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    Clinical Trial Results:
    A Randomized, Double-Blind, Controlled Study to Evaluate the Efficacy and Safety of the Combination of ABT-450/Ritonavir/ABT-267 (ABT 450/r/ABT-267) and ABT-333 With and Without Ribavirin (RBV) in Treatment-Naïve Adults with Genotype 1b Chronic Hepatitis C Virus (HCV) Infection (PEARL-III)

    Due to the EudraCT – Results system being out of service between 31 July 2015 and 12 January 2016, these results have been published in compliance with revised timelines.
    Summary
    EudraCT number
    		 2012-003687-52
    Trial protocol
    		 PT   BE   HU   AT   IT   ES   PL  
    Global end of trial date
    19 Aug 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    13 May 2016
    First version publication date
    13 May 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    M13-961
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01767116
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    AbbVie Deutschland GmbH & Co. KG
    Sponsor organisation address
    Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire, United Kingdom, SL6 4XE
    Public contact
    Global Medical Information, AbbVie, 001 800-633-9110,
    Scientific contact
    Dan Cohen, MD, AbbVie, daniel.cohen@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
    19 Aug 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    19 Aug 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of this study is to evaluate the safety and antiviral activity of ABT-450/ritonavir/ABT-267 (ABT-450/r/ABT-267; ABT-450 also known as paritaprevir; ABT-267 also known as ombitasvir) and ABT-333 (also known as dasabuvir) with and without ribavirin (RBV) in patients with chronic hepatitis C virus genotype 1b (HCV GT1b) infection without cirrhosis.
    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
    11 Dec 2012
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Poland: 39
    Country: Number of subjects enrolled
    Portugal: 16
    Country: Number of subjects enrolled
    Spain: 31
    Country: Number of subjects enrolled
    Austria: 21
    Country: Number of subjects enrolled
    Belgium: 26
    Country: Number of subjects enrolled
    Hungary: 21
    Country: Number of subjects enrolled
    Italy: 26
    Country: Number of subjects enrolled
    Israel: 58
    Country: Number of subjects enrolled
    Romania: 48
    Country: Number of subjects enrolled
    Russian Federation: 38
    Country: Number of subjects enrolled
    United States: 95
    Worldwide total number of subjects
    419
    EEA total number of subjects
    228
    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)
    386
    From 65 to 84 years
    33
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 The study included a screening period of 35 days.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 ABT-450/r/ABT-267 and ABT-333, Plus RBV
    Arm description
    		 ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
    Arm type
    		 Experimental

    Investigational medicinal product name
    ABT-450/r/ABT-267
    Investigational medicinal product code
    Other name
    ABT-267 also known as ombitasvir, ABT-450 also known as paritaprevir, Viekirax
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    ABT-450 (150 mg) coformulated with ritonavir (100 mg) and ABT-267 (25 mg)

    Investigational medicinal product name
    ABT-333
    Investigational medicinal product code
    Other name
    dasabuvir, Exviera
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    250 mg twice daily

    Investigational medicinal product name
    Ribavirin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Weight-based (dosed 1,000 or 1,200 mg daily divided twice a day)

    Arm title
    		 ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV
    Arm description
    		 ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks plus placebo RBV (twice daily) for 12 weeks
    Arm type
    		 Experimental

    Investigational medicinal product name
    ABT-450/r/ABT-267
    Investigational medicinal product code
    Other name
    ABT-267 also known as ombitasvir, ABT-450 also known as paritaprevir, Viekirax
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    ABT-450 (150 mg) coformulated with ritonavir (100 mg) and ABT-267 (25 mg)

    Investigational medicinal product name
    ABT-333
    Investigational medicinal product code
    Other name
    dasabuvir, Exviera
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    250 mg twice daily

    Investigational medicinal product name
    Placebo for Ribavirin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Twice daily

    Number of subjects in period 1
    		ABT-450/r/ABT-267 and ABT-333, Plus RBV ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV
    Started
    210
    209
    Completed
    208
    207
    Not completed
    2
    2
         Lost to follow-up
    2
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    ABT-450/r/ABT-267 and ABT-333, Plus RBV
    Reporting group description
    		 ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks

    Reporting group title
    ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV
    Reporting group description
    		 ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks plus placebo RBV (twice daily) for 12 weeks

    Reporting group values
    		 ABT-450/r/ABT-267 and ABT-333, Plus RBV ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV Total
    Number of subjects
    		 210 209 419
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 48.4 ± 11.94 49.2 ± 12.03 -
    Gender categorical
    Units: Subjects
        Female
    		 104 123 227
        Male
    		 106 86 192

