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    Clinical Trial Results:
    A phase III, randomised, double-blind and placebo-controlled study of once daily BI 201335 120 mg for 12 or 24 weeks or BI 201335 240 mg for 12 weeks in combination with pegylated interferon-α and ribavirin in treatment-naïve patients with genotype 1 chronic hepatitis C infection.

    Due to a system error, the data reported in v1 is not correct and has been removed from public view.
    Summary
    EudraCT number
    		 2010-021716-42
    Trial protocol
    		 PT   BE   GB   DE   ES   AT  
    Global end of trial date
    12 Mar 2014

    Results information
    Results version number
    		 v2(current)
    This version publication date
    02 Jul 2016
    First version publication date
    26 Jul 2015
    Other versions
    		 v1 (removed from public view)
    Version creation reason
    • Correction of full data set
    Data correction due to system error in EudraCT- Results

    Trial information

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    Trial identification
    Sponsor protocol code
    1220.30
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01343888
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Boehringer Ingelheim
    Sponsor organisation address
    Binger Strasse 173 , Ingelheim am Rhein, Germany, 55216
    Public contact
    QRPE Processes and Systems Coordination Clinical Trial Information Disclosure, Boehringer Ingelheim, +1 800 243 0127, clintriage.rdg@boehringer-ingelheim.com
    Scientific contact
    QRPE Processes and Systems Coordination Clinical Trial Information Disclosure, Boehringer Ingelheim, +1 800 243 0127 , clintriage.rdg@boehringer-ingelheim.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
    15 Apr 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    24 Jan 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    12 Mar 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The objective of this trial is to show superior efficacy of treatment with BI 201335 combined with PegIFN/RBV as compared to PegIFN/RBV alone (SOC) in patients with genotype 1 (GT-1) chronic hepatitis C infection
    Protection of trial subjects
    Only subjects that met all the study inclusion and none of the exclusion criteria were to be entered in the study. All subjects were free to withdraw from the clinical trial at any time for any reason given. Close monitoring of all subjects was adhered to throughout the trial conduct.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    11 Apr 2011
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety
    Long term follow-up duration
    		 11 Months
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Austria: 41
    Country: Number of subjects enrolled
    Belgium: 43
    Country: Number of subjects enrolled
    France: 92
    Country: Number of subjects enrolled
    Germany: 94
    Country: Number of subjects enrolled
    Japan: 151
    Country: Number of subjects enrolled
    Portugal: 51
    Country: Number of subjects enrolled
    Romania: 61
    Country: Number of subjects enrolled
    Russian Federation: 77
    Country: Number of subjects enrolled
    Spain: 62
    Country: Number of subjects enrolled
    Switzerland: 37
    Country: Number of subjects enrolled
    United Kingdom: 69
    Worldwide total number of subjects
    778
    EEA total number of subjects
    513
    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)
    719
    From 65 to 84 years
    59
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 All subjects were screened for eligibility to participate in the trial. Subjects attended specialist sites which would then ensure that they (the subject) met all strictly implemented inclusion/exclusion criteria. Subjects were not to be randomised to trial treatment if any one of the specific entry criteria were violated.

    Period 1
    Period 1 title
    Treatment period (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Faldaprevir 120mg and PegIFN/RBV
    Arm description
    		 Faldaprevir (BI 201335) 120 mg once daily (oral) plus Pegylated Interferon-alpha (PegIFN)/ Ribavirin (RBV) (subcutaneous injection/oral) for 12 or 24 weeks, depending on achievement of early treatment success (ETS). Patients with ETS received this treatment for 12 weeks and subsequently PegIFN/RBV alone up to Week 24; patients without ETS received this treatment for 24 weeks and subsequently PegIFN/RBV alone up to Week 48. Two subject screened/randomised to Faldaprevir 120mg and PegIFN/RBV was not treated. Although actual number of subjects started is 261, 259 were reported to ensure consistent reporting with baseline characteristics that includes only treated subjects.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Faldaprevir 120mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, soft
    Routes of administration
    Oral use
    Dosage and administration details
    Faldaprevir 120mg administered orally in a form of soft gelatine capsule once daily

    Investigational medicinal product name
    Pegylated Interferon-alpha
    Investigational medicinal product code
    Other name
    Pegasys®
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    180 µg Pegylated Interferon-alpha in 0.5 mL solution administered via subcutaneous injection once weekly. For Japan: 180 µg Pegylated Interferon-alpha in 1 mL solution administered via subcutaneous injection once weekly.

    Investigational medicinal product name
    Ribavirin
    Investigational medicinal product code
    Other name
    Copegus®
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1000 mg (<75 kg body weight) or 1200 mg (>=75 kg body weight) of Ribavirin administered orally in 2 divided doses in a form of a tablet. For Japan: 600 mg (<=60 kg body weight), 800 mg (>60 kg and <=80 kg body weight), or 1000 mg (>80 kg body weight) of Ribavirin administered orally in 2 divided doses in a form of a tablet.

    Arm title
    		 Faldaprevir 240mg and PegIFN/RBV
    Arm description
    		 Faldaprevir 240 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 weeks, followed by PegIFN/RBV up to Week 24. Patients with ETS stopped all study medication at Week 24; patients without ETS subsequently received PegIFN/RBV alone up to Week 48. One subject screened/randomised to Faldaprevir 240mg and PegIFN/RBV was not treated. Although actual number of subjects started is 262, 261 were reported to ensure consistent reporting with baseline characteristics that includes only treated subjects.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Faldaprevir 240mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, soft
    Routes of administration
    Oral use
    Dosage and administration details
    Faldaprevir 240mg administered orally in a form of soft gelatine capsule once daily

    Investigational medicinal product name
    Pegylated Interferon-alpha
    Investigational medicinal product code
    Other name
    Pegasys®
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    180 µg Pegylated Interferon-alpha in 0.5 mL solution administered via subcutaneous injection once weekly. For Japan: 180 µg Pegylated Interferon-alpha in 1 mL solution administered via subcutaneous injection once weekly.

