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Chronic Hepatitis CPhase 3NCT01590225

Efficacy and Safety of Boceprevir in Combination With Peginterferon Alfa-2b Plus Ribavirin in Pediatric Subjects With Chronic Hepatitis C Genotype 1 (P08034)

A Phase 3 study testing Boceprevir, Peginterferon alpha-2b and Ribavirin in people with Chronic Hepatitis C, run by Merck Sharp & Dohme LLC.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 3 to 17 years
Conditions the study is for
Chronic Hepatitis C
What is being tested?
Boceprevir, Peginterferon alpha-2b and Ribavirin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
28 Jan 2013to 18 Aug 2021
Phase
Phase 3
Are there results?
None posted in the registry

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

  • CHC GT1 infection for at least 6 months with with HCV-RNA ≥10,000 IU/mL.
  • Treatment naive, non-cirrhotic participants will be eligible for inclusion in Study Part A
  • Non-cirrhotic subjects who failed previous (peg)interferon/ribavirin treatment for CHC and cirrhotics, whether treatment naive or treatment failure, will be eligible for inclusion in Study Part B
  • To participate in Study Part C, participants must have completed the required post-treatment follow-up in Study Part A or Part B
  • Weight ≥ 10 kg to ≤ 125 kg
  • Body surface area (BSA) ≥0.46 m^2 and ≤2.5 m^2
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  • Previous liver biopsy with histology consistent with chronic hepatitis C and no other etiology within 2 years of the screening visit
  • Participants with bridging fibrosis or cirrhosis must have an ultrasound within 6 months of the screening visit or between the screening visit and Day 1 with no findings suspicious for hepatocellular carcinoma
  • Participant must be able to adhere to dose and visit schedules

Who cannot join

  • Known co-infection with the the human immunodeficiency virus (HIV) or hepatitis B virus (HBsAg positive)
  • For Study Part A, participant received any prior hepatitis C treatment, including herbal remedies, with known hepatotoxicity
  • For Study Part B, participant received treatment with ribavirin within 90 days or any interferon alpha within 30 days prior to screening
  • For Study Part B, participant received previous treatment with a hepatitis C virus protease inhibitor (excepting participants in study P07614, Pharmacokinetics of Boceprevir in Pediatric Subjects With Chronic Hepatitis C Genotype 1)
  • For Study Part B, participant required discontinuation of previous (peg)interferon/ribavirin therapy for an adverse event considered by the investigator to be related to (peg)interferon and/or ribavirin
  • For Study Part B, participant is currently taking any antiviral/immunomodulatory treatment for hepatitis C
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  • Participant has taken any investigational drugs, except boceprevir
  • Participant has received any of the following medication(s) within 2 weeks prior to the Day 1 visit: midazolam, pimozide, amiodarone, flecainide,
  • propafenone, quinidine, and ergot derivatives (dihydroergotamine, ergonovine,
  • ergotamine, methylergonovine)
  • Participation in any other clinical trial within 30 days of enrollment or
  • intent to participate in another clinical trial during participation in the current study
  • Evidence of decompensated liver disease
  • Child Pugh score >6 (class B and C)
  • History of diabetes or hypertension or was born prior to 32 weeks
  • of gestation and has clinically significant ocular examination findings
  • Pre-existing clinically significant psychiatric condition(s)
  • Clinical diagnosis of substance abuse
  • Any pre-existing medical condition that could interfere with participation in and completion of the study
  • Evidence of active or suspected malignancy
  • Females who are pregnant, nursing, or intend to become pregnant during
  • the study period
  • Allergy or sensitivity to the investigational products or excipients

About this study

Official title: A Phase 3 Study to Assess the Efficacy and Safety of Boceprevir in Combination With Peginterferon Alfa-2b Plus Ribavirin in Pediatric Subjects With Chronic Hepatitis C Genotype 1

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.

Being tested
Boceprevir, Peginterferon alpha-2b, Ribavirin, Peginterferon alfa-2b
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 Victrelis®, SCH 503034

    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.

  • Peginterferon alpha-2bDrug

    Also called Pegintron®, Sylatron®

    Peginterferon alpha-2b will be administered subcutaneously at a dose of 60 μg/m^2 once weekly (QW) for 24 weeks.

  • RibavirinDrug

    Also called Copegus®, Rebetol®, RibaTab®, Ribasphere®

    The dose of ribavirin will be approximately 15 mg/kg/day administered orally in two divided doses (twice daily [BID]) for 24 weeks.

  • BoceprevirDrug

    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.