    End points

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    End points reporting groups
    Reporting group title
    ABT-450/r/ABT-267 and ABT-333, Plus RBV
    Reporting group description
    		 ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks

    Reporting group title
    ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV
    Reporting group description
    		 ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks plus placebo RBV (twice daily) for 12 weeks

    Primary: Percentage of Subjects With Sustained Virologic Response 12 Weeks After Treatment; Noninferiority Analyses of Each Treatment Arm Compared to Historical Rate

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    End point title
    		 Percentage of Subjects With Sustained Virologic Response 12 Weeks After Treatment; Noninferiority Analyses of Each Treatment Arm Compared to Historical Rate [1]
    End point description
    The percentage of subjects with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug. The LLOQ for the assay was 25 IU/mL. Subjects with missing data were counted as non-responders. The primary endpoints were noninferiority of the percentage of subjects who achieved sustained virologic response 12 weeks after treatment in each treatment arm compared with the historical control rate for noncirrhotic, treatment-naïve subjects with HCV GT1b infection treated with telaprevir and peginterferon/RBV (pegIFN). Based on a 2-sided significance level of 0.05 and an underlying rate of ≥92% in each arm, a sample size of 200 subjects per treatment arm provides >95% power to demonstrate noninferiority of each regimen to the historical rate (84%) (based on the normal approximation of a single binomial proportion in a one-sample test for superiority)
    End point type
    Primary
    End point timeframe
    12 weeks after last 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: The lower confidence bound of the 2-sided 95% CI must exceed 73% to achieve noninferiority. ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV: 95% CI calculated using the Wilson score method for the single proportion; ABT-450/r/ABT-267 and ABT-333, Plus RBV: 95% CI calculated using the normal approximation to the binomial distribution.
    End point values
    		 ABT-450/r/ABT-267 and ABT-333, Plus RBV ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV
    Number of subjects analysed
    210 [2]
    209 [3]
    Units: percentage of subjects
        number (confidence interval 95%)
    99.5 (98.6 to 100)
    100 (98.2 to 100)
    Notes
    [2] - All randomized subjects who received at least 1 dose of study drug (intent-to-treat [ITT])
    [3] - All randomized subjects who received at least 1 dose of study drug (intent-to-treat [ITT])
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Sustained Virologic Response 12 Weeks After Treatment; Noninferiority Analysis of ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV Compared With ABT-450/r/ABT-267 and ABT-333, Plus RBV

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    End point title
    		 Percentage of Subjects With Sustained Virologic Response 12 Weeks After Treatment; Noninferiority Analysis of ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV Compared With ABT-450/r/ABT-267 and ABT-333, Plus RBV
    End point description
    The percentage of subjects with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug. Subjects with missing data were counted as non-responders. The secondary endpoint was the noninferiority of the percentage of subjects who achieved sustained virologic response 12 weeks after treatment who received ABT-450/r/ABT-267 and ABT-333, plus placebo RBV compared with those who received ABT-450/r/ABT-267 and ABT-333, plus RBV.
    End point type
    Secondary
    End point timeframe
    12 weeks after last dose of study drug
    End point values
    		 ABT-450/r/ABT-267 and ABT-333, Plus RBV ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV
    Number of subjects analysed
    210 [4]
    209 [5]
    Units: percentage of subjects
        number (not applicable)
    99.5
    100
    Notes
    [4] - ITT population
    [5] - ITT population
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    For the secondary efficacy endpoint of sustained virologic response at 12 weeks after treatment, based on a -10% margin, a 2-sided significance level of 0.05 and an underlying rate of 92% or higher in each arm, a sample size of 200 subjects per arm provides >95% power to demonstrate noninferiority of ABT-450/r/ABT-267 and ABT-333, plus Placebo RBV compared with ABT-450/r/ABT-267 and ABT-333, plus RBV (normal approximation of a single binomial proportion in a 1-sample test for superiority).
    Comparison groups
    ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV v ABT-450/r/ABT-267 and ABT-333, Plus RBV
    Number of subjects included in analysis
    419
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [6]
    Method
    Parameter type
    		 difference in percentage of subjects
    Point estimate
    0.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.5
         upper limit
    		 1.4
    Notes
    [6] - Noninferiority of the rate of sustained virologic response at 12 weeks after treatment for the ABT-450/r/ABT-267 and ABT-333, plus placebo RBV treatment group as compared with the ABT-450/r/ABT-267 and ABT-333, plus RBV treatment group was analyzed using a noninferiority margin of -10.5%. The lower confidence bound of the 2-sided 95% CI for the difference in percentage of subjects with sustained virologic response at 12 weeks after treatment must exceed -10.5% to achieve noninferiority.

