Hepatitis C, ChronicPhase 1NCT01425190

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

A Phase 1 study testing Boceprevir in people with Hepatitis C, Chronic, run by Merck Sharp & Dohme LLC.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial summary

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. Read more about this study

Who is it for?: Ages 3 to 17 years
Conditions the study is for: Hepatitis C, Chronic
What is being tested?: Boceprevir
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 16 participants
Where: No sites listed yet
Study dates: 4 Jan 2012to 20 Mar 2013
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 3 to 17 years
All sexes
No healthy volunteers
Child

Who may be able to join

Documented chronic hepatitis C (CHC) genotype 1 infection
Treatment naïve or failed previous interferon/ribavirin therapy (≥12 uninterrupted weeks)
Weigh between 10 kg to 90 kg inclusive at screening and baseline (Day -1).
Body Mass Index (BMI) from the 5th to the 95th percentile for the participant's age and gender, inclusive, per tables from the Center for Disease Control and Prevention, USA
Use of acceptable methods of contraception for at least 3 months prior to baseline and continue on study

Who cannot join

Co-infection with the human immunodeficiency virus (HIV) or hepatitis B virus (HBsAg positive).
Treatment with ribavirin within 90 days, or any interferon-alfa within 30 days
Discontinued from interferon treatment due to adverse events
Currently receiving antiviral/immunomodulating therapy for hepatitis C
Prior treatment with an HCV protease inhibitor
Prior treatment with any known hepatotoxic agent (including herbal remedies)

Show all 13Show fewer

Use of investigational drugs within 30 days of enrollment into study
Evidence of de-compensated liver disease including, but not limited to, a history or presence of clinical ascites, bleeding varices, or hepatic encephalopathy.
Substance abuse (including but not limited to alcohol abuse, illicit drugs,
inhalational drugs, marijuana use, etc) any time prior to entry into the study
Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of any drug.
Pregnant or breastfeeding female
Meeting any of the laboratory exclusion criteria

About this study

Official title: Assessment of the Pharmacokinetics of Boceprevir in Pediatric Subjects With Chronic Hepatitis C Genotype 1 (Phase 1b); Protocol No. P07614

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.

Conditions: Hepatitis C, Chronic
Being tested: Boceprevir
Medical subject headings: Hepatitis C, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BoceprevirDrug
Also called SCH 503034
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

Study groups in NCT01425190
Study group	Role	What they receive
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. Receives: Drug: Boceprevir
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. Receives: Drug: Boceprevir
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. Receives: Drug: Boceprevir

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Jan 201220 Mar 2013

First posted29 Aug 2011 (estimated)
Study start4 Jan 2012
Primary completion20 Mar 2013
Study completion20 Mar 2013

Why it stopped: The US FDA and the EU CHMP provided guidance indicating preference for intereferon-free regimens in pediatric studies of HCV infection.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Hepatitis C, ChronicStudies of the same condition, open and under way.
More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01425190
Sponsor's protocol ID: P07614
Other IDs: 2010-023498-20, MK-3034-063
Status last verified: Aug 2018
First submitted: 26 Aug 2011
Last updated: 11 Sep 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 4
People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents
Diabetes Mellitus, Hepatitis C, Chronic
RecruitingObservational study
"Constitution of a Biological Collection to Establish Preclinical Translational Models for the Study of Tumors and Chronic Liver Diseases".
Chronic Liver Disease and Cirrhosis, Liver Cancer
Active, not recruitingPhase 4
Sofosbuvir/Velpatasvir Treatment of Chronic Hepatitis C During Pregnancy
Hepatitis C, Chronic, Pregnancy; Infection
Enrolling by invitationObservational study
Comparative Autoantibody and Immunologic Cell Marker Study
Autoimmune Diseases, Lupus Erythematosus, Systemic

All Hepatitis C, Chronic trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Assessment of the Pharmacokinetics of Boceprevir in Pediatric Subjects With Chronic Hepatitis C Genotype 1 (Phase 1b); Protocol No. P07614
ClinicalTrials.gov ID: NCT01425190
Acronym / sponsor ID: P07614
Conditions: Hepatitis C, Chronic
Phase: Phase 1
Study type: Interventional
Recruitment status: TerminatedReason stopped: The US FDA and the EU CHMP provided guidance indicating preference for intereferon-free regimens in pediatric studies of HCV infection.
Enrolment: 16 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 4 Jan 2012 (actual)
Primary completion: 20 Mar 2013 (actual)
Study completion: 20 Mar 2013 (actual)
First posted: 29 Aug 2011 (estimated)
Results: Posted 8 Oct 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Cohort 1: Children 17 to ≥13 years	Experimental	Drug: BoceprevirParticipants 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.
Cohort 2: Children <13 to ≥7 years	Experimental	Drug: BoceprevirParticipants 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.
Cohort 3: Children <7 to ≥3 years	Experimental	Drug: BoceprevirParticipants 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.

