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    Clinical Trial Results:
    Open-Label, Phase 3b Study To Determine Efficacy and Safety of Telaprevir, Pegylated-Interferon-alfa-2a and Ribavirin in Hepatitis C Genotype 1 Infected, Stable Liver Transplant Subjects

    Due to a system error, the data reported in v1 is not correct and has been removed from public view.
    Summary
    EudraCT number
    2011-004724-35
    Trial protocol
    DE   ES   GB   IT   AT   BE  
    Global end of trial date
    15 Jul 2014

    Results information
    Results version number
    v2(current)
    This version publication date
    16 Jul 2016
    First version publication date
    31 Jul 2015
    Other versions
    v1 (removed from public view)
    Version creation reason
    • Correction of full data set
    Review of data

    Trial information

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    Trial identification
    Sponsor protocol code
    VX-950HPC3006
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01571583
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Janssen-Cilag International NV
    Sponsor organisation address
    Turnhoutseweg 30, 2340 Beerse, Belgium,
    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
    15 Jul 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    15 Jul 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To determine the efficacy of telaprevir administered as 750 milligram (mg) every 8 hours (q8h) in combination with pegylated interferon (Peg-IFN)-alfa-2a and ribavirin (RBV) in genotype 1 chronic HCV infected liver transplant patients as measured by sustained virologic response SVR12planned. SVR12planned is defined as having HCV RNA < 25 IU/mL 12 weeks after the last planned dose of study medication.
    Protection of trial subjects
    This 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. Known instances of nonconformance were documented and are not considered to have had an impact on the overall conclusions of this study.The study protocol and amendments were reviewed by an Independent Ethics Committee or Institutional Review Board.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    28 Dec 2011
    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
    Austria: 5
    Country: Number of subjects enrolled
    Belgium: 2
    Country: Number of subjects enrolled
    Germany: 12
    Country: Number of subjects enrolled
    Spain: 25
    Country: Number of subjects enrolled
    France: 7
    Country: Number of subjects enrolled
    United Kingdom: 10
    Country: Number of subjects enrolled
    Italy: 13
    Worldwide total number of subjects
    74
    EEA total number of subjects
    74
    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)
    71
    From 65 to 84 years
    3
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Approximately 72 participants were planned to be included in this study.

    Pre-assignment
    Screening details
    74 participants received at least one dose of study drugs: 50 participants were on a stable regimen with tacrolimus (TAC) and 24 participants were on a stable regimen with cyclosporine A (CsA).

    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
    Telaprevir/Peg-IFN-alfa-2a/RBV and Tacrolimus
    Arm description
    Subjects received Telaprevir 750 mg q8h in combination with Peg-IFN-alfa-2a, RBV and Tacrolimus. All subjects received Tacrolimus (Immunosuppressive therapy) throughout the study. Prestudy, this immunosuppressant therapy had to be stable, defined as no change in immunosuppressive agents and dose for 1 month prior to the screening visit.
    Arm type
    Experimental

    Investigational medicinal product name
    Telaprevir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    750 miligram (mg), administrered as two 375-mg tablets, every 8 hours (q8h) up to Week 12.

    Investigational medicinal product name
    Pegylated interferon [Peg-IFN-alfa-2a]
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    180 microgram per week [μg/week], up to 48 weeks.

    Investigational medicinal product name
    Ribavirin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    600 milligram per day [mg/day] (twice daily regimen) as starting dose.

    Investigational medicinal product name
    Tacrolimus (TAC)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    For subjects whose pre-telaprevir TAC dose was 5 mg or less daily, the starting dose was between 0.2 mg (pediatric formulation) and 0.5 mg of TAC with subsequent dosing every 3 to 5 days.

    Arm title
    Telaprevir/Peg-IFN-alfa-2a/RBV and Cyclosporine A
    Arm description
    Subjects received Telaprevir 750 mg q8h in combination with Peg-IFN-alfa-2a, RBV and cyclosporine A. All subjects received cyclosporine A (Immunosuppressive therapy) throughout the study. Prestudy, this immunosuppressant therapy had to be stable, defined as no change in immunosuppressive agents and dose for 1 month prior to the screening visit.
    Arm type
    Experimental

    Investigational medicinal product name
    Telaprevir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    750 miligram (mg), administrered as two 375-mg tablets, every 8 hours (q8h) up to Week 12.

    Investigational medicinal product name
    Pegylated interferon [Peg-IFN-alfa-2a]
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    180 microgram per week [μg/week], up to 48 weeks.

