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A Study of Safety and Efficacy of Vaniprevir Administered With Pegylated-Interferon and Ribavirin in Japanese Participants With Chronic Hepatitis C Infection (7009-016)

Primary Purpose

Hepatitis C

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Vaniprevir
Pegylated Interferon (peg-IFN)
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

20 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Has chronic genotype 1 Hepatitis C infection

Exclusion Criteria:

  • Has not tolerated previous course of peg-IFN and ribavirin
  • Has 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 Type

    Experimental

    Experimental

    Experimental

    Placebo Comparator

    Arm Label

    Vaniprevir 200 mg + peg-IFN + ribavirin

    Vaniprevir 600 mg + peg-IFN + ribavirin

    Vaniprevir 1200 mg + peg-IFN + ribavirin

    Placebo + peg-IFN + ribavirin

    Arm Description

    Participants will receive vaniprevir 100 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants will continue peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.

    Participants will receive vaniprevir 300 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants will continue peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.

    Participants will receive vaniprevir 600 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants will continue peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.

    Participants will receive placebo twice daily in combination with peg-IFN and ribavirin for 28 days. Participants will continue peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.

    Outcomes

    Primary Outcome Measures

    Percentage of Participants Achieving Rapid Viral Response
    Rapid viral response (RVR) is defined as undetectable hepatitis C virus ribonucleic acid (HCV RNA) at Week 4. Serum HCV RNA levels were measured using Roche COBAS TaqMan HCV Auto assay. The limit of quantification was 1.2 log IU/mL (15 IU/mL) and the limit of detection was <1.2 log IU/mL, but with no specific value. The Data-As-Observed (DAO) approach was used to handle missing data.

    Secondary Outcome Measures

    Percentage of Participants Achieving a > or = 2-log10 Decrease in HCV RNA From Baseline to Week 4
    Serum HCV RNA levels were measured using Roche COBAS TaqMan HCV Auto assay. The DAO approach was used to handle missing data.
    Percentage of Participants Achieving a > or = 3-log10 Decrease in HCV RNA From Baseline to Week 4
    Serum HCV RNA levels were measured using Roche COBAS TaqMan HCV Auto assay. The DAO approach was used to handle missing data.
    Change From Baseline in HCV RNA in log10 at Week 4
    Change from baseline in HCV RNA at Week 4 was calculated by subtracting Week 4 HCV RNA level from Baseline HCV RNA level. HCV RNA is measured as International Units per milliliter (IU/mL). Serum HCV RNA levels were measured using Roche COBAS TaqMan HCV Auto assay. The DAO approach was used to handle missing data.
    Number of Participants Who Experienced at Least One Adverse Event
    An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment.
    Number of Participants Who Discontinued Study Drug Due to an Adverse Event
    An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment.

    Full Information

    First Posted
    April 10, 2009
    Last Updated
    September 10, 2018
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00880763
    Brief Title
    A Study of Safety and Efficacy of Vaniprevir Administered With Pegylated-Interferon and Ribavirin in Japanese Participants With Chronic Hepatitis C Infection (7009-016)
    Official Title
    A Phase II Randomized Placebo-controlled Study to Evaluate the Safety and Efficacy of MK-7009 Administered Concomitantly With Pegylated-Interferon and Ribavirin for 28 Days in Japanese Treatment-Experienced Patients With Chronic Hepatitis C Infection
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    April 20, 2009 (Actual)
    Primary Completion Date
    June 3, 2010 (Actual)
    Study Completion Date
    February 23, 2012 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The study evaluates safety and efficacy of vaniprevir (MK7009), when administered with Pegylated-Interferon (peg-IFN) and Ribavirin, in Japanese patients with Hepatitis C infection. The primary hypotheses are that 1.) the proportion of patients achieving rapid viral response (RVR) in one or more of the vaniprevir treatment groups is superior to that in the placebo group, when each is administered concomitantly with pegylated interferon (peg-IFN) α-2a and ribavirin; and 2.) vaniprevir at the studied doses is well tolerated compared with placebo, when each is administered concomitantly with peg-IFN α-2a and ribavirin for 28 days.