    Investigational medicinal product name
    Ribavirin
    Investigational medicinal product code
    Other name
    Copegus®
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1000 mg (<75 kg body weight) or 1200 mg (>=75 kg body weight) of Ribavirin administered orally in 2 divided doses in a form of a tablet. For Japan: 600 mg (<=60 kg body weight), 800 mg (>60 kg and <=80 kg body weight), or 1000 mg (>80 kg body weight) of Ribavirin administered orally in 2 divided doses in a form of a tablet.

    Arm title
    		 Placebo and PegIFN/RBV
    Arm description
    		 Placebo (oral) once daily plus PegIFN/RBV (subcutaneous injection/oral) for 24 weeks, followed by PegIFN/RBV alone up to Week 48. One subject screened/randomised toPlacebo and PegIFN/RBV was not treated. Although actual number of subjects started is 133, 132 were reported to ensure consistent reporting with baseline characteristics that includes only treated subjects.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, soft
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo matching Faldaprevir soft gelatine capsule administered orally, once daily.

    Investigational medicinal product name
    Pegylated Interferon-alpha
    Investigational medicinal product code
    Other name
    Pegasys®
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    180 µg Pegylated Interferon-alpha in 0.5 mL solution administered via subcutaneous injection once weekly. For Japan: 180 µg Pegylated Interferon-alpha in 1 mL solution administered via subcutaneous injection once weekly.

    Investigational medicinal product name
    Ribavirin
    Investigational medicinal product code
    Other name
    Copegus®
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1000 mg (<75 kg body weight) or 1200 mg (>=75 kg body weight) of Ribavirin administered orally in 2 divided doses in a form of a tablet. For Japan: 600 mg (<=60 kg body weight), 800 mg (>60 kg and <=80 kg body weight), or 1000 mg (>80 kg body weight) of Ribavirin administered orally in 2 divided doses in a form of a tablet.

    Number of subjects in period 1 [1]
    		Faldaprevir 120mg and PegIFN/RBV Faldaprevir 240mg and PegIFN/RBV Placebo and PegIFN/RBV
    Started
    259
    261
    132
    Completed
    234
    222
    110
    Not completed
    25
    39
    22
         Consent withdrawn by subject
    4
    4
    2
         Adverse event, non-fatal
    12
    22
    5
         Lost to follow-up
    -
    2
    1
         Lack of efficacy
    9
    9
    13
         Protocol deviation
    -
    2
    -
         Reasons other than stated above
    -
    -
    1
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: Baseline characteristics are based on patients who were randomised after successfully completing the screening period and received at least one dose of the trial medication.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Faldaprevir 120mg and PegIFN/RBV
    Reporting group description
    		 Faldaprevir (BI 201335) 120 mg once daily (oral) plus Pegylated Interferon-alpha (PegIFN)/ Ribavirin (RBV) (subcutaneous injection/oral) for 12 or 24 weeks, depending on achievement of early treatment success (ETS). Patients with ETS received this treatment for 12 weeks and subsequently PegIFN/RBV alone up to Week 24; patients without ETS received this treatment for 24 weeks and subsequently PegIFN/RBV alone up to Week 48. Two subject screened/randomised to Faldaprevir 120mg and PegIFN/RBV was not treated. Although actual number of subjects started is 261, 259 were reported to ensure consistent reporting with baseline characteristics that includes only treated subjects.

    Reporting group title
    Faldaprevir 240mg and PegIFN/RBV
    Reporting group description
    		 Faldaprevir 240 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 weeks, followed by PegIFN/RBV up to Week 24. Patients with ETS stopped all study medication at Week 24; patients without ETS subsequently received PegIFN/RBV alone up to Week 48. One subject screened/randomised to Faldaprevir 240mg and PegIFN/RBV was not treated. Although actual number of subjects started is 262, 261 were reported to ensure consistent reporting with baseline characteristics that includes only treated subjects.

    Reporting group title
    Placebo and PegIFN/RBV
    Reporting group description
    		 Placebo (oral) once daily plus PegIFN/RBV (subcutaneous injection/oral) for 24 weeks, followed by PegIFN/RBV alone up to Week 48. One subject screened/randomised toPlacebo and PegIFN/RBV was not treated. Although actual number of subjects started is 133, 132 were reported to ensure consistent reporting with baseline characteristics that includes only treated subjects.

    Reporting group values
    		 Faldaprevir 120mg and PegIFN/RBV Faldaprevir 240mg and PegIFN/RBV Placebo and PegIFN/RBV Total
    Number of subjects
    		 259 261 132 652
    Age categorical
    Units: Subjects
    Age Continuous |
    Units: years
        arithmetic mean (standard deviation)
    		 47.9 ± 11.44 48.3 ± 11.89 46.6 ± 12.53 -
    Gender, Male/Female
    Units: participants
        Female
    		 138 115 57 310
        Male
    		 121 146 75 342

    End points

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    End points reporting groups
    Reporting group title
    Faldaprevir 120mg and PegIFN/RBV
    Reporting group description
    		 Faldaprevir (BI 201335) 120 mg once daily (oral) plus Pegylated Interferon-alpha (PegIFN)/ Ribavirin (RBV) (subcutaneous injection/oral) for 12 or 24 weeks, depending on achievement of early treatment success (ETS). Patients with ETS received this treatment for 12 weeks and subsequently PegIFN/RBV alone up to Week 24; patients without ETS received this treatment for 24 weeks and subsequently PegIFN/RBV alone up to Week 48. Two subject screened/randomised to Faldaprevir 120mg and PegIFN/RBV was not treated. Although actual number of subjects started is 261, 259 were reported to ensure consistent reporting with baseline characteristics that includes only treated subjects.

