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

This study has been terminated.
(The US FDA and the EU CHMP provided guidance indicating preference for intereferon-free regimens in pediatric studies of HCV infection.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01425190
First Posted: August 29, 2011
Last Update Posted: April 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
  Purpose
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.

Condition Intervention Phase
Hepatitis C, Chronic Drug: Boceprevir Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Assessment of the Pharmacokinetics of Boceprevir in Pediatric Subjects With Chronic Hepatitis C Genotype 1 (Phase 1b); Protocol No. P07614

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Area Under the Plasma Concentration Time Curve (AUC) From 0-Infinity of Single Dose Boceprevir [ Time Frame: 0 (pre-dose), 0.5, 1, 2, 2.5, 4.5, 5.5, 8, and 10 hours post dose ]
    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 [ Time Frame: 0 (pre-dose), 0.5, 1, 2, 2.5, 4.5, 5.5, 8, and 10 hours post dose ]
    The maximum observed plasma concentration of boceprevir across sampling intervals was determined.

  • Time of Maximum Plasma Concentration (Tmax) of Single Dose Boceprevir [ Time Frame: 0 (pre-dose), 0.5, 1, 2, 2.5, 4.5, 5.5, 8, and 10 hours post dose ]
    The time at which the maximum plasma boceprevir concentration was observed.

  • Final Dose of Boceprevir By Age Group [ Time Frame: Day 1 ]

Enrollment: 16
Study Start Date: January 2012
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort 1: Children 17 to ≥13 years
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.
Drug: Boceprevir
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
Other Name: SCH 503034
Experimental: Cohort 2: Children <13 to ≥7 years
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.
Drug: Boceprevir
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
Other Name: SCH 503034
Experimental: Cohort 3: Children <7 to ≥3 years
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.
Drug: Boceprevir
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
Other Name: SCH 503034

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01425190


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Director Merck Sharp & Dohme Corp.
  More Information

Study Data/Documents: CSR Synopsis  This link exits the ClinicalTrials.gov site

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01425190     History of Changes
Other Study ID Numbers: P07614
2010-023498-20 ( EudraCT Number )
MK-3034-063 ( Other Identifier: Merck )
First Submitted: August 26, 2011
First Posted: August 29, 2011
Results First Submitted: October 3, 2014
Results First Posted: October 8, 2014
Last Update Posted: April 7, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf

http://engagezone.msd.com/ds_documentation.php


Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis, Chronic
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections