Efficacy and Safety of Boceprevir in Combination With Peginterferon Alfa-2b Plus Ribavirin in Pediatric Subjects With Chronic Hepatitis C Genotype 1 (P08034)

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01590225
First received: May 1, 2012
Last updated: March 16, 2014
Last verified: March 2014
  Purpose

This is 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 will 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 is long-term follow up and no study treatment will be administered during this period, but participants who do not achieve viral clearance will be allowed to receive other treatments for CHC.


Condition Intervention Phase
Chronic Hepatitis C
Drug: Boceprevir
Drug: Peginterferon alpha-2b
Drug: Ribavirin
Drug: Peginterferon alfa-2b
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Participants Achieving Sustained Viral Response (SVR) at Follow-Up Week 24 in Study Part A [ Time Frame: Follow-Up Week 24 ] [ Designated as safety issue: No ]
  • Participants Achieving SVR at Follow-Up Week 24 in Study Part B [ Time Frame: Follow-Up Week 24 ] [ Designated as safety issue: No ]
  • Time to Viral Relapse in Study Part C [ Time Frame: Follow-Up Week 24 to 5 Years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of Participants With Alanine Aminotransferase (ALT) Normalization in Study Part A [ Time Frame: Week 2, Week 4, Week 8, Week 12 ] [ Designated as safety issue: Yes ]
  • Participants With Early Virologic Response in Study Part A [ Time Frame: Week 2, Week 4, Week 8, Week 12 ] [ Designated as safety issue: No ]
  • Proportion of Participants With Undetectable Hepatitis C Virus Ribonucleic Acid (HCV-RNA) in Study Part A [ Time Frame: Week 12, End of Treatment, Follow-Up Week 24 ] [ Designated as safety issue: No ]
  • Proportion of Participants With Undetectable HCV-RNA Who Also Achieved SVR in Study Part A [ Time Frame: Follow-Up Week 12 ] [ Designated as safety issue: No ]
  • Proportion of Participants With Alanine Aminotransferase (ALT) Normalization in Study Part B [ Time Frame: Week 2, Week 4, Week 8, Week 12 ] [ Designated as safety issue: Yes ]
  • Proportion of Participants With Undetectable HCV-RNA in Study Part B [ Time Frame: Week 24, End of Treatment, Follow-Up Week 12 ] [ Designated as safety issue: No ]
  • Proportion of Participants With Undetectable HCV-RNA Who Also Achieved SVR in Study Part B [ Time Frame: Follow-Up Week 12 ] [ Designated as safety issue: No ]
  • Number of Participants Experiencing Treatment-Emergent Adverse Events (AEs) in Study Part A [ Time Frame: Week 1 to Follow-Up Visit 24 ] [ Designated as safety issue: Yes ]
  • Number of Participants Experiencing Treatment-Emergent Treatment-Related AEs in Study Part A [ Time Frame: Week 1 to Follow-Up Week 24 ] [ Designated as safety issue: Yes ]
  • Number of Participants Experiencing Serious AEs (SAEs) in Study Part A [ Time Frame: Week 1 to Follow-Up Week 24 ] [ Designated as safety issue: Yes ]
  • Participants Discontinuing Treatment Due to AEs in Study Part A [ Time Frame: Week 1 to Follow-Up Week 24 ] [ Designated as safety issue: Yes ]
  • Change from Baseline in Participant Laboratory Values in Study Part A [ Time Frame: Baseline to Follow-Up Week 24 ] [ Designated as safety issue: Yes ]
  • Change From Baseline in Participant Vital Signs in Study Part A [ Time Frame: Baseline to Follow-Up Week 24 ] [ Designated as safety issue: Yes ]
  • Number of Participants Experiencing AEs in Study Part B [ Time Frame: Week 1 to Follow-Up Week 24 ] [ Designated as safety issue: Yes ]
  • Number of Participants Experiencing SAEs in Study Part B [ Time Frame: Week 1 to Follow-Up Week 24 ] [ Designated as safety issue: Yes ]
  • Change from Baseline in Participant Laboratory Values in Study Part B [ Time Frame: Week 1 to Follow-Up Week 24 ] [ Designated as safety issue: Yes ]
  • Change From Baseline in Participant Vital Signs in Study Part B [ Time Frame: Week 1 to Follow-Up Week 24 ] [ Designated as safety issue: Yes ]
  • Number of Participants Discontinuing From Study Treatment Due to AEs in Study Part B [ Time Frame: Week 1 to Follow-Up Week 24 ] [ Designated as safety issue: Yes ]

