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    Clinical Trial Results:
    A Two-Part, Open-Label, Single-Arm Phase 1/2 Study of Safety, Pharmacokinetics, and Efficacy of Telaprevir in Combination With Peginterferon alfa-2b and Ribavirin in Pediatric Subjects Aged 3 to 17 Infected With Genotype 1 Hepatitis C Virus

    Due to the EudraCT – Results system being out of service between 31 July 2015 and 12 January 2016, these results have been published in compliance with revised timelines.
    Summary
    EudraCT number
    2011-004564-30
    Trial protocol
    GB   DE   BE   IT   ES  
    Global end of trial date
    07 Apr 2015

    Results information
    Results version number
    v1(current)
    This version publication date
    13 Jul 2016
    First version publication date
    13 Jul 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    VX11-950-118
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01701063
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Vertex Pharmaceuticals Incorporated
    Sponsor organisation address
    50 Northern Avenue, Boston, Massachusetts, United States, 02210-1862
    Public contact
    Medical Monitor, Vertex Pharmaceuticals Incorporated, +1 617341-6777, medicalinfo@vrtx.com
    Scientific contact
    Medical Monitor, Vertex Pharmaceuticals Incorporated, +1 617341-6777, medicalinfo@vrtx.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    EMEA-000196-PIP01-08
    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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    22 May 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    07 Apr 2015
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    PART A - To evaluate the short-term safety of telaprevir in combination with pegylated interferon (Peg-IFN) and ribavirin (RBV) (Peg-IFN/RBV) in treatment-naive pediatric subjects without cirrhosis. - To evaluate the pharmacokinetics (PK) and determine the appropriate dose of telaprevir in combination with Peg-IFN/RBV in treatment-naive pediatric subjects without cirrhosis. PART B - To evaluate the safety of telaprevir in combination with Peg-IFN/RBV in treatment-naive and peginterferon/RBV treatment-experienced pediatric subjects with or without cirrhosis.
    Protection of trial subjects
    The study was conducted in accordance with the ethical principles stated in the Declaration of Helsinki and the International Conference on Harmonization (ICH) Guideline for Good Clinical Practice (GCP).
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    10 Jan 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: 7
    Country: Number of subjects enrolled
    United Kingdom: 3
    Country: Number of subjects enrolled
    United States: 28
    Country: Number of subjects enrolled
    Belgium: 3
    Country: Number of subjects enrolled
    Italy: 1
    Worldwide total number of subjects
    42
    EEA total number of subjects
    14
    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)
    25
    Adolescents (12-17 years)
    15
    Adults (18-64 years)
    2
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    The study was planned to be conducted in 2 parts (Part A and Part B), which would use separate groups of subjects. However, the study was terminated early (12 weeks after last dose of study drug in Part A) and Part B was not conducted.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Cohort 1 (13-17 Years): Telaprevir + Peg-IFN-alfa-2b + RBV
    Arm description
    Subjects aged 13 to 17 years received telaprevir twice daily for 12 weeks either as a film coated tablet (15 milligram per kilogram [mg/kg] of body weight) or as a chewable tablet (14 mg/kg of body weight) in combination with pegylated interferon alfa 2b (Peg-IFN-alfa-2b) 60 microgram per meter square (mcg/m^2) subcutaneous injection weekly and ribavirin (RBV) 200 mg capsules or 40 milligram per milliliter (mg/mL) solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in subjects who achieved extended rapid virologic response (eRVR) or for 48 weeks in subjects who did not achieve eRVR. eRVR was defined as undetectable hepatitis C virus ribonucleic acid (HCV RNA) levels at Week 4 and Week 12.
    Arm type
    Experimental

    Investigational medicinal product name
    Telaprevir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Chewable tablet, Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Telaprevir twice daily for 12 weeks either as a film coated tablet (15 mg/kg of body weight) or as a chewable tablet (14 mg/kg of body weight).

    Investigational medicinal product name
    Peg-IFN-alfa-2b
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly for 24 weeks in subjects who achieved eRVR or for 48 weeks in subjects who did not achieve eRVR.

    Investigational medicinal product name
    Ribavirin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, Oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    RBV 200 mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day for 24 weeks in subjects who achieved eRVR or for 48 weeks in subjects who did not achieve eRVR.

    Arm title
    Cohort 2 (7-12 Years): Telaprevir + Peg-IFN-alfa-2b + RBV
    Arm description
    Subjects aged 7 to 12 years received telaprevir twice daily for 12 weeks as a chewable tablet (16 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in subjects who achieved eRVR or for 48 weeks in subjects who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
    Arm type
    Experimental

    Investigational medicinal product name
    Telaprevir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Chewable tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Telaprevir twice daily for 12 weeks as a chewable tablet (16 mg/kg of body weight)

    Investigational medicinal product name
    Peg-IFN-alfa-2b
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly for 24 weeks in subjects who achieved eRVR or for 48 weeks in subjects who did not achieve eRVR.

    Investigational medicinal product name
    Ribavirin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, Oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    RBV 200 mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day for 24 weeks in subjects who achieved eRVR or for 48 weeks in subjects who did not achieve eRVR.

    Arm title
    Cohort 3 (3-6 Years): Telaprevir + Peg-IFN-alfa-2b + RBV
    Arm description
    Subjects aged 3 to 6 years received telaprevir twice daily for 12 weeks as a chewable tablet (18 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in subjects who achieved eRVR or for 48 weeks in subjects who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
    Arm type
    Experimental

    Investigational medicinal product name
    Telaprevir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Chewable tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Telaprevir twice daily for 12 weeks as a chewable tablet (18 mg/kg of body weight)

    Investigational medicinal product name
    Peg-IFN-alfa-2b
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly for 24 weeks in subjects who achieved eRVR or for 48 weeks in subjects who did not achieve eRVR.