    Secondary: Percentage of Subjects With Hemoglobin Decrease to Below the Lower Limit of Normal (LLN) At End of Treatment

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    End point title
    		 Percentage of Subjects With Hemoglobin Decrease to Below the Lower Limit of Normal (LLN) At End of Treatment
    End point description
    The percentage of subjects with a decrease in hemoglobin from greater than or equal to the lower limit of normal (≥ LLN) at baseline to < LLN at the end of treatment.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) and Week 12 (End of Treatment)
    End point values
    		 ABT-450/r/ABT-267 and ABT-333, Plus RBV ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV
    Number of subjects analysed
    207 [7]
    205 [8]
    Units: percentage of subjects
        number (not applicable)
    51.2
    3.4
    Notes
    [7] - Subjects in ITT population who had hemoglobin ≥ LLN reference range at baseline
    [8] - Subjects in ITT population who had hemoglobin ≥ LLN reference range at baseline
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    ABT-450/r/ABT-267 and ABT-333, Plus RBV v ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV
    Number of subjects included in analysis
    412
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 Fisher exact
    Confidence interval

    Secondary: Percentage of Subjects With Sustained Virologic Response 12 Weeks After Treatment; Superiority Analyses of Each Treatment Arm Compared to Historical Rate

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    End point title
    		 Percentage of Subjects With Sustained Virologic Response 12 Weeks After Treatment; Superiority Analyses of Each Treatment Arm Compared to Historical Rate
    End point description
    The percentage of subjects with sustained virologic response (plasma HCV RNA less than the lower limit of quantitation [<LLOQ]) 12 weeks after the last dose of study drug. Subjects with missing data were counted as non-responders. The secondary endpoints were superiority of the percentage of subjects who achieved sustained virologic response 12 weeks after treatment in each treatment arm compared with the historical control rate for noncirrhotic, treatment-naïve subjects with HCV GT1b treated with telaprevir and pegIFN/RBV. 95% CI (plus RBV arm: calculated using the normal approximation to the binomial distribution; plus placebo RBV arm: calculated using the Wilson score method for the single proportion); the lower confidence bound for the percentage of subjects with sustained virologic response at 12 weeks after treatment must exceed 84% to achieve superiority.
    End point type
    Secondary
    End point timeframe
    12 weeks after last dose of study drug
    End point values
    		 ABT-450/r/ABT-267 and ABT-333, Plus RBV ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV
    Number of subjects analysed
    210 [9]
    209 [10]
    Units: percentage of subjects
        number (confidence interval 95%)
    99.5 (98.6 to 100)
    100 (98.2 to 100)
    Notes
    [9] - ITT population
    [10] - ITT population
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Virologic Failure During Treatment

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    End point title
    		 Percentage of Subjects With Virologic Failure During Treatment
    End point description
    Virologic failure during treatment was defined as rebound (confirmed HCV RNA greater than or equal to the lower limit of quantitation [≥ LLOQ] after HCV RNA < LLOQ during treatment, or confirmed increase from the lowest value post baseline in HCV RNA [2 consecutive HCV RNA measurements > 1 log10 IU/mL above the lowest value post baseline] at any time point during treatment), or failure to suppress (HCV RNA ≥ LLOQ persistently during treatment with at least 6 weeks [≥ 36 days] of treatment).
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1), and Treatment Weeks 1, 2, 4, 6, 8, 10, and 12
    End point values
    		 ABT-450/r/ABT-267 and ABT-333, Plus RBV ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV
    Number of subjects analysed
    210 [11]
    209 [12]
    Units: percentage of subjects
    number (not applicable)
        Rebound
    0.5
    0
        Failure to suppress
    0
    0
    Notes
    [11] - ITT population
    [12] - ITT population
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Virologic Relapse After Treatment

