Clinical trial NCT01590225: Efficacy and Safety of Boceprevir in Combination With Peginterferon Alfa-2b Plus Ribavirin in Pediatric Subjects With Chronic Hepatitis C Genotype 1 (P08034)
Official title: 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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Chronic Hepatitis C
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2012-05-02
Enrollment: 0
Sex: ALL
Minimum age (years): 3
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Participants Achieving Sustained Viral Response (SVR) at Follow-Up Week 24 in Study Part A
timeFrame: Follow-Up Week 24
measure: Participants Achieving SVR at Follow-Up Week 24 in Study Part B
timeFrame: Follow-Up Week 24
measure: Time to Viral Relapse in Study Part C
timeFrame: Follow-Up Week 24 to 5 Years
Secondary outcomes:
measure: Proportion of Participants With Alanine Aminotransferase (ALT) Normalization in Study Part A
timeFrame: Week 2, Week 4, Week 8, Week 12
measure: Participants With Early Virologic Response in Study Part A
timeFrame: Week 2, Week 4, Week 8, Week 12
measure: Proportion of Participants With Undetectable Hepatitis C Virus Ribonucleic Acid (HCV-RNA) in Study Part A
timeFrame: Week 12, End of Treatment, Follow-Up Week 24
measure: Proportion of Participants With Undetectable HCV-RNA Who Also Achieved SVR in Study Part A
timeFrame: Follow-Up Week 12
measure: Proportion of Participants With Alanine Aminotransferase (ALT) Normalization in Study Part B
timeFrame: Week 2, Week 4, Week 8, Week 12
measure: Proportion of Participants With Undetectable HCV-RNA in Study Part B
timeFrame: Week 24, End of Treatment, Follow-Up Week 12
measure: Proportion of Participants With Undetectable HCV-RNA Who Also Achieved SVR in Study Part B
timeFrame: Follow-Up Week 12
measure: Number of Participants Experiencing Treatment-Emergent Adverse Events (AEs) in Study Part A
timeFrame: Week 1 to Follow-Up Visit 24
measure: Number of Participants Experiencing Treatment-Emergent Treatment-Related AEs in Study Part A
timeFrame: Week 1 to Follow-Up Week 24
measure: Number of Participants Experiencing Serious AEs (SAEs) in Study Part A
timeFrame: Week 1 to Follow-Up Week 24
measure: Participants Discontinuing Treatment Due to AEs in Study Part A
timeFrame: Week 1 to Follow-Up Week 24
measure: Change from Baseline in Participant Laboratory Values in Study Part A
timeFrame: Baseline to Follow-Up Week 24
measure: Change From Baseline in Participant Vital Signs in Study Part A
timeFrame: Baseline to Follow-Up Week 24
measure: Number of Participants Experiencing AEs in Study Part B
timeFrame: Week 1 to Follow-Up Week 24
measure: Number of Participants Experiencing SAEs in Study Part B
timeFrame: Week 1 to Follow-Up Week 24
measure: Change from Baseline in Participant Laboratory Values in Study Part B
timeFrame: Week 1 to Follow-Up Week 24
measure: Change From Baseline in Participant Vital Signs in Study Part B
timeFrame: Week 1 to Follow-Up Week 24
measure: Number of Participants Discontinuing From Study Treatment Due to AEs in Study Part B
timeFrame: Week 1 to Follow-Up Week 24
Other outcomes:
Locations:
Study officials:
References: