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Grazoprevir (MK-5172) and Elbasvir (MK-8742) Combination for Chronic Hepatitis C Virus (HCV) Genotypes 1, 4, and 6 (MK-5172-065)

Primary Purpose

Hepatitis C

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Grazoprevir + Elbasvir
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 - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • has HCV GT1, GT4, or GT6 with sickle cell anemia, thalassemia, or hemophilia/von Willebrand disease
  • has cirrhosis or is non-cirrhotic
  • is human immunodeficiency virus (HIV) coinfected or not infected with HIV
  • is a female of non childbearing potential, or is male or female and uses an acceptable method(s) of contraception

Exclusion Criteria:

  • has evidence of decompensated liver disease
  • is coinfected with hepatitis B
  • has had a malignancy ≤5 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer
  • has hepatocellular carcinoma (HCC) or is under evaluation for HCC
  • has clinically-relevant drug or alcohol abuse within 12 months of screening

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Immediate Treatment

    Deferred Treatment

    Arm Description

    Participants will take grazoprevir 100 mg + elbasvir 50 mg once daily during the 12-week treatment period and then will be monitored for safety during a 24-week follow-up period.

    Participants will take placebo tablets once daily during the 12-week treatment period and will then be monitored for safety during a 4-week follow-up period. Participants will then begin open-label treatment with grazoprevir 100 mg + elbasvir 50 mg for a 12-week treatment period and will then be monitored for safety during a 24-week follow-up period.

    Outcomes

    Primary Outcome Measures

    Percentage of Participants Achieving Sustained Virologic Response 12 Weeks After Completing Study Therapy (SVR12)
    The percentage of participants in the both arms achieving SVR12 (i.e., HCV riboncleic acid [RNA] level below the lower limit of quantification [LLoQ] 12 weeks after completing study therapy) was determined. HCV RNA levels were measured using the Roche COBAS™ Taqman™ HCV Test v2.0 (High Pure System), which has a LLoQ of <15 IU/mL.
    Percentage of Participants Experiencing an Adverse Event (AE)
    An AE is any untoward medical occurrence which does not necessarily have to have a causal relationship with this treatment.
    Percentage of Participants Discontinuing From Study Treatment Due to an AE(s)
    An AE is any untoward medical occurrence which does not necessarily have to have a causal relationship with this treatment.

    Secondary Outcome Measures

    Percentage of Participants Achieving Sustained Virologic Response 24 Weeks After Completing Study Therapy (SVR24)
    The percentage of participants in both arms achieving SVR24 (i.e., HCV RNA level below the LLoQ 24 weeks after completing study therapy) was determined. HCV RNA levels were measured using the Roche COBAS™ Taqman™ HCV Test v2.0 (High Pure System), which has a LLoQ of <15 IU/mL.

    Full Information

    First Posted
    September 25, 2014
    Last Updated
    September 3, 2018
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02252016
    Brief Title
    Grazoprevir (MK-5172) and Elbasvir (MK-8742) Combination for Chronic Hepatitis C Virus (HCV) Genotypes 1, 4, and 6 (MK-5172-065)
    Official Title
    A Phase III Double Blind Clinical Trial to Study the Efficacy and Safety of the Combination Regimen of MK-5172 and MK-8742 in Subjects With Chronic HCV GT1, GT4 and GT6 Infection With Inherited Blood Disorders With and Without HIV Co-Infection
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    October 22, 2014 (Actual)
    Primary Completion Date
    December 7, 2015 (Actual)
    Study Completion Date
    June 14, 2016 (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
    This is a randomized, multi-site, placebo-controlled trial of a fixed dose combination (FDC) of grazoprevir (MK-5172) 100 mg + elbasvir (MK-8742) 50 mg in participants with chronic Hepatitis C Virus (HCV) genotype (GT) 1, GT4 or GT6 with inherited blood disorders. The primary hypothesis is that the proportion of participants treated with grazoprevir+elbasvir achieving Sustained Virologic Response (SVR) 12 weeks after the end of all study therapy (SVR12) will be greater than the reference rate of 40%.

