NCT01425190

Pharmacokinetics of Boceprevir in Pediatric Subjects With Chronic Hepatitis C Genotype 1 (P07614)

Terminated Phase 1 Results posted Last updated 11 September 2018

What this trial tests

Phase 1 trial testing Boceprevir in Hepatitis C, Chronic in 16 participants. Terminated before completion.

Timeline

4 January 2012

Primary endpoint
20 March 2013

20 March 2013

Quick facts

Lead sponsor	Merck Sharp & Dohme LLC
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	16
Start date	4 January 2012
Primary completion	20 March 2013
Estimated completion	20 March 2013

Drugs / interventions tested

• Boceprevir (BOCEPREVIR) — full drug profile →

Conditions studied

• Hepatitis C, Chronic — all drugs for Hepatitis C, Chronic →

Sponsor

Merck Sharp & Dohme LLC — full company profile →

Who can join

Adults 3 to 17, any sex, with Hepatitis C, Chronic. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Area Under the Plasma Concentration Time Curve (AUC) From 0-Infinity of Single Dose Boceprevir Primary · 0 (pre-dose), 0.5, 1, 2, 2.5, 4.5, 5.5, 8, and 10 hours post dose

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.

Group	Value	95% CI
Cohort 1: Children 17 to ≥13 Years	6660	3860 – 10500

Maximum Plasma Concentration (Cmax) of Single Dose Boceprevir Primary · 0 (pre-dose), 0.5, 1, 2, 2.5, 4.5, 5.5, 8, and 10 hours post dose

The maximum observed plasma concentration of boceprevir across sampling intervals was determined.

Group	Value	95% CI
Cohort 1: Children 17 to ≥13 Years	1710	985 – 2320

Time of Maximum Plasma Concentration (Tmax) of Single Dose Boceprevir Primary · 0 (pre-dose), 0.5, 1, 2, 2.5, 4.5, 5.5, 8, and 10 hours post dose

The time at which the maximum plasma boceprevir concentration was observed.

Group	Value	95% CI
Cohort 1: Children 17 to ≥13 Years	1.87	0.4 – 4.5

Adverse events — posted to ClinicalTrials.gov

Time frame: 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.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Cohort 1: Children 17 to ≥13 Years

Serious: 1/16 (6%)

Deaths: —

Cohort 2: Children <13 to ≥7 Years

Serious: 0

Deaths: —

Cohort 3: Children <7 to ≥3 Years

Serious: 0

Deaths: —

Serious adverse events (2 terms)

Reaction	System	Cohort 1: Children 17 to ≥…	Cohort 2: Children <13 to …	Cohort 3: Children <7 to ≥…
Alanine aminotransferase increased	Investigations	—	—	—
Liver function test abnormal	Investigations	—	—	—

Other adverse events (7 terms — click to expand)

Reaction	System	Cohort 1: Children 17 to ≥…	Cohort 2: Children <13 to …	Cohort 3: Children <7 to ≥…
Syncope	Nervous system disorders	—	—	—
Nausea	Gastrointestinal disorders	—	—	—
Asthenia	General disorders	—	—	—
Malaise	General disorders	—	—	—
Blood pressure systolic increased	Investigations	—	—	—
Hepatic enzyme increased	Investigations	—	—	—
Dysgeusia	Nervous system disorders	—	—	—

Most-reported serious reactions: Alanine aminotransferase increased, Liver function test abnormal.

Data from ClinicalTrials.gov NCT01425190 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. New prospects for the treatment and prevention of hepatitis C in children.
   Ohmer S, Honegger J. · · 2016 · cited 17× · PMID 26709684 · DOI 10.1097/mop.0000000000000313