    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
    90 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Vaniprevir 200 mg + peg-IFN + ribavirin
    Arm Type
    Experimental
    Arm Description
    Participants will receive vaniprevir 100 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants will continue peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
    Arm Title
    Vaniprevir 600 mg + peg-IFN + ribavirin
    Arm Type
    Experimental
    Arm Description
    Participants will receive vaniprevir 300 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants will continue peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
    Arm Title
    Vaniprevir 1200 mg + peg-IFN + ribavirin
    Arm Type
    Experimental
    Arm Description
    Participants will receive vaniprevir 600 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants will continue peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
    Arm Title
    Placebo + peg-IFN + ribavirin
    Arm Type
    Placebo Comparator
    Arm Description
    Participants will receive placebo twice daily in combination with peg-IFN and ribavirin for 28 days. Participants will continue peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
    Intervention Type
    Drug
    Intervention Name(s)
    Vaniprevir
    Other Intervention Name(s)
    MK7009
    Intervention Description
    Vaniprevir oral capsule administered twice daily (200, 600 or 1200 mg/day) for 28 days
    Intervention Type
    Drug
    Intervention Name(s)
    Pegylated Interferon (peg-IFN)
    Intervention Description
    Open-label peg-IFN alfa-2a subcutaneous injection (sourced locally) administered weekly, 180 micrograms, for 6 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Ribavirin
    Intervention Description
    Open-label ribavirin (sourced locally) administered orally twice daily, 600 to 1000 mg/day, for 6 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: Placebo
    Intervention Description
    Placebo to vaniprevir oral capsule twice daily for 28 days
    Primary Outcome Measure Information:
    Title
    Percentage of Participants Achieving Rapid Viral Response
    Description
    Rapid viral response (RVR) is defined as undetectable hepatitis C virus ribonucleic acid (HCV RNA) at Week 4. Serum HCV RNA levels were measured using Roche COBAS TaqMan HCV Auto assay. The limit of quantification was 1.2 log IU/mL (15 IU/mL) and the limit of detection was <1.2 log IU/mL, but with no specific value. The Data-As-Observed (DAO) approach was used to handle missing data.
    Time Frame
    Week 4
    Secondary Outcome Measure Information:
    Title
    Percentage of Participants Achieving a > or = 2-log10 Decrease in HCV RNA From Baseline to Week 4
    Description
    Serum HCV RNA levels were measured using Roche COBAS TaqMan HCV Auto assay. The DAO approach was used to handle missing data.
    Time Frame
    Baseline and Week 4
    Title
    Percentage of Participants Achieving a > or = 3-log10 Decrease in HCV RNA From Baseline to Week 4
    Description
    Serum HCV RNA levels were measured using Roche COBAS TaqMan HCV Auto assay. The DAO approach was used to handle missing data.
    Time Frame
    Baseline and Week 4
    Title
    Change From Baseline in HCV RNA in log10 at Week 4
    Description
    Change from baseline in HCV RNA at Week 4 was calculated by subtracting Week 4 HCV RNA level from Baseline HCV RNA level. HCV RNA is measured as International Units per milliliter (IU/mL). Serum HCV RNA levels were measured using Roche COBAS TaqMan HCV Auto assay. The DAO approach was used to handle missing data.
    Time Frame
    Baseline and Week 4
    Title
    Number of Participants Who Experienced at Least One Adverse Event
    Description
    An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment.
    Time Frame
    Up to 6 weeks
    Title
    Number of Participants Who Discontinued Study Drug Due to an Adverse Event
    Description
    An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment.
    Time Frame
    Up to 6 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    64 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Has chronic genotype 1 Hepatitis C infection Exclusion Criteria: Has not tolerated previous course of peg-IFN and ribavirin Has 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
    25115901
    Citation
    Hayashi N, Mobashery N, Izumi N. Vaniprevir plus peginterferon alfa-2a and ribavirin in treatment-experienced Japanese patients with hepatitis C virus genotype 1 infection: a randomized phase II study. J Gastroenterol. 2015 Feb;50(2):238-48. doi: 10.1007/s00535-014-0979-2. Epub 2014 Aug 13.
    Results Reference
    result
    Available IPD and Supporting Information:
    Available IPD/Information Type
    CSR Synopsis
    Available IPD/Information URL
    http://www.merck.com/clinical-trials/study.html?id=7009-016&kw=7009-016&tab=access

    Learn more about this trial

    A Study of Safety and Efficacy of Vaniprevir Administered With Pegylated-Interferon and Ribavirin in Japanese Participants With Chronic Hepatitis C Infection (7009-016)

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