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    Clinical Trial Results:
    Assessment of the Pharmacokinetics of Boceprevir in Pediatric Subjects with Chronic Hepatitis C Genotype 1 (Phase 1b); Protocol No. P07614

    Summary
    EudraCT number
    		 2010-023498-20
    Trial protocol
    		 GB   PL   ES   DE   Outside EU/EEA  
    Global end of trial date
    21 Jan 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    05 Apr 2016
    First version publication date
    05 Jul 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    P07614
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01425190
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Merck Sharp & Dohme Corp.
    Sponsor organisation address
    2000 Galloping Hill Road, Kenilworth, NJ, United States, 07033
    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-000583-PIP09-05
    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
    20 Mar 2013
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    20 Mar 2013
    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
    The objective of this study was to determine weight based doses of boceprevir for children 3 to 17 years of age in 3 separate age-based cohorts.
    Protection of trial subjects
    This study was conducted in conformance with Good Clinical Practice standards and applicable country and/or local statutes and regulations regarding ethical committee review, informed consent, and the protection of human subjects participating in biomedical research.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    04 Jan 2012
    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
    Poland: 6
    Country: Number of subjects enrolled
    Spain: 1
    Country: Number of subjects enrolled
    United Kingdom: 5
    Country: Number of subjects enrolled
    Germany: 3
    Country: Number of subjects enrolled
    United States: 1
    Worldwide total number of subjects
    16
    EEA total number of subjects
    15
    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)
    16
    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
    		 The study was designed to assess the pharmacokinetics (PK) of boceprevir in pediatric participants infected with Hepatitis C virus (HCV) genotype (GT) 1 across 3 age-based cohorts (Cohort 1: 17 to ≥13 years; Cohort 2: >13 to ≥7 years; Cohort 3: >3 to ≥7 years).

    Pre-assignment
    Screening details
    		 This study enrolled pediatric participants between the ages of 3 to 17 years who were infected with HCV GT1.

    Period 1
    Period 1 title
    Boceprevir Administration (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    This was an open-label study.

    Arms
    Arm title
    		 Cohort 1: Children <17 to ≥13 Years of Age
    Arm description
    		 Pediatric HCV-infected participants <17 to ≥13 years of age were administered a single weight-based dose of boceprevir on Day 1.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Boceprevir
    Investigational medicinal product code
    Other name
    Victrelis™
    Pharmaceutical forms
    Powder for oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    Boceprevir was supplied as a powder to be dispensed in a suitable dosing vehicle (e.g., applesauce, Nutella, pudding). For each participant, dose was calculated by multiplying body weight on Day 1 by 11.4 mg/kg and rounding up or down to the nearest 50 mg. The maximum possible dose was 800 mg.

    Number of subjects in period 1
    		Cohort 1: Children <17 to ≥13 Years of Age
    Started
    16
    Completed
    15
    Not completed
    1
         Full dose not consumed.
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Cohort 1: Children <17 to ≥13 Years of Age
    Reporting group description
    		 Pediatric HCV-infected participants <17 to ≥13 years of age were administered a single weight-based dose of boceprevir on Day 1.

    Reporting group values
    		 Cohort 1: Children <17 to ≥13 Years of Age Total
    Number of subjects
    		 16 16
    Age categorical
    Units: Subjects
        Adolescents (12-17 years)
    		 16 16
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 14.9 ± 1.2 -
    Gender categorical
    Units: Subjects
        Female
    		 7 7
        Male
    		 9 9

    End points

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    End points reporting groups
    Reporting group title
    Cohort 1: Children <17 to ≥13 Years of Age
    Reporting group description
    		 Pediatric HCV-infected participants <17 to ≥13 years of age were administered a single weight-based dose of boceprevir on Day 1.