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    End point title
    		 Percentage of Subjects With Virologic Relapse After Treatment
    End point description
    Subjects who completed treatment with plasma HCV RNA less than the lower limit of quantification (<LLOQ) at the end of treatment were considered to have virologic relapse if they had confirmed HCV RNA ≥ LLOQ during the post-treatment period.
    End point type
    Secondary
    End point timeframe
    Between End of Treatment (Week 12) and Post-treatment (up to Week 12 Post-treatment)
    End point values
    		 ABT-450/r/ABT-267 and ABT-333, Plus RBV ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV
    Number of subjects analysed
    208 [13]
    207 [14]
    Units: percentage of subjects
        number (not applicable)
    0
    0
    Notes
    [13] - ITT population with HCV RNA < LLOQ at the final treatment visit and completed treatment
    [14] - ITT population with HCV RNA < LLOQ at the final treatment visit and completed treatment
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    AEs were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks); SAEs were also collected from the time that informed consent was obtained until the end of participation in the study (up to 65 weeks)
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.0
    Reporting groups
    Reporting group title
    ABT-450/r/ABT-267 and ABT-333, Plus RBV
    Reporting group description
    		 ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks

    Reporting group title
    ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV
    Reporting group description
    		 ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks plus placebo RBV (twice daily) for 12 weeks

    Serious adverse events
    		 ABT-450/r/ABT-267 and ABT-333, Plus RBV ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 210 (1.90%)
    4 / 209 (1.91%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Intraductal proliferative breast lesion
         subjects affected / exposed
    0 / 210 (0.00%)
    1 / 209 (0.48%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    1 / 210 (0.48%)
    0 / 209 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary artery disease
         subjects affected / exposed
    1 / 210 (0.48%)
    0 / 209 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Epididymitis
         subjects affected / exposed
    1 / 210 (0.48%)
    0 / 209 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uterine polyp
         subjects affected / exposed
    0 / 210 (0.00%)
    1 / 209 (0.48%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Nephrolithiasis
         subjects affected / exposed
    1 / 210 (0.48%)
    0 / 209 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthritis
         subjects affected / exposed
    0 / 210 (0.00%)
    1 / 209 (0.48%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myalgia
         subjects affected / exposed
    0 / 210 (0.00%)
    1 / 209 (0.48%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 ABT-450/r/ABT-267 and ABT-333, Plus RBV ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    133 / 210 (63.33%)
    97 / 209 (46.41%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    51 / 210 (24.29%)
    49 / 209 (23.44%)
         occurrences all number
    61
    58
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    14 / 210 (6.67%)
    1 / 209 (0.48%)
         occurrences all number
    15
    1
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    22 / 210 (10.48%)
    12 / 209 (5.74%)
         occurrences all number
    26
    13
    Fatigue
         subjects affected / exposed
    45 / 210 (21.43%)
    49 / 209 (23.44%)
         occurrences all number
    48
    52
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    11 / 210 (5.24%)
    6 / 209 (2.87%)
         occurrences all number
    12
    7
    Diarrhoea
         subjects affected / exposed
    9 / 210 (4.29%)
    13 / 209 (6.22%)
         occurrences all number
    9
    15
    Dyspepsia
         subjects affected / exposed
    14 / 210 (6.67%)
    9 / 209 (4.31%)
         occurrences all number
    14
    9
    Nausea
         subjects affected / exposed
    23 / 210 (10.95%)
    9 / 209 (4.31%)
         occurrences all number
    23
    11
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    19 / 210 (9.05%)
    5 / 209 (2.39%)
         occurrences all number
    19
    5
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    25 / 210 (11.90%)
    11 / 209 (5.26%)
         occurrences all number
    28
    14
    Rash
         subjects affected / exposed
    12 / 210 (5.71%)
    8 / 209 (3.83%)
         occurrences all number
    12
    11
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    19 / 210 (9.05%)
    7 / 209 (3.35%)
         occurrences all number
    21
    7

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    12 Nov 2012
    The purpose of the amendment is to ● update the introduction to provide more current data from ongoing clinical trials. ● update the thresholds for the primary and secondary endpoints to be based on historical sustained virologic response (SVR) rates from telaprevir plus pegIFN and RBV therapy. ● update primary and secondary endpoints to remove rapid virologic response (RVR) and end of treatment response (EOTR), which are irrelevant in the absence of SVR, and to include rebound and relapse rates, which are relevant in clinical practice when using direct-acting antiviral agent (DAAs). ● clarify inclusion/exclusion criteria to ensure the appropriate subject population was enrolled. ● update plan for resistance analysis throughout the protocol to clarify and more accurately reflect plans for assessing resistance development. ● update RBV toxicity management to align better with the RBV label. ● address inconsistencies throughout the protocol.
    08 Apr 2013
    The purpose of the amendment is to prohibit the use of hormonal contraceptives during study drug administration.

    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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