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    Clinical Trial Results:
    A Phase II, Randomized, Open-Label Clinical Trial to Study the Efficacy and Safety of the Combination Regimen of MK-3682B (MK-5172 + MK-3682 + MK-8408 Fixed Dose Combination (FDC)) in Subjects with Chronic HCV GT1 or GT3 Infection who have failed a Direct Acting Antiviral Regimen

    Summary
    EudraCT number
    2015-001483-19
    Trial protocol
    SE   DE   ES  
    Global end of trial date
    25 Sep 2017

    Results information
    Results version number
    v1(current)
    This version publication date
    24 Mar 2018
    First version publication date
    24 Mar 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    3682-021
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02613403
    WHO universal trial number (UTN)
    -
    Other trial identifiers
    Merck Protocol Number: MK-3682-021
    Sponsors
    Sponsor organisation name
    Merck Sharp & Dohme Corp.
    Sponsor organisation address
    2000 Galloping Hill Road, Kenilworth, NJ, United States, 07033
    Public contact
    Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.com
    Scientific contact
    Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    27 Mar 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    25 Sep 2017
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    This is a randomized, multicenter, 2-part, open-label trial to evaluate the efficacy of the fixed-dose combination (FDC) regimen of grazoprevir (GZR; MK-5172), uprifosbuvir (UPR; MK-3682) and ruzasvir (RZR; MK-8408), referred to as MK-3682B, +/- ribavirin (RBV) in cirrhotic (C) or non-cirrhotic (NC) participants infected with hepatitis C virus (HCV) previously failing a direct-acting antiviral (DAA) regimen. In Part A, C or NC participants with HCV genotype (GT) 1 infection previously failing a DAA regimen of sofosbuvir (SOF)/ledipasvir (LDV) [Arms 1 and 2] or elbasvir (EBR)/GZR [Arms 3 and 4] receive: 1) MK-3682B + RBV for 16 weeks [Arms 1 and 3]; or 2) MK-3682B for 24 weeks [Arms 2 and 4]. In Part B, C or NC participants with HCV GT1-6 infection previously failing any all-oral DAA regimen (GT1-6) or SOF/pegylated interferon and ribavirin (PR) regimen (GT3 only) were to receive MK-3682B for 16 weeks. However, the trial was terminated prior to participant enrollment for Part B.
    Protection of trial subjects
    This study was conducted in conformance with Good Clinical Practice standards and applicable country and/or local statutes and regulations regarding ethical committee review, informed consent, and the protection of human subjects participating in biomedical research.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    10 Dec 2015
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    France: 6
    Country: Number of subjects enrolled
    Germany: 8
    Country: Number of subjects enrolled
    Spain: 3
    Country: Number of subjects enrolled
    Sweden: 2
    Country: Number of subjects enrolled
    United States: 75
    Worldwide total number of subjects
    94
    EEA total number of subjects
    19
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    76
    From 65 to 84 years
    18
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    Part A randomized 94 C/NC participants with chronic HCV GT1 failing a DAA regimen; 1 participant withdrew prior to treatment. Part B was to evaluate MK-3682B in C/NC HCV GT1-6 participants failing any all-oral DAA (GT1-6) or PR (GT 3) regimen, enrolling after Part A completed. Part A completed as planned; trial terminated before Part B enrollment.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    [Part A, Arm 1] Prior SOF/LDV Failure: MK-3682B + RBV
    Arm description
    C or NC HCV GT1 participants previously failing a DAA regimen of sofosbuvir (SOF)/ledipasvir (LDV) receive MK-3682B, a fixed dose combination (FDC) of grazoprevir (GZR; MK-5172 [50 mg]) + uprifosbuvir (UPR; MK-3682 [225 mg]) + ruzasvir (RZR; MK-8408 [30 mg]), administered as 2 tablets once daily in combination with ribavirin (RBV) twice daily for 16 weeks.
    Arm type
    Experimental

    Investigational medicinal product name
    Ribavirin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Ribavirin 200 mg capsules, taken twice daily by mouth as part of a weight-based dosing regimen. Depending on participant body weight, total daily dose of Ribavirin may be 800, 1000, 1200 or 1400 mg per day.

    Investigational medicinal product name
    MK-3682B
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Two MK-3682B 1,136 mg FDC tablets each containing 50 mg MK-5172 (GZR), 225 mg MK-3682 (UPR, formerly IDX21437), and 30 mg MK-8408 (RZR) taken once daily by mouth.