    Investigational medicinal product name
    Ribavirin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    600 milligram per day [mg/day] (twice daily regimen) as starting dose.

    Investigational medicinal product name
    Cyclosporine A
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    For subjects whose pre-telaprevir dose was 100 to 200 mg CsA daily, the starting dose of CsA was between 25 and 50 mg daily.

    Number of subjects in period 1
    Telaprevir/Peg-IFN-alfa-2a/RBV and Tacrolimus Telaprevir/Peg-IFN-alfa-2a/RBV and Cyclosporine A
    Started
    50
    24
    Completed
    43
    21
    Not completed
    7
    3
         Consent withdrawn by subject
    4
    3
         Subject ineligible to continue the trial
    2
    -
         Lost to follow-up
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Telaprevir/Peg-IFN-alfa-2a/RBV and Tacrolimus
    Reporting group description
    Subjects received Telaprevir 750 mg q8h in combination with Peg-IFN-alfa-2a, RBV and Tacrolimus. All subjects received Tacrolimus (Immunosuppressive therapy) throughout the study. Prestudy, this immunosuppressant therapy had to be stable, defined as no change in immunosuppressive agents and dose for 1 month prior to the screening visit.

    Reporting group title
    Telaprevir/Peg-IFN-alfa-2a/RBV and Cyclosporine A
    Reporting group description
    Subjects received Telaprevir 750 mg q8h in combination with Peg-IFN-alfa-2a, RBV and cyclosporine A. All subjects received cyclosporine A (Immunosuppressive therapy) throughout the study. Prestudy, this immunosuppressant therapy had to be stable, defined as no change in immunosuppressive agents and dose for 1 month prior to the screening visit.

    Reporting group values
    Telaprevir/Peg-IFN-alfa-2a/RBV and Tacrolimus Telaprevir/Peg-IFN-alfa-2a/RBV and Cyclosporine A Total
    Number of subjects
    50 24 74
    Title for AgeCategorical
    Units: subjects
        Children (2-11 years)
    0 0 0
        Adolescents (12-17 years)
    0 0 0
        Adults (18-65 years)
    48 23 71
        From 66 to 84 years
    2 1 3
        85 years and over
    0 0 0
    Title for AgeContinuous
    Units: years
        arithmetic mean (standard deviation)
    57 ± 5.25 54.9 ± 6.33 -
    Title for Gender
    Units: subjects
        Female
    3 3 6
        Male
    47 21 68

    End points

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    End points reporting groups
    Reporting group title
    Telaprevir/Peg-IFN-alfa-2a/RBV and Tacrolimus
    Reporting group description
    Subjects received Telaprevir 750 mg q8h in combination with Peg-IFN-alfa-2a, RBV and Tacrolimus. All subjects received Tacrolimus (Immunosuppressive therapy) throughout the study. Prestudy, this immunosuppressant therapy had to be stable, defined as no change in immunosuppressive agents and dose for 1 month prior to the screening visit.

    Reporting group title
    Telaprevir/Peg-IFN-alfa-2a/RBV and Cyclosporine A
    Reporting group description
    Subjects received Telaprevir 750 mg q8h in combination with Peg-IFN-alfa-2a, RBV and cyclosporine A. All subjects received cyclosporine A (Immunosuppressive therapy) throughout the study. Prestudy, this immunosuppressant therapy had to be stable, defined as no change in immunosuppressive agents and dose for 1 month prior to the screening visit.

    Subject analysis set title
    All Subjects (Full Analysis (FA) Set)
    Subject analysis set type
    Full analysis
    Subject analysis set description
    FAS included all subjects who received at least one dose of study drugs.

    Primary: Percentage of Participants Achieving Sustained Virologic Response (SVR12) (planned [snapshot])

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    End point title
    Percentage of Participants Achieving Sustained Virologic Response (SVR12) (planned [snapshot]) [1]
    End point description
    SVR12 (planned) is defined as having plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels less than (<) 25 international unit per milliliter (IU/mL), 12 weeks after the last planned dose of study drugs. Snapshot approach is where the SVR assessment was based on the last HCV RNA value using a lower limit of quantification (LLOQ) of 25 IU/mL in the Week 12 follow-up visit window. The primary analysis on the primary endpoint was conducted using descriptive statistics along with the 95% exact CI for the proportion. The lower bound of the 2-sided 95% CI of SVR12planned in this study (59.9%) excluded the prespecified historical control SVR rate with Peg-IFN/RBV only (31%). Consequently, the null hypothesis that SVR in this study is 31%, is rejected.
    End point type
    Primary
    End point timeframe
    Week 60
    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 were done, no inferential statistical analyses were performed
    End point values
    Telaprevir/Peg-IFN-alfa-2a/RBV and Tacrolimus Telaprevir/Peg-IFN-alfa-2a/RBV and Cyclosporine A All Subjects (Full Analysis (FA) Set)
    Number of subjects analysed
    50 [2]
    24 [3]
    74 [4]
    Units: percentage of participants
        number (confidence interval 95%)
    66 (51.2 to 78.8)
    83.3 (62.6 to 95.3)
    71.6 (59.9 to 81.5)
    Notes
    [2] - FAS
    [3] - FAS
    [4] - FAS
    No statistical analyses for this end point

