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Grazoprevir (MK-5172) With Peg-Interferon and Ribavirin in Participants With Chronic Genotype 2 or 3 Hepatitis C (MK-5172-012)

Primary Purpose

Hepatitis C, Chronic

Status
Terminated
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Grazoprevir
Placebo to Grazoprevir
Peginterferon alfa-2b (Peg-IFN)
Ribavirin (RBV)
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, Chronic

Eligibility Criteria

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

Inclusion Criteria:

  • Body weight ≥ 88 lbs and ≤ 275 lbs
  • Documented chronic Hepatitis C (CHC) GT2 or GT3 infection
  • No known cirrhosis
  • Agrees to use two acceptable methods of birth control during study and through 6 months after last dose of study drug
  • Chest X-ray within the last 6 months
  • Eye exam within the last 6 months

Exclusion Criteria:

  • Known to be human immunodeficiency virus (HIV) positive or co-infected with active hepatitis B virus (positive for Hepatitis B surface antigen)
  • Prior approved or investigational treatment for hepatitis C
  • Evidence of hepatocellular carcinoma
  • Diabetic and/or high blood pressure with clinically significant eye exam findings
  • Pre-existing psychiatric condition
  • Clinical diagnosis of abuse of certain substances within specified timeframes
  • Known medical condition that could interfere with participation
  • Active or suspected cancer within the last 5 years
  • Female who is pregnant, breastfeeding, or expecting to conceive or donate eggs
  • Male who is planning to impregnate partner or donate sperm
  • Male with a pregnant female partner
  • Chronic hepatitis not caused by HCV

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Placebo Comparator

    Experimental

    Arm Label

    Grazoprevir 200 mg + Peg-IFN + RBV

    Grazoprevir 400 mg + Peg-IFN + RBV

    Placebo + Peg-IFN + RBV

    Grazoprevir 800 mg + Peg-IFN + RBV

    Arm Description

    Grazoprevir 200 mg in combination with Peg-IFN and RBV for 12 weeks.

    Grazoprevir 400 mg in combination with Peg-IFN and RBV for 12 weeks.

    Placebo to grazoprevir in combination with Peg-IFN and RBV for 12 weeks, followed by open-label Peg-IFN and RBV for an additional 12 weeks.

    Grazoprevir 800 mg in combination with Peg-IFN and RBV for 12 weeks.

    Outcomes

    Primary Outcome Measures

    Number of Participants Achieving Complete Early Virologic Response (cEVR) in the Grazoprevir Treatment Arms
    cEVR was defined as undetectable hepatitis C virus (HCV) ribonucleic acid (RNA) at Week 12. HCV RNA was measured using the Roche COBAS® Taqman® HCV Test, v.2.0 assay.

    Secondary Outcome Measures

    Time to First Achievement of Undetectable HCV Ribonucleic Acid (RNA)
    Time to first achievement of undetectable HCV RNA was determined by measuring HCV RNA at Treatment Days 1, 3, and 7; Treatment Weeks 2, 4, 8, 12, 16, 20, and 24; as well as Follow-up Weeks 4, 12, and 24. HCV RNA was measured using the Roche COBAS® Taqman® HCV Test, v2.0 assay.
    Number of Participants Achieving Rapid Viral Response (RVR)
    RVR was defined as undetectable HCV RNA at Week 4. HCV RNA was measured using the Roche COBAS® Taqman® HCV Test, v2.0 assay.
    Number of Participants Achieving Sustained Viral Response 12 Weeks After Completion of Therapy (SVR12)
    SVR12 was defined as undetectable HCV RNA 12 weeks after completion of study therapy. HCV RNA was measured using the Roche COBAS® Taqman® HCV Test, v2.0 assay.
    Number of Participants Achieving Sustained Viral Response 24 Weeks After Completion of Therapy (SVR24)
    SVR24 was defined as undetectable HCV RNA 24 weeks after completion of study therapy. HCV RNA was measured using the Roche COBAS® Taqman® HCV Test, v2.0 assay.
    Number of Participants Achieving Undetectable HCV RNA at Week 12 in the Placebo Arm
    HCV RNA was measured using the Roche COBAS® Taqman® HCV Test, v2.0 assay.
    Number of Participants Achieving Complete Early Virologic Response (cEVR) at Week 24 in the Placebo Arm
    cEVR was defined as undetectable hepatitis C virus (HCV) ribonucleic acid (RNA) at Week 24 (i.e., after 12 weeks of placebo + 12 weeks of grazoprevir treatment). HCV RNA was measured using the Roche COBAS® Taqman® HCV Test, v2.0 assay.