    Investigational medicinal product name
    Ribavirin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, Oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    RBV 200 mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day for 24 weeks in subjects who achieved eRVR or for 48 weeks in subjects who did not achieve eRVR.

    Number of subjects in period 1
    Cohort 1 (13-17 Years): Telaprevir + Peg-IFN-alfa-2b + RBV Cohort 2 (7-12 Years): Telaprevir + Peg-IFN-alfa-2b + RBV Cohort 3 (3-6 Years): Telaprevir + Peg-IFN-alfa-2b + RBV
    Started
    13
    19
    10
    Completed
    13
    18
    8
    Not completed
    0
    1
    2
         Unspecified
    -
    -
    1
         Consent withdrawn by subject
    -
    -
    1
         Lost to follow-up
    -
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Cohort 1 (13-17 Years): Telaprevir + Peg-IFN-alfa-2b + RBV
    Reporting group description
    Subjects aged 13 to 17 years received telaprevir twice daily for 12 weeks either as a film coated tablet (15 milligram per kilogram [mg/kg] of body weight) or as a chewable tablet (14 mg/kg of body weight) in combination with pegylated interferon alfa 2b (Peg-IFN-alfa-2b) 60 microgram per meter square (mcg/m^2) subcutaneous injection weekly and ribavirin (RBV) 200 mg capsules or 40 milligram per milliliter (mg/mL) solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in subjects who achieved extended rapid virologic response (eRVR) or for 48 weeks in subjects who did not achieve eRVR. eRVR was defined as undetectable hepatitis C virus ribonucleic acid (HCV RNA) levels at Week 4 and Week 12.

    Reporting group title
    Cohort 2 (7-12 Years): Telaprevir + Peg-IFN-alfa-2b + RBV
    Reporting group description
    Subjects aged 7 to 12 years received telaprevir twice daily for 12 weeks as a chewable tablet (16 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in subjects who achieved eRVR or for 48 weeks in subjects who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.

    Reporting group title
    Cohort 3 (3-6 Years): Telaprevir + Peg-IFN-alfa-2b + RBV
    Reporting group description
    Subjects aged 3 to 6 years received telaprevir twice daily for 12 weeks as a chewable tablet (18 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in subjects who achieved eRVR or for 48 weeks in subjects who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.

    Reporting group values
    Cohort 1 (13-17 Years): Telaprevir + Peg-IFN-alfa-2b + RBV Cohort 2 (7-12 Years): Telaprevir + Peg-IFN-alfa-2b + RBV Cohort 3 (3-6 Years): Telaprevir + Peg-IFN-alfa-2b + RBV Total
    Number of subjects
    13 19 10 42
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    14.9 ± 2.06 10.2 ± 1.57 4.9 ± 0.88 -
    Gender categorical
    Units: Subjects
        Female
    11 13 4 28
        Male
    2 6 6 14

    End points

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    End points reporting groups
    Reporting group title
    Cohort 1 (13-17 Years): Telaprevir + Peg-IFN-alfa-2b + RBV
    Reporting group description
    Subjects aged 13 to 17 years received telaprevir twice daily for 12 weeks either as a film coated tablet (15 milligram per kilogram [mg/kg] of body weight) or as a chewable tablet (14 mg/kg of body weight) in combination with pegylated interferon alfa 2b (Peg-IFN-alfa-2b) 60 microgram per meter square (mcg/m^2) subcutaneous injection weekly and ribavirin (RBV) 200 mg capsules or 40 milligram per milliliter (mg/mL) solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in subjects who achieved extended rapid virologic response (eRVR) or for 48 weeks in subjects who did not achieve eRVR. eRVR was defined as undetectable hepatitis C virus ribonucleic acid (HCV RNA) levels at Week 4 and Week 12.

    Reporting group title
    Cohort 2 (7-12 Years): Telaprevir + Peg-IFN-alfa-2b + RBV
    Reporting group description
    Subjects aged 7 to 12 years received telaprevir twice daily for 12 weeks as a chewable tablet (16 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in subjects who achieved eRVR or for 48 weeks in subjects who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.

    Reporting group title
    Cohort 3 (3-6 Years): Telaprevir + Peg-IFN-alfa-2b + RBV
    Reporting group description
    Subjects aged 3 to 6 years received telaprevir twice daily for 12 weeks as a chewable tablet (18 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in subjects who achieved eRVR or for 48 weeks in subjects who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.

    Subject analysis set title
    Overall Subjects
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Subjects aged 3 to 17 years received telaprevir twice daily for 12 weeks either as a film coated tablet (15 mg/kg of body weight) or as a chewable tablet (14 to 18 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200 mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in subjects who achieved eRVR or for 48 weeks in subjects who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.

    Primary: Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)

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    End point title
    Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs) [1]
    End point description
    AE: any adverse change from the subject's baseline (pre-treatment) condition, including any adverse experience, abnormal recording or clinical laboratory assessment value which occurs during the course of the study, whether it is considered related to the study drug or not. An adverse event includes any newly occurring event or previous condition that has increased in severity or frequency since the administration of study drug. SAE: medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. "Study drug" includes all investigational agents administered during the course of the study. Safety set included all subjects who received at least 1 dose of study drug.
    End point type
    Primary
    End point timeframe
    Baseline up to Week 52
    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: No inferential statistics was planned for this endpoint.
    End point values
    Cohort 1 (13-17 Years): Telaprevir + Peg-IFN-alfa-2b + RBV Cohort 2 (7-12 Years): Telaprevir + Peg-IFN-alfa-2b + RBV Cohort 3 (3-6 Years): Telaprevir + Peg-IFN-alfa-2b + RBV
    Number of subjects analysed
    13
    19
    10
    Units: subjects
        Subjects with SAEs
    0
    0
    1
        Subjects with AEs
    13
    18
    10
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Sustained Viral Response 12 Weeks After Last Planned Dose of Study Drug (SVR12)