    Arm title
    [Part A, Arm 2] Prior SOF/LDV Failure: MK-3682B
    Arm description
    C or NC HCV GT1 participants previously failing a DAA regimen of SOF/LDV receive MK-3682B, an FDC of GZR (MK-5172 [50 mg]) + UPR (MK-3682 [225 mg]) + RZR (MK-8408 [30 mg]), administered as 2 tablets once daily for 24 weeks.
    Arm type
    Experimental

    Investigational medicinal product name
    MK-3682B
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Two MK-3682B 1,136 mg FDC tablets each containing 50 mg MK-5172 (GZR), 225 mg MK-3682 (UPR, formerly IDX21437), and 30 mg MK-8408 (RZR) taken once daily by mouth.

    Arm title
    [Part A, Arm 3] Prior GZR/EBR Failure: MK-3682B + RBV
    Arm description
    C or NC HCV GT1 participants previously failing a DAA regimen of GZR/elbasvir (EBR) (MK-5172/MK-8742) receive MK-3682B, an FDC of GZR (MK-5172 [50 mg]) + UPR (MK-3682 [225 mg]) + RZR (MK-8408 [30 mg]), administered as 2 tablets once daily in combination with RBV twice daily for 16 weeks.
    Arm type
    Experimental

    Investigational medicinal product name
    Ribavirin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Ribavirin 200 mg capsules, taken twice daily by mouth as part of a weight-based dosing regimen. Depending on participant body weight, total daily dose of Ribavirin may be 800, 1000, 1200 or 1400 mg per day.

    Investigational medicinal product name
    MK-3682B
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Two MK-3682B 1,136 mg FDC tablets each containing 50 mg MK-5172 (GZR), 225 mg MK-3682 (UPR, formerly IDX21437), and 30 mg MK-8408 (RZR) taken once daily by mouth.

    Arm title
    [Part A, Arm 4] Prior GZR/EBR Failure: MK-3682B
    Arm description
    C or NC HCV GT1 participants previously failing a DAA regimen of GZR/EBR (MK-5172/MK-8742) receive MK-3682B, an FDC of GZR (MK-5172 [50 mg]) + UPR (MK-3682 [225 mg]) + RZR (MK-8408 [30 mg]), administered as 2 tablets once daily for 24 weeks.
    Arm type
    Experimental

    Investigational medicinal product name
    MK-3682B
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Two MK-3682B 1,136 mg FDC tablets each containing 50 mg MK-5172 (GZR), 225 mg MK-3682 (UPR, formerly IDX21437), and 30 mg MK-8408 (RZR) taken once daily by mouth.

    Number of subjects in period 1
    [Part A, Arm 1] Prior SOF/LDV Failure: MK-3682B + RBV [Part A, Arm 2] Prior SOF/LDV Failure: MK-3682B [Part A, Arm 3] Prior GZR/EBR Failure: MK-3682B + RBV [Part A, Arm 4] Prior GZR/EBR Failure: MK-3682B
    Started
    36
    36
    9
    13
    Treated
    35
    36
    9
    13
    Completed
    34
    35
    9
    13
    Not completed
    2
    1
    0
    0
         Consent withdrawn by subject
    2
    -
    -
    -
         Lost to follow-up
    -
    1
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    [Part A, Arm 1] Prior SOF/LDV Failure: MK-3682B + RBV
    Reporting group description
    C or NC HCV GT1 participants previously failing a DAA regimen of sofosbuvir (SOF)/ledipasvir (LDV) receive MK-3682B, a fixed dose combination (FDC) of grazoprevir (GZR; MK-5172 [50 mg]) + uprifosbuvir (UPR; MK-3682 [225 mg]) + ruzasvir (RZR; MK-8408 [30 mg]), administered as 2 tablets once daily in combination with ribavirin (RBV) twice daily for 16 weeks.

    Reporting group title
    [Part A, Arm 2] Prior SOF/LDV Failure: MK-3682B
    Reporting group description
    C or NC HCV GT1 participants previously failing a DAA regimen of SOF/LDV receive MK-3682B, an FDC of GZR (MK-5172 [50 mg]) + UPR (MK-3682 [225 mg]) + RZR (MK-8408 [30 mg]), administered as 2 tablets once daily for 24 weeks.

    Reporting group title
    [Part A, Arm 3] Prior GZR/EBR Failure: MK-3682B + RBV
    Reporting group description
    C or NC HCV GT1 participants previously failing a DAA regimen of GZR/elbasvir (EBR) (MK-5172/MK-8742) receive MK-3682B, an FDC of GZR (MK-5172 [50 mg]) + UPR (MK-3682 [225 mg]) + RZR (MK-8408 [30 mg]), administered as 2 tablets once daily in combination with RBV twice daily for 16 weeks.