    Full Information

    First Posted
    September 22, 2011
    Last Updated
    August 16, 2018
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01440595
    Brief Title
    Grazoprevir (MK-5172) With Peg-Interferon and Ribavirin in Participants With Chronic Genotype 2 or 3 Hepatitis C (MK-5172-012)
    Official Title
    A Randomized, Partially Double-Blind, Active-Controlled, Dose-Ranging Estimation Study to Evaluate the Safety, Tolerability, and Efficacy of Different Regimens of MK-5172 When Administered Concomitantly With Pegylated-Interferon and Ribavirin in Treatment-Naive Patients With Chronic Genotype 2 or 3 Hepatitis C Virus Infection
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2018
    Overall Recruitment Status
    Terminated
    Why Stopped
    Preliminary results of MK-5172 PN003 (NCT01353911) suggested a possible dose relationship to elevated transaminase levels in treatment with grazoprevir.
    Study Start Date
    November 28, 2011 (Actual)
    Primary Completion Date
    May 1, 2012 (Actual)
    Study Completion Date
    May 1, 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
    This study will evaluate the safety, tolerability, and antiviral activity of grazoprevir (MK-5172) when administered concomitantly with peg-interferon alfa-2b (Peg-IFN) and ribavirin (RBV) to treatment-naïve participants with chronic genotype 2 (GT2) or genotype 3 (GT3) hepatitis C virus (HCV) infections.

    6. Conditions and Keywords

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

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Grazoprevir 200 mg + Peg-IFN + RBV
    Arm Type
    Experimental
    Arm Description
    Grazoprevir 200 mg in combination with Peg-IFN and RBV for 12 weeks.
    Arm Title
    Grazoprevir 400 mg + Peg-IFN + RBV
    Arm Type
    Experimental
    Arm Description
    Grazoprevir 400 mg in combination with Peg-IFN and RBV for 12 weeks.
    Arm Title
    Placebo + Peg-IFN + RBV
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo to grazoprevir in combination with Peg-IFN and RBV for 12 weeks, followed by open-label Peg-IFN and RBV for an additional 12 weeks.
    Arm Title
    Grazoprevir 800 mg + Peg-IFN + RBV
    Arm Type
    Experimental
    Arm Description
    Grazoprevir 800 mg in combination with Peg-IFN and RBV for 12 weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    Grazoprevir
    Other Intervention Name(s)
    MK-5172
    Intervention Description
    Grazoprevir 100 mg tablets once daily for 12 weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo to Grazoprevir
    Intervention Description
    Placebo to Grazoprevir once daily for 12 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Peginterferon alfa-2b (Peg-IFN)
    Other Intervention Name(s)
    PegIntron®, SCH 054031
    Intervention Description
    Peg-IFN weekly subcutaneous injection at 1.5 mcg/kg/week for 12 or 24 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Ribavirin (RBV)
    Other Intervention Name(s)
    Rebetol®, SCH 018908
    Intervention Description
    Ribavirin 200 mg capsules twice daily at a dose of 600 mg to 1400 mg based on weight for 12 or 24 weeks
    Primary Outcome Measure Information:
    Title
    Number of Participants Achieving Complete Early Virologic Response (cEVR) in the Grazoprevir Treatment Arms
    Description
    cEVR was defined as undetectable hepatitis C virus (HCV) ribonucleic acid (RNA) at Week 12. HCV RNA was measured using the Roche COBAS® Taqman® HCV Test, v.2.0 assay.
    Time Frame
    Week 12
    Secondary Outcome Measure Information:
    Title
    Time to First Achievement of Undetectable HCV Ribonucleic Acid (RNA)
    Description
    Time to first achievement of undetectable HCV RNA was determined by measuring HCV RNA at Treatment Days 1, 3, and 7; Treatment Weeks 2, 4, 8, 12, 16, 20, and 24; as well as Follow-up Weeks 4, 12, and 24. HCV RNA was measured using the Roche COBAS® Taqman® HCV Test, v2.0 assay.
    Time Frame
    Baseline to Week 12 for Grazoprevir treatment arms, Week 24 for Placebo arm
    Title
    Number of Participants Achieving Rapid Viral Response (RVR)
    Description
    RVR was defined as undetectable HCV RNA at Week 4. HCV RNA was measured using the Roche COBAS® Taqman® HCV Test, v2.0 assay.
    Time Frame
    Week 4
    Title
    Number of Participants Achieving Sustained Viral Response 12 Weeks After Completion of Therapy (SVR12)
    Description
    SVR12 was defined as undetectable HCV RNA 12 weeks after completion of study therapy. HCV RNA was measured using the Roche COBAS® Taqman® HCV Test, v2.0 assay.
    Time Frame
    Week 24 for Grazoprevir treatment arms, Week 36 for Placebo arm
    Title
    Number of Participants Achieving Sustained Viral Response 24 Weeks After Completion of Therapy (SVR24)
    Description
    SVR24 was defined as undetectable HCV RNA 24 weeks after completion of study therapy. HCV RNA was measured using the Roche COBAS® Taqman® HCV Test, v2.0 assay.
    Time Frame
    Week 36 for Grazoprevir treatment arms, Week 48 for Placebo arm
    Title
    Number of Participants Achieving Undetectable HCV RNA at Week 12 in the Placebo Arm
    Description
    HCV RNA was measured using the Roche COBAS® Taqman® HCV Test, v2.0 assay.
    Time Frame
    Week 12
    Title
    Number of Participants Achieving Complete Early Virologic Response (cEVR) at Week 24 in the Placebo Arm
    Description
    cEVR was defined as undetectable hepatitis C virus (HCV) ribonucleic acid (RNA) at Week 24 (i.e., after 12 weeks of placebo + 12 weeks of grazoprevir treatment). HCV RNA was measured using the Roche COBAS® Taqman® HCV Test, v2.0 assay.
    Time Frame
    Week 24

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Body weight ≥ 88 lbs and ≤ 275 lbs Documented chronic Hepatitis C (CHC) GT2 or GT3 infection No known cirrhosis Agrees to use two acceptable methods of birth control during study and through 6 months after last dose of study drug Chest X-ray within the last 6 months Eye exam within the last 6 months Exclusion Criteria: Known to be human immunodeficiency virus (HIV) positive or co-infected with active hepatitis B virus (positive for Hepatitis B surface antigen) Prior approved or investigational treatment for hepatitis C Evidence of hepatocellular carcinoma Diabetic and/or high blood pressure with clinically significant eye exam findings Pre-existing psychiatric condition Clinical diagnosis of abuse of certain substances within specified timeframes Known medical condition that could interfere with participation Active or suspected cancer within the last 5 years Female who is pregnant, breastfeeding, or expecting to conceive or donate eggs Male who is planning to impregnate partner or donate sperm Male with a pregnant female partner Chronic hepatitis not caused by HCV
    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
    Available IPD and Supporting Information:
    Available IPD/Information Type
    CSR Synopsis
    Available IPD/Information URL
    http://www.merck.com/clinical-trials/study.html?id=5172-012&kw=5172-012&tab=access

    Learn more about this trial

    Grazoprevir (MK-5172) With Peg-Interferon and Ribavirin in Participants With Chronic Genotype 2 or 3 Hepatitis C (MK-5172-012)

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