    Reporting group title
    Faldaprevir 240mg and PegIFN/RBV
    Reporting group description
    		 Faldaprevir 240 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 weeks, followed by PegIFN/RBV up to Week 24. Patients with ETS stopped all study medication at Week 24; patients without ETS subsequently received PegIFN/RBV alone up to Week 48. One subject screened/randomised to Faldaprevir 240mg and PegIFN/RBV was not treated. Although actual number of subjects started is 262, 261 were reported to ensure consistent reporting with baseline characteristics that includes only treated subjects.

    Reporting group title
    Placebo and PegIFN/RBV
    Reporting group description
    		 Placebo (oral) once daily plus PegIFN/RBV (subcutaneous injection/oral) for 24 weeks, followed by PegIFN/RBV alone up to Week 48. One subject screened/randomised toPlacebo and PegIFN/RBV was not treated. Although actual number of subjects started is 133, 132 were reported to ensure consistent reporting with baseline characteristics that includes only treated subjects.

    Primary: Sustained Virological Response 12 weeks post-treatment (SVR12)

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    End point title
    		 Sustained Virological Response 12 weeks post-treatment (SVR12)
    End point description
    Sustained Virological Response 12 weeks post-treatment (SVR12), defined as plasma Hepatitis C virus (HCV) Ribonucleic acid (RNA) level < 25 IU/mL (undetected) 12 weeks after the originally planned treatment duration. Full analysis set (FAS) included all randomised patients who were dispensed study medication and were documented to have taken at least one dose of study medication.
    End point type
    Primary
    End point timeframe
    12 weeks post treatment, up to 60 weeks
    End point values
    		 Faldaprevir 120mg and PegIFN/RBV Faldaprevir 240mg and PegIFN/RBV Placebo and PegIFN/RBV
    Number of subjects analysed
    259 [1]
    261 [2]
    132 [3]
    Units: percentage of participants
        number (confidence interval 95%)
    79.5 (74.6 to 84.4)
    80.5 (75.6 to 85.3)
    52.3 (43.8 to 60.8)
    Notes
    [1] - FAS
    [2] - FAS
    [3] - FAS
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    The Cochran-Mantel-Haenszel method stratified by genotype subtype (1a, 1b, and non-1a/1b) and race (Black, Asian, other) was used, where Faldaprevir 120 mg was compared to placebo. The proportions of responders were calculated per group and 95% confidence intervals (CI) reported, adjusted for stratification factors.
    Comparison groups
    Faldaprevir 120mg and PegIFN/RBV v Placebo and PegIFN/RBV
    Number of subjects included in analysis
    391
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Koch's method
    Point estimate
    27.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 17.9
         upper limit
    		 37
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    The Cochran-Mantel-Haenszel method stratified by genotype subtype (1a, 1b, and non-1a/1b) and race (Black, Asian, other) was used, where Faldaprevir 240 mg was compared to placebo. The proportions of responders were calculated per group and 95% confidence intervals (CI) reported, adjusted for stratification factors.
    Comparison groups
    Faldaprevir 240mg and PegIFN/RBV v Placebo and PegIFN/RBV
    Number of subjects included in analysis
    393
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Koch's method
    Point estimate
    28.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 19
         upper limit
    		 38.2
    Statistical analysis title
    		 Statistical Analysis 3
    Statistical analysis description
    The Cochran-Mantel-Haenszel method stratified by genotype subtype (1a, 1b, and non-1a/1b) and race (Black, Asian, other) was used, where Faldaprevir 120 mg was compared to Faldaprevir 240 mg The proportions of responders were calculated per group and 95% confidence intervals (CI) reported, adjusted for stratification factors.
    Comparison groups
    Faldaprevir 120mg and PegIFN/RBV v Faldaprevir 240mg and PegIFN/RBV
    Number of subjects included in analysis
    520
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Koch's methond
    Point estimate
    -1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.9
         upper limit
    		 5.8

    Secondary: Sustained Virological Response 24 weeks post-treatment (SVR24)

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    End point title
    		 Sustained Virological Response 24 weeks post-treatment (SVR24)
    End point description
    Sustained Virological Response 24 weeks post-treatment (SVR24), defined as plasma HCV RNA level < 25 IU/mL (undetected) 24 weeks after the originally planned treatment duration.
    End point type
    Secondary
    End point timeframe
    24 weeks post treatment, up to 72 weeks
    End point values
    		 Faldaprevir 120mg and PegIFN/RBV Faldaprevir 240mg and PegIFN/RBV Placebo and PegIFN/RBV
    Number of subjects analysed
    259 [4]
    261 [5]
    132 [6]
    Units: percentage of participants
        number (confidence interval 95%)
    79.2 (74.2 to 84.1)
    79.7 (74.8 to 84.6)
    52.3 (43.8 to 60.8)
    Notes
    [4] - FAS
    [5] - FAS
    [6] - FAS
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    The Cochran-Mantel-Haenszel method stratified by genotype subtype (1a, 1b, and non-1a/1b) and race (Black, Asian, other) was used, where Faldaprevir 120 mg was compared to placebo. The proportions of responders were calculated per group and 95% confidence intervals (CI) reported, adjusted for stratification factors.
    Comparison groups
    Faldaprevir 120mg and PegIFN/RBV v Placebo and PegIFN/RBV
    Number of subjects included in analysis
    391
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Koch's method
    Point estimate
    27.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 17.5
         upper limit
    		 36.7
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    The Cochran-Mantel-Haenszel method stratified by genotype subtype (1a, 1b, and non-1a/1b) and race (Black, Asian, other) was used, where Faldaprevir 240 mg was compared to placebo. The proportions of responders were calculated per group and 95% confidence intervals (CI) reported, adjusted for stratification factors.
    Comparison groups
    Faldaprevir 240mg and PegIFN/RBV v Placebo and PegIFN/RBV
    Number of subjects included in analysis
    393
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Koch's method
    Point estimate
    27.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 18.2
         upper limit
    		 37.4
    Statistical analysis title
    		 Statistical Analysis 3
    Statistical analysis description
    The Cochran-Mantel-Haenszel method stratified by genotype subtype (1a, 1b, and non-1a/1b) and race (Black, Asian, other) was used, where Faldaprevir 120 mg was compared to Faldaprevir 240 mg. The proportions of responders were calculated per group and 95% confidence intervals (CI) reported, adjusted for stratification factors.
    Comparison groups
    Faldaprevir 120mg and PegIFN/RBV v Faldaprevir 240mg and PegIFN/RBV
    Number of subjects included in analysis
    520
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Koch's method
    Point estimate
    -0.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.6
         upper limit
    		 6.3