    Secondary: Percentage of Participants Achieving sustained virologic response (SVR) 24 planned

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    End point title
    Percentage of Participants Achieving sustained virologic response (SVR) 24 planned
    End point description
    SVR24 planned is defined as having plasma HCV RNA levels <25 IU/mL 24 weeks after the last planned dose of study drugs, based on the last plasma HCV RNA value using an LLOQ of 25 IU/mL in the Week 24 follow-up visit window.
    End point type
    Secondary
    End point timeframe
    Week 72
    End point values
    Telaprevir/Peg-IFN-alfa-2a/RBV and Tacrolimus Telaprevir/Peg-IFN-alfa-2a/RBV and Cyclosporine A All Subjects (Full Analysis (FA) Set)
    Number of subjects analysed
    50 [5]
    24 [6]
    74 [7]
    Units: Percentage of Participants
        number (not applicable)
    68
    83.3
    73
    Notes
    [5] - FAS
    [6] - FAS
    [7] - FAS
    No statistical analyses for this end point

    Secondary: Percentage of Participants with Rapid Virologic Response (RVR)

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    End point title
    Percentage of Participants with Rapid Virologic Response (RVR)
    End point description
    RVR defined as having plasma HCV RNA levels ‘<25 IU/mL, target not detected’ at Week 4 of treatment.
    End point type
    Secondary
    End point timeframe
    Week 4
    End point values
    Telaprevir/Peg-IFN-alfa-2a/RBV and Tacrolimus Telaprevir/Peg-IFN-alfa-2a/RBV and Cyclosporine A All Subjects (Full Analysis (FA) Set)
    Number of subjects analysed
    50 [8]
    24 [9]
    74 [10]
    Units: Percentage of Participants
        number (not applicable)
    38
    16.7
    31.1
    Notes
    [8] - FAS
    [9] - FAS
    [10] - FAS
    No statistical analyses for this end point

    Secondary: Percentage of Participants with Extended Rapid Virologic Response (eRVR)

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    End point title
    Percentage of Participants with Extended Rapid Virologic Response (eRVR)
    End point description
    eRVR is defined as having plasma HCV RNA levels <25 IU/mL, 'target not detected’ at Week 4 and Week 12 of treatment.
    End point type
    Secondary
    End point timeframe
    Week 4, Week 12
    End point values
    Telaprevir/Peg-IFN-alfa-2a/RBV and Tacrolimus Telaprevir/Peg-IFN-alfa-2a/RBV and Cyclosporine A All Subjects (Full Analysis (FA) Set)
    Number of subjects analysed
    50 [11]
    24 [12]
    74 [13]
    Units: Percentage of Participants
        number (not applicable)
    38
    16.7
    31.1
    Notes
    [11] - FAS
    [12] - FAS
    [13] - FAS
    No statistical analyses for this end point

    Secondary: Percentage of Participants with Complete Early Virologic Response (cEVR)

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    End point title
    Percentage of Participants with Complete Early Virologic Response (cEVR)
    End point description
    cEVR is defined as having plasma HCV RNA levels <25 IU/mL, target not detected at Week 12 of treatment.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    Telaprevir/Peg-IFN-alfa-2a/RBV and Tacrolimus Telaprevir/Peg-IFN-alfa-2a/RBV and Cyclosporine A All Subjects (Full Analysis (FA) Set)
    Number of subjects analysed
    50 [14]
    24 [15]
    74 [16]
    Units: Percentage of Participants
        number (not applicable)
    80
    87.5
    82.4
    Notes
    [14] - FAS
    [15] - FAS
    [16] - FAS
    No statistical analyses for this end point

    Secondary: Percentage of Participants Having Plasma HCV RNA levels <25 IU/mL, Target not Detected’ at the Actual End of Treatment

