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Safety and Efficacy of Vaniprevir (MK7009) Administered With Pegylated-Interferon and Ribavirin (MK-7009-007)

Primary Purpose

Hepatitis C

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Comparator: Vaniprevir
Comparator: Pegylated-Interferon (Peg-IFN)
Comparator: Ribavirin
Comparator: placebo
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis C

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patient has chronic Genotype 1 Hepatitis C infection

Exclusion Criteria:

  • Subject has been previously treated for HCV
  • Has Human Immunodeficiency Virus (HIV)
  • Has Hepatitis B
  • Has a history of clinically significant medical condition that may interfere with the study (e.g., stroke or chronic seizures or major neurological disorder) or is contraindicated for treatment with peg-IFN and Ribavirin

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm Type

    Placebo Comparator

    Experimental

    Experimental

    Experimental

    Experimental

    Arm Label

    Placebo + Peg-IFN/Ribavirin

    Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavirin

    Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavirin

    Vaniprevir 600 mg q.d. + Peg-IFN/Ribavirin

    Vaniprevir 800 mg q.d. + Peg-IFN/Ribavirin

    Arm Description

    Participants took double-blind Placebo + Peg-IFN/Ribavirin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavirin from Week 5 to Week 48.

    Participants took double-blind Vaniprevir 300 mg twice daily (b.i.d.) + Peg-IFN/Ribavirin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavirin from Week 5 to Week 48.

    Participants took double-blind Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavirin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavirin from Week 5 to Week 48.

    Participants took double-blind Vaniprevir 600 mg q.d. + Peg-IFN/Ribavirin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavirin from Week 5 to Week 48.

    Participants took double-blind Vaniprevir 800 mg q.d. + Peg-IFN/Ribavirin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavirin from Week 5 to Week 48.

    Outcomes

    Primary Outcome Measures

    Percentage of Participants Achieving RVR
    Rapid Viral Response (RVR) was declared if Hepatitis C Virus (HCV) ribonucleic acid (RNA) was undetectable at Week 4.
    Number of Participants Experiencing an Adverse Event (AE)
    The number of participants experiencing AEs in each treatment group was monitored during the Vaniprevir/Placebo treatment (Day 1 to Day 28) and safety follow-up (Day 29 to Day 42) periods.
    Number of Participants Discontinuing From Study Therapy Due to AEs
    An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of study therapy, whether or not considered related to the use of the product.

    Secondary Outcome Measures

    Number of Participants With ≥2-log10 Decrease in HCV RNA
    The number of participants with at least a 2-log10 decrease from baseline in HCV RNA following 4 weeks of treatment with Placebo or Vaniprevir.
    Number of Participants With ≥3-log10 Decrease in HCV RNA
    The number of participants with at least a 3-log10 decrease from baseline in HCV RNA following 4 weeks of treatment with Placebo or Vaniprevir.
    Mean Log Change From Baseline in HCV RNA
    The mean changes from baseline in log10 HCV RNA in each vaniprevir group was compared against control treatment at Week 4.

    Full Information

    First Posted
    June 23, 2008
    Last Updated
    September 10, 2018
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00704184
    Brief Title
    Safety and Efficacy of Vaniprevir (MK7009) Administered With Pegylated-Interferon and Ribavirin (MK-7009-007)
    Official Title
    A Phase II, Randomized, Placebo-Controlled Study to Evaluate the Safety and Efficacy of MK7009 Administered Concomitantly With Pegylated-Interferon and Ribavirin for 28 Days in Treatment-Naive Patients With Chronic Hepatitis C Infection
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    July 25, 2008 (Actual)
    Primary Completion Date
    December 12, 2008 (Actual)
    Study Completion Date
    April 14, 2010 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Merck Sharp & Dohme LLC

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    A study to evaluate how effective different levels of Vaniprevir (MK-7009), when administered with Pegylated-Interferon (Peg-IFN) and Ribavirin, are at achieving rapid viral response (RVR) i.e., undetectable hepatitis C virus [HCV] viral ribonucleic acid [RNA] at Week 4 in participants with chronic HCV infection. The primary hypothesis was that the proportion of participants in one or more of the Vaniprevir treatment groups achieving RVR would be greater than the proportion of placebo participants achieving RVR when Vaniprevir and placebo were co-administered with Peg-IFN/Ribavirin.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hepatitis C

