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

NCT01590225 | Withdrawn Phase 3 DMC

• 2 other identifiers: P080342010-024260-17
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Chronic Hepatitis C

Outcome Measures

Primary Outcomes (3)

• Participants Achieving Sustained Viral Response (SVR) at Follow-Up Week 24 in Study Part A

  Follow-Up Week 24

• Participants Achieving SVR at Follow-Up Week 24 in Study Part B

  Follow-Up Week 24

• Time to Viral Relapse in Study Part C

  Follow-Up Week 24 to 5 Years

Secondary Outcomes (18)

• Proportion of Participants With Alanine Aminotransferase (ALT) Normalization in Study Part A

  Week 2, Week 4, Week 8, Week 12

• Participants With Early Virologic Response in Study Part A

  Week 2, Week 4, Week 8, Week 12

• Proportion of Participants With Undetectable Hepatitis C Virus Ribonucleic Acid (HCV-RNA) in Study Part A

  Week 12, End of Treatment, Follow-Up Week 24

• Proportion of Participants With Undetectable HCV-RNA Who Also Achieved SVR in Study Part A

  Follow-Up Week 12

• Proportion of Participants With Alanine Aminotransferase (ALT) Normalization in Study Part B

  Week 2, Week 4, Week 8, Week 12

Study Arms (2)

Part A: boceprevir + peginterferon alpha-2b + ribavirin

EXPERIMENTAL

Drug: Boceprevir; Drug: Peginterferon alpha-2b; Drug: Ribavirin

Part B: boceprevir + peginterferon alpha-2b + ribavirin

EXPERIMENTAL

Drug: Boceprevir; Drug: Peginterferon alfa-2b; Drug: Ribavirin

Interventions

Boceprevir DRUG

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.

Also known as: Victrelis®, SCH 503034

Part A: boceprevir + peginterferon alpha-2b + ribavirin

Peginterferon alpha-2b DRUG

Peginterferon alpha-2b will be administered subcutaneously at a dose of 60 μg/m\^2 once weekly (QW) for 24 weeks.

Also known as: Pegintron®, Sylatron®

Part A: boceprevir + peginterferon alpha-2b + ribavirin

Ribavirin DRUG

The dose of ribavirin will be approximately 15 mg/kg/day administered orally in two divided doses (twice daily \[BID\]) for 24 weeks.

Also known as: Copegus®, Rebetol®, RibaTab®, Ribasphere®

Part A: boceprevir + peginterferon alpha-2b + ribavirin

Peginterferon alfa-2b DRUG

Peginterferon alpha-2b will be administered subcutaneously at a dose of 60 μg/m\^2 once weekly (QW) for 48 weeks.

Also known as: Pegintron®, Sylatron®

Part B: boceprevir + peginterferon alpha-2b + ribavirin

Eligibility Criteria

• Age: 3 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• CHC GT1 infection for at least 6 months with with HCV-RNA ≥10,000 IU/mL.
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Hepatitis C, Chronic

Interventions

N-(3-amino-1-(cyclobutylmethyl)-2,3-dioxopropyl)-3-(2-((((1,1-dimethylethyl)amino)carbonyl)amino)-3,3-dimethyl-1-oxobutyl)-6,6-dimethyl-3-azabicyclo(3.1.0)hexan-2-carboxamide; peginterferon alfa-2b; Ribavirin

Condition Hierarchy (Ancestors)

Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2012
• First Posted: May 2, 2012
• Study Start: January 28, 2013
• Primary Completion: August 18, 2021
• Study Completion: August 18, 2021
• Last Updated: January 29, 2021

Record last verified: 2021-01