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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-024260-17 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: boceprevir + peginterferon alpha-2b + ribavirin | Experimental |
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| Part B: boceprevir + peginterferon alpha-2b + ribavirin | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Boceprevir | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Participants Achieving Sustained Viral Response (SVR) at Follow-Up Week 24 in Study Part A | Follow-Up Week 24 | |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants With Alanine Aminotransferase (ALT) Normalization in Study Part A | Week 2, Week 4, Week 8, Week 12 | |
| Participants With Early Virologic Response in Study Part A | Week 2, Week 4, Week 8, Week 12 |
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Inclusion Criteria:
Exclusion Criteria:
propafenone, quinidine, and ergot derivatives (dihydroergotamine, ergonovine,
ergotamine, methylergonovine)
intent to participate in another clinical trial during participation in the current study
of gestation and has clinically significant ocular examination findings
the study period
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| Peginterferon alpha-2b | Drug | Peginterferon alpha-2b will be administered subcutaneously at a dose of 60 μg/m^2 once weekly (QW) for 24 weeks. |
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| Ribavirin | Drug | The dose of ribavirin will be approximately 15 mg/kg/day administered orally in two divided doses (twice daily [BID]) for 24 weeks. |
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| Boceprevir | Drug | 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. |
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| Peginterferon alfa-2b | Drug | Peginterferon alpha-2b will be administered subcutaneously at a dose of 60 μg/m^2 once weekly (QW) for 48 weeks. |
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| Ribavirin | Drug | 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. |
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| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Number of Participants Experiencing SAEs 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 |
| Number of Participants Discontinuing From Study Treatment Due to AEs in Study Part B | Week 1 to Follow-Up Week 24 |
| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C512204 | N-(3-amino-1-(cyclobutylmethyl)-2,3-dioxopropyl)-3-(2-((((1,1-dimethylethyl)amino)carbonyl)amino)-3,3-dimethyl-1-oxobutyl)-6,6-dimethyl-3-azabicyclo(3.1.0)hexan-2-carboxamide |
| C417083 | peginterferon alfa-2b |
| D012254 | Ribavirin |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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