    Primary: Area Under the Plasma Concentration-Time Curve from Time 0 to Infinity (AUC0-∞)

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    End point title
    		 Area Under the Plasma Concentration-Time Curve from Time 0 to Infinity (AUC0-∞) [1]
    End point description
    AUC(0-∞) was assessed pre-dose, 0.5, 1, 2, 2.5, 4.5, 5.5, 8, and 10 hours post-dose.
    End point type
    Primary
    End point timeframe
    Pre-dose to 10 hours Post-dose
    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: Only summary statistics for the primary PK measures for Cohort 1 are provided.
    End point values
    		 Cohort 1: Children <17 to ≥13 Years of Age
    Number of subjects analysed
    14
    Units: ng hr/mL
        arithmetic mean (full range (min-max))
    6660 (3860 to 10500)
    No statistical analyses for this end point

    Primary: Maximum Plasma Concentration (Cmax)

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    End point title
    		 Maximum Plasma Concentration (Cmax) [2]
    End point description
    Cmax was assessed pre-dose, 0.5, 1, 2, 2.5, 4.5, 5.5, 8, and 10 hours post-dose.
    End point type
    Primary
    End point timeframe
    From Pre-dose to 10 hours Post-dose
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only summary statistics for the primary PK measures for Cohort 1 are provided.
    End point values
    		 Cohort 1: Children <17 to ≥13 Years of Age
    Number of subjects analysed
    15
    Units: ng/mL
        arithmetic mean (full range (min-max))
    1710 (985 to 2320)
    No statistical analyses for this end point

    Primary: Time of Maximum Plasma Concentration (Tmax)

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    End point title
    		 Time of Maximum Plasma Concentration (Tmax) [3]
    End point description
    Tmax was assessed pre-dose, 0.5, 1, 2, 2.5, 4.5, 5.5, 8, and 10 hours post-dose.
    End point type
    Primary
    End point timeframe
    From Pre-dose to 10 hours Post-dose
    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: Only summary statistics for the primary PK measures for Cohort 1 are provided.
    End point values
    		 Cohort 1: Children <17 to ≥13 Years of Age
    Number of subjects analysed
    15
    Units: hour
        arithmetic mean (full range (min-max))
    1.87 (0.4 to 4.5)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Day 1
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.1
    Reporting groups
    Reporting group title
    Cohort 1: Children <17 to ≥13 Years of Age
    Reporting group description
    		 All participants who received study drug in the study are included.

    Serious adverse events
    		 Cohort 1: Children <17 to ≥13 Years of Age
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 16 (6.25%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    Investigations
    Liver function test abnormal
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Cohort 1: Children <17 to ≥13 Years of Age
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    6 / 16 (37.50%)
    Investigations
    Blood pressure systolic increased
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    1
    Hepatic enzyme increased
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    1
    Nervous system disorders
    Dysgeusia
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    1
    Syncope
         subjects affected / exposed
    3 / 16 (18.75%)
         occurrences all number
    3
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    1
    Malaise
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    1
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    2 / 16 (12.50%)
         occurrences all number
    2

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    20 Jul 2010
    This amendment indicated that dosing should be conducted immediately prior to breakfast to ensure consumption of the entire dose, clarified that water could be consumed after dosing, and clarified the blood sampling intervals.
    17 Jun 2011
    This amendment added a new clinical monitor to replace an outgoing monitor, indicated that two instead of one 5mL blood sample should be collected, and indicated that fasting would not be required for the blood sample collected at follow-up.
    27 Jun 2011
    This amendment indicated that a second barrier method of birth control was required and prohibited use of oral contraceptives containing drospirenone.
    28 Mar 2012
    This amendment removed the requirement that participants be naive antiviral/immunomodulatory treatment for HCV infection, clarified that participants with mixed GT HCV infection were not eligible, and indicated that use of ribavirin 90 days prior or interferon-alpha 30 days prior to screening was not allowed.

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    22 Mar 2013
    The oldest age cohort of 17 to ≥13 years of age was completed on 20MAR2013. The trial was terminated prior to enrollment of participants in the two younger age cohorts. In view of the shift in therapy to interferon-free regiments, the FDA and the EMA have been reassessing treatment regimens for pediatric studies of HCV infection. Following discussion with the agencies, in which both concurred that priority should be given to interferon-free regimens, P07614 was terminated and study sites were closed out. For this reason, the end of trial date of 21JAN2014 was the date of official study termination.
    -

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    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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