    Secondary: Early treatment success (ETS)

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    End point title
    		 Early treatment success (ETS)
    End point description
    Early treatment success (ETS), defined as a plasma HCV RNA level <25 IU/mL (detected or undetected) at week 4 and HCV RNA <25 IU/mL (undetected) at week 8.
    End point type
    Secondary
    End point timeframe
    week 4 and week 8
    End point values
    		 Faldaprevir 120mg and PegIFN/RBV Faldaprevir 240mg and PegIFN/RBV Placebo and PegIFN/RBV
    Number of subjects analysed
    259 [7]
    261 [8]
    132 [9]
    Units: percentage of participants
        number (not applicable)
    87.3
    89.3
    22
    Notes
    [7] - FAS
    [8] - FAS
    [9] - FAS
    No statistical analyses for this end point

    Secondary: Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at End of Treatment (EoT) When SVR12=YES

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    End point title
    		 Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at End of Treatment (EoT) When SVR12=YES
    End point description
    This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline
    End point type
    Secondary
    End point timeframe
    12 weeks post treatment, up to 60 weeks
    End point values
    		 Faldaprevir 120mg and PegIFN/RBV Faldaprevir 240mg and PegIFN/RBV Placebo and PegIFN/RBV
    Number of subjects analysed
    259 [10]
    261 [11]
    132 [12]
    Units: participants
        SVR12 = Yes
    206
    210
    69
        SVR12 = Yes, BL normal to EOT normal
    66
    68
    27
        SVR12 = Yes, BL elevated to EOT normal
    97
    115
    31
        SVR12 = Yes, No ALT data available at EoT
    0
    0
    0
    Notes
    [10] - FAS
    [11] - FAS
    [12] - FAS
    No statistical analyses for this end point

    Secondary: Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at End of Treatment (EoT) When SVR12= NO

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    End point title
    		 Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at End of Treatment (EoT) When SVR12= NO
    End point description
    This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline
    End point type
    Secondary
    End point timeframe
    12 weeks post treatment, up to 60 weeks
    End point values
    		 Faldaprevir 120mg and PegIFN/RBV Faldaprevir 240mg and PegIFN/RBV Placebo and PegIFN/RBV
    Number of subjects analysed
    259 [13]
    261 [14]
    132 [15]
    Units: participants
        SVR12 = No
    53
    51
    63
        SVR12 = No, BL normal to EOT normal
    15
    10
    15
        SVR12 = No, BL elevated to EOT normal
    16
    22
    20
        SVR12 = No, No ALT data available at EoT
    0
    0
    1
    Notes
    [13] - FAS
    [14] - FAS
    [15] - FAS
    No statistical analyses for this end point

    Secondary: Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=YES

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    End point title
    		 Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=YES
    End point description
    This will be presented as the number of patients. BL = Baseline
    End point type
    Secondary
    End point timeframe
    12 weeks post treatment, up to 60 weeks
    End point values
    		 Faldaprevir 120mg and PegIFN/RBV Faldaprevir 240mg and PegIFN/RBV Placebo and PegIFN/RBV
    Number of subjects analysed
    259 [16]
    261 [17]
    132 [18]
    Units: participants
        SVR12 = Yes
    206
    210
    69
        SVR12 = Yes, BL normal to SVR12 normal
    72
    73
    27
        SVR12 = Yes, BL elevated to SVR12 normal
    125
    126
    39
        SVR12 = Yes, No ALT data available post treatment
    4
    5
    1
    Notes
    [16] - FAS
    [17] - FAS
    [18] - FAS
    No statistical analyses for this end point

    Secondary: Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=NO

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    End point title
    		 Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=NO
    End point description
    This will be presented as the number of patients. BL = Baseline
    End point type
    Secondary
    End point timeframe
    12 weeks post treatment, up to 60 weeks
    End point values
    		 Faldaprevir 120mg and PegIFN/RBV Faldaprevir 240mg and PegIFN/RBV Placebo and PegIFN/RBV
    Number of subjects analysed
    259 [19]
    261 [20]
    132 [21]
    Units: participants
        SVR12 = No
    53
    51
    63
        SVR12 = No, BL normal to SVR12 normal
    9
    5
    5
        SVR12 = No, BL elevated to SVR12 normal
    6
    6
    1
        SVR12 = No, No ALT data available post treatment
    8
    14
    45
    Notes
    [19] - FAS
    [20] - FAS
    [21] - FAS
    No statistical analyses for this end point

    Secondary: Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at End of Treatment (EoT) When SVR12=YES

