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    Clinical Trial Results:
    A Follow-up Study to Assess Resistance and Durability of Response to AbbVie Direct-Acting Antiviral Agent (DAA) Therapy in Subjects Who Participated in Phase 2 or 3 Clinical Studies for the Treatment of Chronic Hepatitis C Virus (HCV) Infection

    Summary
    EudraCT number
    2012-003073-26
    Trial protocol
    GB   IE   DE   ES   HU   AT   BE   DK   PT   PL   CZ   IT  
    Global end of trial date
    20 Oct 2016

    Results information
    Results version number
    v1(current)
    This version publication date
    21 Oct 2017
    First version publication date
    21 Oct 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    M13-102
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01773070
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    AbbVie Deutschland GmbH & Co.KG
    Sponsor organisation address
    AbbVie House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire, United Kingdom, SL6-4UB
    Public contact
    Rebecca Craft, AbbVie, rebecca.craft@abbvie.com
    Scientific contact
    Mariem Charafeddine MD, AbbVie, mariem.charafeddine@abbvie.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 Oct 2016
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    20 Oct 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The objectives of this study are as follows: ●Assess the persistence of specific HCV amino acid variants associated with drug resistance in subjects who experience virologic failure. ●Assess the durability of response for subjects who achieved SVR12 with a regimen including an AbbVie DAA.
    Protection of trial subjects
    Participant and/or legal guardian read and understood the information provided about the study and gave written permission.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    06 Jun 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
    Spain: 56
    Country: Number of subjects enrolled
    United Kingdom: 21
    Country: Number of subjects enrolled
    United States: 328
    Country: Number of subjects enrolled
    Australia: 6
    Country: Number of subjects enrolled
    Belgium: 6
    Country: Number of subjects enrolled
    Canada: 26
    Country: Number of subjects enrolled
    Denmark: 5
    Country: Number of subjects enrolled
    Germany: 29
    Country: Number of subjects enrolled
    New Zealand: 1
    Worldwide total number of subjects
    478
    EEA total number of subjects
    117
    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)
    434
    From 65 to 84 years
    44
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    Subjects who received ABT-450, ABT-333 or ABT-267 at any dose level in an eligible prior AbbVie Phase 2 or 3 study for the treatment of chronic HCV and met other inclusion/exclusion criteria had the option to enroll in this follow-up study.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Not applicable
    Blinding used
    Not blinded

    Arms
    Arm title
    All Subjects
    Arm description
    Subjects who received ABT-450, ABT-333 or ABT-267 at any dose level in an eligible prior AbbVie Phase 2 or 3 study for the treatment of chronic HCV, followed for up to 3 years post-treatment.
    Arm type
    non-interventional

    Investigational medicinal product name
    ABT-450/ritonavir
    Investigational medicinal product code
    Other name
    ABT-450 also known as paritaprevir
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    ABT-450 coformulated with ritonavir. Drug is not administered -- this study is follow-up for subjects previously receiving the drug.

    Investigational medicinal product name
    ABT-333
    Investigational medicinal product code
    Other name
    dasabuvir
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Drug is not administered -- this study is follow-up for subjects previously receiving the drug.

    Investigational medicinal product name
    ABT-267
    Investigational medicinal product code
    Other name
    ombitasvir
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Drug is not administered -- this study is follow-up for subjects previously receiving the drug.

    Number of subjects in period 1
    All Subjects
    Started
    478
    Completed
    397
    Not completed
    81
         Death
    3
         Not specified
    15
         Consent withdrawn by subject
    24
         Lost to follow-up
    39

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall Study
    Reporting group description
    -

    Reporting group values
    Overall Study Total
    Number of subjects
    478 478
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    53 ± 9.85 -
    Gender categorical
    Units: Subjects
        Female
    227 227
        Male
    251 251

    End points

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    End points reporting groups
    Reporting group title
    All Subjects
    Reporting group description
    Subjects who received ABT-450, ABT-333 or ABT-267 at any dose level in an eligible prior AbbVie Phase 2 or 3 study for the treatment of chronic HCV, followed for up to 3 years post-treatment.

    Subject analysis set title
    NS3, NS5A, NS5B Resistance Analyses: GT1a-Infected Subjects
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    GT1a-infected participants who experienced virologic failure after receiving ABT-450, ABT-333 or ABT-267, and had not achieved SVR12 and had postbaseline sequencing data for NS3, NS5A, or NS5B at given time point.

