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Chronic Hepatitis CPhase 2NCT00423670

Safety and Efficacy of SCH 503034 in Previously Untreated Subjects With Chronic Hepatitis C Infected With Genotype 1 (Study P03523)

A Phase 2 study testing boceprevir (SCH 503034), peginterferon-alfa 2b (PegIntron) and ribavirin in people with Chronic Hepatitis C, run by Merck Sharp & Dohme LLC.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This was an open-label, randomized safety and efficacy trial in adult, treatment-naïve Chronic Hepatitis C (CHC) participants with genotype 1 infection. The study conducted in 2 parts, compared standard-of-care PegIntron (1.5 μg/kg, once weekly [QW]), plus ribavirin (800 to 1400 mg/day), for 48 weeks to five treatment… Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Chronic Hepatitis C
What is being tested?
boceprevir (SCH 503034), peginterferon-alfa 2b (PegIntron) and ribavirin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
765 participants
Where
No sites listed yet
Study dates
Jan 2007to Nov 2008
Phase
Phase 2
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 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Age between 18 and 60 years;
  • Body weight between 45 and 125 kg;
  • Documented chronic hepatitis C genotype 1;
  • Liver biopsy with histology consistent with chronic hepatitis and no other etiology for chronic liver disease within of 5 years of Day 1;
  • Participant and participant's partner(s) must each agree to use acceptable methods of contraception 2 weeks prior to Day 1 and at least 6 months after the last dose of study medication;
  • Written informed consent.

Who cannot join

  • Include, but are not limited to, the following:
  • Prior treatment for hepatitis C;
  • Co-infection with HIV or hepatitis B virus (HBsAg positive);
  • Evidence of decompensated liver disease;
  • Diabetic and hypertensive participants with clinically significant ocular exam findings;
  • Pre-existing psychiatric condition, including but not limited to:
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  • Current moderate or severe depression;
  • History of depression associated with any of the following:
  • Hospitalization for depression;
  • Electroconvulsive therapy for depression;
  • Depression that resulted in a prolonged absence from work and/or significant disruption of daily functions;
  • Suicidal or homicidal ideation and/or attempt;
  • History of severe psychiatric disorders (including but not limited to schizophrenia, psychosis, bipolar disorder, post-traumatic stress disorder or mania);
  • Past history or current use of lithium;
  • Past history or current use of antipsychotic drugs for listed conditions.
  • Substance abuse within protocol specified timeframes;
  • Pre-existing medical conditions that could interfere with the participant's participation in and completion of the study, including but not limited to chronic pulmonary disease, cardiac dysfunction or immunologically-mediated disease;
  • Active or suspected malignancy or history of malignancy within the past 5 years;
  • Participants who are pregnant or nursing; participants who intend to become pregnant during the study period. Male participants with partners who are, or intend to become, pregnant during the study period.
  • Treatment with any investigational drug or participation in any clinical trial 30 days within Screening;
  • Hemoglobin <12 g/dL for females and <13 g/dL for males;
  • Neutrophils <1500 mm^3; Blacks: <1200/mm^3;
  • Platelets <100,000/mm^3;
  • Other clinically significant laboratory test abnormalities.

About this study

Official title: A Safety and Efficacy Study of SCH 503034 in Previously Untreated Subjects With Chronic Hepatitis C Infected With Genotype 1

This was an open-label, randomized safety and efficacy trial in adult, treatment-naïve Chronic Hepatitis C (CHC) participants with genotype 1 infection. The study conducted in 2 parts, compared standard-of-care PegIntron (1.5 μg/kg, once weekly [QW]), plus ribavirin (800 to 1400 mg/day), for 48 weeks to five treatment paradigms containing boceprevir (SCH 503034) 800 mg thrice a day (TID). The five treatments included boceprevir (BOC) plus standard-of-care for 28 or 48 weeks, with and without a 4-week lead-in with PegIntron (PEG) and ribavirin (RBV), and exploration of PegIntron plus low-dose ribavirin (400 to 1000 mg/day) plus boceprevir for 48 weeks.

Read the detailed description

The study was conducted in 2 parts.