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    End point title
    Percentage of Participants Having Plasma HCV RNA levels <25 IU/mL, Target not Detected’ at the Actual End of Treatment
    End point description
    End point type
    Secondary
    End point timeframe
    Week 48 or early discontinuation
    End point values
    Telaprevir/Peg-IFN-alfa-2a/RBV and Tacrolimus Telaprevir/Peg-IFN-alfa-2a/RBV and Cyclosporine A All Subjects (Full Analysis (FA) Set)
    Number of subjects analysed
    50 [17]
    24 [18]
    74 [19]
    Units: Percentage of Participants
        number (not applicable)
    78
    83.3
    79.7
    Notes
    [17] - FAS
    [18] - FAS
    [19] - FAS
    No statistical analyses for this end point

    Secondary: Percentage of Participants Having Plasma HCV RNA levels <25 IU/mL, Target not Detected, at the Planned End of Treatment

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    End point title
    Percentage of Participants Having Plasma HCV RNA levels <25 IU/mL, Target not Detected, at the Planned End of Treatment
    End point description
    End point type
    Secondary
    End point timeframe
    Week 48
    End point values
    Telaprevir/Peg-IFN-alfa-2a/RBV and Tacrolimus Telaprevir/Peg-IFN-alfa-2a/RBV and Cyclosporine A All Subjects (Full Analysis (FA) Set)
    Number of subjects analysed
    44 [20]
    21 [21]
    65 [22]
    Units: Percentage of Participants
        number (not applicable)
    79.5
    90.5
    83.1
    Notes
    [20] - FAS
    [21] - FAS
    [22] - FAS
    No statistical analyses for this end point

    Secondary: Percentage of Participants with On-treatment Virologic Failure

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    End point title
    Percentage of Participants with On-treatment Virologic Failure
    End point description
    Virologic failure (ie, subjects who met a virologic stopping rule and/or met the definition of viral breakthrough)
    End point type
    Secondary
    End point timeframe
    Baseline (Week 1) up to Week 48
    End point values
    Telaprevir/Peg-IFN-alfa-2a/RBV and Tacrolimus Telaprevir/Peg-IFN-alfa-2a/RBV and Cyclosporine A All Subjects (Full Analysis (FA) Set)
    Number of subjects analysed
    50 [23]
    24 [24]
    74 [25]
    Units: Percentage of Participants
        number (not applicable)
    12
    8.3
    10.8
    Notes
    [23] - FAS
    [24] - FAS
    [25] - FAS
    No statistical analyses for this end point

    Secondary: Percentage of Participants with Relapse (Snapshot)

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    End point title
    Percentage of Participants with Relapse (Snapshot)
    End point description
    Relapse (Snapshot), defined as having confirmed detectable plasma HCV RNA (greater than or equal to (>=) 25 IU/mL) from planned end of treatment (ie, Week 48) onwards after previous ‘<25 IU/mL at planned end of treatment, and not achieving SVR12planned (Snapshot). Number of subjects analyzed included subjects who had HCV RNA <25 IU/mL at planned end of treatment, or a missing HCV RNA assessment at planned end of treatment (EOT) and HCV RNA <25 IU/mL during follow-up from planned EOT onwards.
    End point type
    Secondary
    End point timeframe
    Week 48 up to Week 60
    End point values
    Telaprevir/Peg-IFN-alfa-2a/RBV and Tacrolimus Telaprevir/Peg-IFN-alfa-2a/RBV and Cyclosporine A All Subjects (Full Analysis (FA) Set)
    Number of subjects analysed
    37 [26]
    19 [27]
    56 [28]
    Units: Percentage of Participants
        number (not applicable)
    10.8
    0
    7.1
    Notes
    [26] - FAS
    [27] - FAS
    [28] - FAS
    No statistical analyses for this end point

    Secondary: Percentage of Participants with Viral Breakthrough

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    End point title
    Percentage of Participants with Viral Breakthrough
    End point description
    Viral breakthrough, defined as an increase >1 log10 in plasma HCV RNA level from the lowest level reached, or a value of HCV RNA >100 IU/mL in subjects whose HCV RNA had previously became <25 IU/mL during treatment.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 1) up to Week 48
    End point values
    Telaprevir/Peg-IFN-alfa-2a/RBV and Tacrolimus Telaprevir/Peg-IFN-alfa-2a/RBV and Cyclosporine A All Subjects (Full Analysis (FA) Set)
    Number of subjects analysed
    50 [29]
    24 [30]
    74 [31]
    Units: Percentage of Participants
        number (not applicable)
    10
    8.3
    9.5
    Notes
    [29] - FAS
    [30] - FAS
    [31] - FAS
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Timeframe for AE
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    14.1
    Reporting groups
    Reporting group title
    Telaprevir/Peg-IFN-alfa-2a/RBV and cyclosporine A
    Reporting group description
    Subjects received Telaprevir 750 mg q8h in combination with Peg-IFN-alfa-2a, RBV and cyclosporine A.

