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    Clinical Trial Results:
    A Prospective 3-Year Follow-up Study in Subjects Treated in a Preceding Phase 2 or 3 Study With a Regimen Containing Odalasvir and AL-335 With or Without Simeprevir for the Treatment of Hepatitis C Virus (HCV) Infection

    Summary
    EudraCT number
    2016-002608-19
    Trial protocol
    BE   DE   PL   ES  
    Global end of trial date
    13 Feb 2018

    Results information
    Results version number
    v1(current)
    This version publication date
    01 Mar 2019
    First version publication date
    01 Mar 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    64294178HPC3001
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT03099135
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Janssen-Cilag International NV
    Sponsor organisation address
    Turnhoutseweg, 30, Beerse, Belgium, 2340
    Public contact
    Clinical Registry Group, Janssen-Cilag International NV, ClinicalTrialsEU@its.jnj.com
    Scientific contact
    Clinical Registry Group, Janssen-Cilag International NV, ClinicalTrialsEU@its.jnj.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
    13 Feb 2018
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    13 Feb 2018
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The main purpose of the study was to evaluate the durability of sustained virologic response (SVR) in subjects treated for hepatitis C virus (HCV) infection in a preceding Phase 2 or Phase 3 study who had achieved SVR at last post-therapy visit of the parent study (LPVPS).
    Protection of trial subjects
    The study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with Good Clinical Practices and applicable regulatory requirements. The safety assessments included monitoring of adverse events, clinical laboratory assessments (serum chemistry, hematology, coagulation, and alpha-fetoprotein), and electrocardiograms (ECGs).
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    11 Apr 2017
    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
    Canada: 6
    Country: Number of subjects enrolled
    New Zealand: 43
    Country: Number of subjects enrolled
    Poland: 3
    Country: Number of subjects enrolled
    Singapore: 2
    Worldwide total number of subjects
    54
    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)
    52
    From 65 to 84 years
    2
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    A total of 54 subjects were enrolled from parent studies AL-335-604 (NCT02569710) and 64294178HPC2001 (NCT02765490) and analyzed in this follow-up study.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    SVR at LPVPS
    Arm description
    Subjects who completed the last post-therapy visit of the parent study (LPVPS) (Phase 2 or Phase 3 study), in which they received a regimen containing odalasvir and AL-335 with or without simeprevir for the treatment of hepatitis C virus (HCV) infection, and who agreed to participate in this follow-up study was assessed for durability of sustained virologic response (SVR), incidence of late viral relapse, presence and long term-persistence of resistance associated substitutions (RAS) and liver disease status. SVR at the LPVPS is defined as subjects who achieved SVR 12 weeks after the end of treatment (SVR12) in the parent study, and maintained HCV ribonucleic acid (RNA) less than (<) the lower limit of quantification (LLOQ) until LPVPS.
    Arm type
    other

    Investigational medicinal product name
    Odalasvir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received odalasvir as oral tablets in parent studies.

    Investigational medicinal product name
    AL-335
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received AL-335 as oral tablets in parent studies.

    Investigational medicinal product name
    Simeprevir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received simeprevir as oral capsules in previous parent studies.

    Arm title
    No SVR at LPVPS
    Arm description
    Subjects who completed the LPVPS (Phase 2 or Phase 3 study), in which they received a regimen containing odalasvir and AL-335 with or without simeprevir for the treatment of HCV infection, and who agree to participate in this follow-up study was assessed for presence and long term-persistence of RAS and liver disease status.
    Arm type
    other

    Investigational medicinal product name
    Odalasvir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received odalasvir as oral tablets in parent studies.

    Investigational medicinal product name
    AL-335
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received AL-335 as oral tablets in parent studies.

    Investigational medicinal product name
    Simeprevir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received simeprevir as oral capsules in parent studies.

    Number of subjects in period 1
    SVR at LPVPS No SVR at LPVPS
    Started
    53
    1
    Completed
    53
    0
    Not completed
    0
    1
         Consent withdrawn by subject
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    SVR at LPVPS
    Reporting group description
    Subjects who completed the last post-therapy visit of the parent study (LPVPS) (Phase 2 or Phase 3 study), in which they received a regimen containing odalasvir and AL-335 with or without simeprevir for the treatment of hepatitis C virus (HCV) infection, and who agreed to participate in this follow-up study was assessed for durability of sustained virologic response (SVR), incidence of late viral relapse, presence and long term-persistence of resistance associated substitutions (RAS) and liver disease status. SVR at the LPVPS is defined as subjects who achieved SVR 12 weeks after the end of treatment (SVR12) in the parent study, and maintained HCV ribonucleic acid (RNA) less than (<) the lower limit of quantification (LLOQ) until LPVPS.