Part 1 of the study had 5 arms using weight based ribavirin 800-1400 mg/day and compared:

  • PegIntron and ribavirin for 48 weeks (Arm 1 - Control)
  • PegIntron, ribavirin, and boceprevir for 28 weeks (Arm 2)
  • Lead-in with PegIntron and ribavirin for 4 weeks followed by PegIntron, ribavirin and boceprevir for 24 weeks (Arm 3)
  • PegIntron, ribavirin and boceprevir for 48 weeks (Arm 4)
  • Lead-in with PegIntron and ribavirin for 4 weeks, followed by PegIntron, ribavirin and boceprevir for 44 weeks (Arm 5)

Participants from Arm 1 receiving PegIntron and ribavirin that were HCV positive after 24 weeks of treatment had the option to receive boceprevir in combination with PegIntron and ribavirin for an additional 24 weeks. All participants from Arm 1 that started boceprevir after Week 24 formed the crossover arm (Arm 8).

Part 2 of the study assessed the safety and efficacy of low dose ribavirin (400-1000 mg/day) and compared:

  • PegIntron, ribavirin (800-1400 mg/day) and boceprevir for 48 weeks (Arm 6)
  • PegIntron, low-dose ribavirin (400-1000 mg/day) and boceprevir for 48 weeks (Arm 7)

Follow-up for all participants was up to 72 weeks after randomization.

Being tested
boceprevir (SCH 503034), peginterferon-alfa 2b (PegIntron), ribavirin, ribavirin (low-dose)
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.

  • boceprevir (SCH 503034)Drug

    Also called Boceprevir, Victrelis, SCH 503034

    200 mg capsules taken as 800 mg orally three times daily (TID)

  • peginterferon-alfa 2b (PegIntron)Drug

    1.5 μg/kg subcutaneously (SC) once weekly (QW)

  • ribavirinDrug

    200 mg capsules in doses of 800 to 1400 mg/day (based on weight) taken orally divided twice daily

  • ribavirin (low-dose)Drug

    200 mg capsules in doses of 400 to 1000 mg/day (based on weight) taken orally divided twice daily

Study groups in NCT00423670
Study groupRoleWhat they receive
Arm 1. PEG +RBV for 48 Wks (Part I)Active comparatorParticipants treated with PegIntron (1.5 μg/kg, once weekly [QW]) and Ribavirin (800 to 1400 mg/day) for 48 weeks. Participants with detectable HCV-RNA levels after 24 weeks of treatment had the option of crossing over to receive 24 weeks of PegIntron (1.5 μg/kg, QW), Ribavirin (800 to 1400 mg/day), and boceprevir (800 mg three times daily [TID]) for 24 additional weeks. The participants that crossed over to receive boceprevir formed Arm 8. The total treatment duration was up to 54 weeks.
Receives: Drug: peginterferon-alfa 2b (PegIntron); Drug: ribavirin
Arm 2. PEG + RBV + BOC for 28 Wks (Part I)ExperimentalParticipants receiving boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 28 weeks.
Receives: Drug: boceprevir (SCH 503034); Drug: peginterferon-alfa 2b (PegIntron); Drug: ribavirin
Arm 3. PEG + RBV + BOC (from Wk 4) for 24 Wks (Part I)ExperimentalParticipants receiving a lead-in treatment with PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for 4 weeks, followed by boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 24 weeks.
Receives: Drug: boceprevir (SCH 503034); Drug: peginterferon-alfa 2b (PegIntron); Drug: ribavirin
Arm 4. PEG +RBV + BOC for 48 Wks (Part I)ExperimentalParticipants receiving boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 48 weeks.
Receives: Drug: boceprevir (SCH 503034); Drug: peginterferon-alfa 2b (PegIntron); Drug: ribavirin
Arm 5. PEG + RBV + BOC (from Wk 4) for 44 Wks (Part I)ExperimentalParticipants receiving a lead-in treatment with PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for 4 weeks, followed by boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 44 weeks.
Receives: Drug: boceprevir (SCH 503034); Drug: peginterferon-alfa 2b (PegIntron); Drug: ribavirin
Arm 6. PEG + RBV + BOC for 48 Wks (Part II)ExperimentalParticipants receiving PegIntron (1.5 μg/kg QW), ribavirin (800 to 1400 mg/day) and boceprevir (800 mg TID) for up to 48 weeks during Part II of the study. Part II was initiated after participants were fully enrolled for Part I.
Receives: Drug: boceprevir (SCH 503034); Drug: peginterferon-alfa 2b (PegIntron); Drug: ribavirin
Arm 7. PEG +Low-dose RBV + BOC for 48 Wks (Part II)ExperimentalParticipants receiving PegIntron (1.5 μg/kg QW), low-dose ribavirin (400 to 1000 mg/day) and boceprevir (800 mg TID) for up to 48 weeks (Arm 7) during Part II of the study. Part II was initiated after participants were fully enrolled for Part I.
Receives: Drug: boceprevir (SCH 503034); Drug: peginterferon-alfa 2b (PegIntron); Drug: ribavirin (low-dose)
Arm 8. PEG + RBV + BOC (from Wk 24) for 48 Wks (Part I)ExperimentalParticipants that started in Arm 1 and had detectable HCV-RNA levels after 24 weeks of treatment had the option of receiving boceprevir (800 mg TID) with PegIntron (1.5 μg/kg QW), and ribavirin (800 to 1400 mg/day). Participants that took the option of crossing over to receive PegIntron, ribavirin, and boceprevir (800 mg TID) for 24 additional weeks constitute Arm 8. The total treatment duration was up to 54 weeks.
Receives: Drug: boceprevir (SCH 503034); Drug: peginterferon-alfa 2b (PegIntron); Drug: ribavirin