    Reporting group title
    Telaprevir/Peg-IFN-alfa-2a/RBV and Tacrolimus
    Reporting group description
    Subjects received Telaprevir 750 mg q8h in combination with Peg-IFN-alfa-2a, RBV and tacrolimus.

    Serious adverse events
    Telaprevir/Peg-IFN-alfa-2a/RBV and cyclosporine A Telaprevir/Peg-IFN-alfa-2a/RBV and Tacrolimus
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 24 (8.33%)
    7 / 50 (14.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 50 (2.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 50 (2.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Lens Dislocation
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 50 (2.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General Physical Health Deterioration
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 50 (2.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Depression
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 50 (2.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Ascites
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 50 (2.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Renal Failure Acute
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 50 (2.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Autoimmune Hepatitis
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholestasis
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 50 (2.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Urinary Tract Infection
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 50 (2.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    Telaprevir/Peg-IFN-alfa-2a/RBV and cyclosporine A Telaprevir/Peg-IFN-alfa-2a/RBV and Tacrolimus
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    24 / 24 (100.00%)
    50 / 50 (100.00%)
    Vascular disorders
    Flushing
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    1
    Hot Flush
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    1
    Hypertension
         subjects affected / exposed
    1 / 24 (4.17%)
    1 / 50 (2.00%)
         occurrences all number
    1
    1
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Cholesteatoma
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    1
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    11 / 24 (45.83%)
    15 / 50 (30.00%)
         occurrences all number
    19
    19
    Fatigue
         subjects affected / exposed
    5 / 24 (20.83%)
    16 / 50 (32.00%)
         occurrences all number
    5
    22
    Chills
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    1
    Feeling Cold
         subjects affected / exposed
    2 / 24 (8.33%)
    0 / 50 (0.00%)
         occurrences all number
    2
    0
    Feeling Hot
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    1
    Influenza Like Illness
         subjects affected / exposed
    1 / 24 (4.17%)
    2 / 50 (4.00%)
         occurrences all number
    1
    3
    Irritability
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    1
    Injection Site Erythema
         subjects affected / exposed
    0 / 24 (0.00%)
    2 / 50 (4.00%)
         occurrences all number
    0
    4
    Mucosal Dryness
         subjects affected / exposed
    1 / 24 (4.17%)
    1 / 50 (2.00%)
         occurrences all number
    1
    2
    Malaise
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    1
    Mucosal Inflammation
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 50 (0.00%)
         occurrences all number
    1
    0
    Oedema Peripheral
         subjects affected / exposed
    0 / 24 (0.00%)
    3 / 50 (6.00%)
         occurrences all number
    0
    3
    Pyrexia
         subjects affected / exposed
    5 / 24 (20.83%)
    10 / 50 (20.00%)
         occurrences all number
    10
    13
    Psychiatric disorders
    Affect Lability
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 50 (0.00%)
         occurrences all number
    1
    0
    Anxiety
         subjects affected / exposed
    0 / 24 (0.00%)
    2 / 50 (4.00%)
         occurrences all number
    0
    2
    Depressed Mood
         subjects affected / exposed
    0 / 24 (0.00%)
    2 / 50 (4.00%)
         occurrences all number
    0
    2
    Depression
         subjects affected / exposed
    1 / 24 (4.17%)
    3 / 50 (6.00%)
         occurrences all number
    1
    3
    Insomnia
         subjects affected / exposed
    4 / 24 (16.67%)
    6 / 50 (12.00%)
         occurrences all number
    4
    6
    Mood Swings
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    1
    Nervousness
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    1
    Reproductive system and breast disorders
    Erectile Dysfunction
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    1
    Penile Blister
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    1
    Prostatitis
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    1
    Injury, poisoning and procedural complications
    Excoriation
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    1
    Incisional Hernia
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    1
    Limb Injury
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    1
    Scratch
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    1
    Skin Injury
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    1
    Sunburn
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    1
    Investigations
