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

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