Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    A phase II, randomized, double-blind, multicenter, active-controlled, parallel group study to evaluate the sustained virologic response of the HCV polymerase inhibitor prodrug RO5024048 in combination with Telaprevir and Pegasus/Copegus compared with Telaprevir and Pegasys/Copegus in patients with chronic Hepatitis C Genotype 1 virus infection who were prior null responders to treatment with Pegylated Interferon/Ribavirin.

    Summary
    EudraCT number
    		 2011-002715-28
    Trial protocol
    		 GB   DE   ES   IT  
    Global end of trial date
    28 Jan 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    22 Apr 2016
    First version publication date
    06 Aug 2015
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    NV27779
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01482390
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    F. Hoffmann-La Roche AG
    Sponsor organisation address
    Grenzacherstrasse 124, Basel, Switzerland, CH-4070
    Public contact
    Roche Trial Information Hotline, F. Hoffmann-La Roche AG, +41 061 6878333, global.trial_information@roche.com
    Scientific contact
    Roche Trial Information Hotline, F. Hoffmann-La Roche AG, +41 061 6878333, global.trial_information@roche.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
    28 Jan 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    28 Jan 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To estimate the difference in sustained virologic response 12 weeks after treatment (SVR-12) between each of the following three experimental treatment groups (regimens containing RO5024048, telaprevir, Pegasys, and Copegus) and the control treatment group (regimen containing telaprevir, Pegasys, and Copegus) in patients with previous null response to pegylated interferon/ribavirin (PEG-IFN/RBV) combination therapy, defined as a < 2 log10 IU/mL decrease in viral titer after at least 12 weeks of treatment with PEG-IFN/RBV.
    Protection of trial subjects
    The study was conducted in accordance with the principles of the “Declaration of Helsinki” and Good Clinical Practice. All subjects signed an informed consent form.
    Background therapy
    		 There were no background therapies indicated for this study.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    14 Nov 2011
    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: 15
    Country: Number of subjects enrolled
    United Kingdom: 14
    Country: Number of subjects enrolled
    France: 9
    Country: Number of subjects enrolled
    Germany: 5
    Country: Number of subjects enrolled
    Canada: 17
    Country: Number of subjects enrolled
    United States: 20
    Worldwide total number of subjects
    80
    EEA total number of subjects
    43
    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)
    78
    From 65 to 84 years
    2
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Screened over a period of 12 weeks

    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, Monitor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Arm A-TVR 12WKS, MCB 24WKS, P/R 24WKS
    Arm description
    		 Twelve weeks of therapy with mericitabine (MCB), telaprevir (TVR), Pegasys and Copegus (P/R), followed by 12 weeks of therapy with MCB + Pegasys/Copegus (triple) (total treatment duration of 24 weeks), followed by a 24-week treatment-free follow-up period.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Copegus
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Total daily dose of 1000 mg (<75 kg) or 1200 mg (≥75 kg) taken orally within 30 minutes after meal or snack for 24 weeks

    Investigational medicinal product name
    Mericitabine
    Investigational medicinal product code
    Other name
    RO5024048
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Administered at a dose of 1000 mg orally twice daily within 30 minutes of eating meal or snack for 24 weeks

    Investigational medicinal product name
    Pegasys
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Administered at a dose of 180 μg via subcutaneous route once weekly for 24 weeks

    Investigational medicinal product name
    Telaprevir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Administered at a dose of 750 mg orally three times daily (at recommended intervals of 7-9 hours) within 30 minutes after meal or snack for 12 weeks

    Arm title
    		 Arm B-TVR 12WKS,MCB 24WKS, P/R 48WKS
    Arm description
    		 Twelve weeks of therapy with mericitabine (MCB), telaprevir (TVR), Pegasys and Copegus (P/R), followed by 12 weeks of therapy with MCB + Pegasys/Copegus (triple), followed by 24 weeks of therapy with Pegasys/Copegus (total treatment duration of 48 weeks), followed by a 24−week treatment-free follow-up period.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Copegus
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Total daily dose of 1000 mg (<75 kg) or 1200 mg (≥75 kg) taken orally within 30 minutes after meal or snack for 48 weeks

    Investigational medicinal product name
    Mericitabine
    Investigational medicinal product code
    Other name
    RO5024048
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Administered at a dose of 1000 mg orally twice daily within 30 minutes of eating meal or snack for 24 weeks

    Investigational medicinal product name
    Pegasys
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Administered at a dose of 180 μg via subcutaneous route once weekly for 48 weeks

    Investigational medicinal product name
    Telaprevir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Administered at a dose of 750 mg orally three times daily (at recommended intervals of 7-9 hours) within 30 minutes after meal or snack for 12 weeks

    Arm title
    		 Arm C-TVR 12WKS, MCB 12WKS, PLAC MCB 12WKS, P/R 48WKS
    Arm description
    		 Twelve weeks of therapy with mericitabine (MCB), telaprevir (TVR), Pegasys and Copegus (P/R), followed by 12 weeks of therapy with MCB placebo (PLAC) + Pegasys/Copegus (triple), followed by 24 weeks of therapy with Pegasys/Copegus (total treatment duration of 48 weeks), followed by a 24−week treatment-free follow-up period.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Copegus
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Total daily dose of 1000 mg (<75 kg) or 1200 mg (≥75 kg) taken orally within 30 minutes after meal or snack for 48 weeks

    Investigational medicinal product name
    Mericitabine
    Investigational medicinal product code
    Other name
    RO5024048
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Administered at a dose of 1000 mg orally twice daily within 30 minutes of eating meal or snack for 12 weeks

    Investigational medicinal product name
    Pegasys
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Administered at a dose of 180 μg via subcutaneous route once weekly for 48 weeks

    Investigational medicinal product name
    Telaprevir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Administered at a dose of 750 mg orally three times daily (at recommended intervals of 7-9 hours) within 30 minutes after meal or snack for 12 weeks

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Administered 1000 mg orally twice daily for 12 weeks

