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    Clinical Trial Results:
    A Randomized, Open-Label, Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Co-Administration of ABT-493 and ABT-530 (or ABT-493/ABT-530) With and Without Ribavirin in Adults With Chronic Hepatitis C Virus (HCV) Infection who Failed a Prior Direct-Acting Antiviral Agent (DAA)-Containing Therapy

    Summary
    EudraCT number
    2015-002350-13
    Trial protocol
    ES   GB  
    Global end of trial date
    23 Jan 2017

    Results information
    Results version number
    v1(current)
    This version publication date
    15 Dec 2017
    First version publication date
    15 Dec 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    M15-410
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02446717
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    AbbVie Deutschland GmbH & Co. KG
    Sponsor organisation address
    AbbVie House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire, United Kingdom, SL6-4UB
    Public contact
    Global Medical Services, Abbvie, 001 800-633-9110,
    Scientific contact
    Armen Asatryan, Abbvie, armen.asatryan@abbvie.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
    23 Jan 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    23 Jan 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of this study is to assess the efficacy and safety of ABT-493 and ABT-530 with or without ribavirin (RBV) in participants with chronic hepatitis C virus, (HCV)-infection who previously failed treatment with a direct acting antiviral (DAA)-containing regimen.
    Protection of trial subjects
    Subject read and understood the information provided about the study and gave written permission.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    23 Apr 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
    Spain: 9
    Country: Number of subjects enrolled
    United Kingdom: 2
    Country: Number of subjects enrolled
    France: 9
    Country: Number of subjects enrolled
    Australia: 24
    Country: Number of subjects enrolled
    Puerto Rico: 3
    Country: Number of subjects enrolled
    United States: 94
    Worldwide total number of subjects
    141
    EEA total number of subjects
    20
    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)
    126
    From 65 to 84 years
    15
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    This study included a 42-day screening period.

    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
    Arm A
    Arm description
    ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (80 mg) QD for 12 weeks in chronic HCV genotype 1- infected participants without cirrhosis.
    Arm type
    Experimental

    Investigational medicinal product name
    ABT-493, ABT-530
    Investigational medicinal product code
    Other name
    ABT-493 also known as glecaprevir, ABT-530 also known as pibrentasvir, ABT-493/ABT-530 (ABT-493 coformulated with ABT-267) also known as MAVIRET
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    ABT-493 (tablet) dosed with ABT-530 (tablet)

    Arm title
    ARM B
    Arm description
    ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD plus ribavirin (RBV) for 12 weeks in chronic HCV genotype 1- infected participants without cirrhosis.
    Arm type
    Experimental

    Investigational medicinal product name
    ABT-493, ABT-530
    Investigational medicinal product code
    Other name
    ABT-493 also known as glecaprevir, ABT-530 also known as pibrentasvir, ABT-493/ABT-530 (ABT-493 coformulated with ABT-267) also known as MAVIRET
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    ABT-493 (tablet) dosed with ABT-530 (tablet)

    Investigational medicinal product name
    ribavirin (RBV)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Tablet

    Arm title
    ARM C
    Arm description
    ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in chronic HCV genotype 1- infected participants without cirrhosis.
    Arm type
    Experimental

    Investigational medicinal product name
    ABT-493, ABT-530
    Investigational medicinal product code
    Other name
    ABT-493 also known as glecaprevir, ABT-530 also known as pibrentasvir, ABT-493/ABT-530 (ABT-493 coformulated with ABT-267) also known as MAVIRET
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    ABT-493 (tablet) dosed with ABT-530 (tablet)

    Arm title
    ARM D
    Arm description
    ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks in HCV genotypes 1- or 4-6- infected participants with or without cirrhosis.
    Arm type
    Experimental

    Investigational medicinal product name
    ABT-493/ABT-530
    Investigational medicinal product code
    Other name
    ABT-493 also known as glecaprevir, ABT-530 also known as pibrentasvir, MAVIRET
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Tablet; ABT-493 coformulated with ABT-530

    Arm title
    ARM E
    Arm description
    ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 16 weeks in HCV genotype 1- or 4-6- infected participants with or without cirrhosis.
    Arm type
    Experimental

    Investigational medicinal product name
    ABT-493/ABT-530
    Investigational medicinal product code
    Other name
    ABT-493 also known as glecaprevir, ABT-530 also known as pibrentasvir, MAVIRET
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Tablet; ABT-493 coformulated with ABT-530

    Number of subjects in period 1
    Arm A ARM B ARM C ARM D ARM E
    Started
    6
    22
    22
    44
    47
    Completed
    6
    21
    20
    43
    46
    Not completed
    0
    1
    2
    1
    1
         Adverse event
    -
    -
    1
    -
    -
         Withdrew consent
    -
    -
    -
    1
    -
         Lost to follow-up
    -
    1
    1
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Arm A
    Reporting group description
    ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (80 mg) QD for 12 weeks in chronic HCV genotype 1- infected participants without cirrhosis.