    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 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    159 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Immediate Treatment
    Arm Type
    Experimental
    Arm Description
    Participants will take grazoprevir 100 mg + elbasvir 50 mg once daily during the 12-week treatment period and then will be monitored for safety during a 24-week follow-up period.
    Arm Title
    Deferred Treatment
    Arm Type
    Placebo Comparator
    Arm Description
    Participants will take placebo tablets once daily during the 12-week treatment period and will then be monitored for safety during a 4-week follow-up period. Participants will then begin open-label treatment with grazoprevir 100 mg + elbasvir 50 mg for a 12-week treatment period and will then be monitored for safety during a 24-week follow-up period.
    Intervention Type
    Drug
    Intervention Name(s)
    Grazoprevir + Elbasvir
    Intervention Description
    FDC tablet containing grazoprevir 100 mg + elbasvir 50 mg taken once daily by mouth.
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Placebo tablets matching grazoprevir + elbasvir FDC tablets taken once daily by mouth.
    Primary Outcome Measure Information:
    Title
    Percentage of Participants Achieving Sustained Virologic Response 12 Weeks After Completing Study Therapy (SVR12)
    Description
    The percentage of participants in the both arms achieving SVR12 (i.e., HCV riboncleic acid [RNA] level below the lower limit of quantification [LLoQ] 12 weeks after completing study therapy) was determined. HCV RNA levels were measured using the Roche COBAS™ Taqman™ HCV Test v2.0 (High Pure System), which has a LLoQ of <15 IU/mL.
    Time Frame
    12 weeks after completing study therapy (Week 24)
    Title
    Percentage of Participants Experiencing an Adverse Event (AE)
    Description
    An AE is any untoward medical occurrence which does not necessarily have to have a causal relationship with this treatment.
    Time Frame
    Up to Week 14
    Title
    Percentage of Participants Discontinuing From Study Treatment Due to an AE(s)
    Description
    An AE is any untoward medical occurrence which does not necessarily have to have a causal relationship with this treatment.
    Time Frame
    Up to Week 12
    Secondary Outcome Measure Information:
    Title
    Percentage of Participants Achieving Sustained Virologic Response 24 Weeks After Completing Study Therapy (SVR24)
    Description
    The percentage of participants in both arms achieving SVR24 (i.e., HCV RNA level below the LLoQ 24 weeks after completing study therapy) was determined. HCV RNA levels were measured using the Roche COBAS™ Taqman™ HCV Test v2.0 (High Pure System), which has a LLoQ of <15 IU/mL.
    Time Frame
    24 weeks after completing study therapy (Week 36)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: has HCV GT1, GT4, or GT6 with sickle cell anemia, thalassemia, or hemophilia/von Willebrand disease has cirrhosis or is non-cirrhotic is human immunodeficiency virus (HIV) coinfected or not infected with HIV is a female of non childbearing potential, or is male or female and uses an acceptable method(s) of contraception Exclusion Criteria: has evidence of decompensated liver disease is coinfected with hepatitis B has had a malignancy ≤5 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer has hepatocellular carcinoma (HCC) or is under evaluation for HCC has clinically-relevant drug or alcohol abuse within 12 months of screening
    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
    28256747
    Citation
    Hezode C, Colombo M, Bourliere M, Spengler U, Ben-Ari Z, Strasser SI, Lee WM, Morgan L, Qiu J, Hwang P, Robertson M, Nguyen BY, Barr E, Wahl J, Haber B, Chase R, Talwani R, Marco VD; C-EDGE IBLD Study Investigators. Elbasvir/Grazoprevir for Patients With Hepatitis C Virus Infection and Inherited Blood Disorders: A Phase III Study. Hepatology. 2017 Sep;66(3):736-745. doi: 10.1002/hep.29139. Epub 2017 Jul 20.
    Results Reference
    result
    PubMed Identifier
    29461687
    Citation
    Asselah T, Reesink H, Gerstoft J, de Ledinghen V, Pockros PJ, Robertson M, Hwang P, Asante-Appiah E, Wahl J, Nguyen BY, Barr E, Talwani R, Serfaty L. Efficacy of elbasvir and grazoprevir in participants with hepatitis C virus genotype 4 infection: A pooled analysis. Liver Int. 2018 Sep;38(9):1583-1591. doi: 10.1111/liv.13727. Epub 2018 Mar 31.
    Results Reference
    derived

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    Grazoprevir (MK-5172) and Elbasvir (MK-8742) Combination for Chronic Hepatitis C Virus (HCV) Genotypes 1, 4, and 6 (MK-5172-065)

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