    Arm title
    		 Arm D-TVR 12WKS, MCB or PLAC MCB, 24WKS, P/R 48WKS
    Arm description
    		 Twelve weeks of therapy with mericitabine (MCB) placebo (PLAC), telaprevir (TVR), Pegasys and Copegus (P/R), followed by 12 weeks of therapy with MCB placebo + Pegasys/Copegus (triple), followed by 24 weeks of therapy with Pegasys/Copegus (total treatment duration of 48 weeks), followed by a 24−week treatment-free follow-up period.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Copegus
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Total daily dose of 1000 mg (<75 kg) or 1200 mg (≥75 kg) taken orally within 30 minutes after meal or snack for 48 weeks

    Investigational medicinal product name
    Pegasys
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Administered at a dose of 180 μg via subcutaneous route once weekly for 48 weeks

    Investigational medicinal product name
    Telaprevir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Administered at a dose of 750 mg orally three times daily (at recommended intervals of 7-9 hours) within 30 minutes after meal or snack for 12 weeks

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Administered 1000 mg orally twice daily for 24 weeks

    Number of subjects in period 1
    		Arm A-TVR 12WKS, MCB 24WKS, P/R 24WKS Arm B-TVR 12WKS,MCB 24WKS, P/R 48WKS Arm C-TVR 12WKS, MCB 12WKS, PLAC MCB 12WKS, P/R 48WKS Arm D-TVR 12WKS, MCB or PLAC MCB, 24WKS, P/R 48WKS
    Started
    21
    24
    24
    11
    Completed
    18
    22
    24
    11
    Not completed
    3
    2
    0
    0
         Physician decision
    1
    -
    -
    -
         Not specified
    1
    -
    -
    -
         Did not receive study drug
    -
    1
    -
    -
         Lost to follow-up
    -
    1
    -
    -
         Withdrawal by subject
    1
    -
    -
    -

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Arm A-TVR 12WKS, MCB 24WKS, P/R 24WKS
    Reporting group description
    		 Twelve weeks of therapy with mericitabine (MCB), telaprevir (TVR), Pegasys and Copegus (P/R), followed by 12 weeks of therapy with MCB + Pegasys/Copegus (triple) (total treatment duration of 24 weeks), followed by a 24-week treatment-free follow-up period.

    Reporting group title
    Arm B-TVR 12WKS,MCB 24WKS, P/R 48WKS
    Reporting group description
    		 Twelve weeks of therapy with mericitabine (MCB), telaprevir (TVR), Pegasys and Copegus (P/R), followed by 12 weeks of therapy with MCB + Pegasys/Copegus (triple), followed by 24 weeks of therapy with Pegasys/Copegus (total treatment duration of 48 weeks), followed by a 24−week treatment-free follow-up period.

    Reporting group title
    Arm C-TVR 12WKS, MCB 12WKS, PLAC MCB 12WKS, P/R 48WKS
    Reporting group description
    		 Twelve weeks of therapy with mericitabine (MCB), telaprevir (TVR), Pegasys and Copegus (P/R), followed by 12 weeks of therapy with MCB placebo (PLAC) + Pegasys/Copegus (triple), followed by 24 weeks of therapy with Pegasys/Copegus (total treatment duration of 48 weeks), followed by a 24−week treatment-free follow-up period.

    Reporting group title
    Arm D-TVR 12WKS, MCB or PLAC MCB, 24WKS, P/R 48WKS
    Reporting group description
    		 Twelve weeks of therapy with mericitabine (MCB) placebo (PLAC), telaprevir (TVR), Pegasys and Copegus (P/R), followed by 12 weeks of therapy with MCB placebo + Pegasys/Copegus (triple), followed by 24 weeks of therapy with Pegasys/Copegus (total treatment duration of 48 weeks), followed by a 24−week treatment-free follow-up period.

    Reporting group values
    		 Arm A-TVR 12WKS, MCB 24WKS, P/R 24WKS Arm B-TVR 12WKS,MCB 24WKS, P/R 48WKS Arm C-TVR 12WKS, MCB 12WKS, PLAC MCB 12WKS, P/R 48WKS Arm D-TVR 12WKS, MCB or PLAC MCB, 24WKS, P/R 48WKS Total
    Number of subjects
    		 21 24 24 11 80
    Age categorical
    Units: Subjects
        <18 years
    		 0 0 0 0 0
        >=18-<=65 years
    		 20 24 23 11 78
        >65
    		 1 0 1 0 2
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 51.9 ± 10.1 54 ± 7.6 53.5 ± 7.7 52.8 ± 6.7 -
    Gender categorical
    Units: Subjects
        Female
    		 6 7 7 2 22
        Male
    		 15 17 17 9 58

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Arm A-TVR 12WKS, MCB 24WKS, P/R 24WKS
    Reporting group description
    		 Twelve weeks of therapy with mericitabine (MCB), telaprevir (TVR), Pegasys and Copegus (P/R), followed by 12 weeks of therapy with MCB + Pegasys/Copegus (triple) (total treatment duration of 24 weeks), followed by a 24-week treatment-free follow-up period.

    Reporting group title
    Arm B-TVR 12WKS,MCB 24WKS, P/R 48WKS
    Reporting group description
    		 Twelve weeks of therapy with mericitabine (MCB), telaprevir (TVR), Pegasys and Copegus (P/R), followed by 12 weeks of therapy with MCB + Pegasys/Copegus (triple), followed by 24 weeks of therapy with Pegasys/Copegus (total treatment duration of 48 weeks), followed by a 24−week treatment-free follow-up period.

    Reporting group title
    Arm C-TVR 12WKS, MCB 12WKS, PLAC MCB 12WKS, P/R 48WKS
    Reporting group description
    		 Twelve weeks of therapy with mericitabine (MCB), telaprevir (TVR), Pegasys and Copegus (P/R), followed by 12 weeks of therapy with MCB placebo (PLAC) + Pegasys/Copegus (triple), followed by 24 weeks of therapy with Pegasys/Copegus (total treatment duration of 48 weeks), followed by a 24−week treatment-free follow-up period.

    Reporting group title
    Arm D-TVR 12WKS, MCB or PLAC MCB, 24WKS, P/R 48WKS
    Reporting group description
    		 Twelve weeks of therapy with mericitabine (MCB) placebo (PLAC), telaprevir (TVR), Pegasys and Copegus (P/R), followed by 12 weeks of therapy with MCB placebo + Pegasys/Copegus (triple), followed by 24 weeks of therapy with Pegasys/Copegus (total treatment duration of 48 weeks), followed by a 24−week treatment-free follow-up period.