    Reporting group title
    ARM B
    Reporting group description
    ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD plus ribavirin (RBV) for 12 weeks in chronic HCV genotype 1- infected participants without cirrhosis.

    Reporting group title
    ARM C
    Reporting group description
    ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in chronic HCV genotype 1- infected participants without cirrhosis.

    Reporting group title
    ARM D
    Reporting group description
    ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks in HCV genotypes 1- or 4-6- infected participants with or without cirrhosis.

    Reporting group title
    ARM E
    Reporting group description
    ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 16 weeks in HCV genotype 1- or 4-6- infected participants with or without cirrhosis.

    Reporting group values
    Arm A ARM B ARM C ARM D ARM E Total
    Number of subjects
    6 22 22 44 47 141
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    53.5 ± 9.16 55.2 ± 6.29 58.5 ± 6.56 55.6 ± 8.57 55.6 ± 8.31 -
    Gender categorical
    Units: Subjects
        Female
    3 2 4 13 14 36
        Male
    3 20 18 31 33 105

    End points

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    End points reporting groups
    Reporting group title
    Arm A
    Reporting group description
    ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (80 mg) QD for 12 weeks in chronic HCV genotype 1- infected participants without cirrhosis.

    Reporting group title
    ARM B
    Reporting group description
    ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD plus ribavirin (RBV) for 12 weeks in chronic HCV genotype 1- infected participants without cirrhosis.

    Reporting group title
    ARM C
    Reporting group description
    ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in chronic HCV genotype 1- infected participants without cirrhosis.

    Reporting group title
    ARM D
    Reporting group description
    ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks in HCV genotypes 1- or 4-6- infected participants with or without cirrhosis.

    Reporting group title
    ARM E
    Reporting group description
    ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 16 weeks in HCV genotype 1- or 4-6- infected participants with or without cirrhosis.

    Primary: Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)

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    End point title
    Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) [1]
    End point description
    SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [<LLOQ]) 12 weeks after the last dose of study drug. Participants with missing data after backwards imputation were imputed as nonresponders.
    End point type
    Primary
    End point timeframe
    12 weeks after the last actual dose of study drug
    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: Descriptive data are summarized for this end point per protocol.
    End point values
    Arm A ARM B ARM C ARM D ARM E
    Number of subjects analysed
    6 [2]
    22 [3]
    22 [4]
    44 [5]
    47 [6]
    Units: percentage of participants
        number (confidence interval 95%)
    100 (61.0 to 100)
    95.5 (78.2 to 99.2)
    86.4 (66.7 to 95.3)
    88.6 (76.0 to 95.0)
    91.5 (80.1 to 96.6)
    Notes
    [2] - Intent-to-treat population: all participants who received at least 1 dose of study drug
    [3] - Intent-to-treat population: all participants who received at least 1 dose of study drug
    [4] - Intent-to-treat population: all participants who received at least 1 dose of study drug
    [5] - Intent-to-treat population: all participants who received at least 1 dose of study drug
    [6] - Intent-to-treat population: all participants who received at least 1 dose of study drug
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Sustained Virologic Response 4 Weeks Post-treatment (SVR4)

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    End point title
    Percentage of Participants With Sustained Virologic Response 4 Weeks Post-treatment (SVR4)
    End point description
    SVR4 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [<LLOQ]) 4 weeks after the last dose of study drug. Participants with missing data after backwards imputation were imputed as nonresponders.
    End point type
    Secondary
    End point timeframe
    4 weeks after the last actual dose of study drug
    End point values
    Arm A ARM B ARM C ARM D ARM E
    Number of subjects analysed
    6 [7]
    22 [8]
    22 [9]
    44 [10]
    47 [11]
    Units: percentage of participants
        number (confidence interval 95%)
    100.0 (61.0 to 100.0)
    95.5 (78.2 to 99.2)
    95.5 (78.2 to 99.2)
    90.9 (78.8 to 96.4)
    91.5 (80.1 to 96.6)
    Notes
    [7] - ITT population
    [8] - ITT population
    [9] - ITT population
    [10] - ITT population
    [11] - ITT population
    No statistical analyses for this end point