    Alanine Aminotransferase Increased
         subjects affected / exposed
    0 / 24 (0.00%)
    2 / 50 (4.00%)
         occurrences all number
    0
    2
    Blood Bilirubin Increased
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    1
    Blood Amylase Increased
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 50 (0.00%)
         occurrences all number
    1
    0
    Blood Creatinine Increased
         subjects affected / exposed
    0 / 24 (0.00%)
    2 / 50 (4.00%)
         occurrences all number
    0
    2
    Blood Glucose Increased
         subjects affected / exposed
    0 / 24 (0.00%)
    2 / 50 (4.00%)
         occurrences all number
    0
    2
    Blood Magnesium Decreased
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    1
    Blood Uric Acid Increased
         subjects affected / exposed
    1 / 24 (4.17%)
    7 / 50 (14.00%)
         occurrences all number
    2
    15
    Blood Phosphorus Decreased
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 50 (0.00%)
         occurrences all number
    1
    0
    Body Temperature Increased
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    1
    Blood Urine Present
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    1
    Electrocardiogram QT Prolonged
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    1
    Electrocardiogram T Wave Inversion
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    1
    Haemoglobin Decreased
         subjects affected / exposed
    1 / 24 (4.17%)
    1 / 50 (2.00%)
         occurrences all number
    1
    1
    Gamma-Glutamyltransferase Increased
         subjects affected / exposed
    1 / 24 (4.17%)
    1 / 50 (2.00%)
         occurrences all number
    1
    1
    Mean Cell Volume Increased
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    1
    Platelet Count Decreased
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    1
    Weight Decreased
         subjects affected / exposed
    1 / 24 (4.17%)
    2 / 50 (4.00%)
         occurrences all number
    1
    3
    White Blood Cell Count Decreased
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    1
    Cardiac disorders
    Sinus Tachycardia
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    1
    Rebound Tachycardia
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 50 (0.00%)
         occurrences all number
    1
    0
    Tachycardia
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 50 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    4 / 24 (16.67%)
    5 / 50 (10.00%)
         occurrences all number
    4
    5
    Asthma
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 50 (0.00%)
         occurrences all number
    1
    0
    Dyspnoea
         subjects affected / exposed
    4 / 24 (16.67%)
    8 / 50 (16.00%)
         occurrences all number
    4
    8
    Dyspnoea Exertional
         subjects affected / exposed
    0 / 24 (0.00%)
    3 / 50 (6.00%)
         occurrences all number
    0
    3
    Nasal Congestion
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    1
    Oropharyngeal Pain
         subjects affected / exposed
    0 / 24 (0.00%)
    2 / 50 (4.00%)
         occurrences all number
    0
    3
    Pleural Effusion
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    13 / 24 (54.17%)
    24 / 50 (48.00%)
         occurrences all number
    27
    38
    Lymphopenia
         subjects affected / exposed
    0 / 24 (0.00%)
    2 / 50 (4.00%)
         occurrences all number
    0
    3
    Leukopenia
         subjects affected / exposed
    3 / 24 (12.50%)
    7 / 50 (14.00%)
         occurrences all number
    4
    12
    Pancytopenia
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    1
    Neutropenia
         subjects affected / exposed
    4 / 24 (16.67%)
    8 / 50 (16.00%)
         occurrences all number
    4
    11
    Thrombocytopenia
         subjects affected / exposed
    4 / 24 (16.67%)
    14 / 50 (28.00%)
         occurrences all number
    6
    22
    Nervous system disorders
    Disturbance in Attention
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    1
    Burning Sensation
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    1
    Dizziness
         subjects affected / exposed
    1 / 24 (4.17%)
    4 / 50 (8.00%)
         occurrences all number
    1
    5
    Dysgeusia
         subjects affected / exposed
    0 / 24 (0.00%)
    3 / 50 (6.00%)
         occurrences all number
    0
    3
    Headache
         subjects affected / exposed
    8 / 24 (33.33%)
    17 / 50 (34.00%)
         occurrences all number
    12
    21
    Lethargy
         subjects affected / exposed
    0 / 24 (0.00%)
    2 / 50 (4.00%)
         occurrences all number
    0
    2
    Neuropathy Peripheral
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    1
    Migraine
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    1
    Restless Legs Syndrome
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    1
    Syncope
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    1
    Tremor
         subjects affected / exposed
    1 / 24 (4.17%)
    1 / 50 (2.00%)
         occurrences all number
    1
    1
    Eye disorders
    Blepharitis
         subjects affected / exposed
    0 / 24 (0.00%)
    2 / 50 (4.00%)
         occurrences all number
    0
    2
    Vision Blurred
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    1
    Dry Eye
         subjects affected / exposed
    0 / 24 (0.00%)
    2 / 50 (4.00%)
         occurrences all number
    0
    2
    Ear and labyrinth disorders
    Ear Discomfort
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    2
    Ear Pruritus
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 50 (0.00%)
         occurrences all number
    2
    0
    Vertigo
         subjects affected / exposed
    2 / 24 (8.33%)
    0 / 50 (0.00%)
         occurrences all number
    2
    0
    Gastrointestinal disorders
    Abdominal Discomfort
         subjects affected / exposed
    1 / 24 (4.17%)
    2 / 50 (4.00%)
         occurrences all number
    1
    2
    Abdominal Distension
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    1
    Abdominal Pain Upper
         subjects affected / exposed
    0 / 24 (0.00%)
    2 / 50 (4.00%)
         occurrences all number
    0
    2
    Abdominal Pain
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    2
    Anal Pruritus
         subjects affected / exposed
    5 / 24 (20.83%)
    9 / 50 (18.00%)
         occurrences all number
    7
    9
    Anorectal Discomfort
         subjects affected / exposed
    3 / 24 (12.50%)
    6 / 50 (12.00%)
         occurrences all number
    3
    7
    Aphthous Stomatitis
         subjects affected / exposed
    2 / 24 (8.33%)
    1 / 50 (2.00%)
         occurrences all number
    2
    1
    Ascites
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    1
    Breath Odour
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    1
    Chapped Lips
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    1
    Cheilitis
         subjects affected / exposed
    2 / 24 (8.33%)
    0 / 50 (0.00%)
         occurrences all number
    2
    0
    Constipation
         subjects affected / exposed
    2 / 24 (8.33%)
    1 / 50 (2.00%)
         occurrences all number
    2
    1
    Diarrhoea
         subjects affected / exposed
    2 / 24 (8.33%)
    17 / 50 (34.00%)
         occurrences all number
    2
    19
    Dry Mouth
         subjects affected / exposed
    1 / 24 (4.17%)
    2 / 50 (4.00%)
         occurrences all number
    1
    2
    Dyspepsia
         subjects affected / exposed
    4 / 24 (16.67%)
    2 / 50 (4.00%)
         occurrences all number
    4
    2
    Gastrooesophageal Reflux Disease
         subjects affected / exposed
    1 / 24 (4.17%)
    1 / 50 (2.00%)
         occurrences all number
    1
    1
    Gingival Pain
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    1
    Glossodynia
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    1
    Haemorrhoids
         subjects affected / exposed
    2 / 24 (8.33%)
    8 / 50 (16.00%)
         occurrences all number
    2
    8
    Haematochezia
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 50 (0.00%)
         occurrences all number
    1
    0
    Hyperchlorhydria
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    1
    Nausea
         subjects affected / exposed
    6 / 24 (25.00%)
    11 / 50 (22.00%)
         occurrences all number
    8
    15
    Painful Defaecation
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    1
    Proctalgia
         subjects affected / exposed
    0 / 24 (0.00%)
    5 / 50 (10.00%)
         occurrences all number
    0
    5
    Rectal Haemorrhage
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    1
    Swollen Tongue
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    1
    Stomatitis
         subjects affected / exposed
    0 / 24 (0.00%)
    2 / 50 (4.00%)
         occurrences all number
    0
    2
    Tongue Ulceration
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 50 (0.00%)
         occurrences all number
    1
    0
    Toothache
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 50 (0.00%)
         occurrences all number
    1
    0
    Vomiting
         subjects affected / exposed
    2 / 24 (8.33%)
    6 / 50 (12.00%)
         occurrences all number
    3
    7
    Renal and urinary disorders
    Azotaemia
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    1
    Incontinence
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    1
    Dysuria
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 50 (0.00%)
         occurrences all number
    1
    0
    Nocturia
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 50 (0.00%)
         occurrences all number
    1
    0
    Renal Failure
         subjects affected / exposed
    1 / 24 (4.17%)
    1 / 50 (2.00%)
         occurrences all number
    1
    1
    Renal Impairment
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    1
    Hepatobiliary disorders
    Hyperbilirubinaemia
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    2
    Jaundice
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    1
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    0 / 24 (0.00%)
    2 / 50 (4.00%)
         occurrences all number
    0
    2
    Dermatitis
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 50 (0.00%)
         occurrences all number
    1
    0
    Dry Skin
         subjects affected / exposed
    2 / 24 (8.33%)
    5 / 50 (10.00%)
         occurrences all number
    2
    6
    Eczema
         subjects affected / exposed
    0 / 24 (0.00%)
    2 / 50 (4.00%)
         occurrences all number
    0
    2
    Erythema
         subjects affected / exposed
    1 / 24 (4.17%)
    2 / 50 (4.00%)