    Subject analysis set title
    Hepatitis C Virus (HCV)-resistance Monitoring Set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All patients who received therapy were monitored for the presence of resistance mutations.

    Primary: Percent of Subjects With Sustained Virological Response 12 Weeks After Treatment (SVR12)

    		 Close Top of page
    End point title
    		 Percent of Subjects With Sustained Virological Response 12 Weeks After Treatment (SVR12) [1]
    End point description
    Response was defined as an unquantifiable (less than the lower limit of quantification [LLOQ]; <25 International Units [IU]/mL) serum HCV-RNA 12 weeks after the actual end of treatment (EOT) (a single last unquantifiable HCV-RNA within 8-20 weeks after the last day of study drug administration). Serum HCV RNA was assessed in all randomized patients by polymerase chain reaction (PCR) techniques using the Roche COBAS TaqMan HCV v2.0 Test.
    End point type
    Primary
    End point timeframe
    Up to 60 weeks
    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: No formal hypothesis testing was conducted in this exploratory study. The primary efficacy endpoint (SVR12 [actual]) for each of the treatment groups was summarized by using descriptive statistics.
    End point values
    		 Arm A-TVR 12WKS, MCB 24WKS, P/R 24WKS Arm B-TVR 12WKS,MCB 24WKS, P/R 48WKS Arm C-TVR 12WKS, MCB 12WKS, PLAC MCB 12WKS, P/R 48WKS Arm D-TVR 12WKS, MCB or PLAC MCB, 24WKS, P/R 48WKS
    Number of subjects analysed
    21
    23
    24
    11
    Units: percentage
        number (not applicable)
    81
    95.7
    70.8
    90.9
    No statistical analyses for this end point

    Secondary: Percent of Subjects With SVR4

    		 Close Top of page
    End point title
    		 Percent of Subjects With SVR4
    End point description
    Response was defined as an unquantifiable (less than the lower limit of quantification [LLOQ]; <25 International Units [IU]/mL) serum HCV-RNA within 2 − 8 weeks after the last day of study drug administration. Serum HCV RNA was assessed in all randomized patients by polymerase chain reaction (PCR) techniques using the Roche COBAS TaqMan HCV v2.0 Test.
    End point type
    Secondary
    End point timeframe
    Up to 52 weeks
    End point values
    		 Arm A-TVR 12WKS, MCB 24WKS, P/R 24WKS Arm B-TVR 12WKS,MCB 24WKS, P/R 48WKS Arm C-TVR 12WKS, MCB 12WKS, PLAC MCB 12WKS, P/R 48WKS Arm D-TVR 12WKS, MCB or PLAC MCB, 24WKS, P/R 48WKS
    Number of subjects analysed
    21
    23
    24
    11
    Units: percentage
        number (not applicable)
    85.7
    95.7
    70.8
    90.9
    No statistical analyses for this end point

    Secondary: Percent of Subjects With SVR24

    		 Close Top of page
    End point title
    		 Percent of Subjects With SVR24
    End point description
    Response was defined as an unquantifiable (less than the lower limit of quantification [LLOQ]; <25 International Units [IU]/mL) serum HCV-RNA ≥ 20 weeks after the last day of study drug administration. Serum HCV RNA was assessed in all randomized patients by polymerase chain reaction (PCR) techniques using the Roche COBAS TaqMan HCV v2.0 Test.
    End point type
    Secondary
    End point timeframe
    Up to 72 weeks
    End point values
    		 Arm A-TVR 12WKS, MCB 24WKS, P/R 24WKS Arm B-TVR 12WKS,MCB 24WKS, P/R 48WKS Arm C-TVR 12WKS, MCB 12WKS, PLAC MCB 12WKS, P/R 48WKS Arm D-TVR 12WKS, MCB or PLAC MCB, 24WKS, P/R 48WKS
    Number of subjects analysed
    21
    23
    24
    11
    Units: percentage
        number (not applicable)
    76.2
    95.7
    70.8
    90.9
    No statistical analyses for this end point

    Secondary: Percent of Subjects With Virologic Response Over Time From Week 2 to Week 48

    		 Close Top of page
    End point title
    		 Percent of Subjects With Virologic Response Over Time From Week 2 to Week 48
    End point description
    Response was defined as an unquantifiable (less than the lower limit of quantification [LLOQ]; <25 International Units [IU]/mL) serum HCV-RNA. Serum HCV RNA was assessed in all randomized patients by polymerase chain reaction (PCR) techniques using the Roche COBAS TaqMan HCV v2.0 Test.
    End point type
    Secondary
    End point timeframe
    Up to 48 weeks
    End point values
    		 Arm A-TVR 12WKS, MCB 24WKS, P/R 24WKS Arm B-TVR 12WKS,MCB 24WKS, P/R 48WKS Arm C-TVR 12WKS, MCB 12WKS, PLAC MCB 12WKS, P/R 48WKS Arm D-TVR 12WKS, MCB or PLAC MCB, 24WKS, P/R 48WKS
    Number of subjects analysed
    21
    23
    24
    11
    Units: percentage
    number (not applicable)
        Week 2
    85.7
    65.2
    70.8
    54.5
        Week 4
    100
    95.7
    91.7
    100
        Week 12
    100
    95.7
    91.7
    90.9
        Week 24
    100
    91.3
    75
    90.9
        Week 48
    0
    78.3
    54.2
    81.8
    No statistical analyses for this end point

    Secondary: Number of Subjects With Treatment-resistant Mutations

    		 Close Top of page
    End point title
    		 Number of Subjects With Treatment-resistant Mutations
    End point description
    Blood samples were collected throughout the study to monitor for the development of drug resistance. During the course of the study, phenotypic and/or sequence analyses were performed on samples from patients who experienced virologic breakthrough, partial response, non-response, or relapse. Patients who developed resistance to MCB and/or to telaprevir were monitored for the persistence of resistant mutation(s) during the follow-up period. The genotype of samples from telaprevir- and/or RO5024048-resistant subjects were determined through population sequencing of the non-structural protein 3/non-structural protein 4a (NS3-4a) and nonstructural protein 5B (NS5B) coding regions by using standard sequencing technology.
    End point type
    Secondary
    End point timeframe
    60 weeks
    End point values
    		 Hepatitis C Virus (HCV)-resistance Monitoring Set
    Number of subjects analysed
    79
    Units: subjects
        Subjects with telaprevir resistance mutations
    10
        Subjects with MCB resistance mutations
    0
    No statistical analyses for this end point