    Reporting group title
    No SVR at LPVPS
    Reporting group description
    Subjects who completed the LPVPS (Phase 2 or Phase 3 study), in which they received a regimen containing odalasvir and AL-335 with or without simeprevir for the treatment of HCV infection, and who agree to participate in this follow-up study was assessed for presence and long term-persistence of RAS and liver disease status.

    Reporting group values
    SVR at LPVPS No SVR at LPVPS Total
    Number of subjects
    53 1 54
    Title for AgeCategorical
    Units: subjects
        Children (2-11 years)
    0 0 0
        Adolescents (12-17 years)
    0 0 0
        Adults (18-64 years)
    51 1 52
        From 65 to 84 years
    2 0 2
        85 years and over
    0 0 0
    Title for AgeContinuous
    Units: years
        median (full range (min-max))
    57 (32 to 67) 51 (51 to 51) -
    Title for Gender
    Units: subjects
        Female
    21 0 21
        Male
    32 1 33

    End points

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    End points reporting groups
    Reporting group title
    SVR at LPVPS
    Reporting group description
    Subjects who completed the last post-therapy visit of the parent study (LPVPS) (Phase 2 or Phase 3 study), in which they received a regimen containing odalasvir and AL-335 with or without simeprevir for the treatment of hepatitis C virus (HCV) infection, and who agreed to participate in this follow-up study was assessed for durability of sustained virologic response (SVR), incidence of late viral relapse, presence and long term-persistence of resistance associated substitutions (RAS) and liver disease status. SVR at the LPVPS is defined as subjects who achieved SVR 12 weeks after the end of treatment (SVR12) in the parent study, and maintained HCV ribonucleic acid (RNA) less than (<) the lower limit of quantification (LLOQ) until LPVPS.

    Reporting group title
    No SVR at LPVPS
    Reporting group description
    Subjects who completed the LPVPS (Phase 2 or Phase 3 study), in which they received a regimen containing odalasvir and AL-335 with or without simeprevir for the treatment of HCV infection, and who agree to participate in this follow-up study was assessed for presence and long term-persistence of RAS and liver disease status.

    Subject analysis set title
    SVR at LPVPS + No SVR at LPVPS
    Subject analysis set type
    Full analysis
    Subject analysis set description
    All subjects (SVR at LPVPS + No SVR at LPVPS) who received odalasvir and AL-335 with or without simeprevir in parent studies were followed up in this study. SVR at LPVPS is defined as subjects who achieved SVR 12 weeks after the end of treatment (SVR12) in the parent study and maintained HCV RNA < LLOQ until LPVPS.

    Primary: Percentage of Subjects who Maintained Sustained Virologic Response (SVR) Until the End of the Long-Term Follow-up

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    End point title
    Percentage of Subjects who Maintained Sustained Virologic Response (SVR) Until the End of the Long-Term Follow-up [1] [2]
    End point description
    Percentage of subjects who maintained SVR (if hepatitis C virus [HCV] ribonucleic acid [RNA] was less than [<] lower limit of quantification (LLOQ) (Detected or Not Detected) at each time point in the present study) was reported. Here 'endpoint' refers to the last available measurement in this study. Population included all enrolled subjects with SVR at last post therapy visit of the parent study (LPVPS). Here 'n' refers to number of subjects who were evaluable at each specified time point. If a measurement at a time point was missing but a measurement was available at a later time point, the missing measurement was imputed with the measurement at the later time point.
    End point type
    Primary
    End point timeframe
    LPVPS, Months 6, 12, 18 and Endpoint (up to 3 years)
    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 (percentage and 95% confidence interval provided) were done, no inferential statistical analyses were performed.
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Endpoint was planned to be analyzed for specified arm only.
    End point values
    SVR at LPVPS
    Number of subjects analysed
    53
    Units: Percentage of subjects
    number (confidence interval 95%)
        LPVPS (n=53)
    100 (93.3 to 100)
        Month 6 (n=44)
    100 (92.0 to 100)
        Month 12 (n=38)
    100 (90.7 to 100)
        Month 18 (n=15)
    100 (78.2 to 100)
        Endpoint (n=44)
    100 (92.0 to 100)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with Late Viral Relapse Among Subjects Who Achieved SVR at Last Post-therapy Visit of the Parent Study