    Primary: Percentage of Subjects Who Experienced Relapse12overall With and Without New HCV Infection

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    End point title
    Percentage of Subjects Who Experienced Relapse12overall With and Without New HCV Infection [1]
    End point description
    Relapse is defined as a confirmed HCV RNA ≥ LLOQ at any time during the post-treatment period for a subject who had HCV RNA < LLOQ at the end of treatment. Relapse12overall is defined as a confirmed HCV RNA ≥ LLOQ at any time after the SVR12 assessment time point for a subject who achieved SVR12 and had post-SVR12 HCV RNA data available. SVR12 is defined as HCV RNA < LLOQ in the SVR12 window (12 weeks after the last actual dose of study drug) without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. New HCV infection is defined as re-infection with a different HCV isolate. Subjects who did not have any post-treatment HCV RNA values were excluded from the relapse analyses.
    End point type
    Primary
    End point timeframe
    Up to 3 years post-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: Descriptive statistics are presented, per protocol.
    End point values
    All Subjects
    Number of subjects analysed
    457
    Units: percentage of subjects
    number (not applicable)
        Relapse12overall With New HCV Infection
    0.2
        Relapse12overall Without New HCV Infection
    0.2
    No statistical analyses for this end point

    Primary: Number of HCV Genotype (GT)1a-Infected Subjects With Persistence of Treatment-Emergent Substitutions in NS3, NS5A, or NS5B

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    End point title
    Number of HCV Genotype (GT)1a-Infected Subjects With Persistence of Treatment-Emergent Substitutions in NS3, NS5A, or NS5B [2]
    End point description
    The persistence of specific hepatitis C amino acid variants (treatment-emergent substitutions) associated with drug resistance in NS3, NS5A, or NS5B was evaluated in subjects who had not achieved SVR12. Post-baseline time points were calculated relative to the last dose of study drug in the previous study.
    End point type
    Primary
    End point timeframe
    from the last dose of study drug in the previous study up to 3 years post-treatment
    Notes
    [2] - 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: Descriptive statistics are presented, per protocol.
    End point values
    NS3, NS5A, NS5B Resistance Analyses: GT1a-Infected Subjects
    Number of subjects analysed
    18 [3]
    Units: subjects
    number (not applicable)
        NS3: time of failure; n=18
    7
        NS3: post-treatment week 48; n=7
    0
        NS5A: time of failure; n=18
    13
        NS5A: post-treatment week 48; n=10
    10
        NS5A: post-treatment week 96; n=8
    6
        NS5A: post-treatment week 132; n=8
    4
        NS5B: time of failure; n=15
    7
        NS5B: post-treatment week 24; n=4
    3
        NS5B: post-treatment week 96; n=5
    1
    Notes
    [3] - n=number of subjects with an assessment at given time point
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Who Experienced Relapse12 Without and With New HCV Infection

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    End point title
    Percentage of Subjects Who Experienced Relapse12 Without and With New HCV Infection
    End point description
    Relapse is defined as a confirmed HCV RNA ≥ LLOQ at any time during the post-treatment period for a subject who had HCV RNA < LLOQ at the end of treatment. Relapse12 is defined as a confirmed HCV RNA ≥ LLOQ between end of treatment and 12 weeks after last actual dose of study drug (up to and including the SVR12 assessment time point) for a subject with HCV RNA < LLOQ at Final Treatment Visit who completed treatment. Subjects who did not have any post-treatment HCV RNA values were excluded from the relapse analyses.
    End point type
    Secondary
    End point timeframe
    From the end of treatment through 12 weeks post-treatment
    End point values
    All Subjects
    Number of subjects analysed
    458 [4]
    Units: percentage of participants
    number (not applicable)
        Relapse12 Without New HCV Infection
    2
        Relapse12 With New HCV Infection
    0
    Notes
    [4] - Subjects with HCV RNA < LLOQ at Final Treatment Visit who completed treatment.
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Who Experienced Relapse24 Without and With New HCV Infection

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    End point title
    Percentage of Subjects Who Experienced Relapse24 Without and With New HCV Infection
    End point description
    Relapse is defined as a confirmed HCV RNA ≥ LLOQ at any time during the post-treatment period for a subject who had HCV RNA < LLOQ at the end of treatment. Relapse24 is defined as a confirmed HCV RNA ≥ LLOQ within the sustained virologic response at Week 24 post-dosing (SVR24) window for a subject who achieved SVR12 and had HCV RNA data available in the SVR24 window. Subjects who did not have any post-treatment HCV RNA values were excluded from the relapse analyses.
    End point type
    Secondary
    End point timeframe
    From the end of treatment through 24 weeks post-treatment
    End point values
    All Subjects
    Number of subjects analysed
    403 [5]
    Units: percentage of subjects
    number (not applicable)
        Relapse24 Without New HCV Infection
    0.2
        Relapse24 With New HCV Infection
    0
    Notes
    [5] - Subjects who achieved SVR12 and had HCV RNA data available in the SVR24 window.
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Who Experienced Relapse˅overall Without and With New HCV Infection