    Secondary: Number of Subjects With Adverse Events

    		 Close Top of page
    End point title
    		 Number of Subjects With Adverse Events
    End point description
    Adverse events were systematically monitored throughout the study.
    End point type
    Secondary
    End point timeframe
    60 weeks
    End point values
    		 Arm A-TVR 12WKS, MCB 24WKS, P/R 24WKS Arm B-TVR 12WKS,MCB 24WKS, P/R 48WKS Arm C-TVR 12WKS, MCB 12WKS, PLAC MCB 12WKS, P/R 48WKS Arm D-TVR 12WKS, MCB or PLAC MCB, 24WKS, P/R 48WKS
    Number of subjects analysed
    21
    23
    24
    11
    Units: Subjects
        Serious adverse events
    4
    6
    3
    0
        Non-serious adverse events
    20
    23
    24
    11
    No statistical analyses for this end point

    Secondary: Trough Concentration of RO4995855

    		 Close Top of page
    End point title
    		 Trough Concentration of RO4995855
    End point description
    Trough concentration was defined as the minimum observed drug concentration during a dosing interval. Pharmacokinetic (PK) plasma and serum samples were collected from all patients to measure RO4995855, its metabolite (RO5012433), and telaprevir before the morning dose of all study drugs on Day 1 (baseline) and at Week 8. Plasma concentrations for RO4995855, RO5012433, and telaprevir were measured by specific and validated liquid chromatography tandem mass spectrometry methods. The value reported is the average trough plasma concentration for Week 8.
    End point type
    Secondary
    End point timeframe
    Day 1 and Week 8
    End point values
    		 Arm A-TVR 12WKS, MCB 24WKS, P/R 24WKS Arm B-TVR 12WKS,MCB 24WKS, P/R 48WKS Arm C-TVR 12WKS, MCB 12WKS, PLAC MCB 12WKS, P/R 48WKS Arm D-TVR 12WKS, MCB or PLAC MCB, 24WKS, P/R 48WKS
    Number of subjects analysed
    20
    22
    23
    4
    Units: ng/mL
        arithmetic mean (standard deviation)
    3147.75 ± 1711.91
    2716.77 ± 1508.75
    3933.09 ± 1938.6
    1277 ± 2068
    No statistical analyses for this end point

    Secondary: Trough Concentration of RO5012433

    		 Close Top of page
    End point title
    		 Trough Concentration of RO5012433
    End point description
    Trough concentration was defined as the minimum observed drug concentration during a dosing interval. Pharmacokinetic (PK) plasma and serum samples were collected from all patients to measure RO4995855, its metabolite (RO5012433), and telaprevir before the morning dose of all study drugs on Day 1 (baseline) and at Week 8. Plasma concentrations for RO4995855, RO5012433, and telaprevir were measured by specific and validated liquid chromatography tandem mass spectrometry methods. The value reported is the average trough plasma concentration for Week 8.
    End point type
    Secondary
    End point timeframe
    Day 1 and week 8
    End point values
    		 Arm A-TVR 12WKS, MCB 24WKS, P/R 24WKS Arm B-TVR 12WKS,MCB 24WKS, P/R 48WKS Arm C-TVR 12WKS, MCB 12WKS, PLAC MCB 12WKS, P/R 48WKS Arm D-TVR 12WKS, MCB or PLAC MCB, 24WKS, P/R 48WKS
    Number of subjects analysed
    20
    22
    23
    4
    Units: ng/mL
        arithmetic mean (standard deviation)
    727.4 ± 373.47
    638.68 ± 307.73
    853.3 ± 407.2
    394 ± 669.8
    No statistical analyses for this end point

    Secondary: Trough Concentration of Telaprevir

    		 Close Top of page
    End point title
    		 Trough Concentration of Telaprevir
    End point description
    Trough concentration was defined as the minimum observed drug concentration during a dosing interval. Pharmacokinetic (PK) plasma and serum samples were collected from all patients to measure RO4995855, its metabolite (RO5012433), and telaprevir before the morning dose of all study drugs on Day 1 (baseline) and at Week 8. Plasma concentrations for RO4995855, RO5012433, and telaprevir were measured by specific and validated liquid chromatography tandem mass spectrometry methods. The value reported is the average trough plasma concentration for Week 8.
    End point type
    Secondary
    End point timeframe
    Day 1 and week 8
    End point values
    		 Arm A-TVR 12WKS, MCB 24WKS, P/R 24WKS Arm B-TVR 12WKS,MCB 24WKS, P/R 48WKS Arm C-TVR 12WKS, MCB 12WKS, PLAC MCB 12WKS, P/R 48WKS Arm D-TVR 12WKS, MCB or PLAC MCB, 24WKS, P/R 48WKS
    Number of subjects analysed
    9
    12
    9
    4
    Units: ng/mL
        arithmetic mean (standard deviation)
    2070.56 ± 1240.77
    2020.83 ± 465.31
    2288.89 ± 623.83
    1663.25 ± 614.95
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    48 week timeframe for reporting adverse events
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.1
    Reporting groups
    Reporting group title
    Arm A-TVR 12WKS, MCB 24WKS, P/R 24WKS
    Reporting group description
    		 Twelve weeks of therapy with mericitabine (MCB), telaprevir (TVR), Pegasys and Copegus (P/R), followed by 12 weeks of therapy with MCB + Pegasys/Copegus (triple) (total treatment duration of 24 weeks), followed by a 24-week treatment-free follow-up period.