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    End point title
    Percentage of Subjects with Late Viral Relapse Among Subjects Who Achieved SVR at Last Post-therapy Visit of the Parent Study [3]
    End point description
    Late viral relapse is defined as subjects who had achieved SVR at LPVPS but who had confirmed HCV RNA greater than or equal to (>=) LLOQ during follow-up in the present study. SVR at LPVPS is defined as subject who achieved SVR 12 weeks after the end of treatment (SVR12) in the parent study and maintained HCV RNA < LLOQ until LPVPS. Population included all enrolled subjects with SVR at LPVPS. Here 'n' refers to number of subjects who were evaluable at each specified time point. If a measurement at a time point is missing but a measurement is available at a later time window, the missing measurement is imputed with the measurement at the later time point.
    End point type
    Secondary
    End point timeframe
    Months 6, 12 and 18 (up to 3 years)
    Notes
    [3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Endpoint was planned to be analyzed for specified arm only.
    End point values
    SVR at LPVPS
    Number of subjects analysed
    53
    Units: Percentage of subjects
    number (confidence interval 95%)
        Month 6 (n=44)
    0 (0 to 8.0)
        Month 12 (n=38)
    0 (0 to 9.3)
        Month 18 (n=15)
    0 (0 to 21.8)
    No statistical analyses for this end point

    Secondary: Change from Last Post-therapy Visit of the Parent Study in Albumin Levels at Month 6, 12, 18 and Endpoint

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    End point title
    Change from Last Post-therapy Visit of the Parent Study in Albumin Levels at Month 6, 12, 18 and Endpoint
    End point description
    Change from LPVPS in albumin levels to the last available measurement (endpoint) was reported as measure of liver disease status. All enrolled analysis set included all subjects who signed an informed consent form (ICF) for the present study. Here 'n' refers to number of subjects who were evaluable at each time point.
    End point type
    Secondary
    End point timeframe
    LPVPS, Months 6, 12, 18 and Endpoint (up to 3 years)
    End point values
    SVR at LPVPS + No SVR at LPVPS
    Number of subjects analysed
    54
    Units: grams per liter (g/L)
    arithmetic mean (standard deviation)
        LPVPS (n=54)
    38.5 ± 4.66
        Month 6 (n=27)
    6.4 ± 3.89
        Month 12 (n=38)
    8.0 ± 2.47
        Month 18 (n=15)
    8.5 ± 2.80
        Endpoint (n=46)
    7.4 ± 3.62
    No statistical analyses for this end point

    Secondary: Change from Last Post-therapy Visit of the Parent Study in Alanine Aminotransferase Levels at Month 6, 12, 18 and Endpoint

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    End point title
    Change from Last Post-therapy Visit of the Parent Study in Alanine Aminotransferase Levels at Month 6, 12, 18 and Endpoint
    End point description
    Change from LPVPS in alanine aminotransferase levels to the last available measurement (endpoint) was reported as measure of liver disease status. All enrolled analysis set included all subjects who signed an ICF for the present study. Here 'n' refers to number of subjects who were evaluable at each time point.
    End point type
    Secondary
    End point timeframe
    LPVPS, Months 6, 12, 18 and Endpoint (up to 3 years)
    End point values
    SVR at LPVPS + No SVR at LPVPS
    Number of subjects analysed
    54
    Units: Units per liter (U/L)
    arithmetic mean (standard deviation)
        LPVPS (n=54)
    19.1 ± 8.89
        Month 6 (n=27)
    -1.8 ± 7.67
        Month 12 (n=38)
    -0.3 ± 8.11
        Month 18 (n=15)
    -2.1 ± 8.22
        Endpoint (n=46)
    -0.9 ± 8.47
    No statistical analyses for this end point

    Secondary: Change from Last Post-therapy Visit of the Parent Study in Alkaline Phosphatase Levels at Month 6, 12, 18 and Endpoint