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    End point title
    Percentage of Subjects Who Experienced Relapse˅overall Without and With New HCV Infection
    End point description
    Relapse is defined as a confirmed HCV RNA ≥ LLOQ at any time during the post-treatment period for a subject who had HCV RNA < LLOQ at the end of treatment. Relapse˅overall was defined as a confirmed HCV RNA ≥ LLOQ between end of treatment and up to and including the last HCV RNA measurement collected in the Post-Treatment Period for a subject with HCV RNA < LLOQ at Final Treatment Visit who completed treatment. Subjects who did not have any post-treatment HCV RNA values were excluded from the relapse analyses.
    End point type
    Secondary
    End point timeframe
    Up to 3 years post-treatment
    End point values
    All Subjects
    Number of subjects analysed
    458 [6]
    Units: percentage of subjects
    number (not applicable)
        Relapse˅overall Without New HCV Infection
    2.2
        Relapse˅overall With New HCV Infection
    0.2
    Notes
    [6] - Subjects with HCV RNA < LLOQ at Final Treatment Visit who completed treatment.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    From last dose of direct-acting antiviral agent treatment in the previous study to last HCV RNA assessment in M13-102 (mean [SD] duration: 146.3 [28.16] weeks).
    Adverse event reporting additional description
    Per protocol, only serious adverse events that the investigator considered to be causally related to study procedures (i.e., venipunctures) were collected in this study. Non-serious adverse events were not collected.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    All subjects
    Reporting group description
    -

    Serious adverse events
    All subjects
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 478 (0.00%)
         number of deaths (all causes)
    3
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    All subjects
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 478 (0.00%)
    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: Non-serious adverse events were not collected in this study, per protocol.

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    08 Mar 2013
    ● Clarify the collection of events related to HCV or liver disease. ● Add that some study visits and visit activities (including but not limited to vital signs, clinical laboratory tests, and concomitant medication assessment) could be conducted in the home or in a non-hospital/clinic environment at the request of the Investigator and with the agreement of the subject. ● Incorporate Administrative Changes
    22 Nov 2013
    ● Update the list of abbreviations and definition of terms. ● Increase the anticipated number of subjects from ~500 to ~2000 and the anticipated number of sites from ~125 to ~350 to reflect potential enrollment from all eligible prior sites. ● Add that it was preferable that subjects complete the full Post-treatment Period of the prior study before enrolling in Study M13-102. ● Remove vital signs from the list of study activities that could be conducted in the home or non-hospital/clinic environment because vital signs were not assessed in this study. ● Clarify that only prior studies being submitted as a US IND were eligible and provide a list of eligible prior studies. ● Delete the inclusion criterion that subjects were required to commit to up to 3 years of participation in the study. ● Prohibit the use of any investigational medication while participating in the Study M13-102. ● Clarify that the study visit that fell closest to 3 years since the subject's last dose of an AbbVie DAA was considered the final visit. ● Add that study visits were ideally to take place within 3 weeks of the planned visit date, and visits that occurred more than a specified number of weeks later than planned were to be considered as the next visit in the schedule. ● Clarify that only mortality events related to liver disease (not all deaths) were to be collected. ● Clarify the central laboratory location to where samples were to be shipped and analyzed/stored. ● Add the LLOD levels for HCV genotypes 2, 3, and 4. ● Change providing archive plasma and serum samples from mandatory to preferable. ● Clarify that only SAEs that the investigator considered causally related to a study procedure would be collected.
    22 Nov 2013
    (continued) ● Add that pregnancies in subjects who entered Study M13-102 within 7 months of the last dose of study drug in a prior study were to be reported for the prior study (not Study M13-102) according to the requirements of the prior study. ● Update contact names and contact information throughout the protocol. ● Clarify and provide additional details regarding the resistance analyses.
    28 Apr 2014
    ● Decrease the number of anticipated subjects from ~2000 to ~500. ● Add that subjects were required to have completed the Post-treatment Period of the prior study before enrolling in Study M13-102. ● Clarify that visits that were allowed to occur outside of the primary clinic would be arranged by the Investigator and had to be pre-approved by the sponsor. ● Remove measurement of IP-10 and clinical chemistry testing at Months 12 and 18. ● Update the description of the resistance analyses. ● Update how the sample size was determined. ● Update the contact information for adverse event reporting. ● Update contact names and contact information throughout the protocol. ● Update the basis for the number of subjects enrolled in the study. ● Update reference list to include more recent Investigator Brochures. ● Update the list of eligible prior studies.

    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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