    Secondary: Percentage of Participants With On-treatment Virologic Failure

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    End point title
    Percentage of Participants With On-treatment Virologic Failure
    End point description
    On-treatment virologic failure was defined as confirmed HCV RNA ≥ 100 IU after HCV RNA < LLOQ during treatment; confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline in HCV RNA during treatment; or HCV RNA ≥ LLOQ at end of treatment with at least 6 weeks of treatment.
    End point type
    Secondary
    End point timeframe
    Day 3, Treatment Weeks 1, 2, 4, 6, 8, 10, 12 (end of treatment for 12-week treatment arms), and 16 (end of treatment for 16-week treatment arm) or premature discontinuation from treatment
    End point values
    Arm A ARM B ARM C ARM D ARM E
    Number of subjects analysed
    6 [12]
    22 [13]
    22 [14]
    44 [15]
    47 [16]
    Units: percentage of participants
        number (confidence interval 95%)
    0.0 (0.0 to 39.0)
    0.0 (0.0 to 14.9)
    4.5 (0.8 to 21.8)
    2.3 (0.4 to 11.8)
    8.5 (3.4 to 19.9)
    Notes
    [12] - ITT population
    [13] - ITT population
    [14] - ITT population
    [15] - ITT population
    [16] - ITT population
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Post-treatment Relapse

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    End point title
    Percentage of Participants With Post-treatment Relapse
    End point description
    Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants with HCV RNA levels < LLOQ at the end of treatment, excluding reinfection.
    End point type
    Secondary
    End point timeframe
    From the end of treatment through 12 weeks after the last dose of study drug
    End point values
    Arm A ARM B ARM C ARM D ARM E
    Number of subjects analysed
    6 [17]
    21 [18]
    21 [19]
    43 [20]
    43 [21]
    Units: percentage of participants
        number (confidence interval 95%)
    0.0 (0.0 to 39.0)
    4.8 (0.8 to 22.7)
    0.0 (0.0 to 15.5)
    9.3 (3.7 to 21.6)
    0.0 (0.0 to 8.2)
    Notes
    [17] - ITT population who completed treatment and had HCV RNA <LLOQ at the final treatment visit
    [18] - ITT population who completed treatment and had HCV RNA <LLOQ at the final treatment visit
    [19] - ITT population who completed treatment and had HCV RNA <LLOQ at the final treatment visit
    [20] - ITT population who completed treatment and had HCV RNA <LLOQ at the final treatment visit
    [21] - ITT population who completed treatment and had HCV RNA <LLOQ at the final treatment visit
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug (up to 20 weeks).
    Adverse event reporting additional description
    TEAEs and TESAEs are defined as any AE or SAE with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    Arm A
    Reporting group description
    ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (80 mg) QD for 12 weeks in chronic HCV genotype 1- infected participants without cirrhosis.

    Reporting group title
    ARM B
    Reporting group description
    ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD plus ribavirin (RBV) for 12 weeks in chronic HCV genotype 1- infected participants without cirrhosis.

    Reporting group title
    ARM C
    Reporting group description
    ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in chronic HCV genotype 1- infected participants without cirrhosis.

    Reporting group title
    ARM D
    Reporting group description
    ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks in HCV genotypes 1- or 4-6- infected participants with or without cirrhosis.

    Reporting group title
    ARM E
    Reporting group description
    ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 16 weeks in HCV genotype 1- or 4-6- infected participants with or without cirrhosis.

