Treatment
    Reporting group description
    		 Adult male and female participants who had previously participated in an Idenix HCV study in which they had previously received ≥3 doses of a DAA.

    Reporting group values
    		 Prior Idenix DAA Treatment Total
    Number of subjects
    		 145 145
    Age Categorical
    Units: Subjects
        Adults (18-64 years)
    		 138 138
        Adults (65 to 84 years)
    		 7 7
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 51.4 ( 10.5 ) -
    Gender Categorical
    Units: Subjects
        Female
    		 70 70
        Male
    		 75 75

    End points

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    End points reporting groups
    Reporting group title
    Prior Idenix DAA Treatment
    Reporting group description
    		 Adult male and female participants who had previously participated in an Idenix HCV study in which they had previously received ≥3 doses of a DAA.

    Primary: Number of participants with HCV RNA <LLoQ

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    End point title
    		 Number of participants with HCV RNA <LLoQ [1]
    End point description
    The number of participants with HCV ribonucleic acid (RNA) below the lower limit of quantification (LLoQ) at consecutive 3-month intervals after prior IDX DAA treatment was determined. Plasma HCV RNA was assessed using the Roche COBAS Taqman 96 assay v.2.0, which has a LLoQ of 15 IU/mL.
    End point type
    Primary
    End point timeframe
    Months 0, 3, 6, 9, 12, 15, 18, 21, 24, 27, and 30
    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: Per protocol, only descriptive statistics were presented.
    End point values
    		 Prior Idenix DAA Treatment
    Number of subjects analysed
    144
    Units: Number of participants
        Month 0 (n=144)
    81
        Month 3 (n=134)
    73
        Month 6 (n=115)
    61
        Month 9 (n=94)
    44
        Month 12 (n=62)
    24
        Month 15 (n=46)
    17
        Month 18 (n=45)
    15
        Month 21 (n=32)
    8
        Month 24 (n=27)
    6
        Month 27 (n=13)
    2
        Month 30 (n=1)
    0
    No statistical analyses for this end point

    Secondary: Kinetics of resistance associated variants (RAVs)

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    End point title
    		 Kinetics of resistance associated variants (RAVs)
    End point description
    The kinetics of RAVs to IDX DAAs in participants who were virologic failures in the initial studies, or had relapsed in this study, were to be analyzed. However, analysis of RAVs was not performed due to early termination of this study.
    End point type
    Secondary
    End point timeframe
    Months 0, 3, 6, 9, 12, 15, 18, 21, 24, 27, and 30
    End point values
    		 Prior Idenix DAA Treatment
    Number of subjects analysed
    0 [2]
    Units: RAVs
    Notes
    [2] - Analysis of RAVs was not performed due to early study termination.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Safety data (including adverse events) were not collected and therefore no analysis was planned.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 Not applicable
    Dictionary version
    N/A
    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: Safety data (including adverse events) were not collected and therefore no analysis was planned.

    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
    19 Mar 2015
    The integration of Idenix compounds into the Merck HCV antiviral pipeline resulted in revisions to the clinical development plan. Merck discontinued development of IDX18719 (MK-1894) and Idenix had discontinued IDX14184 (MK-2355) prior to acquisition. Consequently, the IDX-03YF study involving these two compounds was terminated early.
    -

    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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