    Reporting group title
    Arm B-TVR 12WKS,MCB 24WKS, P/R 48WKS
    Reporting group description
    		 Twelve weeks of therapy with mericitabine (MCB), telaprevir (TVR), Pegasys and Copegus (P/R), followed by 12 weeks of therapy with MCB + Pegasys/Copegus (triple), followed by 24 weeks of therapy with Pegasys/Copegus (total treatment duration of 48 weeks), followed by a 24−week treatment-free follow-up period.

    Reporting group title
    Arm C-TVR 12WKS, MCB 12WKS, PLAC MCB 12WKS, P/R 48WKS
    Reporting group description
    		 Twelve weeks of therapy with mericitabine (MCB), telaprevir (TVR), Pegasys and Copegus (P/R), followed by 12 weeks of therapy with MCB placebo (PLAC) + Pegasys/Copegus (triple), followed by 24 weeks of therapy with Pegasys/Copegus (total treatment duration of 48 weeks), followed by a 24−week treatment-free follow-up period.

    Reporting group title
    Arm D-TVR 12WKS, MCB or PLAC MCB, 24WKS, P/R 48WKS
    Reporting group description
    		 Twelve weeks of therapy with mericitabine (MCB) placebo (PLAC), telaprevir (TVR), Pegasys and Copegus (P/R), followed by 12 weeks of therapy with MCB placebo + Pegasys/Copegus (triple), followed by 24 weeks of therapy with Pegasys/Copegus (total treatment duration of 48 weeks), followed by a 24−week treatment-free follow-up period.

