Back to resultsEfficacy and Safety of Boceprevir in Combination With Peginterferon Alfa-2b Plus Ribavirin in Pediatric Subjects With Chronic Hepatitis C Genotype 1 (P08034)
Primary Purpose
Chronic Hepatitis C
Status
Withdrawn
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Boceprevir
Peginterferon alpha-2b
Ribavirin
Boceprevir
Peginterferon alfa-2b
Ribavirin
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Hepatitis C
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Part A: boceprevir + peginterferon alpha-2b + ribavirin
Part B: boceprevir + peginterferon alpha-2b + ribavirin
Arm Description
Outcomes
Primary Outcome Measures
Participants Achieving Sustained Viral Response (SVR) at Follow-Up Week 24 in Study Part A
Participants Achieving SVR at Follow-Up Week 24 in Study Part B
Time to Viral Relapse in Study Part C
Secondary Outcome Measures
Proportion of Participants With Alanine Aminotransferase (ALT) Normalization in Study Part A
Participants With Early Virologic Response in Study Part A
Proportion of Participants With Undetectable Hepatitis C Virus Ribonucleic Acid (HCV-RNA) in Study Part A
Proportion of Participants With Undetectable HCV-RNA Who Also Achieved SVR in Study Part A
Proportion of Participants With Alanine Aminotransferase (ALT) Normalization in Study Part B
Proportion of Participants With Undetectable HCV-RNA in Study Part B
Proportion of Participants With Undetectable HCV-RNA Who Also Achieved SVR in Study Part B
Number of Participants Experiencing Treatment-Emergent Adverse Events (AEs) in Study Part A
Number of Participants Experiencing Treatment-Emergent Treatment-Related AEs in Study Part A
Number of Participants Experiencing Serious AEs (SAEs) in Study Part A
Participants Discontinuing Treatment Due to AEs in Study Part A
Change from Baseline in Participant Laboratory Values in Study Part A
Change From Baseline in Participant Vital Signs in Study Part A
Number of Participants Experiencing AEs in Study Part B
Number of Participants Experiencing SAEs in Study Part B
Change from Baseline in Participant Laboratory Values in Study Part B
Change From Baseline in Participant Vital Signs in Study Part B
Number of Participants Discontinuing From Study Treatment Due to AEs in Study Part B
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01590225
Brief Title
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
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Withdrawn
Study Start Date
January 28, 2013 (Actual)
Primary Completion Date
August 18, 2021 (Anticipated)
Study Completion Date
August 18, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis C
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Part A: boceprevir + peginterferon alpha-2b + ribavirin
Arm Type
Experimental
Arm Title
Part B: boceprevir + peginterferon alpha-2b + ribavirin
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Boceprevir
Other Intervention Name(s)
Victrelis®, SCH 503034
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Peginterferon alpha-2b
Other Intervention Name(s)
Pegintron®, Sylatron®
Intervention Description
Peginterferon alpha-2b will be administered subcutaneously at a dose of 60 μg/m^2 once weekly (QW) for 24 weeks.
Intervention Type
Drug
Intervention Name(s)
Ribavirin
Other Intervention Name(s)
Copegus®, Rebetol®, RibaTab®, Ribasphere®
Intervention Description
The dose of ribavirin will be approximately 15 mg/kg/day administered orally in two divided doses (twice daily [BID]) for 24 weeks.
Intervention Type
Drug
Intervention Name(s)
Boceprevir
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Peginterferon alfa-2b
Other Intervention Name(s)
Pegintron®, Sylatron®
Intervention Description
Peginterferon alpha-2b will be administered subcutaneously at a dose of 60 μg/m^2 once weekly (QW) for 48 weeks.
Intervention Type
Drug
Intervention Name(s)
Ribavirin
Other Intervention Name(s)
Copegus®, Rebetol®, RibaTab®, Ribasphere®
Intervention Description
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.
Primary Outcome Measure Information:
Title
Participants Achieving Sustained Viral Response (SVR) at Follow-Up Week 24 in Study Part A
Time Frame
Follow-Up Week 24
Title
Participants Achieving SVR at Follow-Up Week 24 in Study Part B
Time Frame
Follow-Up Week 24
Title
Time to Viral Relapse in Study Part C
Time Frame
Follow-Up Week 24 to 5 Years
Secondary Outcome Measure Information:
Title
Proportion of Participants With Alanine Aminotransferase (ALT) Normalization in Study Part A
Time Frame
Week 2, Week 4, Week 8, Week 12
Title
Participants With Early Virologic Response in Study Part A
Time Frame
Week 2, Week 4, Week 8, Week 12
Title
Proportion of Participants With Undetectable Hepatitis C Virus Ribonucleic Acid (HCV-RNA) in Study Part A
Time Frame
Week 12, End of Treatment, Follow-Up Week 24
Title
Proportion of Participants With Undetectable HCV-RNA Who Also Achieved SVR in Study Part A
Time Frame
Follow-Up Week 12
Title
Proportion of Participants With Alanine Aminotransferase (ALT) Normalization in Study Part B
Time Frame
Week 2, Week 4, Week 8, Week 12
Title
Proportion of Participants With Undetectable HCV-RNA in Study Part B
Time Frame
Week 24, End of Treatment, Follow-Up Week 12
Title
Proportion of Participants With Undetectable HCV-RNA Who Also Achieved SVR in Study Part B
Time Frame
Follow-Up Week 12
Title
Number of Participants Experiencing Treatment-Emergent Adverse Events (AEs) in Study Part A
Time Frame
Week 1 to Follow-Up Visit 24
Title
Number of Participants Experiencing Treatment-Emergent Treatment-Related AEs in Study Part A
Time Frame
Week 1 to Follow-Up Week 24
Title
Number of Participants Experiencing Serious AEs (SAEs) in Study Part A
Time Frame
Week 1 to Follow-Up Week 24
Title
Participants Discontinuing Treatment Due to AEs in Study Part A
Time Frame
Week 1 to Follow-Up Week 24
Title
Change from Baseline in Participant Laboratory Values in Study Part A
Time Frame
Baseline to Follow-Up Week 24
Title
Change From Baseline in Participant Vital Signs in Study Part A
Time Frame
Baseline to Follow-Up Week 24
Title
Number of Participants Experiencing AEs in Study Part B
Time Frame
Week 1 to Follow-Up Week 24
Title
Number of Participants Experiencing SAEs in Study Part B
Time Frame
Week 1 to Follow-Up Week 24
Title
Change from Baseline in Participant Laboratory Values in Study Part B
Time Frame
Week 1 to Follow-Up Week 24
Title
Change From Baseline in Participant Vital Signs in Study Part B
Time Frame
Week 1 to Follow-Up Week 24
Title
Number of Participants Discontinuing From Study Treatment Due to AEs in Study Part B
Time Frame
Week 1 to Follow-Up Week 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of Boceprevir in Combination With Peginterferon Alfa-2b Plus Ribavirin in Pediatric Subjects With Chronic Hepatitis C Genotype 1 (P08034)
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