search
Back to results

Pharmacokinetics of Boceprevir in Pediatric Subjects With Chronic Hepatitis C Genotype 1 (P07614)

Primary Purpose

Hepatitis C, Chronic

Status
Terminated
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Boceprevir
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis C, Chronic

Eligibility Criteria

3 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Documented chronic hepatitis C (CHC) genotype 1 infection
  • Treatment naïve or failed previous interferon/ribavirin therapy (≥12 uninterrupted weeks)
  • Weigh between 10 kg to 90 kg inclusive at screening and baseline (Day -1).
  • Body Mass Index (BMI) from the 5th to the 95th percentile for the participant's age and gender, inclusive, per tables from the Center for Disease Control and Prevention, USA
  • Use of acceptable methods of contraception for at least 3 months prior to baseline and continue on study

Exclusion Criteria:

  • Co-infection with the human immunodeficiency virus (HIV) or hepatitis B virus (HBsAg positive).
  • Treatment with ribavirin within 90 days, or any interferon-alfa within 30 days
  • Discontinued from interferon treatment due to adverse events
  • Currently receiving antiviral/immunomodulating therapy for hepatitis C
  • Prior treatment with an HCV protease inhibitor
  • Prior treatment with any known hepatotoxic agent (including herbal remedies)
  • Use of investigational drugs within 30 days of enrollment into study
  • Evidence of de-compensated liver disease including, but not limited to, a history or presence of clinical ascites, bleeding varices, or hepatic encephalopathy.
  • Substance abuse (including but not limited to alcohol abuse, illicit drugs,

inhalational drugs, marijuana use, etc) any time prior to entry into the study

  • Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of any drug.
  • Pregnant or breastfeeding female
  • Meeting any of the laboratory exclusion criteria

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Experimental

    Arm Label

    Cohort 1: Children 17 to ≥13 years

    Cohort 2: Children <13 to ≥7 years

    Cohort 3: Children <7 to ≥3 years

    Arm Description

    Participants were administered a single dose of boceprevir powder mixed in a suitable vehicle such pudding or applesauce. The first 4 participants were treated with a 11.4 mg/kg dose of boceprevir powder. The dose/weight ratio may be adjusted for the next 12 participants based on the evaluation of the PK, safety, and tolerability data from the first 4 participants.

    Participants were administered a single dose of boceprevir powder mixed in a suitable vehicle such as pudding or applesauce. The first 4 participants were treated with boceprevir at a dose contingent on the PK and safety results in Cohort 1. The dose/weight ratio may be adjusted for the next 12 participants based on the evaluation of the PK, safety, and tolerability data from the first 4 participants.

    Participants were administered a single dose of boceprevir powder mixed in a suitable vehicle such as pudding or applesauce. The first 4 participants were treated with boceprevir at a dose contingent on the PK and safety results in Cohort 2. The dose/weight ratio may be adjusted for the next 12 participants based on the evaluation of the PK, safety, and tolerability data from the first 4 participants.

    Outcomes

    Primary Outcome Measures

    Area Under the Plasma Concentration Time Curve (AUC) From 0-Infinity of Single Dose Boceprevir
    Plasma concentrations of boceprevir were determined at 0 (pre-dose), 0.5, 1, 2, 2.5, 4.5, 5.5, 8, and 10 hours post dose.
    Maximum Plasma Concentration (Cmax) of Single Dose Boceprevir
    The maximum observed plasma concentration of boceprevir across sampling intervals was determined.
    Time of Maximum Plasma Concentration (Tmax) of Single Dose Boceprevir
    The time at which the maximum plasma boceprevir concentration was observed.
    Final Dose of Boceprevir By Age Group

    Secondary Outcome Measures

    Full Information

    First Posted
    August 26, 2011
    Last Updated
    August 13, 2018
    Sponsor
    Merck Sharp & Dohme LLC
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT01425190
    Brief Title
    Pharmacokinetics of Boceprevir in Pediatric Subjects With Chronic Hepatitis C Genotype 1 (P07614)
    Official Title
    Assessment of the Pharmacokinetics of Boceprevir in Pediatric Subjects With Chronic Hepatitis C Genotype 1 (Phase 1b); Protocol No. P07614
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2018
    Overall Recruitment Status
    Terminated
    Why Stopped
    The US FDA and the EU CHMP provided guidance indicating preference for intereferon-free regimens in pediatric studies of HCV infection.
    Study Start Date
    January 4, 2012 (Actual)
    Primary Completion Date
    March 20, 2013 (Actual)
    Study Completion Date
    March 20, 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Merck Sharp & Dohme LLC

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This is a study to determine the pharmacokinetics (PK) and weight-based dose of boceprevir following single oral dose administration in Chronic Hepatitis C Virus (HCV) pediatric participants.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hepatitis C, Chronic

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    16 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Cohort 1: Children 17 to ≥13 years
    Arm Type
    Experimental
    Arm Description
    Participants were administered a single dose of boceprevir powder mixed in a suitable vehicle such pudding or applesauce. The first 4 participants were treated with a 11.4 mg/kg dose of boceprevir powder. The dose/weight ratio may be adjusted for the next 12 participants based on the evaluation of the PK, safety, and tolerability data from the first 4 participants.
    Arm Title
    Cohort 2: Children <13 to ≥7 years
    Arm Type
    Experimental
    Arm Description
    Participants were administered a single dose of boceprevir powder mixed in a suitable vehicle such as pudding or applesauce. The first 4 participants were treated with boceprevir at a dose contingent on the PK and safety results in Cohort 1. The dose/weight ratio may be adjusted for the next 12 participants based on the evaluation of the PK, safety, and tolerability data from the first 4 participants.
    Arm Title
    Cohort 3: Children <7 to ≥3 years
    Arm Type
    Experimental
    Arm Description
    Participants were administered a single dose of boceprevir powder mixed in a suitable vehicle such as pudding or applesauce. The first 4 participants were treated with boceprevir at a dose contingent on the PK and safety results in Cohort 2. The dose/weight ratio may be adjusted for the next 12 participants based on the evaluation of the PK, safety, and tolerability data from the first 4 participants.
    Intervention Type
    Drug
    Intervention Name(s)
    Boceprevir
    Other Intervention Name(s)
    SCH 503034
    Intervention Description
    Single dose of boceprevir powder prior to breakfast in a dosing vehicle of chocolate pudding (i.e., a mousse or custard), apple sauce, Nutella, fruit pudding such as strawberry, cherry, or raspberry pudding, or yogurt or a similar semi-solid product into which the boceprevir powder can be evenly stirred
    Primary Outcome Measure Information:
    Title
    Area Under the Plasma Concentration Time Curve (AUC) From 0-Infinity of Single Dose Boceprevir
    Description
    Plasma concentrations of boceprevir were determined at 0 (pre-dose), 0.5, 1, 2, 2.5, 4.5, 5.5, 8, and 10 hours post dose.
    Time Frame
    0 (pre-dose), 0.5, 1, 2, 2.5, 4.5, 5.5, 8, and 10 hours post dose
    Title
    Maximum Plasma Concentration (Cmax) of Single Dose Boceprevir
    Description
    The maximum observed plasma concentration of boceprevir across sampling intervals was determined.
    Time Frame
    0 (pre-dose), 0.5, 1, 2, 2.5, 4.5, 5.5, 8, and 10 hours post dose
    Title
    Time of Maximum Plasma Concentration (Tmax) of Single Dose Boceprevir
    Description
    The time at which the maximum plasma boceprevir concentration was observed.
    Time Frame
    0 (pre-dose), 0.5, 1, 2, 2.5, 4.5, 5.5, 8, and 10 hours post dose
    Title
    Final Dose of Boceprevir By Age Group
    Time Frame
    Day 1

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    3 Years
    Maximum Age & Unit of Time
    17 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Documented chronic hepatitis C (CHC) genotype 1 infection Treatment naïve or failed previous interferon/ribavirin therapy (≥12 uninterrupted weeks) Weigh between 10 kg to 90 kg inclusive at screening and baseline (Day -1). Body Mass Index (BMI) from the 5th to the 95th percentile for the participant's age and gender, inclusive, per tables from the Center for Disease Control and Prevention, USA Use of acceptable methods of contraception for at least 3 months prior to baseline and continue on study Exclusion Criteria: Co-infection with the human immunodeficiency virus (HIV) or hepatitis B virus (HBsAg positive). Treatment with ribavirin within 90 days, or any interferon-alfa within 30 days Discontinued from interferon treatment due to adverse events Currently receiving antiviral/immunomodulating therapy for hepatitis C Prior treatment with an HCV protease inhibitor Prior treatment with any known hepatotoxic agent (including herbal remedies) Use of investigational drugs within 30 days of enrollment into study Evidence of de-compensated liver disease including, but not limited to, a history or presence of clinical ascites, bleeding varices, or hepatic encephalopathy. Substance abuse (including but not limited to alcohol abuse, illicit drugs, inhalational drugs, marijuana use, etc) any time prior to entry into the study Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of any drug. Pregnant or breastfeeding female Meeting any of the laboratory exclusion criteria
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Director
    Organizational Affiliation
    Merck Sharp & Dohme LLC
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
    IPD Sharing URL
    http://engagezone.msd.com/ds_documentation.php
    Available IPD and Supporting Information:
    Available IPD/Information Type
    CSR Synopsis
    Available IPD/Information URL
    http://www.merck.com/clinical-trials/study.html?id=P07614&kw=P07614&tab=access

    Learn more about this trial

    Pharmacokinetics of Boceprevir in Pediatric Subjects With Chronic Hepatitis C Genotype 1 (P07614)

    We'll reach out to this number within 24 hrs