NCT01590225

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

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

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 3 Years – 17 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.
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.
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.
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.
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.

Timeline

• Start date: 2013-01-28
• Primary completion: 2021-08-18
• Completion: 2021-08-18
• First posted: 2012-05-02
• Last updated: 2021-01-29