    Serious adverse events
    		 Arm A-TVR 12WKS, MCB 24WKS, P/R 24WKS Arm B-TVR 12WKS,MCB 24WKS, P/R 48WKS Arm C-TVR 12WKS, MCB 12WKS, PLAC MCB 12WKS, P/R 48WKS Arm D-TVR 12WKS, MCB or PLAC MCB, 24WKS, P/R 48WKS
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 21 (19.05%)
    6 / 23 (26.09%)
    3 / 24 (12.50%)
    0 / 11 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Thyroid cancer
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 23 (4.35%)
    0 / 24 (0.00%)
    0 / 11 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatocellular carcinoma
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    1 / 24 (4.17%)
    0 / 11 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Atrioventricular block complete
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 23 (0.00%)
    0 / 24 (0.00%)
    0 / 11 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Amnesia
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 23 (4.35%)
    0 / 24 (0.00%)
    0 / 11 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anemia
         subjects affected / exposed
    1 / 21 (4.76%)
    1 / 23 (4.35%)
    1 / 24 (4.17%)
    0 / 11 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neutropenia
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 23 (4.35%)
    0 / 24 (0.00%)
    0 / 11 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Ophthalmoplegia
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    1 / 24 (4.17%)
    0 / 11 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    2 / 21 (9.52%)
    0 / 23 (0.00%)
    0 / 24 (0.00%)
    0 / 11 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Major depression
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 23 (4.35%)
    0 / 24 (0.00%)
    0 / 11 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Abdominal wall abscess
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 23 (0.00%)
    0 / 24 (0.00%)
    0 / 11 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis viral
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 23 (4.35%)
    0 / 24 (0.00%)
    0 / 11 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Arm A-TVR 12WKS, MCB 24WKS, P/R 24WKS Arm B-TVR 12WKS,MCB 24WKS, P/R 48WKS Arm C-TVR 12WKS, MCB 12WKS, PLAC MCB 12WKS, P/R 48WKS Arm D-TVR 12WKS, MCB or PLAC MCB, 24WKS, P/R 48WKS
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    20 / 21 (95.24%)
    23 / 23 (100.00%)
    24 / 24 (100.00%)
    11 / 11 (100.00%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    1 / 21 (4.76%)
    1 / 23 (4.35%)
    0 / 24 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    1
    1
    0
    1
    Phlebitis
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 24 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    0
    1
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    4 / 21 (19.05%)
    5 / 23 (21.74%)
    6 / 24 (25.00%)
    4 / 11 (36.36%)
         occurrences all number
    4
    5
    7
    4
    Chest discomfort
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 23 (4.35%)
    1 / 24 (4.17%)
    1 / 11 (9.09%)
         occurrences all number
    0
    1
    1
    1
    Chest pain
         subjects affected / exposed
    0 / 21 (0.00%)
    2 / 23 (8.70%)
    0 / 24 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Chills
         subjects affected / exposed
    4 / 21 (19.05%)
    3 / 23 (13.04%)
    2 / 24 (8.33%)
    2 / 11 (18.18%)
         occurrences all number
    4
    3
    2
    2
    Fatigue
         subjects affected / exposed
    12 / 21 (57.14%)
    14 / 23 (60.87%)
    12 / 24 (50.00%)
    4 / 11 (36.36%)
         occurrences all number
    13
    15
    12
    6
    Feeling abnormal
         subjects affected / exposed
    1 / 21 (4.76%)
    1 / 23 (4.35%)
    1 / 24 (4.17%)
    1 / 11 (9.09%)
         occurrences all number
    1
    1
    1
    1
    Feeling hot
         subjects affected / exposed
    2 / 21 (9.52%)
    0 / 23 (0.00%)
    0 / 24 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Influenza like illness
         subjects affected / exposed
    0 / 21 (0.00%)
    5 / 23 (21.74%)
    2 / 24 (8.33%)
    0 / 11 (0.00%)
         occurrences all number
    0
    5
    2
    0
    Injection site rash
         subjects affected / exposed
    0 / 21 (0.00%)
    2 / 23 (8.70%)
    0 / 24 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Irritability
         subjects affected / exposed
    1 / 21 (4.76%)
    6 / 23 (26.09%)
    4 / 24 (16.67%)
    3 / 11 (27.27%)
         occurrences all number
    1
    6
    4
    3
    Local swelling
         subjects affected / exposed
    0 / 21 (0.00%)
    2 / 23 (8.70%)
    2 / 24 (8.33%)
    0 / 11 (0.00%)
         occurrences all number
    0
    2
    2
    0
    Malaise
         subjects affected / exposed
    2 / 21 (9.52%)
    1 / 23 (4.35%)
    0 / 24 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    2
    1
    0
    0
    Pain
         subjects affected / exposed
    1 / 21 (4.76%)
    2 / 23 (8.70%)
    1 / 24 (4.17%)
    2 / 11 (18.18%)
         occurrences all number
    1
    2
    1
    4
    Pyrexia
         subjects affected / exposed
    3 / 21 (14.29%)
    4 / 23 (17.39%)
    4 / 24 (16.67%)
    4 / 11 (36.36%)
         occurrences all number
    3
    4
    5
    5
    Reproductive system and breast disorders
    Erectile dysfunction
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 24 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    2 / 21 (9.52%)
    7 / 23 (30.43%)
    10 / 24 (41.67%)
    3 / 11 (27.27%)
         occurrences all number
    2
    7
    11
    3
    Dyspnoea
         subjects affected / exposed
    1 / 21 (4.76%)
    2 / 23 (8.70%)
    3 / 24 (12.50%)
    2 / 11 (18.18%)
         occurrences all number
    1
    2
    3
    2
    Dyspnoea exertional
         subjects affected / exposed
    3 / 21 (14.29%)
    7 / 23 (30.43%)
    4 / 24 (16.67%)
    2 / 11 (18.18%)
         occurrences all number
    3
    7
    4
    2
    Epistaxis
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 23 (4.35%)
    0 / 24 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    2
    0
    1
    Oropharyngeal pain
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 23 (0.00%)
    2 / 24 (8.33%)
    2 / 11 (18.18%)
         occurrences all number
    1
    0
    2
    2
    Rhinorrhoea
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 23 (0.00%)
    0 / 24 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    1
    0
    0
    1
    Sinus congestion
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 24 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    0
    1
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    2 / 21 (9.52%)
    1 / 23 (4.35%)
    2 / 24 (8.33%)
    1 / 11 (9.09%)
         occurrences all number
    2
    1
    2
    1
    Depressed mood
         subjects affected / exposed
    1 / 21 (4.76%)
    3 / 23 (13.04%)
    2 / 24 (8.33%)
    0 / 11 (0.00%)
         occurrences all number
    1
    3
    2
    0
    Depression
         subjects affected / exposed
    1 / 21 (4.76%)
    4 / 23 (17.39%)
    2 / 24 (8.33%)
    0 / 11 (0.00%)
         occurrences all number
    1
    4
    2
    0
    Emotional disorder
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 24 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    0
    1
    Initial insomnia
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 24 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    0
    1
    Insomnia
         subjects affected / exposed
    2 / 21 (9.52%)
    4 / 23 (17.39%)
    5 / 24 (20.83%)
    0 / 11 (0.00%)
         occurrences all number
    2
    4
    5
    0
    Libido decreased
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 24 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    0
    1
    Mood altered
         subjects affected / exposed
    0 / 21 (0.00%)
    2 / 23 (8.70%)
    0 / 24 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    2
    0
    1
    Mood swings
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 23 (0.00%)
    0 / 24 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    1
    0
    0
    1
    Restlessness
         subjects affected / exposed
    2 / 21 (9.52%)
    0 / 23 (0.00%)
    1 / 24 (4.17%)
    0 / 11 (0.00%)
         occurrences all number
    2
    0
    1
    0
    Sleep disorder
         subjects affected / exposed
    0 / 21 (0.00%)
    2 / 23 (8.70%)
    2 / 24 (8.33%)
    1 / 11 (9.09%)
         occurrences all number
    0
    2
    2
    1
    Stress
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 24 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    0
    1
    Investigations
    Glomerular filtration rate decreased
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 24 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    0
    1
    Weight decreased
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 23 (0.00%)
    3 / 24 (12.50%)
    2 / 11 (18.18%)
         occurrences all number
    1
    0
    3
    2
    Injury, poisoning and procedural complications
    Arthropod bite
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 24 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    0
    1
    Contusion
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 23 (4.35%)
    0 / 24 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    1
    0
    2
    Cardiac disorders
    Atrioventricular block first degree
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 24 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    0
    1
    Tachycardia
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 24 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    0
    1
    Nervous system disorders
    Amnesia
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    1 / 24 (4.17%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    1
    1
    Disturbance in attention
         subjects affected / exposed
    0 / 21 (0.00%)
    3 / 23 (13.04%)
    2 / 24 (8.33%)
    0 / 11 (0.00%)
         occurrences all number
    0
    3
    2
    0
    Dizziness
         subjects affected / exposed
    3 / 21 (14.29%)
    5 / 23 (21.74%)
    2 / 24 (8.33%)
    1 / 11 (9.09%)
         occurrences all number
    3
    5
    2
    1
    Dysgeusia
         subjects affected / exposed
    5 / 21 (23.81%)
    2 / 23 (8.70%)
    2 / 24 (8.33%)
    1 / 11 (9.09%)
         occurrences all number
    5
    2
    2
    1
    Headache
         subjects affected / exposed
    9 / 21 (42.86%)
    9 / 23 (39.13%)
    9 / 24 (37.50%)
    5 / 11 (45.45%)
         occurrences all number
    9
    10
    10
    5
    Hyperaesthesia
         subjects affected / exposed
    0 / 21 (0.00%)
    2 / 23 (8.70%)
    0 / 24 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Hypoaesthesia
         subjects affected / exposed
    1 / 21 (4.76%)
    3 / 23 (13.04%)
    0 / 24 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    1
    3
    0
    1
    Lethargy
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    1 / 24 (4.17%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    1
    1
    Memory impairment
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    2 / 24 (8.33%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Paraesthesia
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    2 / 24 (8.33%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Parosmia
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 23 (4.35%)
    0 / 24 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    1
    0
    1
    Syncope
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 24 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    0
    2
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    6 / 21 (28.57%)
    10 / 23 (43.48%)
    10 / 24 (41.67%)
    6 / 11 (54.55%)
         occurrences all number
    6
    10
    10
    7
    Leukopenia
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 23 (4.35%)
    0 / 24 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    1
    0
    1
    Lymph node pain
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 24 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    0
    1
    Lymphopenia
         subjects affected / exposed
    0 / 21 (0.00%)
    3 / 23 (13.04%)
    1 / 24 (4.17%)
    0 / 11 (0.00%)
         occurrences all number
    0
    3
    1
    0
    Neutropenia
         subjects affected / exposed