  • Peginterferon alfa-2bDrug

    Also called Pegintron®, Sylatron®

    Peginterferon alpha-2b will be administered subcutaneously at a dose of 60 μg/m^2 once weekly (QW) for 48 weeks.

  • RibavirinDrug

    Also called Copegus®, Rebetol®, RibaTab®, Ribasphere®

    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.

Study groups in NCT01590225
Study groupRoleWhat they receive
Part A: boceprevir + peginterferon alpha-2b + ribavirinExperimentalNot described
Receives: Drug: Boceprevir; Drug: Peginterferon alpha-2b; Drug: Ribavirin
Part B: boceprevir + peginterferon alpha-2b + ribavirinExperimentalNot described
Receives: Drug: Boceprevir; Drug: Peginterferon alfa-2b; Drug: Ribavirin

What is being measured

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

  1. Participants Achieving Sustained Viral Response (SVR) at Follow-Up Week 24 in Study Part A

    Measured: Follow-Up Week 24

  2. Participants Achieving SVR at Follow-Up Week 24 in Study Part B

    Measured: Follow-Up Week 24

  3. Time to Viral Relapse in Study Part C

    Measured: Follow-Up Week 24 to 5 Years

Secondary outcomes (18)

  1. Proportion of Participants With Alanine Aminotransferase (ALT) Normalization in Study Part A

    Measured: Week 2, Week 4, Week 8, Week 12

  2. Participants With Early Virologic Response in Study Part A

    Measured: Week 2, Week 4, Week 8, Week 12

  3. Proportion of Participants With Undetectable Hepatitis C Virus Ribonucleic Acid (HCV-RNA) in Study Part A

    Measured: Week 12, End of Treatment, Follow-Up Week 24

  4. Proportion of Participants With Undetectable HCV-RNA Who Also Achieved SVR in Study Part A

    Measured: Follow-Up Week 12

  5. Proportion of Participants With Alanine Aminotransferase (ALT) Normalization in Study Part B

    Measured: Week 2, Week 4, Week 8, Week 12

  6. Proportion of Participants With Undetectable HCV-RNA in Study Part B

    Measured: Week 24, End of Treatment, Follow-Up Week 12

  7. Proportion of Participants With Undetectable HCV-RNA Who Also Achieved SVR in Study Part B

    Measured: Follow-Up Week 12

  8. Number of Participants Experiencing Treatment-Emergent Adverse Events (AEs) in Study Part A

    Measured: Week 1 to Follow-Up Visit 24

  9. Number of Participants Experiencing Treatment-Emergent Treatment-Related AEs in Study Part A

    Measured: Week 1 to Follow-Up Week 24

  10. Number of Participants Experiencing Serious AEs (SAEs) in Study Part A

    Measured: Week 1 to Follow-Up Week 24

  11. Participants Discontinuing Treatment Due to AEs in Study Part A

    Measured: Week 1 to Follow-Up Week 24

  12. Change from Baseline in Participant Laboratory Values in Study Part A

    Measured: Baseline to Follow-Up Week 24

  13. Change From Baseline in Participant Vital Signs in Study Part A

    Measured: Baseline to Follow-Up Week 24

  14. Number of Participants Experiencing AEs in Study Part B

    Measured: Week 1 to Follow-Up Week 24

  15. Number of Participants Experiencing SAEs in Study Part B

    Measured: Week 1 to Follow-Up Week 24

  16. Change from Baseline in Participant Laboratory Values in Study Part B

    Measured: Week 1 to Follow-Up Week 24

  17. Change From Baseline in Participant Vital Signs in Study Part B

    Measured: Week 1 to Follow-Up Week 24

  18. Number of Participants Discontinuing From Study Treatment Due to AEs in Study Part B

    Measured: Week 1 to Follow-Up Week 24

Timeline

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

  1. First posted2 May 2012 (estimated)
  2. Study start28 Jan 2013
  3. Primary completion18 Aug 2021 (estimated)
  4. Study completion18 Aug 2021 (estimated)

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01590225
Sponsor's protocol ID
P08034
Other IDs
2010-024260-17
Status last verified
Jan 2021
First submitted
1 May 2012
Last updated
29 Jan 2021
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Boceprevir, Peginterferon alpha-2b and Ribavirin in people with Chronic Hepatitis C, 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 9 inclusion and 23 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: withdrawn, as of the sponsor's last update on 29 Jan 2021. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

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?

Participants Achieving Sustained Viral Response (SVR) at Follow-Up Week 24 in Study Part A (time frame: Follow-Up Week 24). The study lists 3 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 NCT01590225.

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 29 Jan 2021.

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