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    End point title
    Percentage of Subjects With Sustained Viral Response 12 Weeks After Last Planned Dose of Study Drug (SVR12)
    End point description
    SVR12 was defined as an undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels (less than [<] lower limit of quantification) at 12 weeks after last planned dose of study drug. The plasma HCV RNA level was measured using Roche COBAS TaqMan HCV/High Pure System (HPS) RNA assay version 2.0. The lower limit of quantification was 25 international units per milliliter (IU/mL). Full analysis set (FAS) included all enrolled subjects who received at least 1 dose of study drug.
    End point type
    Secondary
    End point timeframe
    12 weeks after last planned dose of study drug (up to Week 60)
    End point values
    Cohort 1 (13-17 Years): Telaprevir + Peg-IFN-alfa-2b + RBV Cohort 2 (7-12 Years): Telaprevir + Peg-IFN-alfa-2b + RBV Cohort 3 (3-6 Years): Telaprevir + Peg-IFN-alfa-2b + RBV
    Number of subjects analysed
    13
    19
    10
    Units: percentage of subjects
        number (not applicable)
    69.2
    89.5
    40
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Sustained Viral Response 24 Weeks After Last Planned Dose of Study Drug (SVR24)

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    End point title
    Percentage of Subjects With Sustained Viral Response 24 Weeks After Last Planned Dose of Study Drug (SVR24)
    End point description
    SVR24 was defined as an undetectable HCV RNA Levels (< lower limit of quantification) at 24 weeks after last planned dose of study drug. The plasma HCV RNA level was measured using Roche COBAS TaqMan HCV/HPS RNA assay version 2.0. The lower limit of quantification was 25 IU/mL. SVR24 was not analyzed because study was terminated early and follow-up was conducted only up to 12 weeks after planned end of treatment (EOT).
    End point type
    Secondary
    End point timeframe
    24 weeks after last planned dose of study drug (up to Week 72)
    End point values
    Cohort 1 (13-17 Years): Telaprevir + Peg-IFN-alfa-2b + RBV Cohort 2 (7-12 Years): Telaprevir + Peg-IFN-alfa-2b + RBV Cohort 3 (3-6 Years): Telaprevir + Peg-IFN-alfa-2b + RBV
    Number of subjects analysed
    0 [2]
    0 [3]
    0 [4]
    Units: percentage of subjects
        number (not applicable)
    Notes
    [2] - Not analysed as study terminated early and follow-up conducted only up to 12 weeks after EOT.
    [3] - Not analysed as study terminated early and follow-up conducted only up to 12 weeks after EOT.
    [4] - Not analysed as study terminated early and follow-up conducted only up to 12 weeks after EOT.
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Rapid Virologic Response (RVR)

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    End point title
    Percentage of Subjects With Rapid Virologic Response (RVR)
    End point description
    The plasma HCV RNA level was measured using Roche COBAS TaqMan HCV/HPS RNA assay version 2.0. The lower limit of quantification was 25 IU/mL. RVR was defined as an undetectable HCV RNA (<lower limit of quantification) 4 weeks after the start of study treatment. FAS included all enrolled subjects who received at least 1 dose of study drug.
    End point type
    Secondary
    End point timeframe
    Week 4
    End point values
    Cohort 1 (13-17 Years): Telaprevir + Peg-IFN-alfa-2b + RBV Cohort 2 (7-12 Years): Telaprevir + Peg-IFN-alfa-2b + RBV Cohort 3 (3-6 Years): Telaprevir + Peg-IFN-alfa-2b + RBV
    Number of subjects analysed
    13
    19
    10
    Units: percentage of subjects
        number (not applicable)
    69.2
    73.7
    70
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Extended Rapid Virologic Response (eRVR)

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    End point title
    Percentage of Subjects With Extended Rapid Virologic Response (eRVR)
    End point description
    The plasma HCV RNA level was measured using Roche COBAS TaqMan HCV/HPS RNA assay version 2.0. The lower limit of quantification was 25 IU/mL. eRVR was defined as an undetectable HCV RNA (<lower limit of quantification) at both 4 weeks and 12 weeks after the start of study treatment. FAS included all enrolled subjects who received at least 1 dose of study drug.
    End point type
    Secondary
    End point timeframe
    Week 4 and Week 12
    End point values
    Cohort 1 (13-17 Years): Telaprevir + Peg-IFN-alfa-2b + RBV Cohort 2 (7-12 Years): Telaprevir + Peg-IFN-alfa-2b + RBV Cohort 3 (3-6 Years): Telaprevir + Peg-IFN-alfa-2b + RBV
    Number of subjects analysed
    13
    19
    10
    Units: percentage of subjects
        number (not applicable)
    61.5
    73.7
    60
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Undetectable HCV RNA at Week 12

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    End point title
    Percentage of Subjects With Undetectable HCV RNA at Week 12
    End point description
    The plasma HCV RNA level was measured using Roche COBAS TaqMan HCV/HPS RNA assay version 2.0. The lower limit of quantification was 25 IU/mL. FAS included all enrolled subjects who received at least 1 dose of study drug.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    Cohort 1 (13-17 Years): Telaprevir + Peg-IFN-alfa-2b + RBV Cohort 2 (7-12 Years): Telaprevir + Peg-IFN-alfa-2b + RBV Cohort 3 (3-6 Years): Telaprevir + Peg-IFN-alfa-2b + RBV
    Number of subjects analysed
    13
    19
    10
    Units: percentage of subjects
        number (not applicable)
    69.2
    89.5
    70
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With On-treatment Virologic Failure

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    End point title
    Percentage of Subjects With On-treatment Virologic Failure
    End point description
    On treatment virologic failure was defined as meeting any futility rule or completing assigned treatment duration and having detectable HCV RNA at EOT. The plasma HCV RNA level was measured using Roche COBAS TaqMan HCV/HPS RNA assay Version 2.0. The lower limit of quantification was 25 IU/mL. Futility rules: 1) HCV RNA >1000 IU/mL at Week 4; 2) HCV RNA >1000 IU/mL at Week 12; 3) Detectable HCV RNA after Week 12 to end of treatment. FAS included all enrolled subjects who received at least 1 dose of study drug.
    End point type
    Secondary
    End point timeframe
    Baseline up to Week 48
    End point values
    Cohort 1 (13-17 Years): Telaprevir + Peg-IFN-alfa-2b + RBV Cohort 2 (7-12 Years): Telaprevir + Peg-IFN-alfa-2b + RBV Cohort 3 (3-6 Years): Telaprevir + Peg-IFN-alfa-2b + RBV
    Number of subjects analysed
    13
    19
    10
    Units: percentage of subjects
        number (not applicable)
    15.4
    5.3
    30
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Virologic Relapse

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    End point title
    Percentage of Subjects With Virologic Relapse
    End point description
    The plasma HCV RNA level was measured using Roche COBAS TaqMan HCV/HPS RNA assay Version 2.0. The lower limit of quantification was 25 IU/mL. Viral relapse was defined as having detectable HCV at follow-up in subjects who had HCV RNA less than (<) lower limit of quantification (LLOQ) at planned EOT. FAS included all enrolled subjects who received at least 1 dose of study drug. Here 'Number of Subjects Analysed' signifies those subjects who completed the assigned treatment period and had undetectable HCV RNA at EOT.
    End point type
    Secondary
    End point timeframe
    12 weeks after planned EOT (up to Week 60)
    End point values
    Cohort 1 (13-17 Years): Telaprevir + Peg-IFN-alfa-2b + RBV Cohort 2 (7-12 Years): Telaprevir + Peg-IFN-alfa-2b + RBV Cohort 3 (3-6 Years): Telaprevir + Peg-IFN-alfa-2b + RBV
    Number of subjects analysed
    9
    17
    7
    Units: percentage of subjects
        number (not applicable)
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of Subjects With Telaprevir Resistant HCV Variant at Non-Structural Viral Protein 3-4A (NS3-4A) Region

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    End point title
    Number of Subjects With Telaprevir Resistant HCV Variant at Non-Structural Viral Protein 3-4A (NS3-4A) Region
    End point description
    Sequence analysis of the HCV NS3-4A region was performed to monitor telaprevir-resistant variants. HCV RNA was isolated from the plasma, amplified by reverse transcription-polymerase chain reaction (RT-PCR), and sequenced (sequencing assay limit of detection HCV RNA >=1000 IU/mL). Results of this outcome measure were to be reported for overall subjects instead of by age. FAS. Here 'Number of Subjects Analysed' signifies those subjects who were evaluable for this outcome.
    End point type
    Secondary
    End point timeframe
    Baseline, On treatment (up to Week 48)
    End point values
    Overall Subjects
    Number of subjects analysed
    41 [5]
    Units: subjects
        Baseline (n = 41)
    2
        On treatment (n = 6)
    6
    Notes
    [5] - 'n' signifies those subjects who were evaluable at the specified time points.
    No statistical analyses for this end point

    Secondary: Maximum Plasma Concentration (Cmax) of Telaprevir

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    End point title
    Maximum Plasma Concentration (Cmax) of Telaprevir
    End point description
    Cmax was measured for telaprevir only. Pharmacokinetic (PK) population included all subjects who received at least a single dose of telaprevir, whether the subject completed all treatments or not. Here 'Number of Subjects Analysed' signifies those subjects who were evaluable for this outcome measure.
    End point type
    Secondary
    End point timeframe
    Cohort 1: Pre-dose and 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 6.0, and 8.0 hours post-dose on Day 7, Cohort 2: Pre-dose and 0.5, 2.0, 4.0, 5.0, 6.0, and 8.0 hours post-dose on Day 7, Cohort 3: Pre-dose and 1.5, 4.0, and 8.0 hours post-dose on Day 7
    End point values
    Cohort 1 (13-17 Years): Telaprevir + Peg-IFN-alfa-2b + RBV Cohort 2 (7-12 Years): Telaprevir + Peg-IFN-alfa-2b + RBV Cohort 3 (3-6 Years): Telaprevir + Peg-IFN-alfa-2b + RBV
    Number of subjects analysed
    13
    13
    9
    Units: nanogram per milliliter (ng/mL)
        arithmetic mean (standard deviation)
    4310 ± 1160
    5050 ± 884
    4060 ± 1500
    No statistical analyses for this end point

    Secondary: Time to Reach Maximum Plasma Concentration (Tmax) of Telaprevir

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    End point title
    Time to Reach Maximum Plasma Concentration (Tmax) of Telaprevir
    End point description
    Tmax was measured for telaprevir only. PK population. Here 'Number of Subjects Analysed' signifies those subjects who were evaluable for this outcome measure.
    End point type
    Secondary
    End point timeframe
    Cohort 1: Pre-dose and 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 6.0, and 8.0 hours post-dose on Day 7, Cohort 2: Pre-dose and 0.5, 2.0, 4.0, 5.0, 6.0, and 8.0 hours post-dose on Day 7, Cohort 3: Pre-dose and 1.5, 4.0, and 8.0 hours post-dose on Day 7
    End point values
    Cohort 1 (13-17 Years): Telaprevir + Peg-IFN-alfa-2b + RBV Cohort 2 (7-12 Years): Telaprevir + Peg-IFN-alfa-2b + RBV Cohort 3 (3-6 Years): Telaprevir + Peg-IFN-alfa-2b + RBV
    Number of subjects analysed
    13
    13
    9
    Units: hours (h)
        median (full range (min-max))
    4 (1.92 to 8)
    4 (1.98 to 6.02)
    4 (1.5 to 8)
    No statistical analyses for this end point