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    End point title
    		 Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at End of Treatment (EoT) When SVR12=YES
    End point description
    This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline
    End point type
    Secondary
    End point timeframe
    12 weeks post treatment, up to 60 weeks
    End point values
    		 Faldaprevir 120mg and PegIFN/RBV Faldaprevir 240mg and PegIFN/RBV Placebo and PegIFN/RBV
    Number of subjects analysed
    259 [22]
    261 [23]
    132 [24]
    Units: participants
        SVR12 = Yes
    206
    210
    69
        SVR12 = Yes, BL normal to EOT normal
    95
    99
    34
        SVR12 = Yes, BL elevated to EOT normal
    74
    76
    25
        SVR12 = Yes, No AST data available at EoT
    0
    0
    0
    Notes
    [22] - FAS
    [23] - FAS
    [24] - FAS
    No statistical analyses for this end point

    Secondary: Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at End of Treatment (EoT) When SVR12=NO

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    End point title
    		 Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at End of Treatment (EoT) When SVR12=NO
    End point description
    This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline
    End point type
    Secondary
    End point timeframe
    12 weeks post treatment, up to 60 weeks
    End point values
    		 Faldaprevir 120mg and PegIFN/RBV Faldaprevir 240mg and PegIFN/RBV Placebo and PegIFN/RBV
    Number of subjects analysed
    259 [25]
    261 [26]
    132 [27]
    Units: participants
        SVR12 = No
    53
    51
    63
        SVR12 = No, BL normal to EOT normal
    17
    16
    21
        SVR12 = No, BL elevated to EOT normal
    14
    16
    13
        SVR12 = No, No AST data available at EoT
    0
    0
    1
    Notes
    [25] - FAS
    [26] - FAS
    [27] - FAS
    No statistical analyses for this end point

    Secondary: Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=YES

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    End point title
    		 Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=YES
    End point description
    This will be presented as the number of patients. BL = Baseline
    End point type
    Secondary
    End point timeframe
    12 weeks post treatment, up to 60 weeks
    End point values
    		 Faldaprevir 120mg and PegIFN/RBV Faldaprevir 240mg and PegIFN/RBV Placebo and PegIFN/RBV
    Number of subjects analysed
    259 [28]
    261 [29]
    132 [30]
    Units: participants
        SVR12 = Yes
    206
    210
    69
        SVR12 = Yes, BL normal to SVR12 normal
    102
    109
    39
        SVR12 = Yes, BL elevated to SVR12 normal
    90
    88
    27
        SVR12 = Yes, No AST data available post-treatment
    5
    5
    1
    Notes
    [28] - FAS
    [29] - FAS
    [30] - FAS
    No statistical analyses for this end point

    Secondary: Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=NO

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    End point title
    		 Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=NO
    End point description
    This will be presented as the number of patients. BL = Baseline
    End point type
    Secondary
    End point timeframe
    12 weeks post treatment, up to 60 weeks
    End point values
    		 Faldaprevir 120mg and PegIFN/RBV Faldaprevir 240mg and PegIFN/RBV Placebo and PegIFN/RBV
    Number of subjects analysed
    259 [31]
    261 [32]
    132 [33]
    Units: participants
        SVR12 = No
    53
    51
    63
        SVR12 = No, BL normal to SVR12 normal
    10
    10
    5
        SVR12 = No, BL elevated to SVR12 normal
    10
    5
    1
        SVR12 = No, No AST data available post-treatment
    8
    14
    45
    Notes
    [31] - FAS
    [32] - FAS
    [33] - FAS
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    The double-blind treatment phase of the trial was from the randomization visit when the patient received the first dose of study drug to 30 days after the last dose of blinded trial medication up to 206 (176 +30) days.
    Adverse event reporting additional description
    AEs that pre-existed prior to randomization but worsened during treatment were also considered treatment emergent. All patients who received at least 1 dose of study drug after randomization [safety set (SAF)] were included in the presentation of AE data.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.1
    Reporting groups
    Reporting group title
    Faldaprevir 120mg and PegIFN/RBV
    Reporting group description
    		 Faldaprevir 120 mg once daily (oral) plus Pegylated Interferon-alpha (PegIFN)/ Ribavirin (RBV) (subcutaneous injection/oral) for 12 or 24 weeks, depending on achievement of early treatment success (ETS). Patients with ETS received this treatment for 12 weeks and subsequently PegIFN/RBV alone up to Week 24; patients without ETS received this treatment for 24 weeks and subsequently PegIFN/RBV alone up to Week 48. Two subject screened/randomised to Faldaprevir 120mg and PegIFN/RBV was not treated. Although actual number of subjects started is 261, 259 were reported to ensure consistent reporting with baseline characteristics that includes only treated subjects.

    Reporting group title
    Faldaprevir 240mg and PegIFN/RBV
    Reporting group description
    		 Faldaprevir 240 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 weeks, followed by PegIFN/RBV up to Week 24. Patients with ETS stopped all study medication at Week 24; patients without ETS subsequently received PegIFN/RBV alone up to Week 48. One subject screened/randomised to Faldaprevir 240mg and PegIFN/RBV was not treated. Although actual number of subjects started is 262, 261 were reported to ensure consistent reporting with baseline characteristics that includes only treated subjects.

    Reporting group title
    Placebo and PegIFN/RBV
    Reporting group description
    		 Placebo (oral) once daily plus PegIFN/RBV (subcutaneous injection/oral) for 24 weeks, followed by PegIFN/RBV alone up to Week 48. One subject screened/randomised toPlacebo and PegIFN/RBV was not treated. Although actual number of subjects started is 133, 132 were reported to ensure consistent reporting with baseline characteristics that includes only treated subjects.

