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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-023498-20 | EudraCT Number | ||
| MK-3034-063 | Other Identifier | Merck |
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The US FDA and the EU CHMP provided guidance indicating preference for intereferon-free regimens in pediatric studies of HCV infection.
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This is a study to determine the pharmacokinetics (PK) and weight-based dose of boceprevir following single oral dose administration in Chronic Hepatitis C Virus (HCV) pediatric participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: Children 17 to ≥13 years | Experimental | Participants were administered a single dose of boceprevir powder mixed in a suitable vehicle such pudding or applesauce. The first 4 participants were treated with a 11.4 mg/kg dose of boceprevir powder. The dose/weight ratio may be adjusted for the next 12 participants based on the evaluation of the PK, safety, and tolerability data from the first 4 participants. |
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| Cohort 2: Children <13 to ≥7 years | Experimental | Participants were administered a single dose of boceprevir powder mixed in a suitable vehicle such as pudding or applesauce. The first 4 participants were treated with boceprevir at a dose contingent on the PK and safety results in Cohort 1. The dose/weight ratio may be adjusted for the next 12 participants based on the evaluation of the PK, safety, and tolerability data from the first 4 participants. |
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| Cohort 3: Children <7 to ≥3 years | Experimental | Participants were administered a single dose of boceprevir powder mixed in a suitable vehicle such as pudding or applesauce. The first 4 participants were treated with boceprevir at a dose contingent on the PK and safety results in Cohort 2. The dose/weight ratio may be adjusted for the next 12 participants based on the evaluation of the PK, safety, and tolerability data from the first 4 participants. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Boceprevir | Drug | Single dose of boceprevir powder prior to breakfast in a dosing vehicle of chocolate pudding (i.e., a mousse or custard), apple sauce, Nutella, fruit pudding such as strawberry, cherry, or raspberry pudding, or yogurt or a similar semi-solid product into which the boceprevir powder can be evenly stirred |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Plasma Concentration Time Curve (AUC) From 0-Infinity of Single Dose Boceprevir | Plasma concentrations of boceprevir were determined at 0 (pre-dose), 0.5, 1, 2, 2.5, 4.5, 5.5, 8, and 10 hours post dose. | 0 (pre-dose), 0.5, 1, 2, 2.5, 4.5, 5.5, 8, and 10 hours post dose |
| Maximum Plasma Concentration (Cmax) of Single Dose Boceprevir | The maximum observed plasma concentration of boceprevir across sampling intervals was determined. | 0 (pre-dose), 0.5, 1, 2, 2.5, 4.5, 5.5, 8, and 10 hours post dose |
| Time of Maximum Plasma Concentration (Tmax) of Single Dose Boceprevir | The time at which the maximum plasma boceprevir concentration was observed. | 0 (pre-dose), 0.5, 1, 2, 2.5, 4.5, 5.5, 8, and 10 hours post dose |
| Final Dose of Boceprevir By Age Group | Day 1 |
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Inclusion Criteria:
Exclusion Criteria:
inhalational drugs, marijuana use, etc) any time prior to entry into the study
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
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| ID | Type | URL | Comment |
|---|---|---|---|
| CSR Synopsis | View IPD |
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This study originally intended to enroll 3 age-based pediatric cohorts. However the study was terminated after the completion of Cohort 1. No participants were enrolled in either Cohorts 2 or 3. Only data from Cohort 1 was collected.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1: Children 17 to ≥13 Years | Participants were administered a single dose of boceprevir powder mixed in a suitable vehicle such pudding or applesauce. The first 4 participants were treated with a 11.4 mg/kg dose of boceprevir powder. The dose/weight ratio may be adjusted for the next 12 participants based on the evaluation of the PK, safety, and tolerability data from the first 4 participants. |
| FG001 | Cohort 2: Children <13 to ≥7 Years | Participants were administered a single dose of boceprevir powder mixed in a suitable vehicle such as pudding or applesauce. The first 4 participants were treated with boceprevir at a dose contingent on the PK and safety results in Cohort 1. The dose/weight ratio may be adjusted for the next 12 participants based on the evaluation of the PK, safety, and tolerability data from the first 4 participants. |
| FG002 | Cohort 3: Children <7 to ≥3 Years | Participants were administered a single dose of boceprevir powder mixed in a suitable vehicle such as pudding or applesauce. The first 4 participants were treated with boceprevir at a dose contingent on the PK and safety results in Cohort 2. The dose/weight ratio may be adjusted for the next 12 participants based on the evaluation of the PK, safety, and tolerability data from the first 4 participants. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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The Baseline Population includes all participants in Cohort 1 that received boceprevir. The trial was terminated prior to enrolling participants in either Cohorts 2 or 3.
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1: Children 17 to ≥13 Years | Participants were administered a single dose of boceprevir powder mixed in a suitable vehicle such pudding or applesauce. The first 4 participants were treated with a 11.4 mg/kg dose of boceprevir powder. The dose/weight ratio may be adjusted for the next 12 participants based on the evaluation of the PK, safety, and tolerability data from the first 4 participants. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Area Under the Plasma Concentration Time Curve (AUC) From 0-Infinity of Single Dose Boceprevir | Plasma concentrations of boceprevir were determined at 0 (pre-dose), 0.5, 1, 2, 2.5, 4.5, 5.5, 8, and 10 hours post dose. | The Per Protocol (PP) population includes all participants who complied with the protocol sufficiently to ensure that data for this assessment were likely to exhibit the effects of treatment, according to the underlying scientific model. | Posted | Mean | Full Range | ng hr/mL | 0 (pre-dose), 0.5, 1, 2, 2.5, 4.5, 5.5, 8, and 10 hours post dose |
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Nonserious adverse events (AEs) and serious AEs (SAEs) were collected during the time of boceprevir administration until the final PK sample was collected on Day 1.
