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    Clinical Trial Results:
    A Phase 3 Study to Assess the Efficacy and Safety of Boceprevir in Combination With Peginterferon Alfa-2b Plus Ribavirin in Pediatric Subjects With Chronic Hepatitis C Genotype 1

    Summary
    EudraCT number
    		 2010-024260-17
    Trial protocol
    		 DE   AT   BE   PT   CZ   ES   IT   PL   NO   GB  
    Global end of trial date
    21 Jan 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    17 Aug 2020
    First version publication date
    17 Aug 2020
    Other versions
    Summary report(s)
    		 EudraCT Summary Results
    Cancelled/Withdrawn Memo

    Trial information

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    Trial identification
    Sponsor protocol code
    P08034
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01590225
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Merck Sharp & Dohme Corp.
    Sponsor organisation address
    2000 Galloping Hill Road, Kenilworth, NJ, United States,
    Public contact
    Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.com
    Scientific contact
    Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-099999-PIP99-99
    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
    21 Jan 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    21 Jan 2014
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    This trial was to be a three-part (Part A, Part B, and Part C), open-label, multicenter study of boceprevir in pediatric participants with chronic hepatitis C (CHC) genotype 1 (GT1). In Part A and Part B, efficacy and safety were to be evaluated in participants with CHC GT1 who are non-cirrhotic, treatment naïves (Part A) or who are non-cirrhotic, treatment failures to (peg)interferon/ribavirin or who are cirrhotics (whether treatment naïve or treatment failure) (Part B). Part C was to be a long-term follow up and no study treatment was to be administered during this period, but participants who did not achieve viral clearance were to going to be allowed to receive other treatments for CHC. Note: This study was withdrawn. No participants were ever enrolled in it.
    Protection of trial subjects
    N/A
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    28 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: 99999
    Worldwide total number of subjects
    99999
    EEA total number of subjects
    99999
    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)
    99999
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Note: This trial was withdrawn. No participants were ever enrolled in it.

    Pre-assignment
    Screening details
    		 N/A

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

    Arms
    Arm title
    		 Part A and B: boceprevir + peginterferon alpha-2b + ribavirin
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Boceprevir
    Investigational medicinal product code
    Other name
    Victrelis® SCH 503034
    Pharmaceutical forms
    Capsule, Granules in sachet
    Routes of administration
    Oral use
    Dosage and administration details
    Boceprevir will be administered orally at a dose of 11.4 mg/kg three-times daily (TID) for 48 weeks. The boceprevir dose will be calculated based on 11.4 mg/kg and will then be rounded to the nearest 200-mg value for participants in the oldest age group, or to the nearest 100-mg or 200-mg value for the participants in the two youngest age groups.

    Investigational medicinal product name
    Ribavirin
    Investigational medicinal product code
    Other name
    Copegus® Rebetol® RibaTab® Ribasphere®
    Pharmaceutical forms
    Capsule, Oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    The dose of ribavirin will be approximately 15 mg/kg/day administered orally in two divided doses (twice daily [BID]) for 48 weeks.

    Investigational medicinal product name
    Peginterferon alpha-2b
    Investigational medicinal product code
    Other name
    Pegintron® Sylatron®
    Pharmaceutical forms
    Concentrate and solvent for solution for infusion, Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Peginterferon alpha-2b will be administered subcutaneously at a dose of 60 μg/m^2 once weekly (QW) for 48 weeks.

    Number of subjects in period 1
    		Part A and B: boceprevir + peginterferon alpha-2b + ribavirin
    Started
    99999
    Completed
    99999

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Part A and B: boceprevir + peginterferon alpha-2b + ribavirin
    Reporting group description
    		 -

    Reporting group values
    		 Part A and B: boceprevir + peginterferon alpha-2b + ribavirin Total
    Number of subjects
    		 99999 99999
    Age Categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 99999 99999
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 0 0
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age Continuous
    Units: years
        arithmetic mean (full range (min-max))
    		 0 (0 to 0) -
    Gender Categorical
    Units: Subjects
        Female
    		 99999 99999
        Male
    		 0 0

    End points

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    End points reporting groups
    Reporting group title
    Part A and B: boceprevir + peginterferon alpha-2b + ribavirin
    Reporting group description
    		 -

    Primary: Participants Achieving Sustained Viral Response (SVR) at Follow-Up Week 24

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    End point title
    		 Participants Achieving Sustained Viral Response (SVR) at Follow-Up Week 24 [1]
    End point description
    End point type
    Primary
    End point timeframe
    Follow-Up Week 24
    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: Note: This study was withdrawn. No participants were ever enrolled in it.
    End point values
    		 Part A and B: boceprevir + peginterferon alpha-2b + ribavirin
    Number of subjects analysed
    0 [2]
    Units: Participants
    Notes
    [2] - Note: This study was withdrawn. No participants were ever enrolled in it.
    No statistical analyses for this end point