    Serious adverse events
    		 Faldaprevir 120mg and PegIFN/RBV Faldaprevir 240mg and PegIFN/RBV Placebo and PegIFN/RBV
    Total subjects affected by serious adverse events
         subjects affected / exposed
    17 / 259 (6.56%)
    17 / 261 (6.51%)
    8 / 132 (6.06%)
         number of deaths (all causes)
    1
    0
    1
         number of deaths resulting from adverse events
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Cervix carcinoma
         subjects affected / exposed
    0 / 259 (0.00%)
    1 / 261 (0.38%)
    0 / 132 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Hypotension
         subjects affected / exposed
    1 / 259 (0.39%)
    0 / 261 (0.00%)
    0 / 132 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    1 / 259 (0.39%)
    0 / 261 (0.00%)
    0 / 132 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Chest pain
         subjects affected / exposed
    1 / 259 (0.39%)
    0 / 261 (0.00%)
    0 / 132 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    0 / 259 (0.00%)
    1 / 261 (0.38%)
    0 / 132 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    Hypersensitivity
         subjects affected / exposed
    0 / 259 (0.00%)
    1 / 261 (0.38%)
    0 / 132 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sarcoidosis
         subjects affected / exposed
    0 / 259 (0.00%)
    1 / 261 (0.38%)
    0 / 132 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Epistaxis
         subjects affected / exposed
    1 / 259 (0.39%)
    0 / 261 (0.00%)
    0 / 132 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dyspnoea exertional
         subjects affected / exposed
    1 / 259 (0.39%)
    0 / 261 (0.00%)
    0 / 132 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Psychotic disorder
         subjects affected / exposed
    0 / 259 (0.00%)
    1 / 261 (0.38%)
    0 / 132 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Gun shot wound
         subjects affected / exposed
    0 / 259 (0.00%)
    0 / 261 (0.00%)
    1 / 132 (0.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Subdural haematoma
         subjects affected / exposed
    1 / 259 (0.39%)
    0 / 261 (0.00%)
    0 / 132 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    1 / 259 (0.39%)
    0 / 261 (0.00%)
    0 / 132 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    1 / 259 (0.39%)
    0 / 261 (0.00%)
    0 / 132 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebrovascular accident
         subjects affected / exposed
    1 / 259 (0.39%)
    0 / 261 (0.00%)
    0 / 132 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cubital tunnel syndrome
         subjects affected / exposed
    1 / 259 (0.39%)
    0 / 261 (0.00%)
    0 / 132 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dizziness
         subjects affected / exposed
    1 / 259 (0.39%)
    0 / 261 (0.00%)
    0 / 132 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Headache
         subjects affected / exposed
    1 / 259 (0.39%)
    0 / 261 (0.00%)
    0 / 132 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sciatica
         subjects affected / exposed
    1 / 259 (0.39%)
    0 / 261 (0.00%)
    0 / 132 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 259 (0.39%)
    2 / 261 (0.77%)
    1 / 132 (0.76%)
         occurrences causally related to treatment / all
    1 / 1
    2 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Idiopathic thrombocytopenic purpura
         subjects affected / exposed
    0 / 259 (0.00%)
    1 / 261 (0.38%)
    0 / 132 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Leukopenia
         subjects affected / exposed
    1 / 259 (0.39%)
    0 / 261 (0.00%)
    0 / 132 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Histiocytosis haematophagic
         subjects affected / exposed
    1 / 259 (0.39%)
    0 / 261 (0.00%)
    0 / 132 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pancytopenia
         subjects affected / exposed
    0 / 259 (0.00%)
    1 / 261 (0.38%)
    0 / 132 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    1 / 259 (0.39%)
    0 / 261 (0.00%)
    0 / 132 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Optic ischaemic neuropathy
         subjects affected / exposed
    0 / 259 (0.00%)
    1 / 261 (0.38%)
    0 / 132 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Retinopathy
         subjects affected / exposed
    1 / 259 (0.39%)
    0 / 261 (0.00%)
    0 / 132 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Inguinal hernia
         subjects affected / exposed
    0 / 259 (0.00%)
    0 / 261 (0.00%)
    1 / 132 (0.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haemorrhoids
         subjects affected / exposed
    0 / 259 (0.00%)
    1 / 261 (0.38%)
    0 / 132 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pancreatitis
         subjects affected / exposed
    1 / 259 (0.39%)
    0 / 261 (0.00%)
    0 / 132 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    0 / 259 (0.00%)
    2 / 261 (0.77%)
    0 / 132 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis
         subjects affected / exposed
    0 / 259 (0.00%)
    0 / 261 (0.00%)
    1 / 132 (0.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatic lesion
         subjects affected / exposed
    0 / 259 (0.00%)
    0 / 261 (0.00%)
    1 / 132 (0.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Blister
         subjects affected / exposed
    0 / 259 (0.00%)
    0 / 261 (0.00%)
    1 / 132 (0.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Drug eruption
         subjects affected / exposed
    0 / 259 (0.00%)
    1 / 261 (0.38%)
    0 / 132 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Psoriasis
         subjects affected / exposed
    0 / 259 (0.00%)
    1 / 261 (0.38%)
    0 / 132 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Rash
         subjects affected / exposed
    1 / 259 (0.39%)
    1 / 261 (0.38%)
    0 / 132 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Rash maculo-papular
         subjects affected / exposed
    0 / 259 (0.00%)
    0 / 261 (0.00%)
    1 / 132 (0.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Endocrine disorders
    Hypoparathyroidism
         subjects affected / exposed
    1 / 259 (0.39%)
    0 / 261 (0.00%)
    0 / 132 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Muscular weakness
         subjects affected / exposed
    1 / 259 (0.39%)
    0 / 261 (0.00%)
    0 / 132 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Polymyositis
         subjects affected / exposed
    0 / 259 (0.00%)
    0 / 261 (0.00%)
    1 / 132 (0.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Bronchopneumonia
         subjects affected / exposed
    0 / 259 (0.00%)
    1 / 261 (0.38%)
    0 / 132 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    1 / 259 (0.39%)
    0 / 261 (0.00%)
    0 / 132 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 259 (0.00%)
    1 / 261 (0.38%)
    0 / 132 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diverticulitis
         subjects affected / exposed
    0 / 259 (0.00%)
    0 / 261 (0.00%)
    1 / 132 (0.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Diabetes mellitus
         subjects affected / exposed
    1 / 259 (0.39%)
    0 / 261 (0.00%)
    0 / 132 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Faldaprevir 120mg and PegIFN/RBV Faldaprevir 240mg and PegIFN/RBV Placebo and PegIFN/RBV
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    246 / 259 (94.98%)
    250 / 261 (95.79%)
    120 / 132 (90.91%)
    Investigations
    Weight decreased
         subjects affected / exposed
    13 / 259 (5.02%)
    15 / 261 (5.75%)
    10 / 132 (7.58%)
         occurrences all number
    13
    15
    10
    Haemoglobin decreased
         subjects affected / exposed
    15 / 259 (5.79%)
    5 / 261 (1.92%)
    7 / 132 (5.30%)
         occurrences all number
    16
    5
    8
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    17 / 259 (6.56%)
    21 / 261 (8.05%)
    13 / 132 (9.85%)
         occurrences all number
    20
    22
    14
    Dysgeusia
         subjects affected / exposed
    13 / 259 (5.02%)
    10 / 261 (3.83%)
    5 / 132 (3.79%)
         occurrences all number
    13
    10
    5
    Headache
         subjects affected / exposed
    76 / 259 (29.34%)
    70 / 261 (26.82%)
    40 / 132 (30.30%)
         occurrences all number
    102
    81
    54
    Disturbance in attention
         subjects affected / exposed
    10 / 259 (3.86%)
    8 / 261 (3.07%)
    7 / 132 (5.30%)
         occurrences all number
    10
    8
    7
    Blood and lymphatic system disorders
    Neutropenia
         subjects affected / exposed
    32 / 259 (12.36%)
    25 / 261 (9.58%)
    18 / 132 (13.64%)
         occurrences all number
    45
    34
    21
    Anaemia
         subjects affected / exposed
    46 / 259 (17.76%)
    43 / 261 (16.48%)
    23 / 132 (17.42%)
         occurrences all number
    49
    45
    30
    General disorders and administration site conditions
    Malaise
         subjects affected / exposed
    20 / 259 (7.72%)
    16 / 261 (6.13%)
    12 / 132 (9.09%)
         occurrences all number
    20
    18
    12
    Irritability
         subjects affected / exposed
    19 / 259 (7.34%)
    18 / 261 (6.90%)
    9 / 132 (6.82%)
         occurrences all number
    19
    18
    9
    Influenza like illness
         subjects affected / exposed
    40 / 259 (15.44%)
    52 / 261 (19.92%)
    21 / 132 (15.91%)
         occurrences all number
    40
    52
    21
    Pyrexia
         subjects affected / exposed
    57 / 259 (22.01%)
    53 / 261 (20.31%)
    32 / 132 (24.24%)
         occurrences all number
    71
    65
    44
    Asthenia
         subjects affected / exposed
    53 / 259 (20.46%)
    43 / 261 (16.48%)
    27 / 132 (20.45%)
         occurrences all number
    56
    44
    28
    Fatigue
         subjects affected / exposed
    66 / 259 (25.48%)
    77 / 261 (29.50%)
    35 / 132 (26.52%)
         occurrences all number
    71
    77
    37
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    11 / 259 (4.25%)
    15 / 261 (5.75%)
    10 / 132 (7.58%)
         occurrences all number
    13
    17
    10
    Abdominal pain upper
         subjects affected / exposed
    18 / 259 (6.95%)
    24 / 261 (9.20%)
    14 / 132 (10.61%)
         occurrences all number
    20
    26
    15
    Constipation
         subjects affected / exposed
    11 / 259 (4.25%)
    16 / 261 (6.13%)
    5 / 132 (3.79%)
         occurrences all number
    11
    17
    5
    Stomatitis
         subjects affected / exposed
    12 / 259 (4.63%)
    11 / 261 (4.21%)
    7 / 132 (5.30%)
         occurrences all number
    13
    13
    13
    Diarrhoea
         subjects affected / exposed
    53 / 259 (20.46%)
    68 / 261 (26.05%)
    17 / 132 (12.88%)
         occurrences all number
    60
    78
    18
    Dry mouth
         subjects affected / exposed
    8 / 259 (3.09%)
    6 / 261 (2.30%)
    9 / 132 (6.82%)
         occurrences all number
    8
    6
    9
    Dyspepsia
         subjects affected / exposed
    12 / 259 (4.63%)
    14 / 261 (5.36%)
    9 / 132 (6.82%)
         occurrences all number
    12
    14
    10
    Nausea
         subjects affected / exposed
    73 / 259 (28.19%)
    95 / 261 (36.40%)
    19 / 132 (14.39%)
         occurrences all number
    79
    100
    19
    Vomiting
         subjects affected / exposed
    28 / 259 (10.81%)
    52 / 261 (19.92%)
    6 / 132 (4.55%)
         occurrences all number
    34
    66
    6
    Hepatobiliary disorders
    Hyperbilirubinaemia
         subjects affected / exposed
    4 / 259 (1.54%)
    14 / 261 (5.36%)
    1 / 132 (0.76%)
         occurrences all number
    4
    14
    1
    Jaundice
         subjects affected / exposed
    17 / 259 (6.56%)
    48 / 261 (18.39%)
    1 / 132 (0.76%)
         occurrences all number
    17
    49
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    30 / 259 (11.58%)
    28 / 261 (10.73%)
    20 / 132 (15.15%)
         occurrences all number
    31
    28
    22
    Dyspnoea
         subjects affected / exposed
    17 / 259 (6.56%)
    19 / 261 (7.28%)
    16 / 132 (12.12%)
         occurrences all number
    17
    20
    16
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    42 / 259 (16.22%)
    47 / 261 (18.01%)
    15 / 132 (11.36%)
         occurrences all number
    42
    47
    15
    Dry skin
         subjects affected / exposed
    35 / 259 (13.51%)
    45 / 261 (17.24%)
    17 / 132 (12.88%)
         occurrences all number
    35
    47
    17
    Pruritus
         subjects affected / exposed
    82 / 259 (31.66%)
    78 / 261 (29.89%)
    41 / 132 (31.06%)
         occurrences all number
    87
    84
    49
    Erythema
         subjects affected / exposed
    9 / 259 (3.47%)
    18 / 261 (6.90%)
    6 / 132 (4.55%)
         occurrences all number
    10
    23
    7
    Rash
         subjects affected / exposed
    69 / 259 (26.64%)
    70 / 261 (26.82%)
    25 / 132 (18.94%)
         occurrences all number
    80
    83
    31
    Psychiatric disorders
    Depression
         subjects affected / exposed
    20 / 259 (7.72%)
    12 / 261 (4.60%)
    8 / 132 (6.06%)
         occurrences all number
    20
    12
    8
    Insomnia
         subjects affected / exposed
    38 / 259 (14.67%)
    32 / 261 (12.26%)
    22 / 132 (16.67%)
         occurrences all number
    38
    33
    24
    Sleep disorder
         subjects affected / exposed
    12 / 259 (4.63%)
    14 / 261 (5.36%)
    5 / 132 (3.79%)
         occurrences all number
    12
    15
    5
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    19 / 259 (7.34%)
    20 / 261 (7.66%)
    14 / 132 (10.61%)
         occurrences all number
    24
    22
    15
    Back pain
         subjects affected / exposed
    14 / 259 (5.41%)
    8 / 261 (3.07%)
    10 / 132 (7.58%)
         occurrences all number
    17
    8
    10
    Myalgia
         subjects affected / exposed
    22 / 259 (8.49%)
    19 / 261 (7.28%)
    20 / 132 (15.15%)
         occurrences all number
    22
    22
    22
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    14 / 259 (5.41%)
    16 / 261 (6.13%)
    10 / 132 (7.58%)
         occurrences all number
    18
    19
    11
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    35 / 259 (13.51%)
    52 / 261 (19.92%)
    22 / 132 (16.67%)
         occurrences all number
    36
    54
    24