    Reporting group title
    [Part A, Arm 4] Prior GZR/EBR Failure: MK-3682B
    Reporting group description
    C or NC HCV GT1 participants previously failing a DAA regimen of GZR/EBR (MK-5172/MK-8742) receive MK-3682B, an FDC of GZR (MK-5172 [50 mg]) + UPR (MK-3682 [225 mg]) + RZR (MK-8408 [30 mg]), administered as 2 tablets once daily for 24 weeks.

    Reporting group values
    [Part A, Arm 1] Prior SOF/LDV Failure: MK-3682B + RBV [Part A, Arm 2] Prior SOF/LDV Failure: MK-3682B [Part A, Arm 3] Prior GZR/EBR Failure: MK-3682B + RBV [Part A, Arm 4] Prior GZR/EBR Failure: MK-3682B Total
    Number of subjects
    36 36 9 13 94
    Age categorical
    Units: Subjects
        In utero
    0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0 0 0 0
        Newborns (0-27 days)
    0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    0 0 0 0 0
        Children (2-11 years)
    0 0 0 0 0
        Adolescents (12-17 years)
    0 0 0 0 0
        Adults (18-64 years)
    27 30 8 11 76
        From 65-84 years
    9 6 1 2 18
        85 years and over
    0 0 0 0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    59.2 ± 8.3 58.9 ± 6.6 57.3 ± 8.5 53.9 ± 11.0 -
    Sex: Female, Male
    Units: Subjects
        Female
    4 2 3 4 13
        Male
    32 34 6 9 81

    End points

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    End points reporting groups
    Reporting group title
    [Part A, Arm 1] Prior SOF/LDV Failure: MK-3682B + RBV
    Reporting group description
    C or NC HCV GT1 participants previously failing a DAA regimen of sofosbuvir (SOF)/ledipasvir (LDV) receive MK-3682B, a fixed dose combination (FDC) of grazoprevir (GZR; MK-5172 [50 mg]) + uprifosbuvir (UPR; MK-3682 [225 mg]) + ruzasvir (RZR; MK-8408 [30 mg]), administered as 2 tablets once daily in combination with ribavirin (RBV) twice daily for 16 weeks.

    Reporting group title
    [Part A, Arm 2] Prior SOF/LDV Failure: MK-3682B
    Reporting group description
    C or NC HCV GT1 participants previously failing a DAA regimen of SOF/LDV receive MK-3682B, an FDC of GZR (MK-5172 [50 mg]) + UPR (MK-3682 [225 mg]) + RZR (MK-8408 [30 mg]), administered as 2 tablets once daily for 24 weeks.

    Reporting group title
    [Part A, Arm 3] Prior GZR/EBR Failure: MK-3682B + RBV
    Reporting group description
    C or NC HCV GT1 participants previously failing a DAA regimen of GZR/elbasvir (EBR) (MK-5172/MK-8742) receive MK-3682B, an FDC of GZR (MK-5172 [50 mg]) + UPR (MK-3682 [225 mg]) + RZR (MK-8408 [30 mg]), administered as 2 tablets once daily in combination with RBV twice daily for 16 weeks.

    Reporting group title
    [Part A, Arm 4] Prior GZR/EBR Failure: MK-3682B
    Reporting group description
    C or NC HCV GT1 participants previously failing a DAA regimen of GZR/EBR (MK-5172/MK-8742) receive MK-3682B, an FDC of GZR (MK-5172 [50 mg]) + UPR (MK-3682 [225 mg]) + RZR (MK-8408 [30 mg]), administered as 2 tablets once daily for 24 weeks.

    Primary: Percentage of Participants Achieving Sustained Virologic Response 12 Weeks After The End of Study Therapy (SVR12)

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    End point title
    Percentage of Participants Achieving Sustained Virologic Response 12 Weeks After The End of Study Therapy (SVR12) [1]
    End point description
    The percentage of participants achieving SVR12 was determined, defined as having a plasma HCV ribonucleic acid (RNA) level below the lower limit of quantification (LLOQ) 12 weeks after the end of study therapy. Plasma HCV RNA level was measured using the Roche COBAS™ AmpliPrep/COBAS™ Taqman™ HCV Test, v2.0 ® assay with a LLOQ of 15 IU/mL. The analysis population includes all randomized participants in Part A receiving ≥1 dose of study treatment. Part B was terminated prior to participant enrollment and was not included for analysis.
    End point type
    Primary
    End point timeframe
    12 weeks following final dose of study treatment ([MK-3682B + RBV Groups]: Study Week 28; [MK-3682B Groups]: Study Week 36)
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Per study protocol, statistical analysis was not planned for this endpoint.
    End point values
    [Part A, Arm 1] Prior SOF/LDV Failure: MK-3682B + RBV [Part A, Arm 2] Prior SOF/LDV Failure: MK-3682B [Part A, Arm 3] Prior GZR/EBR Failure: MK-3682B + RBV [Part A, Arm 4] Prior GZR/EBR Failure: MK-3682B
    Number of subjects analysed
    35
    36
    9
    13
    Units: Percentage
        number (confidence interval 95%)
    97.1 (85.1 to 99.9)
    100.0 (90.3 to 100.0)
    100.0 (66.4 to 100.0)
    100.0 (75.3 to 100.0)
    No statistical analyses for this end point

    Primary: Number of Participants Who Experienced an Adverse Event

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    End point title
    Number of Participants Who Experienced an Adverse Event [2]
    End point description
    The number of participants experiencing an adverse event (AE) was assessed. An AE is any unfavorable and unintended medical occurrence, symptom, or disease witnessed in a participant, regardless of whether or not a causal relationship with the study treatment can be demonstrated. Further, any worsening of a preexisting condition that is temporally associated with the use of the study treatment is also considered an AE. The analysis population includes all randomized participants in Part A receiving ≥1 dose of study treatment. Part B was terminated prior to participant enrollment and was not included for analysis.
    End point type
    Primary
    End point timeframe
    Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Per study protocol, statistical analysis was not planned for this endpoint.
    End point values
    [Part A, Arm 1] Prior SOF/LDV Failure: MK-3682B + RBV [Part A, Arm 2] Prior SOF/LDV Failure: MK-3682B [Part A, Arm 3] Prior GZR/EBR Failure: MK-3682B + RBV [Part A, Arm 4] Prior GZR/EBR Failure: MK-3682B
    Number of subjects analysed
    35
    36
    9
    13
    Units: Participants
    31
    27
    9
    12
    No statistical analyses for this end point

    Primary: Number of Participants Who Discontinued Study Drug Due to an Adverse Event

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    End point title
    Number of Participants Who Discontinued Study Drug Due to an Adverse Event [3]
    End point description
    The number of participants discontinuing study drug due to an AE was assessed. The analysis population includes all randomized participants in Part A receiving ≥1 dose of study treatment. Part B was terminated prior to participant enrollment and was not included for analysis.
    End point type
    Primary
    End point timeframe
    Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Per study protocol, statistical analysis was not planned for this endpoint.
    End point values
    [Part A, Arm 1] Prior SOF/LDV Failure: MK-3682B + RBV [Part A, Arm 2] Prior SOF/LDV Failure: MK-3682B [Part A, Arm 3] Prior GZR/EBR Failure: MK-3682B + RBV [Part A, Arm 4] Prior GZR/EBR Failure: MK-3682B
    Number of subjects analysed
    35
    36
    9
    13
    Units: Participants
    0
    0
    0
    0
    No statistical analyses for this end point

    Primary: Number of Participants Who Experienced a Serious Adverse Event

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    End point title
    Number of Participants Who Experienced a Serious Adverse Event [4]
    End point description
    The number of participants experiencing a serious adverse event (SAE) was assessed. An SAE is an adverse event that: results in death; is life threatening; results in persistent or significant disability or incapacity; results in or prolongs a hospitalization; is a congenital anomaly or birth defect; is a cancer; or may jeopardize the participant, potentially require medical or surgical intervention. The analysis population includes all randomized participants in Part A receiving ≥1 dose of study treatment. Part B was terminated prior to participant enrollment and was not included for analysis.
    End point type
    Primary
    End point timeframe
    Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
    Notes
    [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Per study protocol, statistical analysis was not planned for this endpoint.
    End point values
    [Part A, Arm 1] Prior SOF/LDV Failure: MK-3682B + RBV [Part A, Arm 2] Prior SOF/LDV Failure: MK-3682B [Part A, Arm 3] Prior GZR/EBR Failure: MK-3682B + RBV [Part A, Arm 4] Prior GZR/EBR Failure: MK-3682B
    Number of subjects analysed
    35
    36
    9
    13
    Units: Participants
    3
    4
    0
    1
    No statistical analyses for this end point

    Primary: Number of Participants Who Experienced a Drug-Related Adverse Event

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    End point title
    Number of Participants Who Experienced a Drug-Related Adverse Event [5]
    End point description
    The number of participants experiencing a drug-related AE was assessed. A drug-related AE was an AE thought to be possibly, probably, or definitely related to the study drug as determined by the investigator. The analysis population includes all randomized participants in Part A receiving ≥1 dose of study treatment. Part B was terminated prior to participant enrollment and was not included for analysis.
    End point type
    Primary
    End point timeframe
    Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
    Notes
    [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Per study protocol, statistical analysis was not planned for this endpoint.
    End point values
    [Part A, Arm 1] Prior SOF/LDV Failure: MK-3682B + RBV [Part A, Arm 2] Prior SOF/LDV Failure: MK-3682B [Part A, Arm 3] Prior GZR/EBR Failure: MK-3682B + RBV [Part A, Arm 4] Prior GZR/EBR Failure: MK-3682B
    Number of subjects analysed
    35
    36
    9
    13
    Units: Participants
    23
    18
    9
    5
    No statistical analyses for this end point