Enrollment: 0
Study Start Date: January 2013
Estimated Study Completion Date: August 2021
Estimated Primary Completion Date: August 2021 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Part A: boceprevir + peginterferon alpha-2b + ribavirin Drug: Boceprevir
Boceprevir will be administered orally at a dose of 11.4 mg/kg three-times daily (TID) for 24 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 subjects in the oldest age group, or to the nearest 100-mg or 200-mg value for the subjects in the two youngest age groups.
Other Names:
  • Victrelis®
  • SCH 503034
Drug: Peginterferon alpha-2b
Peginterferon alpha-2b will be administered subcutaneously at a dose of 60 μg/m^2 once weekly (QW) for 24 weeks.
Other Names:
  • Pegintron®
  • Sylatron®
Drug: Ribavirin
The dose of ribavirin will be approximately 15 mg/kg/day administered orally in two divided doses (twice daily [BID]) for 24 weeks.
Other Names:
  • Copegus®
  • Rebetol®
  • RibaTab®
  • Ribasphere®
Experimental: Part B: boceprevir + peginterferon alpha-2b + ribavirin Drug: Boceprevir
Boceprevir will be administered orally at a dose of 11.4 mg/kg three-times daily (TID) for up to 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 subjects in the oldest age group, or to the nearest 100-mg or 200-mg value for the subjects in the two youngest age groups.
Drug: Peginterferon alfa-2b
Peginterferon alpha-2b will be administered subcutaneously at a dose of 60 μg/m^2 once weekly (QW) for 48 weeks.
Other Names:
  • Pegintron®
  • Sylatron®
Drug: Ribavirin

Drug: Ribavirin

The dose of ribavirin will be approximately 15 mg/kg/day administered orally in two divided doses (twice daily [BID]) for 48 weeks.

Other Names:
  • Copegus®
  • Rebetol®
  • RibaTab®
  • Ribasphere®

  Eligibility

Ages Eligible for Study:   3 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • CHC GT1 infection for at least 6 months with with HCV-RNA ≥10,000 IU/mL.
  • Treatment naive, non-cirrhotic participants will be eligible for inclusion in Study Part A
  • Non-cirrhotic subjects who failed previous (peg)interferon/ribavirin treatment for CHC and cirrhotics, whether treatment naive or treatment failure, will be eligible for inclusion in Study Part B
  • To participate in Study Part C, participants must have completed the required post-treatment follow-up in Study Part A or Part B
  • Weight ≥ 10 kg to ≤ 125 kg
  • Body surface area (BSA) ≥0.46 m^2 and ≤2.5 m^2
  • Previous liver biopsy with histology consistent with chronic hepatitis C and no other etiology within 2 years of the screening visit
  • Participants with bridging fibrosis or cirrhosis must have an ultrasound within 6 months of the screening visit or between the screening visit and Day 1 with no findings suspicious for hepatocellular carcinoma
  • Participant must be able to adhere to dose and visit schedules

Exclusion Criteria:

  • Known co-infection with the the human immunodeficiency virus (HIV) or hepatitis B virus (HBsAg positive)
  • For Study Part A, participant received any prior hepatitis C treatment, including herbal remedies, with known hepatotoxicity
  • For Study Part B, participant received treatment with ribavirin within 90 days or any interferon alpha within 30 days prior to screening
  • For Study Part B, participant received previous treatment with a hepatitis C virus protease inhibitor (excepting participants in study P07614, Pharmacokinetics of Boceprevir in Pediatric Subjects With Chronic Hepatitis C Genotype 1)
  • For Study Part B, participant required discontinuation of previous (peg)interferon/ribavirin therapy for an adverse event considered by the investigator to be related to (peg)interferon and/or ribavirin
  • For Study Part B, participant is currently taking any antiviral/immunomodulatory treatment for hepatitis C
  • Participant has taken any investigational drugs, except boceprevir
  • Participant has received any of the following medication(s) within 2 weeks prior to the Day 1 visit: midazolam, pimozide, amiodarone, flecainide,

propafenone, quinidine, and ergot derivatives (dihydroergotamine, ergonovine,

ergotamine, methylergonovine)

  • Participation in any other clinical trial within 30 days of enrollment or

intent to participate in another clinical trial during participation in the current study

  • Evidence of decompensated liver disease
  • Child Pugh score >6 (class B and C)
  • History of diabetes or hypertension or was born prior to 32 weeks

of gestation and has clinically significant ocular examination findings

  • Pre-existing clinically significant psychiatric condition(s)
  • Clinical diagnosis of substance abuse
  • Any pre-existing medical condition that could interfere with participation in and completion of the study
  • Evidence of active or suspected malignancy
  • Females who are pregnant, nursing, or intend to become pregnant during

the study period

  • Allergy or sensitivity to the investigational products or excipients
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01590225

Locations
United States, Illinois
Call for Information (Investigational Site 0008)
Chicago, Illinois, United States, 60611
United States, Massachusetts
Call for Information (Investigational Site 0006)
Boston, Massachusetts, United States, 02115
United States, Missouri
Call for Information (Investigational Site 0007)
Kansas City, Missouri, United States, 64108
United States, Texas
Call for Information (Investigational Site 0004)
Fort Worth, Texas, United States, 76104
Germany
Merck Sharp & Dohme GmbH
Haar, Germany
Spain
Merck Sharp and Dohme de Espana S.A.
Madrid, Spain
Switzerland
MSD International GmbH
Lucerne 6, Switzerland
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01590225     History of Changes
Other Study ID Numbers: P08034, 2010-024260-17
Study First Received: May 1, 2012
Last Updated: March 16, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis, Chronic
Digestive System Diseases
Enterovirus Infections
Flaviviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Interferon-alpha
Peginterferon alfa-2b
Ribavirin
Anti-Infective Agents
Antimetabolites
Antiviral Agents
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014