    Primary: Participants Achieving SVR at Follow-Up Week 24

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    End point title
    		 Participants Achieving SVR at Follow-Up Week 24 [3]
    End point description
    End point type
    Primary
    End point timeframe
    Follow-Up Week 24
    Notes
    [3] - 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: Note: This study was withdrawn. No participants were ever enrolled in it.
    End point values
    		 Part A and B: boceprevir + peginterferon alpha-2b + ribavirin
    Number of subjects analysed
    0 [4]
    Units: Participants
    Notes
    [4] - Note: This study was withdrawn. No participants were ever enrolled in it.
    No statistical analyses for this end point

    Primary: Time to Viral Relapse in Study Part C: Long-Term Follow Up

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    End point title
    		 Time to Viral Relapse in Study Part C: Long-Term Follow Up [5]
    End point description
    End point type
    Primary
    End point timeframe
    Follow-Up Week 24 to 5 Years
    Notes
    [5] - 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: Note: This study was withdrawn. No participants were ever enrolled in it.
    End point values
    		 Part A and B: boceprevir + peginterferon alpha-2b + ribavirin
    Number of subjects analysed
    0 [6]
    Units: Years
    Notes
    [6] - Note: This study was withdrawn. No participants were ever enrolled in it.
    No statistical analyses for this end point

    Secondary: Proportion of Participants With Alanine Aminotransferase (ALT) Normalization

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    End point title
    		 Proportion of Participants With Alanine Aminotransferase (ALT) Normalization
    End point description
    End point type
    Secondary
    End point timeframe
    Week 2, Week 4, Week 8, Week 12
    End point values
    		 Part A and B: boceprevir + peginterferon alpha-2b + ribavirin
    Number of subjects analysed
    0 [7]
    Units: Proportion of Participants
    Notes
    [7] - Note: This study was withdrawn. No participants were ever enrolled in it.
    No statistical analyses for this end point

    Secondary: Participants With Early Virologic Response

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    End point title
    		 Participants With Early Virologic Response
    End point description
    End point type
    Secondary
    End point timeframe
    Week 2, Week 4, Week 8, Week 12
    End point values
    		 Part A and B: boceprevir + peginterferon alpha-2b + ribavirin
    Number of subjects analysed
    0 [8]
    Units: Participants
    Notes
    [8] - Note: This study was withdrawn. No participants were ever enrolled in it.
    No statistical analyses for this end point

    Secondary: Proportion of Participants With Undetectable Hepatitis C Virus Ribonucleic Acid (HCV-RNA)

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    End point title
    		 Proportion of Participants With Undetectable Hepatitis C Virus Ribonucleic Acid (HCV-RNA)
    End point description
    End point type
    Secondary
    End point timeframe
    Week 12, End of Treatment, Follow-Up Week 24
    End point values
    		 Part A and B: boceprevir + peginterferon alpha-2b + ribavirin
    Number of subjects analysed
    0 [9]
    Units: Percentage of participants
    Notes
    [9] - Note: This study was withdrawn. No participants were ever enrolled in it.
    No statistical analyses for this end point

    Secondary: Proportion of Participants With Undetectable HCV-RNA Who Also Achieved SVR

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    End point title
    		 Proportion of Participants With Undetectable HCV-RNA Who Also Achieved SVR
    End point description
    End point type
    Secondary
    End point timeframe
    Follow-Up Week 12
    End point values
    		 Part A and B: boceprevir + peginterferon alpha-2b + ribavirin
    Number of subjects analysed
    0 [10]
    Units: Percentage of participants
    Notes
    [10] - Note: This study was withdrawn. No participants were ever enrolled in it.
    No statistical analyses for this end point

    Secondary: Proportion of Participants With Alanine Aminotransferase (ALT) Normalization in Study

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    End point title
    		 Proportion of Participants With Alanine Aminotransferase (ALT) Normalization in Study
    End point description
    End point type
    Secondary
    End point timeframe
    Week 2, Week 4, Week 8, Week 12
    End point values
    		 Part A and B: boceprevir + peginterferon alpha-2b + ribavirin
    Number of subjects analysed
    0 [11]
    Units: Percentage of participants
    Notes
    [11] - Note: This study was withdrawn. No participants were ever enrolled in it.
    No statistical analyses for this end point

    Secondary: Proportion of Participants With Undetectable HCV-RNA

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    End point title
    		 Proportion of Participants With Undetectable HCV-RNA
    End point description
    End point type
    Secondary
    End point timeframe
    Week 24, End of Treatment, Follow-Up Week 12
    End point values
    		 Part A and B: boceprevir + peginterferon alpha-2b + ribavirin
    Number of subjects analysed
    0 [12]
    Units: Percentage of participants
    Notes
    [12] - Note: This study was withdrawn. No participants were ever enrolled in it.
    No statistical analyses for this end point

    Secondary: Proportion of Participants With Undetectable HCV-RNA Who Also Achieved SVR