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    95 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Placebo + Peg-IFN/Ribavirin
    Arm Type
    Placebo Comparator
    Arm Description
    Participants took double-blind Placebo + Peg-IFN/Ribavirin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavirin from Week 5 to Week 48.
    Arm Title
    Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavirin
    Arm Type
    Experimental
    Arm Description
    Participants took double-blind Vaniprevir 300 mg twice daily (b.i.d.) + Peg-IFN/Ribavirin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavirin from Week 5 to Week 48.
    Arm Title
    Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavirin
    Arm Type
    Experimental
    Arm Description
    Participants took double-blind Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavirin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavirin from Week 5 to Week 48.
    Arm Title
    Vaniprevir 600 mg q.d. + Peg-IFN/Ribavirin
    Arm Type
    Experimental
    Arm Description
    Participants took double-blind Vaniprevir 600 mg q.d. + Peg-IFN/Ribavirin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavirin from Week 5 to Week 48.
    Arm Title
    Vaniprevir 800 mg q.d. + Peg-IFN/Ribavirin
    Arm Type
    Experimental
    Arm Description
    Participants took double-blind Vaniprevir 800 mg q.d. + Peg-IFN/Ribavirin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavirin from Week 5 to Week 48.
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: Vaniprevir
    Other Intervention Name(s)
    MK-7009
    Intervention Description
    Vaniprevir 300 mg b.i.d., 600 mg b.i.d., 600 mg q.d., or 800 mg q.d.; duration of treatment: 28 days
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: Pegylated-Interferon (Peg-IFN)
    Intervention Description
    Peg-IFN 180 mcg once-weekly subcutaneous injection; duration of treatment: 48 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: Ribavirin
    Intervention Description
    Ribavirin 200 mg tablet b.i.d. (dose based on body weight); duration of treatment: 48 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: placebo
    Intervention Description
    Matching placebo to vaniprevir; duration of treatment: 28 days
    Primary Outcome Measure Information:
    Title
    Percentage of Participants Achieving RVR
    Description
    Rapid Viral Response (RVR) was declared if Hepatitis C Virus (HCV) ribonucleic acid (RNA) was undetectable at Week 4.
    Time Frame
    Week 4
    Title
    Number of Participants Experiencing an Adverse Event (AE)
    Description
    The number of participants experiencing AEs in each treatment group was monitored during the Vaniprevir/Placebo treatment (Day 1 to Day 28) and safety follow-up (Day 29 to Day 42) periods.
    Time Frame
    Up to Day 42
    Title
    Number of Participants Discontinuing From Study Therapy Due to AEs
    Description
    An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of study therapy, whether or not considered related to the use of the product.
    Time Frame
    Day 1 to Day 28
    Secondary Outcome Measure Information:
    Title
    Number of Participants With ≥2-log10 Decrease in HCV RNA
    Description
    The number of participants with at least a 2-log10 decrease from baseline in HCV RNA following 4 weeks of treatment with Placebo or Vaniprevir.
    Time Frame
    Baseline and Week 4
    Title
    Number of Participants With ≥3-log10 Decrease in HCV RNA
    Description
    The number of participants with at least a 3-log10 decrease from baseline in HCV RNA following 4 weeks of treatment with Placebo or Vaniprevir.
    Time Frame
    Baseline and Week 4
    Title
    Mean Log Change From Baseline in HCV RNA
    Description
    The mean changes from baseline in log10 HCV RNA in each vaniprevir group was compared against control treatment at Week 4.
    Time Frame
    Baseline and Week 4

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patient has chronic Genotype 1 Hepatitis C infection Exclusion Criteria: Subject has been previously treated for HCV Has Human Immunodeficiency Virus (HIV) Has Hepatitis B Has a history of clinically significant medical condition that may interfere with the study (e.g., stroke or chronic seizures or major neurological disorder) or is contraindicated for treatment with peg-IFN and Ribavirin
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Director
    Organizational Affiliation
    Merck Sharp & Dohme LLC
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
    IPD Sharing URL
    http://engagezone.msd.com/ds_documentation.php
    Citations:
    PubMed Identifier
    22473713
    Citation
    Manns MP, Gane E, Rodriguez-Torres M, Stoehr A, Yeh CT, Marcellin P, Wiedmann RT, Hwang PM, Caro L, Barnard RJ, Lee AW; MK-7009 Protocol 007 Study Group. Vaniprevir with pegylated interferon alpha-2a and ribavirin in treatment-naive patients with chronic hepatitis C: a randomized phase II study. Hepatology. 2012 Sep;56(3):884-93. doi: 10.1002/hep.25743. Epub 2012 Jul 17.
    Results Reference
    result
    PubMed Identifier
    23747481
    Citation
    Lawitz E, Sulkowski M, Jacobson I, Kraft WK, Maliakkal B, Al-Ibrahim M, Gordon SC, Kwo P, Rockstroh JK, Panorchan P, Miller M, Caro L, Barnard R, Hwang PM, Gress J, Quirk E, Mobashery N. Characterization of vaniprevir, a hepatitis C virus NS3/4A protease inhibitor, in patients with HCV genotype 1 infection: safety, antiviral activity, resistance, and pharmacokinetics. Antiviral Res. 2013 Sep;99(3):214-20. doi: 10.1016/j.antiviral.2013.05.015. Epub 2013 Jun 7.
    Results Reference
    derived
    Available IPD and Supporting Information:
    Available IPD/Information Type
    CSR Synopsis
    Available IPD/Information URL
    http://www.merck.com/clinical-trials/study.html?id=7009-007&kw=7009-007&tab=access

    Learn more about this trial

    Safety and Efficacy of Vaniprevir (MK7009) Administered With Pegylated-Interferon and Ribavirin (MK-7009-007)

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