    4 / 21 (19.05%)
    6 / 23 (26.09%)
    3 / 24 (12.50%)
    1 / 11 (9.09%)
         occurrences all number
    4
    7
    3
    3
    Thrombocytopenia
         subjects affected / exposed
    0 / 21 (0.00%)
    4 / 23 (17.39%)
    1 / 24 (4.17%)
    1 / 11 (9.09%)
         occurrences all number
    0
    4
    1
    1
    Ear and labyrinth disorders
    Ear discomfort
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 24 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    0
    1
    Hyperacusis
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 24 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    0
    1
    Eye disorders
    Dry eye
         subjects affected / exposed
    0 / 21 (0.00%)
    2 / 23 (8.70%)
    2 / 24 (8.33%)
    1 / 11 (9.09%)
         occurrences all number
    0
    3
    2
    1
    Ocular hyperaemia
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 24 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    0
    1
    Photophobia
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 24 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    0
    1
    Vision blurred
         subjects affected / exposed
    0 / 21 (0.00%)
    2 / 23 (8.70%)
    2 / 24 (8.33%)
    0 / 11 (0.00%)
         occurrences all number
    0
    2
    2
    0
    Visual acuity reduced
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    3 / 24 (12.50%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    3
    0
    Visual impairment
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 23 (4.35%)
    1 / 24 (4.17%)
    1 / 11 (9.09%)
         occurrences all number
    0
    1
    1
    1
    Gastrointestinal disorders
    Abdominal distension
         subjects affected / exposed
    0 / 21 (0.00%)
    2 / 23 (8.70%)
    0 / 24 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Abdominal pain upper
         subjects affected / exposed
    2 / 21 (9.52%)
    0 / 23 (0.00%)
    1 / 24 (4.17%)
    1 / 11 (9.09%)
         occurrences all number
    2
    0
    1
    1
    Anal pruritus
         subjects affected / exposed
    5 / 21 (23.81%)
    3 / 23 (13.04%)
    6 / 24 (25.00%)
    2 / 11 (18.18%)
         occurrences all number
    5
    4
    6
    2
    Anorectal discomfort
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    1 / 24 (4.17%)
    2 / 11 (18.18%)
         occurrences all number
    0
    0
    1
    2
    Cheilitis
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    1 / 24 (4.17%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    1
    1
    Constipation
         subjects affected / exposed
    2 / 21 (9.52%)
    1 / 23 (4.35%)
    2 / 24 (8.33%)
    1 / 11 (9.09%)
         occurrences all number
    2
    1
    3
    1
    Dental caries
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 23 (4.35%)
    0 / 24 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    1
    0
    1
    Diarrhoea
         subjects affected / exposed
    5 / 21 (23.81%)
    8 / 23 (34.78%)
    4 / 24 (16.67%)
    2 / 11 (18.18%)
         occurrences all number
    6
    10
    4
    2
    Dry mouth
         subjects affected / exposed
    0 / 21 (0.00%)
    4 / 23 (17.39%)
    3 / 24 (12.50%)
    1 / 11 (9.09%)
         occurrences all number
    0
    4
    3
    1
    Dyspepsia
         subjects affected / exposed
    3 / 21 (14.29%)
    0 / 23 (0.00%)
    3 / 24 (12.50%)
    2 / 11 (18.18%)
         occurrences all number
    3
    0
    3
    2
    Frequent bowel movements
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 23 (4.35%)
    0 / 24 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    1
    0
    1
    Gingival pain
         subjects affected / exposed
    2 / 21 (9.52%)
    0 / 23 (0.00%)
    1 / 24 (4.17%)
    0 / 11 (0.00%)
         occurrences all number
    2
    0
    1
    0
    Haemorrhoids
         subjects affected / exposed
    2 / 21 (9.52%)
    1 / 23 (4.35%)
    3 / 24 (12.50%)
    2 / 11 (18.18%)
         occurrences all number
    2
    1
    3
    2
    Nausea
         subjects affected / exposed
    9 / 21 (42.86%)
    8 / 23 (34.78%)
    7 / 24 (29.17%)
    3 / 11 (27.27%)
         occurrences all number
    9
    13
    7
    3
    Oral pain
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 24 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    0
    1
    Painful defaecation
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 24 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    0
    1
    Rectal haemorrhage
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 24 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    0
    1
    Stomatitis
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 24 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    0
    1
    Tongue disorder
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 24 (0.00%)
    2 / 11 (18.18%)
         occurrences all number
    0
    0
    0
    2
    Tongue dry
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 24 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    0
    1
    Vomiting
         subjects affected / exposed
    2 / 21 (9.52%)
    4 / 23 (17.39%)
    6 / 24 (25.00%)
    0 / 11 (0.00%)
         occurrences all number
    2
    6
    6
    0
    Hepatobiliary disorders
    Jaundice
         subjects affected / exposed
    1 / 21 (4.76%)
    2 / 23 (8.70%)
    1 / 24 (4.17%)
    0 / 11 (0.00%)
         occurrences all number
    1
    2
    1
    0
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    3 / 21 (14.29%)
    3 / 23 (13.04%)
    2 / 24 (8.33%)
    0 / 11 (0.00%)
         occurrences all number
    3
    3
    2
    0
    Dermatitis
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 24 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    0
    1
    Dermatitis psoriasiform
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 23 (4.35%)
    0 / 24 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    1
    0
    1
    Dry skin
         subjects affected / exposed
    2 / 21 (9.52%)
    3 / 23 (13.04%)
    3 / 24 (12.50%)
    1 / 11 (9.09%)
         occurrences all number
    2
    3
    3
    1
    Eczema
         subjects affected / exposed
    1 / 21 (4.76%)
    2 / 23 (8.70%)
    3 / 24 (12.50%)
    2 / 11 (18.18%)
         occurrences all number
    1
    2
    3
    2
    Erythema
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    2 / 24 (8.33%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Night sweats
         subjects affected / exposed
    1 / 21 (4.76%)
    2 / 23 (8.70%)
    1 / 24 (4.17%)
    0 / 11 (0.00%)
         occurrences all number
    1
    2
    1
    0
    Photosensitivity reaction
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    2 / 24 (8.33%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    2
    1
    Pruritus
         subjects affected / exposed
    7 / 21 (33.33%)
    12 / 23 (52.17%)
    9 / 24 (37.50%)
    2 / 11 (18.18%)
         occurrences all number
    8
    13
    11
    9
    Pruritus generalised
         subjects affected / exposed
    2 / 21 (9.52%)
    3 / 23 (13.04%)
    4 / 24 (16.67%)
    2 / 11 (18.18%)
         occurrences all number
    2
    3
    5
    2
    Psoriasis
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    1 / 24 (4.17%)
    2 / 11 (18.18%)
         occurrences all number
    0
    0
    1
    2
    Rash
         subjects affected / exposed
    6 / 21 (28.57%)
    7 / 23 (30.43%)
    14 / 24 (58.33%)
    2 / 11 (18.18%)
         occurrences all number
    7
    7
    21
    2
    Rash erythematous
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 24 (0.00%)
    2 / 11 (18.18%)
         occurrences all number
    0
    0
    0
    9
    Rash generalised
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 23 (0.00%)
    2 / 24 (8.33%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    2
    0
    Rash macular
         subjects affected / exposed
    2 / 21 (9.52%)
    0 / 23 (0.00%)
    1 / 24 (4.17%)
    2 / 11 (18.18%)
         occurrences all number
    2
    0
    1
    4
    Rash maculo-papular
         subjects affected / exposed
    1 / 21 (4.76%)
    2 / 23 (8.70%)
    1 / 24 (4.17%)
    1 / 11 (9.09%)
         occurrences all number
    1
    3
    2
    3
    Skin discolouration
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 24 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    0
    2
    Skin irritation
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 24 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    0
    1
    Renal and urinary disorders
    Dysuria
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 23 (4.35%)
    0 / 24 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    1
    0
    1
    Pollakiuria
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 24 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    0
    1
    Renal colic
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 24 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    0
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    4 / 21 (19.05%)
    6 / 23 (26.09%)
    1 / 24 (4.17%)
    1 / 11 (9.09%)
         occurrences all number
    4
    8
    1
    1
    Back pain
         subjects affected / exposed
    4 / 21 (19.05%)
    4 / 23 (17.39%)
    3 / 24 (12.50%)
    2 / 11 (18.18%)
         occurrences all number
    4
    4
    3
    2
    Flank pain
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 24 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    0
    1
    Muscle spasms
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 24 (0.00%)
    2 / 11 (18.18%)
         occurrences all number
    0
    0
    0
    2
    Muscular weakness
         subjects affected / exposed
    2 / 21 (9.52%)
    1 / 23 (4.35%)
    2 / 24 (8.33%)
    0 / 11 (0.00%)
         occurrences all number
    2
    1
    2
    0
    Myalgia
         subjects affected / exposed
    5 / 21 (23.81%)
    6 / 23 (26.09%)
    4 / 24 (16.67%)
    0 / 11 (0.00%)
         occurrences all number
    5
    6
    4
    0
    Pain in jaw
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 24 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    0
    1
    Infections and infestations
    Ear infection
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 23 (4.35%)
    0 / 24 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    1
    0
    1
    Eye infection
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 23 (4.35%)
    0 / 24 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    1
    0
    1
    Hordeolum
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 24 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    0
    1
    Infection
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 24 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    0
    2
    Oral candidiasis
         subjects affected / exposed
    0 / 21 (0.00%)
    2 / 23 (8.70%)
    2 / 24 (8.33%)
    0 / 11 (0.00%)
         occurrences all number
    0
    2
    2
    0
    Oral herpes
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 23 (0.00%)
    0 / 24 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    1
    0
    0
    1
    Staphylococcal skin infection
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    0 / 24 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    0
    1
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 21 (0.00%)
    3 / 23 (13.04%)
    1 / 24 (4.17%)
    1 / 11 (9.09%)
         occurrences all number
    0
    3
    1
    1
    Urinary tract infection
         subjects affected / exposed
    1 / 21 (4.76%)
    1 / 23 (4.35%)
    4 / 24 (16.67%)
    0 / 11 (0.00%)
         occurrences all number
    1
    1
    6
    0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    5 / 21 (23.81%)
    5 / 23 (21.74%)
    3 / 24 (12.50%)
    4 / 11 (36.36%)
         occurrences all number
    5
    5
    3
    4
    Dehydration
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 23 (0.00%)
    1 / 24 (4.17%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    1
    1
    Gout
         subjects affected / exposed
    0 / 21 (0.00%)
    2 / 23 (8.70%)
    0 / 24 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Hypokalaemia
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 23 (0.00%)
    1 / 24 (4.17%)
    1 / 11 (9.09%)
         occurrences all number
    1
    0
    1
    1