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    End point title
    		 Proportion of Participants With Undetectable HCV-RNA Who Also Achieved SVR
    End point description
    End point type
    Secondary
    End point timeframe
    Follow-Up Week 12
    End point values
    		 Part A and B: boceprevir + peginterferon alpha-2b + ribavirin
    Number of subjects analysed
    0 [13]
    Units: Percentage of participants
    Notes
    [13] - Note: This study was withdrawn. No participants were ever enrolled in it.
    No statistical analyses for this end point

    Secondary: Number of Participants Experiencing Treatment-Emergent Adverse Events (AEs)

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    End point title
    		 Number of Participants Experiencing Treatment-Emergent Adverse Events (AEs)
    End point description
    End point type
    Secondary
    End point timeframe
    Week 1 to Follow-Up Visit 24
    End point values
    		 Part A and B: boceprevir + peginterferon alpha-2b + ribavirin
    Number of subjects analysed
    0 [14]
    Units: Participants
    Notes
    [14] - Note: This study was withdrawn. No participants were ever enrolled in it.
    No statistical analyses for this end point

    Secondary: Number of Participants Experiencing Treatment-Emergent Treatment-Related AEs

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    End point title
    		 Number of Participants Experiencing Treatment-Emergent Treatment-Related AEs
    End point description
    End point type
    Secondary
    End point timeframe
    Week 1 to Follow-Up Week 24
    End point values
    		 Part A and B: boceprevir + peginterferon alpha-2b + ribavirin
    Number of subjects analysed
    0 [15]
    Units: Participants
    Notes
    [15] - Note: This study was withdrawn. No participants were ever enrolled in it.
    No statistical analyses for this end point

    Secondary: Number of Participants Experiencing Serious AEs (SAEs)

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    End point title
    		 Number of Participants Experiencing Serious AEs (SAEs)
    End point description
    End point type
    Secondary
    End point timeframe
    Week 1 to Follow-Up Week 24
    End point values
    		 Part A and B: boceprevir + peginterferon alpha-2b + ribavirin
    Number of subjects analysed
    0 [16]
    Units: Participants
    Notes
    [16] - Note: This study was withdrawn. No participants were ever enrolled in it.
    No statistical analyses for this end point

    Secondary: Number of Participants Discontinuing Treatment Due to AEs

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    End point title
    		 Number of Participants Discontinuing Treatment Due to AEs
    End point description
    End point type
    Secondary
    End point timeframe
    Week 1 to Follow-Up Week 24
    End point values
    		 Part A and B: boceprevir + peginterferon alpha-2b + ribavirin
    Number of subjects analysed
    0 [17]
    Units: Participants
    Notes
    [17] - Note: This study was withdrawn. No participants were ever enrolled in it.
    No statistical analyses for this end point

    Secondary: Change from Baseline in Participant Laboratory Values

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    End point title
    		 Change from Baseline in Participant Laboratory Values
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to Follow-Up Week 24
    End point values
    		 Part A and B: boceprevir + peginterferon alpha-2b + ribavirin
    Number of subjects analysed
    0 [18]
    Units: Number
    Notes
    [18] - Note: This study was withdrawn. No participants were ever enrolled in it.
    No statistical analyses for this end point

    Secondary: Number of Participants Experiencing AEs

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    End point title
    		 Number of Participants Experiencing AEs
    End point description
    End point type
    Secondary
    End point timeframe
    Week 1 to Follow-Up Week 24
    End point values
    		 Part A and B: boceprevir + peginterferon alpha-2b + ribavirin
    Number of subjects analysed
    0 [19]
    Units: Participants
    Notes
    [19] - Note: This study was withdrawn. No participants were ever enrolled in it.
    No statistical analyses for this end point

    Secondary: Change From Baseline in Participant Vital Signs

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    End point title
    		 Change From Baseline in Participant Vital Signs
    End point description
    End point type
    Secondary
    End point timeframe
    Week 1 to Follow-Up Week 24
    End point values
    		 Part A and B: boceprevir + peginterferon alpha-2b + ribavirin
    Number of subjects analysed
    0 [20]
    Units: Number
    Notes
    [20] - Note: This study was withdrawn. No participants were ever enrolled in it.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    All adverse events occurring during the course of the clinical trial were to be collected.
    Adverse event reporting additional description
    99999 is a "Not applicable" value. There were 0 participants. This study was withdrawn. No participants were ever enrolled in it.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    0
    Reporting groups
    Reporting group title
    Part A: boceprevir + peginterferon alpha-2b + ribavirin
    Reporting group description
    		 -

    Reporting group title
    Part B: boceprevir + peginterferon alpha-2b + ribavirin
    Reporting group description
    		 -

    Serious adverse events
    		 Part A: boceprevir + peginterferon alpha-2b + ribavirin Part B: boceprevir + peginterferon alpha-2b + ribavirin
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 99999 (0.00%)
    0 / 99999 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Part A: boceprevir + peginterferon alpha-2b + ribavirin Part B: boceprevir + peginterferon alpha-2b + ribavirin
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 99999 (0.00%)
    0 / 99999 (0.00%)
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: Note: This study was withdrawn. No participants were ever enrolled in it.

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    Note: This study was withdrawn. No participants were ever enrolled in it.
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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