Clinical Trial Results:
Assessment of the Pharmacokinetics of Boceprevir in Pediatric Subjects with Chronic Hepatitis C Genotype 1 (Phase 1b); Protocol No. P07614
Summary
|
|
EudraCT number |
2010-023498-20 |
Trial protocol |
GB PL ES DE Outside EU/EEA |
Global end of trial date |
21 Jan 2014
|
Results information
|
|
Results version number |
v1(current) |
This version publication date |
05 Apr 2016
|
First version publication date |
05 Jul 2015
|
Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
|
|||
Trial identification
|
|||
Sponsor protocol code |
P07614
|
||
Additional study identifiers
|
|||
ISRCTN number |
- | ||
US NCT number |
NCT01425190 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
|
|||
Sponsor organisation name |
Merck Sharp & Dohme Corp.
|
||
Sponsor organisation address |
2000 Galloping Hill Road, Kenilworth, NJ, United States, 07033
|
||
Public contact |
Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.com
|
||
Scientific contact |
Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.com
|
||
Paediatric regulatory details
|
|||
Is trial part of an agreed paediatric investigation plan (PIP) |
Yes
|
||
EMA paediatric investigation plan number(s) |
EMEA-000583-PIP09-05 | ||
Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
|
||
Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
Yes
|
||
Results analysis stage
|
|||
Analysis stage |
Final
|
||
Date of interim/final analysis |
20 Mar 2013
|
||
Is this the analysis of the primary completion data? |
Yes
|
||
Primary completion date |
20 Mar 2013
|
||
Global end of trial reached? |
Yes
|
||
Global end of trial date |
21 Jan 2014
|
||
Was the trial ended prematurely? |
Yes
|
||
General information about the trial
|
|||
Main objective of the trial |
The objective of this study was to determine weight based doses of boceprevir for children 3 to 17 years of age in 3 separate age-based cohorts.
|
||
Protection of trial subjects |
This study was conducted in conformance with Good Clinical Practice standards and applicable country and/or local statutes and regulations regarding ethical committee review, informed consent, and the protection of human subjects participating in biomedical research.
|
||
Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
04 Jan 2012
|
||
Long term follow-up planned |
No
|
||
Independent data monitoring committee (IDMC) involvement? |
No
|
||
Population of trial subjects
|
|||
Number of subjects enrolled per country |
|||
Country: Number of subjects enrolled |
Poland: 6
|
||
Country: Number of subjects enrolled |
Spain: 1
|
||
Country: Number of subjects enrolled |
United Kingdom: 5
|
||
Country: Number of subjects enrolled |
Germany: 3
|
||
Country: Number of subjects enrolled |
United States: 1
|
||
Worldwide total number of subjects |
16
|
||
EEA total number of subjects |
15
|
||
Number of subjects enrolled per age group |
|||
In utero |
0
|
||
Preterm newborn - gestational age < 37 wk |
0
|
||
Newborns (0-27 days) |
0
|
||
Infants and toddlers (28 days-23 months) |
0
|
||
Children (2-11 years) |
0
|
||
Adolescents (12-17 years) |
16
|
||
Adults (18-64 years) |
0
|
||
From 65 to 84 years |
0
|
||
85 years and over |
0
|
|
|||||||||||
Recruitment
|
|||||||||||
Recruitment details |
The study was designed to assess the pharmacokinetics (PK) of boceprevir in pediatric participants infected with Hepatitis C virus (HCV) genotype (GT) 1 across 3 age-based cohorts (Cohort 1: 17 to ≥13 years; Cohort 2: >13 to ≥7 years; Cohort 3: >3 to ≥7 years). | ||||||||||
Pre-assignment
|
|||||||||||
Screening details |
This study enrolled pediatric participants between the ages of 3 to 17 years who were infected with HCV GT1. | ||||||||||
Period 1
|
|||||||||||
Period 1 title |
Boceprevir Administration (overall period)
|
||||||||||
Is this the baseline period? |
Yes | ||||||||||
Allocation method |
Not applicable
|
||||||||||
Blinding used |
Not blinded | ||||||||||
Blinding implementation details |
This was an open-label study.