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    End point title
    Change from Last Post-therapy Visit of the Parent Study in Alkaline Phosphatase Levels at Month 6, 12, 18 and Endpoint
    End point description
    Change from LPVPS in alkaline phosphatase levels to the last available measurement (endpoint) was reported as measure of liver disease status. All enrolled analysis set included all subjects who signed an ICF for the present study. Here 'n' refers to number of subjects who were evaluable at each time point.
    End point type
    Secondary
    End point timeframe
    LPVPS, Months 6, 12, 18 and Endpoint (up to 3 years)
    End point values
    SVR at LPVPS + No SVR at LPVPS
    Number of subjects analysed
    54
    Units: U/L
    arithmetic mean (standard deviation)
        LPVPS (n=54)
    65.2 ± 20.86
        Month 6 (n=27)
    2.5 ± 13.42
        Month 12 (n=38)
    4.9 ± 12.51
        Month 18 (n=15)
    4.1 ± 9.51
        Endpoint (n=46)
    4.6 ± 12.83
    No statistical analyses for this end point

    Secondary: Change from Last Post-therapy Visit of the Parent Study in Aspartate Aminotransferase Levels at Month 6, 12, 18 and Endpoint

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    End point title
    Change from Last Post-therapy Visit of the Parent Study in Aspartate Aminotransferase Levels at Month 6, 12, 18 and Endpoint
    End point description
    Change from LPVPS in aspartate aminotransferase levels to the last available measurement (endpoint) was reported as measure of liver disease status. All enrolled analysis set included all subjects who signed an ICF for the present study. Here 'n' refers to number of subjects who were evaluable at each time point.
    End point type
    Secondary
    End point timeframe
    LPVPS, Months 6, 12, 18 and Endpoint (up to 3 years)
    End point values
    SVR at LPVPS + No SVR at LPVPS
    Number of subjects analysed
    54
    Units: U/L
    arithmetic mean (standard deviation)
        LPVPS (n=54)
    22.3 ± 7.00
        Month 6 (n=27)
    -2.2 ± 4.08
        Month 12 (n=38)
    -0.7 ± 6.11
        Month 18 (n=15)
    -3.3 ± 8.11
        Endpoint (n=46)
    -1.9 ± 6.20
    No statistical analyses for this end point

    Secondary: Change from Last Post-therapy Visit of the Parent Study in Bilirubin Levels at Month 6, 12, 18 and Endpoint

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    End point title
    Change from Last Post-therapy Visit of the Parent Study in Bilirubin Levels at Month 6, 12, 18 and Endpoint
    End point description
    Change from LPVPS in bilirubin levels to the last available measurement (endpoint) was reported as measure of liver disease status. All enrolled analysis set included all subjects who signed an ICF for the present study. Here 'n' refers to number of subjects who were evaluable at each time point.
    End point type
    Secondary
    End point timeframe
    LPVPS, Months 6, 12, 18 and Endpoint (up to 3 years)
    End point values
    SVR at LPVPS + No SVR at LPVPS
    Number of subjects analysed
    54
    Units: micromole per liter (umol/L)
    arithmetic mean (standard deviation)
        LPVPS (n=54)
    10.0 ± 7.11
        Month 6 (n=27)
    -1.5 ± 3.84
        Month 12 (n=38)
    -1.6 ± 4.73
        Month 18 (n=15)
    -1.0 ± 3.12
        Endpoint (n=46)
    -1.2 ± 3.90
    No statistical analyses for this end point

    Secondary: Change from Last Post-therapy Visit of the Parent Study in Direct Bilirubin Levels at Month 6, 12, 18 and Endpoint

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    End point title
    Change from Last Post-therapy Visit of the Parent Study in Direct Bilirubin Levels at Month 6, 12, 18 and Endpoint
    End point description
    Change from LPVPS in direct bilirubin levels to the last available measurement (endpoint) was reported as measure of liver disease status. All enrolled analysis set included all subjects who signed an ICF for the present study. Here 'n' refers to number of subjects who were evaluable at each time point.
    End point type
    Secondary
    End point timeframe
    LPVPS, Months 6, 12, 18 and Endpoint (up to 3 years)
    End point values
    SVR at LPVPS + No SVR at LPVPS
    Number of subjects analysed
    54
    Units: umol/L
    arithmetic mean (standard deviation)
        LPVPS (n=54)
    4.0 ± 1.73
        Month 6 (n=27)
    -2.3 ± 1.11
        Month 12 (n=38)
    -2.6 ± 1.05
        Month 18 (n=15)
    -2.7 ± 1.03
        Endpoint (n=46)
    -2.4 ± 1.13
    No statistical analyses for this end point

    Secondary: Change from Last Post-therapy Visit of the Parent Study in Indirect Bilirubin Levels at Month 6 and Endpoint

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    End point title
    Change from Last Post-therapy Visit of the Parent Study in Indirect Bilirubin Levels at Month 6 and Endpoint
    End point description
    Change from LPVPS in indirect bilirubin levels to the last available measurement (endpoint) was reported as measure of liver disease status. All enrolled analysis set included all subjects who signed an ICF for the present study. Here 'n' refers to number of subjects who were evaluable at each time point.
    End point type
    Secondary
    End point timeframe
    LPVPS, Month 6 and Endpoint (up to 3 years)
    End point values
    SVR at LPVPS + No SVR at LPVPS
    Number of subjects analysed
    54
    Units: umol/L
    arithmetic mean (standard deviation)
        LPVPS (n=11)
    7.6 ± 4.25
        Month 6 (n=3)
    -2.3 ± 2.08
        Endpoint (n=3)
    -2.3 ± 2.08
    No statistical analyses for this end point

    Secondary: Change from Last Post-therapy Visit of the Parent Study in Activated Partial Thromboplastin Time (aPTT) at Month 6, 12, 18 and Endpoint

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    End point title
    Change from Last Post-therapy Visit of the Parent Study in Activated Partial Thromboplastin Time (aPTT) at Month 6, 12, 18 and Endpoint
    End point description
    Change from LPVPS in aPTT to the last available measurement (endpoint) was reported as measure of liver disease status. All enrolled analysis set included all subjects who signed an ICF for the present study. Here 'n' refers to number of subjects who were evaluable at each time point.
    End point type
    Secondary
    End point timeframe
    LPVPS, Months 6, 12, 18 and Endpoint (up to 3 years)
    End point values
    SVR at LPVPS + No SVR at LPVPS
    Number of subjects analysed
    54
    Units: seconds (s)
    median (full range (min-max))
        LPVPS (n=54)
    31.00 (22.6 to 37.0)
        Month 6 (n=27)
    -6.00 (-9.6 to 1.2)
        Month 12 (n=35)
    -6.20 (-12.3 to 7.6)
        Month 18 (n=15)
    -7.20 (-8.9 to -2.9)
        Endpoint (n=46)
    -6.35 (-12.3 to 7.6)
    No statistical analyses for this end point

    Secondary: Change from Last Post-therapy Visit of the Parent Study in Prothrombin International Normalized Ratio (INR) at Month 6, 12, 18 and Endpoint

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    End point title
    Change from Last Post-therapy Visit of the Parent Study in Prothrombin International Normalized Ratio (INR) at Month 6, 12, 18 and Endpoint
    End point description
    Change from LPVPS in prothrombin INR to the last available measurement was reported as measure (endpoint) of liver disease status. All enrolled analysis set included all subjects who signed an ICF for the present study. Here 'n' refers to number of subjects who were evaluable at each time point.
    End point type
    Secondary
    End point timeframe
    LPVPS, Months 6, 12, 18 and Endpoint (up to 3 years)
    End point values
    SVR at LPVPS + No SVR at LPVPS
    Number of subjects analysed
    54
    Units: Ratio
    arithmetic mean (standard deviation)
        LPVPS (n=54)
    1.00 ± 0.073
        Month 6 (n=27)
    -0.05 ± 0.070
        Month 12 (n=35)
    -0.05 ± 0.066
        Month 18 (n=15)
    -0.03 ± 0.070
        Endpoint (n=46)
    -0.03 ± 0.059
    No statistical analyses for this end point

    Secondary: Change from Last Post-therapy Visit of the Parent Study in Prothrombin Time at Month 6, 12, 18 and Endpoint

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    End point title
    Change from Last Post-therapy Visit of the Parent Study in Prothrombin Time at Month 6, 12, 18 and Endpoint
    End point description
    Change from LPVPS in prothrombin time to the last available measurement (endpoint) was reported as measure of liver disease status. All enrolled analysis set included all subjects who signed an ICF for the present study. Here 'n' refers to number of subjects who were evaluable at each time point.
    End point type
    Secondary
    End point timeframe
    LPVPS, Months 6, 12, 18 and Endpoint (up to 3 years)
    End point values
    SVR at LPVPS + No SVR at LPVPS
    Number of subjects analysed
    54
    Units: seconds
    median (full range (min-max))
        LPVPS (n=54)
    13.35 (9.7 to 17.0)
        Month 6 (n=27)
    -3.10 (-5.8 to 0.2)
        Month 12 (n=35)
    -3.50 (-5.8 to -2.6)
        Month 18 (n=15)
    -3.70 (-5.8 to -2.6)
        Endpoint (n=46)
    -3.40 (-5.8 to 0.2)
    No statistical analyses for this end point

