Efficacy and Safety of Boceprevir in Combination With Peginterferon Alfa-2b Plus Ribavirin in Pediatric Subjects With Chronic Hepatitis C Genotype 1 (P08034)
Phase 3
Withdrawn
- Conditions
- Chronic Hepatitis C
- Interventions
- Registration Number
- NCT01590225
- Lead Sponsor
- Merck Sharp & Dohme LLC
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part A: boceprevir + peginterferon alpha-2b + ribavirin Peginterferon alpha-2b - Part B: boceprevir + peginterferon alpha-2b + ribavirin Boceprevir - Part B: boceprevir + peginterferon alpha-2b + ribavirin Ribavirin - Part A: boceprevir + peginterferon alpha-2b + ribavirin Boceprevir - Part A: boceprevir + peginterferon alpha-2b + ribavirin Ribavirin - Part B: boceprevir + peginterferon alpha-2b + ribavirin Peginterferon alfa-2b -
- Primary Outcome Measures
Name Time Method Participants Achieving SVR at Follow-Up Week 24 in Study Part B Follow-Up Week 24 Time to Viral Relapse in Study Part C Follow-Up Week 24 to 5 Years Participants Achieving Sustained Viral Response (SVR) at Follow-Up Week 24 in Study Part A Follow-Up Week 24
- Secondary Outcome Measures
Name Time Method Proportion of Participants With Undetectable HCV-RNA in Study Part B Week 24, End of Treatment, Follow-Up Week 12 Proportion of Participants With Undetectable HCV-RNA Who Also Achieved SVR in Study Part B Follow-Up Week 12 Number of Participants Experiencing Treatment-Emergent Adverse Events (AEs) in Study Part A Week 1 to Follow-Up Visit 24 Participants Discontinuing Treatment Due to AEs in Study Part A Week 1 to Follow-Up Week 24 Change from Baseline in Participant Laboratory Values in Study Part A Baseline to Follow-Up Week 24 Number of Participants Experiencing SAEs in Study Part B Week 1 to Follow-Up Week 24 Proportion of Participants With Alanine Aminotransferase (ALT) Normalization in Study Part A Week 2, Week 4, Week 8, Week 12 Number of Participants Discontinuing From Study Treatment Due to AEs in Study Part B Week 1 to Follow-Up Week 24 Participants With Early Virologic Response in Study Part A Week 2, Week 4, Week 8, Week 12 Proportion of Participants With Undetectable Hepatitis C Virus Ribonucleic Acid (HCV-RNA) in Study Part A Week 12, End of Treatment, Follow-Up Week 24 Proportion of Participants With Undetectable HCV-RNA Who Also Achieved SVR in Study Part A Follow-Up Week 12 Proportion of Participants With Alanine Aminotransferase (ALT) Normalization in Study Part B Week 2, Week 4, Week 8, Week 12 Number of Participants Experiencing Treatment-Emergent Treatment-Related AEs in Study Part A Week 1 to Follow-Up Week 24 Number of Participants Experiencing Serious AEs (SAEs) in Study Part A Week 1 to Follow-Up Week 24 Change From Baseline in Participant Vital Signs in Study Part A Baseline to Follow-Up Week 24 Number of Participants Experiencing AEs in Study Part B Week 1 to Follow-Up Week 24 Change from Baseline in Participant Laboratory Values in Study Part B Week 1 to Follow-Up Week 24 Change From Baseline in Participant Vital Signs in Study Part B Week 1 to Follow-Up Week 24