    Serious adverse events
    Arm A ARM B ARM C ARM D ARM E
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 6 (16.67%)
    1 / 22 (4.55%)
    0 / 22 (0.00%)
    1 / 44 (2.27%)
    2 / 47 (4.26%)
         number of deaths (all causes)
    0
    0
    1
    0
    0
         number of deaths resulting from adverse events
    Injury, poisoning and procedural complications
    Femur fracture
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 22 (4.55%)
    0 / 22 (0.00%)
    0 / 44 (0.00%)
    0 / 47 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Breast cancer
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 22 (0.00%)
    0 / 22 (0.00%)
    0 / 44 (0.00%)
    0 / 47 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 22 (0.00%)
    0 / 22 (0.00%)
    0 / 44 (0.00%)
    1 / 47 (2.13%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Gastrointestinal viral infection
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 22 (0.00%)
    0 / 22 (0.00%)
    1 / 44 (2.27%)
    0 / 47 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Wound infection
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 22 (0.00%)
    0 / 22 (0.00%)
    0 / 44 (0.00%)
    1 / 47 (2.13%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Arm A ARM B ARM C ARM D ARM E
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    4 / 6 (66.67%)
    17 / 22 (77.27%)
    16 / 22 (72.73%)
    23 / 44 (52.27%)
    27 / 47 (57.45%)
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    0 / 6 (0.00%)
    2 / 22 (9.09%)
    1 / 22 (4.55%)
    1 / 44 (2.27%)
    0 / 47 (0.00%)
         occurrences all number
    0
    3
    1
    1
    0
    Dyspnoea
         subjects affected / exposed
    0 / 6 (0.00%)
    3 / 22 (13.64%)
    0 / 22 (0.00%)
    1 / 44 (2.27%)
    0 / 47 (0.00%)
         occurrences all number
    0
    3
    0
    1
    0
    Oropharyngeal pain
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 22 (0.00%)
    2 / 22 (9.09%)
    0 / 44 (0.00%)
    2 / 47 (4.26%)
         occurrences all number
    0
    0
    2
    0
    2
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 6 (16.67%)
    5 / 22 (22.73%)
    8 / 22 (36.36%)
    6 / 44 (13.64%)
    11 / 47 (23.40%)
         occurrences all number
    1
    7
    9
    8
    11
    Hypoaesthesia
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 22 (0.00%)
    2 / 22 (9.09%)
    0 / 44 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    Lethargy
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 22 (0.00%)
    0 / 22 (0.00%)
    3 / 44 (6.82%)
    1 / 47 (2.13%)
         occurrences all number
    0
    0
    0
    3
    1
    Somnolence
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 22 (0.00%)
    0 / 22 (0.00%)
    1 / 44 (2.27%)
    0 / 47 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    Eye disorders
    Dry eye
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 22 (0.00%)
    0 / 22 (0.00%)
    0 / 44 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 22 (0.00%)
    1 / 22 (4.55%)
    1 / 44 (2.27%)
    3 / 47 (6.38%)
         occurrences all number
    0
    0
    1
    1
    6
    Fatigue
         subjects affected / exposed
    1 / 6 (16.67%)
    8 / 22 (36.36%)
    4 / 22 (18.18%)
    3 / 44 (6.82%)
    5 / 47 (10.64%)
         occurrences all number
    1
    8
    4
    3
    5
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 22 (4.55%)
    2 / 22 (9.09%)
    0 / 44 (0.00%)
    2 / 47 (4.26%)
         occurrences all number
    0
    1
    2
    0
    2
    Insomnia
         subjects affected / exposed
    0 / 6 (0.00%)
    6 / 22 (27.27%)
    0 / 22 (0.00%)
    2 / 44 (4.55%)
    2 / 47 (4.26%)
         occurrences all number
    0
    6
    0
    2
    2
    Irritability
         subjects affected / exposed
    0 / 6 (0.00%)
    2 / 22 (9.09%)
    0 / 22 (0.00%)
    0 / 44 (0.00%)
    2 / 47 (4.26%)
         occurrences all number
    0
    2
    0
    0
    2
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    1 / 6 (16.67%)
    2 / 22 (9.09%)
    1 / 22 (4.55%)
    0 / 44 (0.00%)
    4 / 47 (8.51%)
         occurrences all number
    1
    2
    1
    0
    4
    Diarrhoea
         subjects affected / exposed
    0 / 6 (0.00%)
    2 / 22 (9.09%)
    1 / 22 (4.55%)
    2 / 44 (4.55%)
    2 / 47 (4.26%)
         occurrences all number
    0
    3
    1
    2
    2
    Dyspepsia
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 22 (4.55%)
    1 / 22 (4.55%)
    2 / 44 (4.55%)
    4 / 47 (8.51%)
         occurrences all number
    0
    1
    1
    2
    4
    Faeces discoloured
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 22 (0.00%)
    2 / 22 (9.09%)
    0 / 44 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    Flatulence
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 22 (0.00%)
    2 / 22 (9.09%)
    0 / 44 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    1 / 6 (16.67%)
    2 / 22 (9.09%)
    1 / 22 (4.55%)
    0 / 44 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    1
    2
    1
    0
    1
    Nausea
         subjects affected / exposed
    1 / 6 (16.67%)
    6 / 22 (27.27%)
    3 / 22 (13.64%)
    4 / 44 (9.09%)
    3 / 47 (6.38%)
         occurrences all number
    1
    6
    4
    5
    4
    Toothache
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 22 (0.00%)
    2 / 22 (9.09%)
    0 / 44 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    0 / 6 (0.00%)
    3 / 22 (13.64%)
    0 / 22 (0.00%)
    1 / 44 (2.27%)
    2 / 47 (4.26%)
         occurrences all number
    0
    3
    0
    1
    2
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 22 (0.00%)
    4 / 22 (18.18%)
    1 / 44 (2.27%)
    2 / 47 (4.26%)
         occurrences all number
    0
    0
    5
    1
    2
    Musculoskeletal stiffness
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 22 (0.00%)
    0 / 22 (0.00%)
    0 / 44 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Metabolism and nutrition disorders
    Hyponatraemia
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 22 (0.00%)
    0 / 22 (0.00%)
    0 / 44 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    0 / 6 (0.00%)
    3 / 22 (13.64%)
    1 / 22 (4.55%)
    1 / 44 (2.27%)
    1 / 47 (2.13%)
         occurrences all number
    0
    3
    2
    1
    1
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 22 (4.55%)
    1 / 22 (4.55%)
    1 / 44 (2.27%)
    4 / 47 (8.51%)
         occurrences all number
    0
    1
    1
    1
    4