    Primary: Number of Participants Who Experienced a Serious and Drug-Related Adverse Event

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    End point title
    Number of Participants Who Experienced a Serious and Drug-Related Adverse Event [6]
    End point description
    The number of participants experiencing a serious and drug-related AE was assessed. The analysis population includes all randomized participants in Part A receiving ≥1 dose of study treatment. Part B was terminated prior to participant enrollment and was not included for analysis.
    End point type
    Primary
    End point timeframe
    Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
    Notes
    [6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Per study protocol, statistical analysis was not planned for this endpoint.
    End point values
    [Part A, Arm 1] Prior SOF/LDV Failure: MK-3682B + RBV [Part A, Arm 2] Prior SOF/LDV Failure: MK-3682B [Part A, Arm 3] Prior GZR/EBR Failure: MK-3682B + RBV [Part A, Arm 4] Prior GZR/EBR Failure: MK-3682B
    Number of subjects analysed
    35
    36
    9
    13
    Units: Participants
    0
    0
    0
    0
    No statistical analyses for this end point

    Primary: Number of Participants Who Experienced an Accidental or Intentional Overdose Without Adverse Effect

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    End point title
    Number of Participants Who Experienced an Accidental or Intentional Overdose Without Adverse Effect [7]
    End point description
    The number of participants experiencing an accidental or intentional overdose without adverse effect was determined. Per study protocol, any occurrence of a participant receiving either MK-3682B or RBV at any dose higher than prescribed was considered an overdose. If this definition of overdose was met without any associated clinical symptoms or abnormal laboratory results, this occurrence of overdose was reported as an accidental or intentional overdose without adverse effect. The analysis population includes all randomized participants in Part A receiving ≥1 dose of study treatment. Part B was terminated prior to participant enrollment and was not included for analysis.
    End point type
    Primary
    End point timeframe
    Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
    Notes
    [7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Per study protocol, statistical analysis was not planned for this endpoint.
    End point values
    [Part A, Arm 1] Prior SOF/LDV Failure: MK-3682B + RBV [Part A, Arm 2] Prior SOF/LDV Failure: MK-3682B [Part A, Arm 3] Prior GZR/EBR Failure: MK-3682B + RBV [Part A, Arm 4] Prior GZR/EBR Failure: MK-3682B
    Number of subjects analysed
    35
    36
    9
    13
    Units: Participants
        Overdose
    1
    3
    2
    1
    No statistical analyses for this end point

    Primary: Number of Participants Who Experienced a Non-Overdose Event of Clinical Interest

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    End point title
    Number of Participants Who Experienced a Non-Overdose Event of Clinical Interest [8]
    End point description
    The number of participants experiencing a non-overdose event of clinical interest (ECI) was determined. Non-overdose ECIs, assessed from initiation of study therapy through 14 days following study treatment cessation, included the following: 1) aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >500 IU/L; or 2) AST or ALT >3x nadir value and >3X upper limit normal (ULN). The analysis population includes all randomized participants in Part A receiving ≥1 dose of study treatment. Part B was terminated prior to participant enrollment and was not included for analysis.
    End point type
    Primary
    End point timeframe
    Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
    Notes
    [8] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Per study protocol, statistical analysis was not planned for this endpoint.
    End point values
    [Part A, Arm 1] Prior SOF/LDV Failure: MK-3682B + RBV [Part A, Arm 2] Prior SOF/LDV Failure: MK-3682B [Part A, Arm 3] Prior GZR/EBR Failure: MK-3682B + RBV [Part A, Arm 4] Prior GZR/EBR Failure: MK-3682B
    Number of subjects analysed
    35
    36
    9
    13
    Units: Participants
    0
    1
    0
    0
    No statistical analyses for this end point

    Primary: Number of Participants Who Experienced AST/ALT >5x Upper Limit Normal (ULN)