|
||||||||||
Arms
|
|||||||||||
Arm title
|
Cohort 1: Children <17 to ≥13 Years of Age | ||||||||||
Arm description |
Pediatric HCV-infected participants <17 to ≥13 years of age were administered a single weight-based dose of boceprevir on Day 1. | ||||||||||
Arm type |
Experimental | ||||||||||
Investigational medicinal product name |
Boceprevir
|
||||||||||
Investigational medicinal product code |
|||||||||||
Other name |
Victrelis™
|
||||||||||
Pharmaceutical forms |
Powder for oral solution
|
||||||||||
Routes of administration |
Oral use
|
||||||||||
Dosage and administration details |
Boceprevir was supplied as a powder to be dispensed in a suitable dosing vehicle (e.g., applesauce, Nutella, pudding). For each participant, dose was calculated by multiplying body weight on Day 1 by 11.4 mg/kg and rounding up or down to the nearest 50 mg. The maximum possible dose was 800 mg.
|
||||||||||
|
|
|||||||||||||||||||||||||||||||||||||
Baseline characteristics reporting groups
|
|||||||||||||||||||||||||||||||||||||
Reporting group title |
Cohort 1: Children <17 to ≥13 Years of Age
|
||||||||||||||||||||||||||||||||||||
Reporting group description |
Pediatric HCV-infected participants <17 to ≥13 years of age were administered a single weight-based dose of boceprevir on Day 1. | ||||||||||||||||||||||||||||||||||||
|
|
|||
End points reporting groups
|
|||
Reporting group title |
Cohort 1: Children <17 to ≥13 Years of Age
|
||
Reporting group description |
Pediatric HCV-infected participants <17 to ≥13 years of age were administered a single weight-based dose of boceprevir on Day 1. |
|
|||||||||
End point title |
Area Under the Plasma Concentration-Time Curve from Time 0 to Infinity (AUC0-∞) [1] | ||||||||
End point description |
AUC(0-∞) was assessed pre-dose, 0.5, 1, 2, 2.5, 4.5, 5.5, 8, and 10 hours post-dose.
|
||||||||
End point type |
Primary
|
||||||||
End point timeframe |
Pre-dose to 10 hours Post-dose
|
||||||||
Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Only summary statistics for the primary PK measures for Cohort 1 are provided. |
|||||||||
|
|||||||||
No statistical analyses for this end point |
|
|||||||||
End point title |
Maximum Plasma Concentration (Cmax) [2] | ||||||||
End point description |
Cmax was assessed pre-dose, 0.5, 1, 2, 2.5, 4.5, 5.5, 8, and 10 hours post-dose.
|
||||||||
End point type |
Primary
|
||||||||
End point timeframe |
From Pre-dose to 10 hours Post-dose
|
||||||||
Notes [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Only summary statistics for the primary PK measures for Cohort 1 are provided. |
|||||||||
|
|||||||||
No statistical analyses for this end point |
|
|||||||||
End point title |
Time of Maximum Plasma Concentration (Tmax) [3] | ||||||||
End point description |
Tmax was assessed pre-dose, 0.5, 1, 2, 2.5, 4.5, 5.5, 8, and 10 hours post-dose.
|
||||||||
End point type |
Primary
|
||||||||
End point timeframe |
From Pre-dose to 10 hours Post-dose
|
||||||||
Notes [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Only summary statistics for the primary PK measures for Cohort 1 are provided. |
|||||||||
|
|||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Adverse events information
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Timeframe for reporting adverse events |
Day 1
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
16.1
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting groups
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Cohort 1: Children <17 to ≥13 Years of Age
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
All participants who received study drug in the study are included. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|
|||||||
Substantial protocol amendments (globally) |
|||||||
Were there any global substantial amendments to the protocol? Yes | |||||||
Date |
Amendment |
||||||
20 Jul 2010 |
This amendment indicated that dosing should be conducted immediately prior to breakfast to ensure consumption of the entire dose, clarified that water could be consumed after dosing, and clarified the blood sampling intervals. |
||||||
17 Jun 2011 |
This amendment added a new clinical monitor to replace an outgoing monitor, indicated that two instead of one 5mL blood sample should be collected, and indicated that fasting would not be required for the blood sample collected at follow-up. |
||||||
27 Jun 2011 |
This amendment indicated that a second barrier method of birth control was required and prohibited use of oral contraceptives containing drospirenone. |
||||||
28 Mar 2012 |
This amendment removed the requirement that participants be naive antiviral/immunomodulatory treatment for HCV infection, clarified that participants with mixed GT HCV infection were not eligible, and indicated that use of ribavirin 90 days prior or interferon-alpha 30 days prior to screening was not allowed. |
||||||
Interruptions (globally) |
|||||||
Were there any global interruptions to the trial? Yes | |||||||
|
|||||||
Limitations and caveats |
|||||||
Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||||||
None reported |