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    21 Jun 2011
    1. Implementation of a grading system for AEs to harmonize AE reporting across HCV projects 2. Change of procedures and tests at various visits to improve data collection and procedural feasibility at each visit, e.g., HCV RNA test and virology sample were added to FU1 visit, additional laboratory tests were moved from EoT to extended FU. In addition, the time window for the screening visit could be extended to afford more flexibility for centers and subjects 3. Clarification of inclusion criteria: subjects at risk were no longer excluded if they did not have a liver biopsy 4. Clarification of exclusion criteria: incidental steatosis diagnosed by biopsy was no longer an exclusion criterion; decompensated liver disease was based on Child-Turcotte-Pugh classification. In addition, psychiatric conditions and 'creatinine clearance ≤50 mL/min' were added as exclusion criteria to comply with the updated Summary of Product Characteristics for RBV (Copegus) 5. Clarification of definition of SVR: HCV RNA <25 IU/mL (undetected) after the planned end of treatment (based on assigned treatment group and achievement of ETS) 6. Adjustments of the rash management plan to make it consistent across all trials in the program 7. Clarification of details of genotypic and phenotypic viral resistance analysis 8. Modification of procedures for subjects discontinuing treatment prematurely: they were to follow the 48-week visit schedule 9. Modification of safety endpoints: rash and photosensitivity are AEs that are captured in Endpoints 1, 2, 3, and 4 10. Clarification that not every severe or serious AE should prompt treatment discontinuation 11. Clarification on appropriate management of missed PegIFN and RBV doses
    09 Mar 2012
    1. Change of primary endpoint from SVR24 to SVR12: this change was based on FDA public comments and BI retrospective analysis of Phase II data indicating a 98% positive predictive value of SVR12 for SVR24 2. Addition of post-treatment ALT and AST normalization as efficacy endpoint to correlate this with SVR12 3. Addition of SVR24 to better define the post-EoO visit 4. Clarifications were added to the inclusion and exclusion criteria to make them consistent across the FDV program 5. Clarifications of stopping rule criteria 6. Clarification of the blinding process 7. Clarifications of the process for the discontinuation and modification of FDV and PegIFN 8. Modification of compliance assessment: planned interruptions and dose reductions were not automatically to be counted as noncompliance 9. Clarification of the definitions of AEs: worsening of underlying disease or pre-existing conditions and changes in vital signs, ECG, physical examination and laboratory test results (if clinically relevant) were to be recorded as (S)AE, 10. Clarification of definition and reporting of 'always serious adverse events' to comply with a new corporate SOP 11. Clarifications were added for the laboratory test schedule 12. Clarification of grading of the intensity of rash when photo documentation is required 13. Clarification of the process for rash management 14. Statistical analysis of primary and secondary endpoints was adjusted to comply with the changes made in these endpoints 15. An interim analysis was conducted, with SVR12 as the primary endpoint 16. Handling of missing data was changed to include rules for imputing missing SVR12 values 17. The determination of sample size was adjusted for SVR12 as the primary endpoint

    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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