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

NCT ID: NCT01590225

Last Updated: 2021-01-29

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-28
• Study Completion Date: 2021-08-18

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Boceprevir

Intervention Type: 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.

Peginterferon alpha-2b

Intervention Type: DRUG

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

Ribavirin

Intervention Type: DRUG

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

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

Group Type: EXPERIMENTAL

Boceprevir

Intervention Type: DRUG

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.

Peginterferon alfa-2b

Intervention Type: DRUG

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

Ribavirin

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Victrelis®; SCH 503034; Pegintron®; Sylatron®; Copegus®; Rebetol®; RibaTab®; Ribasphere®; Pegintron®; Sylatron®; Copegus®; Rebetol®; RibaTab®; Ribasphere®

Eligibility 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

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

2010-024260-17

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

P08034

Identifier Type: -

Identifier Source: org_study_id