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    23 Mar 2015
    The main purpose of this amendment was to update the dosage strength of ABT-530 from 120 mg QD to 80 mg QD in treatment Arm A and of ABT-493 from 200 mg QD to 300 mg QD in treatment Arm B; clarify inclusion criterion (permitted prior direct acting antiviral agent [DAA] treatment); clarify the definition of on-treatment failure in DAA-experienced subjects; and revise treatment extension (from additional 4 weeks [total duration of 16 weeks] to 12 weeks [total duration of 24 weeks], add ribavirin and sofosbuvir to the treatment regimen for the subjects to whom treatment extension criteria are applied, and classify NS3/4A/NS5A-experienced subjects as NS3/4A-experienced/NS5A-naïve for the purpose of treatment extension).
    24 Apr 2015
    The main purpose of this amendment was to update the definitions of on-treatment failure and post-treatment failure; clarify inclusion criteria (provide examples of prior DAA-containing therapies); update secondary objective to include evaluation of 2 dose levels of ABT-530; and clarify treatment extension criteria.
    16 Jun 2015
    The main purpose of this amendment was to clarify inclusion criteria (definition of true abstinence, clarify when additional assessments for liver cirrhosis need to be made based on the initial test results); stop enrollment in Arm A; update virologic stopping criterion (remove "Failure to achieve hepatitis C virus [HCV] ribonucleic acid [RNA] < LLOQ by Week 6"); and clarify adverse event (AE) collection period.
    10 Sep 2015
    The main purpose of this amendment was to add Part 2 of the study based upon meeting pre specified efficacy and safety criteria; include use of ABT-493/ABT-530 co-formulated tablet for Part 2; clarify rescreening for Part 2; update inclusion criteria (remove upper age limit for inclusion in Part 2; allow enrollment of GT4, 5, and 6 in Part 2; specify acceptable methods of contraception in Parts 1 and 2; clarify the accepted definitions of chronic HCV; specify eligible prior DAA regimens in Part 2; remove the upper BMI limit in Part 2; clarify accepted criteria of defining absence of cirrhosis and include criteria for defining presence of compensated cirrhosis in Part 2; exclude subjects with hepatocellular carcinoma [HCC] in Part 2) and exclusion criteria (exclude subjects with HCV RNA load of < 1000 IU/mL in Part 2); update prohibited therapy; clarify timing of study procedures; and clarify AE collection period.

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    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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