Who may qualify

Ages: 3 to 17 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (5 listed)

Documented chronic hepatitis C (CHC) genotype 1 infection
Treatment naïve or failed previous interferon/ribavirin therapy (≥12 uninterrupted weeks)
Weigh between 10 kg to 90 kg inclusive at screening and baseline (Day -1).
Body Mass Index (BMI) from the 5th to the 95th percentile for the participant's age and gender, inclusive, per tables from the Center for Disease Control and Prevention, USA
Use of acceptable methods of contraception for at least 3 months prior to baseline and continue on study

Key exclusion criteria (13 listed)

Co-infection with the human immunodeficiency virus (HIV) or hepatitis B virus (HBsAg positive).
Treatment with ribavirin within 90 days, or any interferon-alfa within 30 days
Discontinued from interferon treatment due to adverse events
Currently receiving antiviral/immunomodulating therapy for hepatitis C
Prior treatment with an HCV protease inhibitor

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BoceprevirAlso: SCH 503034Single 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	Drug	Cohort 1: Children 17 to ≥13 years, Cohort 2: Children <13 to ≥7 years, Cohort 3: Children <7 to ≥3 years

Primary outcome

Area Under the Plasma Concentration Time Curve (AUC) From 0-Infinity of Single Dose Boceprevir
Time frame: 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.
Maximum Plasma Concentration (Cmax) of Single Dose Boceprevir
Time frame: 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.
Time of Maximum Plasma Concentration (Tmax) of Single Dose Boceprevir
Time frame: 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.
Final Dose of Boceprevir By Age Group
Time frame: Day 1

Results and safety

Results posted to the registry on 8 Oct 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cohort 1: Children 17 to ≥13 Years	16	15
Cohort 2: Children <13 to ≥7 Years	0	0
Cohort 3: Children <7 to ≥3 Years	0	0

Primary outcome: Area Under the Plasma Concentration Time Curve (AUC) From 0-Infinity of Single Dose Boceprevir

Time frame: 0 (pre-dose), 0.5, 1, 2, 2.5, 4.5, 5.5, 8, and 10 hours post dose. Mean (Full Range). Unit: ng hr/mL

Measure	Cohort 1: Children 17 to ≥13 Years n = 14	Cohort 2: Children <13 to ≥7 Years n = 0	Cohort 3: Children <7 to ≥3 Years n = 0
Value	6660 (3860 to 10500)	–	–

Population analysed: 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.

Primary outcome: Maximum Plasma Concentration (Cmax) of Single Dose Boceprevir

Time frame: 0 (pre-dose), 0.5, 1, 2, 2.5, 4.5, 5.5, 8, and 10 hours post dose. Mean (Full Range). Unit: ng/mL

Measure	Cohort 1: Children 17 to ≥13 Years n = 15	Cohort 2: Children <13 to ≥7 Years n = 0	Cohort 3: Children <7 to ≥3 Years n = 0
Value	1710 (985 to 2320)	–	–

Primary outcome: Time of Maximum Plasma Concentration (Tmax) of Single Dose Boceprevir

Time frame: 0 (pre-dose), 0.5, 1, 2, 2.5, 4.5, 5.5, 8, and 10 hours post dose. Mean (Full Range). Unit: Hour

Measure	Cohort 1: Children 17 to ≥13 Years n = 15	Cohort 2: Children <13 to ≥7 Years n = 0	Cohort 3: Children <7 to ≥3 Years n = 0
Value	1.87 (0.4 to 4.5)	–	–

Primary outcome: Final Dose of Boceprevir By Age Group

Time frame: Day 1

Population analysed: This outcome measure could not be analyzed due to termination of the study prior to enrolling Cohorts 2 and 3.

Adverse events

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.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cohort 1: Children 17 to ≥13 Years	1 of 16 (6.3%)	6 of 16 (37.5%)	Not reported
Cohort 2: Children <13 to ≥7 Years	0 of 0	0 of 0	Not reported
Cohort 3: Children <7 to ≥3 Years	0 of 0	0 of 0	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

Related trials for Hepatitis C, Chronic

RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 4
People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents
Diabetes Mellitus, Hepatitis C, Chronic
RecruitingObservational study
"Constitution of a Biological Collection to Establish Preclinical Translational Models for the Study of Tumors and Chronic Liver Diseases".
Chronic Liver Disease and Cirrhosis, Liver Cancer
Active, not recruitingPhase 4
Sofosbuvir/Velpatasvir Treatment of Chronic Hepatitis C During Pregnancy
Hepatitis C, Chronic, Pregnancy; Infection
Enrolling by invitationObservational study
Comparative Autoantibody and Immunologic Cell Marker Study
Autoimmune Diseases, Lupus Erythematosus, Systemic

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Director study director

Merck Sharp & Dohme LLC

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Boceprevir in people with Hepatitis C, Chronic, run by Merck Sharp & Dohme LLC.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 11 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Oct 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Area Under the Plasma Concentration Time Curve (AUC) From 0-Infinity of Single Dose Boceprevir (time frame: 0 (pre-dose), 0.5, 1, 2, 2.5, 4.5, 5.5, 8, and 10 hours post dose). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01425190.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2018.