         occurrences all number
    1
    4
    Lichenification
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    1
    Night Sweats
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    1
    Petechiae
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    1
    Pruritus
         subjects affected / exposed
    6 / 24 (25.00%)
    27 / 50 (54.00%)
         occurrences all number
    8
    31
    Pruritus Generalised
         subjects affected / exposed
    0 / 24 (0.00%)
    2 / 50 (4.00%)
         occurrences all number
    0
    2
    Rash
         subjects affected / exposed
    3 / 24 (12.50%)
    17 / 50 (34.00%)
         occurrences all number
    3
    21
    Rash Erythematous
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    1
    Rash Maculo-Papular
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    2
    Skin Ulcer
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    1
    Rash Papular
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 50 (0.00%)
         occurrences all number
    1
    0
    Swelling Face
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    Back Pain
         subjects affected / exposed
    2 / 24 (8.33%)
    1 / 50 (2.00%)
         occurrences all number
    2
    1
    Arthralgia
         subjects affected / exposed
    3 / 24 (12.50%)
    6 / 50 (12.00%)
         occurrences all number
    3
    7
    Muscle Spasms
         subjects affected / exposed
    1 / 24 (4.17%)
    5 / 50 (10.00%)
         occurrences all number
    1
    5
    Pain in Extremity
         subjects affected / exposed
    0 / 24 (0.00%)
    3 / 50 (6.00%)
         occurrences all number
    0
    3
    Myalgia
         subjects affected / exposed
    2 / 24 (8.33%)
    6 / 50 (12.00%)
         occurrences all number
    3
    6
    Metabolism and nutrition disorders
    Cachexia
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    1
    Decreased Appetite
         subjects affected / exposed
    1 / 24 (4.17%)
    9 / 50 (18.00%)
         occurrences all number
    1
    9
    Hypercholesterolaemia
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 50 (0.00%)
         occurrences all number
    1
    0
    Hypercreatininaemia
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    1
    Hyperglycaemia
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    1
    Hyperkalaemia
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 50 (0.00%)
         occurrences all number
    1
    0
    Hypertriglyceridaemia
         subjects affected / exposed
    1 / 24 (4.17%)
    2 / 50 (4.00%)
         occurrences all number
    1
    3
    Hyperuricaemia
         subjects affected / exposed
    6 / 24 (25.00%)
    3 / 50 (6.00%)
         occurrences all number
    10
    4
    Hypoglycaemia
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    1
    Hypomagnesaemia
         subjects affected / exposed
    0 / 24 (0.00%)
    2 / 50 (4.00%)
         occurrences all number
    0
    3
    Impaired Fasting Glucose
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    1
    Metabolic Disorder
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    1
    Infections and infestations
    Anal Abscess
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 50 (0.00%)
         occurrences all number
    1
    0
    Bronchitis
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 50 (0.00%)
         occurrences all number
    1
    0
    Dermatitis Infected
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    1
    Bronchopneumonia
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    1
    Ear Infection
         subjects affected / exposed
    1 / 24 (4.17%)
    1 / 50 (2.00%)
         occurrences all number
    1
    1
    Enterobiasis
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 50 (0.00%)
         occurrences all number
    2
    0
    Escherichia Sepsis
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    1
    Gastroenteritis
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 50 (0.00%)
         occurrences all number
    1
    0
    Lower Respiratory Tract Infection
         subjects affected / exposed
    0 / 24 (0.00%)
    2 / 50 (4.00%)
         occurrences all number
    0
    2
    Influenza
         subjects affected / exposed
    3 / 24 (12.50%)
    6 / 50 (12.00%)
         occurrences all number
    3
    6
    Oral Candidiasis
         subjects affected / exposed
    0 / 24 (0.00%)
    3 / 50 (6.00%)
         occurrences all number
    0
    3
    Nasopharyngitis
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    1
    Urinary Tract Infection
         subjects affected / exposed
    1 / 24 (4.17%)
    2 / 50 (4.00%)
         occurrences all number
    1
    2

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    31 May 2012
    The primary analysis was changed to a snapshot analysis. SVR12 planned and SVR24 planned were analyzed using a snapshot approach, where the SVR assessment is based on the last HCV RNA value utilizing lower limit of quantification (LLOQ; 25 IU/mL) in the Week 12 and Week 24 follow-up visit window, respectively. The snapshot analysis has been accepted by the European Medicines Agency and Food and Drug Administration for previous telaprevir Phase 3 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
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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