    Secondary: Number of Subjects in Each Child-Pugh Grading Category at Endpoint

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    End point title
    Number of Subjects in Each Child-Pugh Grading Category at Endpoint
    End point description
    Number of subjects in each child-pugh grading category at endpoint was reported. The five clinical measures of liver disease, subsequently used to derive the Child-Pugh score are as followed :1- Encephalopathy grade, 2- Ascites, 3- Serum bilirubin milligram per deciliter (mg/dL), 4-Serum albumin gram per liter (g/L), 5- Prothrombin time, seconds prolonged. Each measure is scored from 1 to 3, with 3 indicating most severe derangement. In subjects with cirrhosis, the sum of the scores provides the child-pugh score as followed: child-pugh A (mild): 5-6 points, child-pugh B (moderate): 7-9 points, and child-pugh C (severe): 10-15 points. All enrolled analysis set included all subjects who signed an ICF for the present study with cirrhosis at baseline.
    End point type
    Secondary
    End point timeframe
    LPVPS to Endpoint (up to 3 years)
    End point values
    SVR at LPVPS No SVR at LPVPS
    Number of subjects analysed
    2
    0 [4]
    Units: Subjects
        Mild
    2
        Moderate
    0
        Severe
    0
    Notes
    [4] - No subjects with child-pugh liver disease grading + cirrhosis at baseline and without SVR at LPVPS.
    No statistical analyses for this end point

    Secondary: Number of Subjects in Each Liver Ultrasound Interpretation Result Category at Endpoint

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    End point title
    Number of Subjects in Each Liver Ultrasound Interpretation Result Category at Endpoint
    End point description
    The number of subjects in each liver ultrasound interpretation result category (normal or abnormal) at endpoint is reported. All enrolled analysis set included all subjects who signed an ICF for the present study with cirrhosis at baseline in 'SVR at LPVPS' group and subjects with metavir score F3 or F4 for 'No SVR at LPVPS' group. Here 'endpoint' refers to the last available measurement in this study.
    End point type
    Secondary
    End point timeframe
    LPVPS to Endpoint (up to 3 years)
    End point values
    SVR at LPVPS No SVR at LPVPS
    Number of subjects analysed
    2
    1
    Units: Subjects
        Abnormal
    0
    0
        Normal
    2
    1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 3 years
    Adverse event reporting additional description
    Safety analysis set included all subjects who received at least 1 dose of study treatment in a previous Phase 2 study and were enrolled into the present study.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    No SVR at LPVPS
    Reporting group description
    Subjects who completed the LPVPS (Phase 2 or Phase 3 study), in which they received a regimen containing odalasvir and AL-335 with or without simeprevir for the treatment of HCV infection, and who agree to participate in this follow-up study was assessed for presence and long term-persistence of RAS and liver disease status. SVR at LPVPS is defined as subjects who achieved SVR12 in the parent study and maintained HCV RNA < LLOQ until LPVPS.

    Reporting group title
    SVR at LPVPS
    Reporting group description
    Subjects who completed the last post-therapy visit of the parent study (LPVPS) (Phase 2 or Phase 3 study), in which they received a regimen containing odalasvir and AL-335 with or without simeprevir for the treatment of hepatitis C virus (HCV) infection, and who agreed to participate in this follow-up study was assessed for durability of sustained virologic response (SVR), incidence of late viral relapse, presence and long term-persistence of resistance associated substitutions (RAS) and liver disease status. SVR at the LPVPS is defined as subjects who achieved SVR 12 weeks after the end of treatment (SVR12) in the parent study, and maintained HCV ribonucleic acid (RNA) less than (<) the lower limit of quantification (LLOQ) until LPVPS.

    Serious adverse events
    No SVR at LPVPS SVR at LPVPS
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 53 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    No SVR at LPVPS SVR at LPVPS
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 1 (0.00%)
    1 / 53 (1.89%)
    Cardiac disorders
    Supraventricular Tachycardia
         subjects affected / exposed
    0 / 1 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    1

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    06 Nov 2017
    The overall reason for the amendment was the decision to discontinue further development of JNJ-64294178 (a combination of three direct acting antivirals - AL-335, odalasvir , and simeprevir), and consequently, the stop of further enrollment in the current study.

    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.
    Due to the early termination of study, only 54 of planned 250 subjects were enrolled, and no subjects completed full 36-month follow-up period. Consequently, only limited long-term follow-up data was available and conclusions could not be drawn.
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    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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