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    End point title
    Number of Participants Who Experienced AST/ALT >5x Upper Limit Normal (ULN) [9]
    End point description
    The number of participants experiencing AST / ALT >5 times ULN from study week 4 until 2 weeks following completion of study therapy was determined. All randomized participants in Part A receiving ≥1 dose of study treatment with ≥1 AST/ALT measurement subsequent to study week 4. One participant with prior SOF/LDV failure receiving MK-3682B + RBV withdrew from study before study week 4 and was excluded from analysis. Part B terminated prior to enrollment and was not included for analysis.
    End point type
    Primary
    End point timeframe
    From Study Week 4 up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
    Notes
    [9] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Per study protocol, statistical analysis was not planned for this endpoint.
    End point values
    [Part A, Arm 1] Prior SOF/LDV Failure: MK-3682B + RBV [Part A, Arm 2] Prior SOF/LDV Failure: MK-3682B [Part A, Arm 3] Prior GZR/EBR Failure: MK-3682B + RBV [Part A, Arm 4] Prior GZR/EBR Failure: MK-3682B
    Number of subjects analysed
    34
    36
    9
    13
    Units: Participants
    0
    0
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)
    Adverse event reporting additional description
    Includes only randomized participants in Study Part A receiving ≥1 dose of study treatment. The trial was terminated prior to participant enrollment for study Part B.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    20.1
    Reporting groups
    Reporting group title
    [Part A, Arm 1] Prior SOF/LDV Failure: MK-3682B + RBV
    Reporting group description
    C or NC HCV GT1 participants previously failing a DAA regimen of SOF/LDV receive MK-3682B, an FDC of GZR (MK-5172 [50 mg]) + UPR (MK-3682 [225 mg]) + RZR (MK-8408 [30 mg]), administered as 2 tablets once daily in combination with RBV twice daily for 16 weeks.

    Reporting group title
    [Part A, Arm 2] Prior SOF/LDV Failure: MK-3682B
    Reporting group description
    C or NC HCV GT1 participants previously failing a DAA regimen of SOF/LDV receive MK-3682B, an FDC of GZR (MK-5172 [50 mg]) + UPR (MK-3682 [225 mg]) + RZR (MK-8408 [30 mg]), administered as 2 tablets once daily for 24 weeks.

    Reporting group title
    [Part A, Arm 3] Prior GZR/EBR Failure: MK-3682B + RBV
    Reporting group description
    C or NC HCV GT1 participants previously failing a DAA regimen of GZR/EBR (MK-5172/MK-8742) receive MK-3682B, an FDC of GZR (MK-5172 [50 mg]) + UPR (MK-3682 [225 mg]) + RZR (MK-8408 [30 mg]), administered as 2 tablets once daily in combination with RBV twice daily for 16 weeks.

    Reporting group title
    [Part A, Arm 4] Prior GZR/EBR Failure: MK-3682B
    Reporting group description
    C or NC HCV GT1 participants previously failing a DAA regimen of GZR/EBR (MK-5172/MK-8742) receive MK-3682B, an FDC of GZR (MK-5172 [50 mg]) + UPR (MK-3682 [225 mg]) + RZR (MK-8408 [30 mg]), administered as 2 tablets once daily for 24 weeks.

    Serious adverse events
    [Part A, Arm 1] Prior SOF/LDV Failure: MK-3682B + RBV [Part A, Arm 2] Prior SOF/LDV Failure: MK-3682B [Part A, Arm 3] Prior GZR/EBR Failure: MK-3682B + RBV [Part A, Arm 4] Prior GZR/EBR Failure: MK-3682B
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 35 (8.57%)
    4 / 36 (11.11%)
    0 / 9 (0.00%)
    1 / 13 (7.69%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 36 (0.00%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Hepatocellular carcinoma
         subjects affected / exposed
    1 / 35 (2.86%)
    1 / 36 (2.78%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Hydrocephalus
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 36 (0.00%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 36 (2.78%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Pancreatitis
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 36 (2.78%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Bone cyst
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 36 (0.00%)
    0 / 9 (0.00%)
    1 / 13 (7.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intervertebral disc protrusion
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 36 (2.78%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    [Part A, Arm 1] Prior SOF/LDV Failure: MK-3682B + RBV [Part A, Arm 2] Prior SOF/LDV Failure: MK-3682B [Part A, Arm 3] Prior GZR/EBR Failure: MK-3682B + RBV [Part A, Arm 4] Prior GZR/EBR Failure: MK-3682B
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    29 / 35 (82.86%)
    25 / 36 (69.44%)
    9 / 9 (100.00%)
    12 / 13 (92.31%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 36 (2.78%)
    0 / 9 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    0
    1
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 36 (2.78%)
    0 / 9 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    0
    1
    Fatigue
         subjects affected / exposed
    15 / 35 (42.86%)
    7 / 36 (19.44%)
    6 / 9 (66.67%)
    5 / 13 (38.46%)
         occurrences all number
    17
    7
    10
    5
    Influenza like illness
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 36 (2.78%)
    1 / 9 (11.11%)
    0 / 13 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Malaise
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 36 (0.00%)
    1 / 9 (11.11%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Oedema peripheral
         subjects affected / exposed
    1 / 35 (2.86%)
    3 / 36 (8.33%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    3
    0
    0
    Pyrexia
         subjects affected / exposed
    0 / 35 (0.00%)
    2 / 36 (5.56%)
    1 / 9 (11.11%)
    0 / 13 (0.00%)
         occurrences all number
    0
    2
    1
    0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 36 (0.00%)
    0 / 9 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    1
    0
    0
    1
    Emotional disorder
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 36 (0.00%)
    0 / 9 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    0
    1
    Insomnia
         subjects affected / exposed
    3 / 35 (8.57%)
    0 / 36 (0.00%)
    1 / 9 (11.11%)
    0 / 13 (0.00%)
         occurrences all number
    3
    0
    1
    0
    Irritability
         subjects affected / exposed
    2 / 35 (5.71%)
    1 / 36 (2.78%)
    0 / 9 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    2
    1
    0
    1
    Mood altered
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 36 (0.00%)
    1 / 9 (11.11%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Nervousness
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 36 (0.00%)
    1 / 9 (11.11%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Stress
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 36 (0.00%)
    0 / 9 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    0
    1
    Injury, poisoning and procedural complications
    Accidental overdose
         subjects affected / exposed
    1 / 35 (2.86%)
    3 / 36 (8.33%)
    2 / 9 (22.22%)
    1 / 13 (7.69%)
         occurrences all number
    1
    3
    2
    1
    Subcutaneous haematoma
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 36 (0.00%)
    0 / 9 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    0
    1
    Wound
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 36 (0.00%)
    0 / 9 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    0
    1
    Investigations
    Haemoglobin decreased
         subjects affected / exposed
    3 / 35 (8.57%)
    0 / 36 (0.00%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    3
    0
    0
    0
    Cardiac disorders
    Palpitations
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 36 (0.00%)
    1 / 9 (11.11%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    2
    0
    Tachycardia
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 36 (0.00%)
    0 / 9 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    1
    0
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    2 / 35 (5.71%)
    2 / 36 (5.56%)
    1 / 9 (11.11%)
    2 / 13 (15.38%)
         occurrences all number
    2
    4
    1
    2
    Dyspnoea
         subjects affected / exposed
    2 / 35 (5.71%)
    2 / 36 (5.56%)
    2 / 9 (22.22%)
    0 / 13 (0.00%)
         occurrences all number
    2
    2
    2
    0
    Dyspnoea exertional
         subjects affected / exposed
    3 / 35 (8.57%)
    0 / 36 (0.00%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    3
    0
    0
    0
    Epistaxis
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 36 (0.00%)
    1 / 9 (11.11%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Respiratory tract congestion
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 36 (0.00%)
    0 / 9 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    0
    1
    Rhinitis allergic
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 36 (0.00%)
    0 / 9 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    0
    1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    3 / 35 (8.57%)
    0 / 36 (0.00%)
    1 / 9 (11.11%)
    0 / 13 (0.00%)
         occurrences all number
    3
    0
    1
    0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    1 / 35 (2.86%)
    2 / 36 (5.56%)
    3 / 9 (33.33%)
    0 / 13 (0.00%)
         occurrences all number
    1
    2
    3
    0
    Dysgeusia
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 36 (0.00%)
    1 / 9 (11.11%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Headache
         subjects affected / exposed
    1 / 35 (2.86%)
    5 / 36 (13.89%)
    5 / 9 (55.56%)
    1 / 13 (7.69%)
         occurrences all number
    1
    5
    7
    1
    Lethargy
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 36 (0.00%)
    1 / 9 (11.11%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Sciatica
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 36 (0.00%)
    0 / 9 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    1
    0
    0
    1
    Syncope
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 36 (0.00%)
    1 / 9 (11.11%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Tremor