AEs were monitored in the All Subjects as Treated (all boceprevir-treated participants) population.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort 1: Children 17 to ≥13 Years | Participants were administered a single dose of boceprevir powder mixed in a suitable vehicle such pudding or applesauce. The first 4 participants were treated with a 11.4 mg/kg dose of boceprevir powder. The dose/weight ratio may be adjusted for the next 12 participants based on the evaluation of the PK, safety, and tolerability data from the first 4 participants. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Alanine aminotransferase increased | Investigations | MedDRA v. 16.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA v.17.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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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 |
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|
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| BG001 | Cohort 2: Children <13 to ≥7 Years | Participants were administered a single dose of boceprevir powder mixed in a suitable vehicle such as pudding or applesauce. The first 4 participants were treated with boceprevir at a dose contingent on the PK and safety results in Cohort 1. The dose/weight ratio may be adjusted for the next 12 participants based on the evaluation of the PK, safety, and tolerability data from the first 4 participants. |
| BG002 | Cohort 3: Children <7 to ≥3 Years | Participants were administered a single dose of boceprevir powder mixed in a suitable vehicle such as pudding or applesauce. The first 4 participants were treated with boceprevir at a dose contingent on the PK and safety results in Cohort 2. The dose/weight ratio may be adjusted for the next 12 participants based on the evaluation of the PK, safety, and tolerability data from the first 4 participants. |
| BG003 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| OG001 | Cohort 2: Children <13 to ≥7 Years | Participants were administered a single dose of boceprevir powder mixed in a suitable vehicle such as pudding or applesauce. The first 4 participants were treated with boceprevir at a dose contingent on the PK and safety results in Cohort 1. The dose/weight ratio may be adjusted for the next 12 participants based on the evaluation of the PK, safety, and tolerability data from the first 4 participants. |
| OG002 | Cohort 3: Children <7 to ≥3 Years | Participants were administered a single dose of boceprevir powder mixed in a suitable vehicle such as pudding or applesauce. The first 4 participants were treated with boceprevir at a dose contingent on the PK and safety results in Cohort 2. The dose/weight ratio may be adjusted for the next 12 participants based on the evaluation of the PK, safety, and tolerability data from the first 4 participants. |
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| Primary | Maximum Plasma Concentration (Cmax) of Single Dose Boceprevir | The maximum observed plasma concentration of boceprevir across sampling intervals was determined. | The Per Protocol (PP) population includes all participants who complied with the protocol sufficiently to ensure that data for this assessment were likely to exhibit the effects of treatment, according to the underlying scientific model. | Posted | Mean | Full Range | ng/mL | 0 (pre-dose), 0.5, 1, 2, 2.5, 4.5, 5.5, 8, and 10 hours post dose |
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| Primary | Time of Maximum Plasma Concentration (Tmax) of Single Dose Boceprevir | The time at which the maximum plasma boceprevir concentration was observed. | The Per Protocol (PP) population includes all participants who complied with the protocol sufficiently to ensure that data for this assessment were likely to exhibit the effects of treatment, according to the underlying scientific model. | Posted | Mean | Full Range | Hour | 0 (pre-dose), 0.5, 1, 2, 2.5, 4.5, 5.5, 8, and 10 hours post dose |
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| Primary | Final Dose of Boceprevir By Age Group | This outcome measure could not be analyzed due to termination of the study prior to enrolling Cohorts 2 and 3. | Posted | Day 1 |
|
|
| 1 |
| 16 |
| 6 |
| 16 |
| EG001 | Cohort 2: Children <13 to ≥7 Years | Participants were administered a single dose of boceprevir powder mixed in a suitable vehicle such as pudding or applesauce. The first 4 participants were treated with boceprevir at a dose contingent on the PK and safety results in Cohort 1. The dose/weight ratio may be adjusted for the next 12 participants based on the evaluation of the PK, safety, and tolerability data from the first 4 participants. | 0 | 0 | 0 | 0 |
| EG002 | Cohort 3: Children <7 to ≥3 Years | Participants were administered a single dose of boceprevir powder mixed in a suitable vehicle such as pudding or applesauce. The first 4 participants were treated with boceprevir at a dose contingent on the PK and safety results in Cohort 2. The dose/weight ratio may be adjusted for the next 12 participants based on the evaluation of the PK, safety, and tolerability data from the first 4 participants. | 0 | 0 | 0 | 0 |
| Liver function test abnormal | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA v.17.0 | Systematic Assessment |
|
| Malaise | General disorders | MedDRA v.17.0 | Systematic Assessment |
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| Blood pressure systolic increased | Investigations | MedDRA v.17.0 | Systematic Assessment |
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| Hepatic enzyme increased | Investigations | MedDRA v.17.0 | Systematic Assessment |
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| Dysgeusia | Nervous system disorders | MedDRA v.17.0 | Systematic Assessment |
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| Syncope | Nervous system disorders | MedDRA v.17.0 | Systematic Assessment |
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The investigator agrees not to publish or publicly present any interim results of the trial without the prior written consent of the sponsor. The investigator further agrees to provide to the sponsor 45 days prior to submission for publication or presentation, review copies of abstracts or manuscripts for publication.
| 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 |