    Secondary: Area Under the Plasma Concentration Versus Time Curve (AUC) of Telaprevir

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    End point title
    Area Under the Plasma Concentration Versus Time Curve (AUC) of Telaprevir
    End point description
    AUC was measured for telaprevir only. AUC 0-t last was defined as the area under the concentration-time curve from the time of dosing to the last measurable concentration. AUC 0-12 hour (AUC 0-12h) was calculated by respecifying predose concentrations as 12 hour concentrations. AUC 0-24h was calculated as AUC 0-12h multiplied by 2. Dose adjusted AUC (AUC 0-24h_Adj) was calculated by multiplying AUC 0-24h by the dose adjustment factor to obtain projected exposures in subjects who were misdosed. Data were presented for AUC 0-t last, AUC 0-12h, AUC 0-24h, AUC 0-24h_Adj. PK population. Here 'Number of Subjects Analyzed' signifies those subjects who were evaluable for this outcome measure.
    End point type
    Secondary
    End point timeframe
    Cohort 1: Pre-dose and 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 6.0, and 8.0 hours post-dose on Day 7, Cohort 2: Pre-dose and 0.5, 2.0, 4.0, 5.0, 6.0, and 8.0 hours post-dose on Day 7, Cohort 3: Pre-dose and 1.5, 4.0, and 8.0 hours post-dose on Day 7
    End point values
    Cohort 1 (13-17 Years): Telaprevir + Peg-IFN-alfa-2b + RBV Cohort 2 (7-12 Years): Telaprevir + Peg-IFN-alfa-2b + RBV Cohort 3 (3-6 Years): Telaprevir + Peg-IFN-alfa-2b + RBV
    Number of subjects analysed
    13
    13
    9
    Units: hours*nanogram per milliliter (h*ng/mL)
    arithmetic mean (standard deviation)
        AUC 0-t last
    39900 ± 11300
    43300 ± 9480
    35300 ± 12000
        AUC 0-12h
    39900 ± 11300
    44100 ± 9020
    35300 ± 12000
        AUC 0-24h
    79900 ± 22700
    88100 ± 18000
    70600 ± 24100
        AUC 0-24h_Adj
    95700 ± 29800
    88600 ± 19200
    76300 ± 22800
    No statistical analyses for this end point

    Secondary: Elimination Half-Life (T1/2) of Telaprevir

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    End point title
    Elimination Half-Life (T1/2) of Telaprevir
    End point description
    T1/2 was defined as the time required for the concentration or amount of drug in the body to be reduced by one-half. Half life was not calculated because the calculation required the slope of terminal elimination phase and the PK sampling was relatively sparse and did not yield a terminal elimination phase from which half-life can be accurately estimated.
    End point type
    Secondary
    End point timeframe
    Cohort 1: Pre-dose and 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 6.0, and 8.0 hours post-dose on Day 7, Cohort 2: Pre-dose and 0.5, 2.0, 4.0, 5.0, 6.0, and 8.0 hours post-dose on Day 7, Cohort 3: Pre-dose and 1.5, 4.0, and 8.0 hours post-dose on Day 7
    End point values
    Cohort 1 (13-17 Years): Telaprevir + Peg-IFN-alfa-2b + RBV Cohort 2 (7-12 Years): Telaprevir + Peg-IFN-alfa-2b + RBV Cohort 3 (3-6 Years): Telaprevir + Peg-IFN-alfa-2b + RBV
    Number of subjects analysed
    0 [6]
    0 [7]
    0 [8]
    Units: hours (h)
        arithmetic mean (standard deviation)
    ±
    ±
    ±
    Notes
    [6] - PK sampling sparse, did not yield terminal elimination phase from which half-life can be calculated.
    [7] - PK sampling sparse, did not yield terminal elimination phase from which half-life can be calculated.
    [8] - PK sampling sparse, did not yield terminal elimination phase from which half-life can be calculated.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline up to Week 52
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    18.0
    Reporting groups
    Reporting group title
    Cohort 1 (13-17 Years): Telaprevir + Peg-IFN-alfa-2b + RBV
    Reporting group description
    Subjects aged 13 to 17 years received telaprevir twice daily for 12 weeks either as a film coated tablet (15 mg/kg of body weight) or as a chewable tablet (14 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200 mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in subjects who achieved eRVR or for 48 weeks in subjects who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.

    Reporting group title
    Cohort 2 (7-12 Years): Telaprevir + Peg-IFN-alfa-2b + RBV
    Reporting group description
    Subjects aged 7 to 12 years received telaprevir twice daily for 12 weeks as a chewable tablet (16 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in subjects who achieved eRVR or for 48 weeks in subjects who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.

    Reporting group title
    Cohort 3 (3-6 Years): Telaprevir + Peg-IFN-alfa-2b + RBV
    Reporting group description
    Subjects aged 3 to 6 years received telaprevir twice daily for 12 weeks as a chewable tablet (18 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in subjects who achieved eRVR or for 48 weeks in subjects who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.

    Serious adverse events
    Cohort 1 (13-17 Years): Telaprevir + Peg-IFN-alfa-2b + RBV Cohort 2 (7-12 Years): Telaprevir + Peg-IFN-alfa-2b + RBV Cohort 3 (3-6 Years): Telaprevir + Peg-IFN-alfa-2b + RBV
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 19 (0.00%)
    1 / 10 (10.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Infections and infestations
    Infection
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 19 (0.00%)
    1 / 10 (10.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    Cohort 1 (13-17 Years): Telaprevir + Peg-IFN-alfa-2b + RBV Cohort 2 (7-12 Years): Telaprevir + Peg-IFN-alfa-2b + RBV Cohort 3 (3-6 Years): Telaprevir + Peg-IFN-alfa-2b + RBV
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    13 / 13 (100.00%)
    18 / 19 (94.74%)
    10 / 10 (100.00%)
    Vascular disorders
    Flushing
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 19 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    Pallor
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 19 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    Immune system disorders
    Seasonal allergy
         subjects affected / exposed
    2 / 13 (15.38%)
    0 / 19 (0.00%)
    2 / 10 (20.00%)
         occurrences all number
    2
    0
    6
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    7 / 13 (53.85%)
    11 / 19 (57.89%)
    8 / 10 (80.00%)
         occurrences all number
    35
    38
    75
    Fatigue
         subjects affected / exposed
    7 / 13 (53.85%)
    5 / 19 (26.32%)
    3 / 10 (30.00%)
         occurrences all number
    7
    11
    7
    Pain
         subjects affected / exposed
    2 / 13 (15.38%)
    4 / 19 (21.05%)
    5 / 10 (50.00%)
         occurrences all number
    6
    8
    23
    Injection site erythema
         subjects affected / exposed
    3 / 13 (23.08%)
    2 / 19 (10.53%)
    3 / 10 (30.00%)
         occurrences all number
    3
    2
    5
    Influenza like illness
         subjects affected / exposed
    1 / 13 (7.69%)
    2 / 19 (10.53%)
    1 / 10 (10.00%)
         occurrences all number
    1
    3
    2
    Chills
         subjects affected / exposed
    2 / 13 (15.38%)
    0 / 19 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    2
    0
    2
    Discomfort
         subjects affected / exposed
    1 / 13 (7.69%)
    2 / 19 (10.53%)
    0 / 10 (0.00%)
         occurrences all number
    2
    10
    0
    Injection site pruritus
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 19 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    2
    0
    1
    Injection site rash
         subjects affected / exposed
    1 / 13 (7.69%)
    1 / 19 (5.26%)
    0 / 10 (0.00%)
         occurrences all number
    1
    1
    0
    Malaise
         subjects affected / exposed
    2 / 13 (15.38%)
    0 / 19 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    4
    0
    0
    Non-cardiac chest pain
         subjects affected / exposed
    2 / 13 (15.38%)
    0 / 19 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    3
    0
    0
    Product taste abnormal
         subjects affected / exposed
    0 / 13 (0.00%)
    2 / 19 (10.53%)
    0 / 10 (0.00%)
         occurrences all number
    0
    2
    0
    Injection site bruising
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 19 (5.26%)
    0 / 10 (0.00%)
         occurrences all number
    0
    2
    0
    Injection site reaction
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 19 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    Peripheral swelling
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 19 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    Temperature intolerance
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 19 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    Vessel puncture site pain
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 19 (5.26%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    2 / 13 (15.38%)
    1 / 19 (5.26%)
    1 / 10 (10.00%)
         occurrences all number
    2
    2
    1
    Depression
         subjects affected / exposed
    1 / 13 (7.69%)
    2 / 19 (10.53%)
    0 / 10 (0.00%)
         occurrences all number
    1
    2
    0
    Affect lability
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 19 (0.00%)
    2 / 10 (20.00%)
         occurrences all number
    0
    0
    2
    Mood altered
         subjects affected / exposed
    0 / 13 (0.00%)
    2 / 19 (10.53%)
    0 / 10 (0.00%)
         occurrences all number
    0
    2
    0
    Mood swings
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 19 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    1
    0
    1
    Agitation
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 19 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    Anxiety
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 19 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    2
    0
    0
    Flat affect
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 19 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    Restlessness
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 19 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    1
    Sleep terror
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 19 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    1
    Reproductive system and breast disorders
    Dysmenorrhoea
         subjects affected / exposed
    1 / 13 (7.69%)
    1 / 19 (5.26%)
    0 / 10 (0.00%)
         occurrences all number
    1
    3
    0
    Amenorrhoea
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 19 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    Oligomenorrhoea
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 19 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    Pruritus genital
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 19 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    1
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    2 / 13 (15.38%)
    1 / 19 (5.26%)
    0 / 10 (0.00%)
         occurrences all number
    2
    1
    0
    Excoriation
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 19 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    Limb injury
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 19 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    1
    Skin abrasion
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 19 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    Investigations
    Blood bicarbonate decreased
         subjects affected / exposed
    2 / 13 (15.38%)
    0 / 19 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    2
    0
    0
    Blood triglycerides increased
         subjects affected / exposed
    0 / 13 (0.00%)
    2 / 19 (10.53%)
    0 / 10 (0.00%)
         occurrences all number
    0
    2
    0
    Blood uric acid increased
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 19 (5.26%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    1
    Weight decreased
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 19 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    2
    0
    1
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 19 (5.26%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    Blood bilirubin increased
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 19 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    Blood creatine phosphokinase increased
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 19 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    Body temperature increased
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 19 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    1
    Haemoglobin decreased
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 19 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    Neutrophil count decreased
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 19 (5.26%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
         subjects affected / exposed
    0 / 13 (0.00%)
    2 / 19 (10.53%)
    2 / 10 (20.00%)
         occurrences all number
    0
    3
    5
    Cough
         subjects affected / exposed
    0 / 13 (0.00%)
    2 / 19 (10.53%)
    1 / 10 (10.00%)
         occurrences all number
    0
    3
    1
    Dyspnoea
         subjects affected / exposed
    2 / 13 (15.38%)
    1 / 19 (5.26%)
    0 / 10 (0.00%)
         occurrences all number
    3
    1
    0
    Dyspnoea exertional
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 19 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    Epistaxis
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 19 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    2
    Paranasal sinus hypersecretion
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 19 (5.26%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    Respiratory distress
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 19 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    Rhinitis allergic
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 19 (5.26%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    4 / 13 (30.77%)
    5 / 19 (26.32%)
    1 / 10 (10.00%)
         occurrences all number
    6
    5
    1
    Neutropenia
         subjects affected / exposed
    4 / 13 (30.77%)
    3 / 19 (15.79%)
    2 / 10 (20.00%)
         occurrences all number
    4
    5
    2
    Leukopenia
         subjects affected / exposed
    1 / 13 (7.69%)
    4 / 19 (21.05%)
    1 / 10 (10.00%)
         occurrences all number
    1
    5
    1
    Lymphadenopathy
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 19 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    Thrombocytopenia
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 19 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    8 / 13 (61.54%)
    16 / 19 (84.21%)
    6 / 10 (60.00%)
         occurrences all number
    31
    79
    12
    Dizziness
         subjects affected / exposed
    5 / 13 (38.46%)
    5 / 19 (26.32%)
    0 / 10 (0.00%)
         occurrences all number
    7
    6
    0
    Lethargy
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 19 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    1
    Paraesthesia
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 19 (5.26%)
    0 / 10 (0.00%)
         occurrences all number
    0
    2
    0
    Presyncope
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 19 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    Somnolence
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 19 (5.26%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    Eye disorders
    Eye irritation
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 19 (5.26%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    Eye pain
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 19 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    1
    Eye pruritus
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 19 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    Mydriasis
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 19 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    Vision blurred
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 19 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 19 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    1
    Gastrointestinal disorders
    Vomiting
         subjects affected / exposed
    8 / 13 (61.54%)
    12 / 19 (63.16%)
    6 / 10 (60.00%)
         occurrences all number
    13
    23
    12
    Nausea
         subjects affected / exposed
    7 / 13 (53.85%)
    5 / 19 (26.32%)
    5 / 10 (50.00%)
         occurrences all number
    9
    9
    14
    Anal pruritus
         subjects affected / exposed
    4 / 13 (30.77%)
    4 / 19 (21.05%)
    3 / 10 (30.00%)
         occurrences all number
    6
    5
    3
    Abdominal pain
         subjects affected / exposed
    5 / 13 (38.46%)
    3 / 19 (15.79%)
    1 / 10 (10.00%)
         occurrences all number
    5
    9
    1
    Abdominal pain upper
         subjects affected / exposed
    2 / 13 (15.38%)
    5 / 19 (26.32%)
    0 / 10 (0.00%)
         occurrences all number
    2
    6
    0
    Diarrhoea
         subjects affected / exposed
    2 / 13 (15.38%)
    3 / 19 (15.79%)
    0 / 10 (0.00%)
         occurrences all number
    2
    6
    0
    Abdominal distension
         subjects affected / exposed
    2 / 13 (15.38%)
    0 / 19 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    2
    0
    0
    Abdominal discomfort
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 19 (5.26%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    Anal fissure
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 19 (5.26%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    Anorectal discomfort
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 19 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    Aphthous stomatitis
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 19 (5.26%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    Cheilitis
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 19 (5.26%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    Constipation
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 19 (5.26%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    Diarrhoea haemorrhagic
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 19 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    2
    0
    0
    Dry mouth
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 19 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    Gingival pain
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 19 (5.26%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    Lip ulceration
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 19 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    Mouth ulceration
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 19 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    1
    Oral disorder
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 19 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    1
    Oral pain
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 19 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    Stomatitis
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 19 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    Tooth impacted
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 19 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    Toothache
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 19 (5.26%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    3 / 13 (23.08%)
    5 / 19 (26.32%)
    3 / 10 (30.00%)
         occurrences all number
    3
    10
    3
    Rash
         subjects affected / exposed
    4 / 13 (30.77%)
    2 / 19 (10.53%)
    3 / 10 (30.00%)
         occurrences all number
    6
    2
    6
    Alopecia
         subjects affected / exposed
    7 / 13 (53.85%)
    1 / 19 (5.26%)
    0 / 10 (0.00%)
         occurrences all number
    7
    1
    0
    Pruritus generalised
         subjects affected / exposed
    1 / 13 (7.69%)
    3 / 19 (15.79%)
    0 / 10 (0.00%)
         occurrences all number
    1
    8
    0
    Dry skin
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 19 (0.00%)
    2 / 10 (20.00%)
         occurrences all number
    0
    0
    2
    Erythema
         subjects affected / exposed
    1 / 13 (7.69%)
    1 / 19 (5.26%)
    0 / 10 (0.00%)
         occurrences all number
    1
    4
    0
    Skin lesion
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 19 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    1
    0
    1
    Cold sweat
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 19 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    Eczema
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 19 (5.26%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    Rash macular
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 19 (5.26%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    Rash papular
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 19 (5.26%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    Skin irritation
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 19 (5.26%)
    0 / 10 (0.00%)
         occurrences all number
    0
    2
    0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    2 / 13 (15.38%)
    2 / 19 (10.53%)
    0 / 10 (0.00%)
         occurrences all number
    2
    3
    0
    Pain in extremity
         subjects affected / exposed
    2 / 13 (15.38%)
    2 / 19 (10.53%)
    0 / 10 (0.00%)
         occurrences all number
    6
    2
    0
    Myalgia
         subjects affected / exposed
    1 / 13 (7.69%)
    2 / 19 (10.53%)
    0 / 10 (0.00%)
         occurrences all number
    1
    2
    0
    Arthralgia
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 19 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    Neck pain
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 19 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    1
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    3 / 13 (23.08%)
    5 / 19 (26.32%)
    3 / 10 (30.00%)
         occurrences all number
    3
    6
    3
    Abnormal loss of weight
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 19 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    Dehydration
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 19 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    Hypercholesterolaemia
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 19 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    1
    Hyperinsulinaemia
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 19 (5.26%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    Hypocalcaemia
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 19 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    Infections and infestations
    Oral herpes
         subjects affected / exposed
    1 / 13 (7.69%)
    1 / 19 (5.26%)
    1 / 10 (10.00%)
         occurrences all number
    1
    1
    1
    Bronchitis
         subjects affected / exposed
    1 / 13 (7.69%)
    1 / 19 (5.26%)
    0 / 10 (0.00%)
         occurrences all number
    1
    1
    0
    Pharyngitis streptococcal
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 19 (0.00%)
    2 / 10 (20.00%)
         occurrences all number
    0
    0
    2
    Sinusitis
         subjects affected / exposed
    2 / 13 (15.38%)
    0 / 19 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    3
    0
    0
    Urinary tract infection
         subjects affected / exposed
    2 / 13 (15.38%)
    0 / 19 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    2
    0
    0
    Vulvovaginal mycotic infection
         subjects affected / exposed
    2 / 13 (15.38%)
    0 / 19 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    2
    0
    0
    Conjunctivitis bacterial
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 19 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    1
    Ear infection
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 19 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    1
    Gastroenteritis
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 19 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    1
    Gastroenteritis viral
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 19 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    1
    Hordeolum
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 19 (5.26%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    Nasopharyngitis
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 19 (5.26%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    Parvovirus infection
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 19 (5.26%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    Pharyngitis
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 19 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    Pneumonia
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 19 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    1
    Rash pustular
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 19 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    1
    Skin infection
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 19 (5.26%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    Tinea infection
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 19 (5.26%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    Tonsillitis
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 19 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    02 Mar 2012
    1) Clarification that subjects in Part A were to be without cirrhosis. 2) Number of subjects was changed from approximately 120 to at least 120, and the minimum number of subjects with prior peginterferon/RBV treatment was increased from 15 to 25. The number of subjects per age group in Part A was clarified to be at least 10 in the older age groups and at least 6 in the youngest age group. 3) Language was changed to specify that at least 30% of all subjects would be from each gender; that half of all subjects would be from the EU, US, or Canada; and that efforts would be made to include subjects from all races. 4) Clarification that the follow-up period would be 5 years from the last dose of study drug (instead of 5 years from the first dose of study drug). 5) Descriptions of informed consent and assent were simplified in anticipation of differences in local (country-specific) rules/regulations. Specifically, statements that assent would be for children older than 12 years were removed. 6) Information on study drug dosing was updated, including addition of language to state that dosing for telaprevir would be based on the subject’s baseline weight, and that the dose for Peg-IFN and RBV would be adjusted using the subject’s current weight at Week 24, if necessary. 7) Ferritin and serology tests for hepatitis C virus and hepatitis A virus were added to the list of assessments to be performed at screening and positive result for anti-hepatitis A virus immunoglobulin M antibody was made an exclusion. 8) Information on detection of liver disease at baseline was updated. It was clarified that results from recent (within 24 months of screening) liver biopsies, if available, would be collected. 9) An exclusion criterion was added for any disease of iron overload, including hemochromatosis, and diseases requiring repeat transfusions. 10) Clarification that a urine home pregnancy test kit would be provided when there were no scheduled study visits.
    21 Jun 2012
    1) Body weight less than 15 kg was made an exclusion criterion for both Part A and Part B of the study. 2) Exclusions for screening laboratory values were modified to be consistent with regulatory requirements. Exclusions related to thyroid dysfunction were modified. A new exclusion criterion was added for subjects who were pregnant, breastfeeding, or planning to get pregnant during study drug administration or within 6 months after the last dose of RBV. 3) “History of intercurrent illness (e.g., upper respiratory illness with fever) within 5 days prior to the first dose of study drug” was made an exclusion criterion. 4) The exclusion criterion with respect to participation in other studies of investigational drugs was significantly modified, including types of studies, time of previous blood draws, and use of a protease inhibitor. 5) Clarification that subjects in Part B could be with or without cirrhosis. 6) The exclusion criterion on previous treatment experience was clarified to state that subjects in Part A could not have been previously treated with any approved or experimental treatment for hepatitis C. 7) The PK blood sample at 12 hours postdose was deleted. 8) The section on contraception was updated for consistency with regulatory guidance and for clarity. 9) Clarification that telaprevir and RBV were to be taken with food within 30 minutes after eating a meal or snack that was not low fat. 10) The recommendation that the chewable tablets could be crushed and taken with whole milk was removed due to new food testing results. 11) Clarification that investigators were to evaluate subjects’ HCV RNA results by Week 24 and inform subject parents/guardians of their total treatment duration. 12) Clarification of scheduling of follow-up visits and assessments to be performed at these visits and futility rules. 14) Canada was removed in the description of the study population because no sites were planned for this country.
    29 Aug 2012
    1) The allowance for an overnight visit the night before Day 7 was removed. 2) A mandatory second visit during the screening period was added for laboratory draws (HCV genotype/subtype, HCV serology, human immunodeficiency virus serology, hepatitis A virus serology, hepatitis B virus serology and DNA and antinuclear antibody) for children in the 3- to 6-year-old and 7- to 12-year-old age groups. This was implemented to ensure that the maximum allowable blood volume drawn was not exceeded. 3) References to the use of a breath alcohol test were removed from the document and replaced with a urine alcohol test. The drug and alcohol tests planned for the treatment period were deleted. 4) The time points for ophthalmologic examinations planned for the treatment/follow-up periods were changed to align with the recommendations in the package insert for Peg-IFN. 5) Exclusion criteria for low hemoglobin and for ophthalmologic disorders were clarified and made more specific.

    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.
    Study was terminated early because it was determined that telaprevir/Peg-IFN/RBV regimen did not present a meaningful therapeutic treatment over existing interferon-free regimens and was unlikely to be used for subjects aged 3 to 17 years.
    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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