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    02 Mar 2012
    This amendment included the following changes: - Additional assessments were added for urine protein analyses – Safety follow-up measures during the study were clarified – Study drug-stopping rules were updated – The definition of the primary efficacy analysis population was revised – SVR4 and SVR24 were specified as secondary efficacy endpoints - Fibroscan assessment allowed to define a liver status - Number of ‘cirrhotic’ patients raised up to 50% - Screening period extended to 24 weeks. - Study changed from active controlled to placebo controlled.
    10 Jul 2012
    This amendment included the following changes: - Control Arm D (MCB-free arm) was removed. Patients enrolled to this arm were offered the option to switch to MCB in addition to their current medications - The 50% cap on patients with a prior null response and compensated cirrhosis was removed - Intensive PK/pharmacodynamic sampling was deleted. Sparse PK sampling from all patients (Week 8 trough concentration) was scheduled to enable the measurement of drug exposure - IP-10 samples were collected only at baseline - The SVR24 analysis was removed and treatment free follow-up was decreased from 24 to 12 weeks - The SAE reporting window was reduced from 1 working day to immediately (i.e., within 24 hours)
    13 Nov 2012
    This amendment included the following changes: - SVR24 was added as the secondary endpoint - The treatment-free follow-up Week 24 visit was reinstated
    15 Feb 2013
    The primary reason for the amendment was the addition of a Week 42 visit to the Schedule of Assessments, with the same procedures as the Week 30 visit.

    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
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Sat Apr 27 00:42:03 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA