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

• Status: Withdrawn
• Trial end date: 2021-08-18
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Interferon-alpha; Peginterferon alfa-2b; Ribavirin

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