What is being measured

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

  1. Number of Participants With Sustained Virologic Response (SVR)

    Participants with undetectable HCV-RNA at FW 24 up to EOF had achieved SVR.

    Participants missing data at FW 24 were considered to achieve SVR if

    1. he/she had undetectable HCV-RNA at FW 12 or later
    2. he/she returned later to the study center and had undetectable HCV-RNA.

    HCV-RNA in plasma samples was detected with reverse-transcriptase-polymerase chain reaction (RT-PCR) assay, with a lower limit of detection (LLD) of 29 international units/mL (IU/mL).

    A participant in Arm 2 with undetectable HCV-RNA at FW 24 had detectable HCV-RNA after FW 24. He is not considered to achieve SVR.

    Measured: From follow-up week (FW) 24 up to end of follow-up (EOF)

Secondary outcomes (7)

  1. Number of Participants With SVR Based on a 4-week lead-in Treatment With PegIntron and Ribavirin

    Number of participants with SVR (undetectable plasma HCV-RNA at FW 24 up to EOF). To assess the effect of lead-in treatment on SVR, participants with (Arm 3 and Arm 5) or without (Arm 2 and Arm 4) lead-in were pooled.

    Participants missing data at FW 24 were considered to achieve SVR if

    1. he/she had undetectable HCV-RNA at FW 12 or later
    2. he/she returned later to the study center and had undetectable HCV-RNA.

    HCV-RNA in plasma samples was detected with an RT-PCR assay. The LLD for the assay was 29 IU/mL.

    Measured: From FW 24 up to EOF

  2. Number of Participants With SVR Based on Duration of Boceprevir Treatment

    Number of participants with SVR (undetectable plasma HCV-RNA at FW 24 up to EOF). Participants from treatment arms receiving boceprevir for 28-weeks (Arm 2 and Arm 3) were pooled, and those receiving boceprevir for 48-weeks (Arm 4 and Arm 5) were pooled for the analysis.

    Participants missing data at FW 24 were considered to achieve SVR if

    1. he/she had undetectable HCV-RNA at FW 12 or later
    2. he/she returned later to the study center and had undetectable HCV-RNA.

    HCV-RNA in plasma samples was detected with an RT-PCR assay. The LLD for the assay was 29 IU/mL.

    Measured: From FW 24 up to EOF

  3. Number of Participants Negative for HCV-RNA at FW 12

    Participants who had undetectable plasma HCV-RNA at FW 12. Also reported are participants for whom the HCV-RNA values were missing. 36 participant who switched over to Arm 8 from Arm 1, are included in the missing values for Arm 1.

    HCV-RNA in plasma samples was detected with an RT-PCR assay. The LLD for the assay was 29 IU/mL.

    Measured: At FW 12

  4. Number of Participants Negative for HCV-RNA at 72 Weeks Post Randomization

    Participants who had undetectable HCV-RNA at 72 weeks post randomization are reported. Participants with missing HCV-RNA values at 72 weeks post randomization are also reported.

    HCV-RNA in plasma samples was detected with an RT-PCR assay. The LLD for the assay was 29 IU/mL.

    Measured: 72 weeks post randomization

  5. Number of Participants With an Early Virologic Response (EVR) That Achieved SVR

    Participants with undetectable HCV-RNA at TW 12 have EVR, and with undetectable HCV-RNA at FW 24 (up to EOF) achieved SVR.

    Participants missing data at FW 24 were considered to achieve SVR if

    1. he/she had undetectable HCV-RNA at FW 12 or later
    2. if he/she returned later to the study center and had undetectable HCV-RNA.

    HCV-RNA in plasma samples was detected with an RT-PCR assay. The LLD for the assay was 29 IU/mL.

    Measured: At TW 12, and at FW 24 up to EOF

  6. Number of Participants With a Virologic Response at Follow-up Week 12 That Achieved SVR

    Treatment-naïve adults with CHC genotype 1 were assigned study medication. Participants with undetectable HCV-RNA at FW 12 that achieved SVR (have undetectable HCV-RNA at FW 24 (up to EOF) are reported.

    Participants missing data at FW 24 were considered to achieve SVR if

    1. he/she had undetectable HCV-RNA at FW 12 or later
    2. if he/she returned later to the study center and had undetectable HCV-RNA.

    HCV-RNA in plasma samples was detected with an RT-PCR assay. The LLD for the assay was 29 IU/mL.

    Measured: At FW 12 and FW 24 up to EOF

  7. Number of Participants With a Virologic Response at 72 Weeks Post Randomization That Achieved SVR

    Participants with undetectable HCV-RNA at 72 weeks post randomization that achieved SVR (have undetectable HCV-RNA at FW 24 up to EOF) are reported.

    Participants missing data at FW 24 were considered to achieve SVR if

    1. he/she had undetectable HCV-RNA at FW 12 or later
    2. if he/she returned later to the study center and had undetectable HCV-RNA.

    HCV-RNA in plasma samples was detected an the RT-PCR assay. The lower limit of detection (LLD) was 29 IU/mL.

    Measured: At FW 24 up to EOF and at 72 weeks post randomization

Timeline

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

  1. First posted18 Jan 2007 (estimated)
  2. Study startJan 2007
  3. Primary completionAug 2008
  4. Study completionNov 2008

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
765 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00423670
Sponsor's protocol ID
P03523
Other IDs
EudraCT No. 2006-002543-92
Status last verified
Mar 2017
First submitted
17 Jan 2007
Last updated
5 Apr 2017
Data monitoring committee
Yes
Individual data sharing
Yes: http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final\_Updated%20July\_9\_2014.pdf http://engagezone.msd.com/ds\_documentation.php

Publications

  • Kwo PY, Lawitz EJ, McCone J, Schiff ER, Vierling JM, Pound D, Davis MN, Galati JS, Gordon SC, Ravendhran N, Rossaro L, Anderson FH, Jacobson IM, Rubin R, Koury K, Pedicone LD, Brass CA, Chaudhri E, Albrecht JK; SPRINT-1 investigators. Efficacy of boceprevir, an NS3 protease inhibitor, in combination with peginterferon alfa-2b and ribavirin in treatment-naive patients with genotype 1 hepatitis C infection (SPRINT-1): an open-label, randomised, multicentre phase 2 trial. Lancet. 2010 Aug 28;376(9742):705-16. doi: 10.1016/S0140-6736(10)60934-8. Epub 2010 Aug 6.

    PubMed 20692693

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing boceprevir (SCH 503034), peginterferon-alfa 2b (PegIntron) 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 6 inclusion and 24 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: finished, as of the sponsor's last update on 5 Apr 2017. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 15 Jun 2011). 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?

Number of Participants With Sustained Virologic Response (SVR) (time frame: From follow-up week (FW) 24 up to end of follow-up (EOF)). 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 NCT00423670, which also lists 1 linked publication.

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 5 Apr 2017.

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