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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
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 will be administered subcutaneously at a dose of 60 μg/m\^2 once weekly (QW) for 24 weeks.
The dose of ribavirin will be approximately 15 mg/kg/day administered orally in two divided doses (twice daily \[BID\]) for 24 weeks.
Participants Achieving Sustained Viral Response (SVR) at Follow-Up Week 24 in Study Part A
Time frame: Follow-Up Week 24
Participants Achieving SVR at Follow-Up Week 24 in Study Part B
Time frame: Follow-Up Week 24
Time to Viral Relapse in Study Part C
Time frame: Follow-Up Week 24 to 5 Years
Proportion of Participants With Alanine Aminotransferase (ALT) Normalization in Study Part A
Time frame: Week 2, Week 4, Week 8, Week 12
Participants With Early Virologic Response in Study Part A
Time frame: Week 2, Week 4, Week 8, Week 12
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
Proportion of Participants With Undetectable HCV-RNA Who Also Achieved SVR in Study Part A
Time frame: Follow-Up Week 12
Proportion of Participants With Alanine Aminotransferase (ALT) Normalization in Study Part B
Time frame: Week 2, Week 4, Week 8, Week 12
Proportion of Participants With Undetectable HCV-RNA in Study Part B
Time frame: Week 24, End of Treatment, Follow-Up Week 12
Proportion of Participants With Undetectable HCV-RNA Who Also Achieved SVR in Study Part B
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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 alpha-2b will be administered subcutaneously at a dose of 60 μg/m\^2 once weekly (QW) for 48 weeks.
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.
Time frame: Follow-Up Week 12
Number of Participants Experiencing Treatment-Emergent Adverse Events (AEs) in Study Part A
Time frame: Week 1 to Follow-Up Visit 24
Number of Participants Experiencing Treatment-Emergent Treatment-Related AEs in Study Part A
Time frame: Week 1 to Follow-Up Week 24
Number of Participants Experiencing Serious AEs (SAEs) in Study Part A
Time frame: Week 1 to Follow-Up Week 24
Participants Discontinuing Treatment Due to AEs in Study Part A
Time frame: Week 1 to Follow-Up Week 24
Change from Baseline in Participant Laboratory Values in Study Part A
Time frame: Baseline to Follow-Up Week 24
Change From Baseline in Participant Vital Signs in Study Part A
Time frame: Baseline to Follow-Up Week 24
Number of Participants Experiencing AEs in Study Part B
Time frame: Week 1 to Follow-Up Week 24
Number of Participants Experiencing SAEs in Study Part B
Time frame: Week 1 to Follow-Up Week 24
Change from Baseline in Participant Laboratory Values in Study Part B
Time frame: Week 1 to Follow-Up Week 24
Change From Baseline in Participant Vital Signs in Study Part B
Time frame: Week 1 to Follow-Up Week 24
Number of Participants Discontinuing From Study Treatment Due to AEs in Study Part B
Time frame: Week 1 to Follow-Up Week 24