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 36 (0.00%)
    1 / 9 (11.11%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    1
    1
    Eye disorders
    Vision blurred
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 36 (2.78%)
    1 / 9 (11.11%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    1
    1
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    2 / 35 (5.71%)
    0 / 36 (0.00%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 36 (0.00%)
    1 / 9 (11.11%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    1
    1
    Abdominal pain upper
         subjects affected / exposed
    1 / 35 (2.86%)
    1 / 36 (2.78%)
    1 / 9 (11.11%)
    2 / 13 (15.38%)
         occurrences all number
    1
    1
    1
    2
    Constipation
         subjects affected / exposed
    0 / 35 (0.00%)
    3 / 36 (8.33%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    3
    0
    0
    Diarrhoea
         subjects affected / exposed
    2 / 35 (5.71%)
    3 / 36 (8.33%)
    2 / 9 (22.22%)
    2 / 13 (15.38%)
         occurrences all number
    3
    4
    2
    3
    Dry mouth
         subjects affected / exposed
    3 / 35 (8.57%)
    0 / 36 (0.00%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    3
    0
    0
    0
    Dyspepsia
         subjects affected / exposed
    2 / 35 (5.71%)
    0 / 36 (0.00%)
    1 / 9 (11.11%)
    0 / 13 (0.00%)
         occurrences all number
    2
    0
    1
    0
    Flatulence
         subjects affected / exposed
    2 / 35 (5.71%)
    1 / 36 (2.78%)
    1 / 9 (11.11%)
    0 / 13 (0.00%)
         occurrences all number
    2
    1
    1
    0
    Gastritis
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 36 (0.00%)
    1 / 9 (11.11%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Large intestine polyp
         subjects affected / exposed
    2 / 35 (5.71%)
    0 / 36 (0.00%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Nausea
         subjects affected / exposed
    1 / 35 (2.86%)
    2 / 36 (5.56%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Proctitis
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 36 (0.00%)
    1 / 9 (11.11%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Rectal haemorrhage
         subjects affected / exposed
    2 / 35 (5.71%)
    0 / 36 (0.00%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Toothache
         subjects affected / exposed
    1 / 35 (2.86%)
    2 / 36 (5.56%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Vomiting
         subjects affected / exposed
    2 / 35 (5.71%)
    2 / 36 (5.56%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    2
    2
    0
    0
    Skin and subcutaneous tissue disorders
    Dry skin
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 36 (0.00%)
    1 / 9 (11.11%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Pruritus
         subjects affected / exposed
    4 / 35 (11.43%)
    0 / 36 (0.00%)
    1 / 9 (11.11%)
    0 / 13 (0.00%)
         occurrences all number
    6
    0
    1
    0
    Rash
         subjects affected / exposed
    6 / 35 (17.14%)
    2 / 36 (5.56%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    8
    2
    0
    0
    Skin lesion
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 36 (0.00%)
    1 / 9 (11.11%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 36 (2.78%)
    0 / 9 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    0
    1
    Arthritis
         subjects affected / exposed
    2 / 35 (5.71%)
    0 / 36 (0.00%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Muscle spasms
         subjects affected / exposed
    2 / 35 (5.71%)
    2 / 36 (5.56%)
    1 / 9 (11.11%)
    0 / 13 (0.00%)
         occurrences all number
    2
    2
    1
    0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 36 (0.00%)
    3 / 9 (33.33%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    3
    0
    Diabetes mellitus
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 36 (0.00%)
    0 / 9 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    0
    1
    Hyperlipidaemia
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 36 (0.00%)
    0 / 9 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    0
    1
    Infections and infestations
    Conjunctivitis
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 36 (0.00%)
    1 / 9 (11.11%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Cystitis
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 36 (0.00%)
    0 / 9 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    0
    2
    Lower respiratory tract infection
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 36 (0.00%)
    0 / 9 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    0
    1
    Nasopharyngitis
         subjects affected / exposed
    2 / 35 (5.71%)
    3 / 36 (8.33%)
    0 / 9 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    2
    4
    0
    1
    Sinusitis
         subjects affected / exposed
    1 / 35 (2.86%)
    1 / 36 (2.78%)
    0 / 9 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    1
    3
    0
    1
    Tooth abscess
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 36 (2.78%)
    1 / 9 (11.11%)
    0 / 13 (0.00%)
         occurrences all number
    0
    2
    1
    0
    Urinary tract infection
         subjects affected / exposed
    1 / 35 (2.86%)
    2 / 36 (5.56%)
    0 / 9 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    1
    2
    0
    1
    Viral upper respiratory tract infection
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 36 (0.00%)
    0 / 9 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    0
    1

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    04 Dec 2015
    Amendment 01: Primary reasons for amendment were: 1) to delay enrollment of GT3-infected participants until the supportive efficacy and safety results from MK-3682-012 Part B are available; and 2) to include an interim analysis for the primary efficacy endpoint in GT1 participants.
    10 Jun 2016
    Amendment 02: Primary reason for amendment was to add statements indicating that the relevant regulatory authority/agency will be notified if: 1) the decision is made to proceed with enrollment of GT3-infected participants; or 2) if study enrollment is paused / stopped based on safety or virologic concerns.
    02 Sep 2016
    Amendment 03: Primary reason for amendment was to indicate that participants considered virologic failures from MK-3682-021 will be eligible for the long term follow up study MK-5172-017.
    19 Jul 2017
    Amendment 04: Primary reason for amendment was to revise the trial to add a Part B, evaluating the safety and efficacy of a 16-week treatment regimen of MK-3682B in C or NC participants with chronic HCV GT1-6 infection (with or without HIV infection) previously failing a DAA regimen.

    Interruptions (globally)

    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    25 Sep 2017
    Trial was terminated early before participant enrollment in study Part B.
    -

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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