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    Clinical Trial Results:
    A Phase II, Randomized, Double-Blind, Multicenter, Parallel Group Study to Evaluate the Sustained Virologic Response of the HCV Polymerase Inhibitor Prodrug RO5024048 in Combination With Boceprevir and Pegasys®/Copegus® in Patients With Chronic Hepatitis C Genotype 1 Virus Infection Who Were Prior Null Responders to Treatment With Pegylated Interferon/Ribavarin

    Summary
    EudraCT number
    		 2011-002714-37
    Trial protocol
    		 DE   ES   IT  
    Global end of trial date
    27 Jan 2014

    Results information
    Results version number
    		 v2(current)
    This version publication date
    01 Jun 2016
    First version publication date
    08 Apr 2016
    Other versions
    		 v1
    Version creation reason
    • Correction of full data set
    The data for 1 of the secondary end point was incorrectly provided. SD values were reported in the place of geometric coefficient of variation.

    Trial information

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    Trial identification
    Sponsor protocol code
    NV27780
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01482403
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    F. Hoffmann-La Roche AG
    Sponsor organisation address
    Grenzacherstrasse124, Basel, Switzerland, CH-4070
    Public contact
    Roche Trial Information Hotline, F.Hoffmann-LaRoche AG, +41 616878333, global.trial_information@roche.com
    Scientific contact
    Roche Trial Information Hotline, F.Hoffmann-LaRoche AG, +41 616878333, 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
    27 Jan 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    27 Jan 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of the study is to estimate the difference in sustained virologic response 12 weeks after treatment (SVR-12) between each of the following two experimental treatment groups (regimens containing mericitabine [MCB, RO5024048], boceprevir [BCP], Pegasys®, and Copegus®) and the control treatment group (regimen containing BCP, Pegasys®, and Copegus®) in participants with previous null response to pegylated interferon alfa and ribavirin (PEG-IFN/RBV) combination therapy, defined as a less than (<) 2 natural logarithm of ten (log10) international units per milliliter (IU/mL) decrease in viral titer after at least 12 weeks of treatment with PEG-IFN/RBV. MCB in combination with BCP and Pegasys/Copegus (P/C) administered for 24 weeks. MCB in combination with P/C administered for 24 weeks followed by BCP and P/C administered for 24 weeks.
    Protection of trial subjects
    The study was conducted in full conformance with the International Conference on Harmonisation (ICH) E6 guideline for Good Clinical Practice and the principles of the Declaration of Helsinki, or the laws and regulations of the country in which the research was conducted, whichever affords greater protection to the participant. This study complied with the requirements of the ICH E2A guideline (Clinical Safety Data Management: Definitions and Standards for Expedited Reporting); U.S. Food and Drug Administration (FDA) regulations and applicable local, state, and federal laws; and the European Union Clinical Trial Directive (2001/20/EC). The investigator, or a person designated by the investigator was responsible for providing participants with an adequate explanation of the aims, methods, anticipated benefits, and potential hazards of the study and obtaining signed informed consent from each participant prior to their participation in this study. Approval from the Independent Ethics Committees (IECs) and Institutional Review Boards (IRBs) was obtained before study start and was documented in a letter to the investigator specifying the date on which the committee met and granted the approval. Approval from the IRB/IEC and regulatory authorities (as locally required) was obtained before implementation of any changes, except for changes necessary to eliminate an immediate hazard to participants or administrative changes. The Sponsor also obtained approval from the relevant Competent Authority prior to starting the study.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    11 Nov 2011
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety, Efficacy
    Long term follow-up duration
    		 6 Months
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Canada: 11
    Country: Number of subjects enrolled
    Spain: 13
    Country: Number of subjects enrolled
    France: 10
    Country: Number of subjects enrolled
    Germany: 9
    Country: Number of subjects enrolled
    United States: 15
    Worldwide total number of subjects
    58
    EEA total number of subjects
    32
    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)
    53
    From 65 to 84 years
    5
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Fifty-eight participants were randomized (25 participants with MCB+BCP+P/C, 20 participants with P/C+MCB+BCP+/BCP+P/C, and 13 participants with P/C+MCB Pbo+BCP Pbo/MCB Pbo+P/C+BCP/BCP+P/C) and included in study.

    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
    		 MCB+BCP+Pegasys/Copegus (P/C)
    Arm description
    		 Participants received 24 weeks of therapy with MCB 1000 milligrams (mg) oral tablets twice a day (BID), BCP 800 mg three times a day (TID) oral capsule, Pegasys 180 micrograms per week (μg/week) subcutaneously (SC) and Copegus 1000/1200 mg/day oral tablets for a total treatment duration of 24 weeks, followed by a 24-week treatment-free follow-up period.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Mericitabine
    Investigational medicinal product code
    RO5024048
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    MCB 1000 mg oral tablets BID for a total treatment duration of 24 weeks.

    Arm title
    		 MCB+BCP+P/C+BCP+P/C
    Arm description
    		 Participants received 24 weeks of therapy with MCB 1000 mg oral tablets BID + BCP 800 mg oral capsule TID + Pegasys 180 μg per week SC injection / Copegus 1000/1200 mg oral tablets followed by 24 weeks of therapy with BCP 800 mg oral capsule TID +Pegasys 180 μg per week SC injection / Copegus 1000/1200 mg oral tablets per day (triple) for a total treatment duration of 48 weeks, followed by a 24-week treatment-free follow-up period.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Mericitabine
    Investigational medicinal product code
    RO5024048
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    MCB 1000 mg oral tablets BID for a total treatment duration of 24 weeks.

    Arm title
    		 P/C+MCB Pbo+BCP Pbo/MCB Pbo+P/C+BCP/BCP+P/C
    Arm description
    		 Participants received 4 weeks of therapy with MCB placebo (MCB pbo), BCP placebo + Pegasys/Copegus, then 20 weeks of therapy with MCB placebo + boceprevir + Pegasys/Copegus, and then 24 weeks of therapy with BCP + Pegasys/Copegus for a total treatment duration of 48 weeks, followed by a 24-week treatment-free follow-up period.
    Arm type
    		 Placebo

    Investigational medicinal product name
    MCB Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Matching MCB oral placebo tablet was administered for 24 weeks of therapy.

    Number of subjects in period 1
    		MCB+BCP+Pegasys/Copegus (P/C) MCB+BCP+P/C+BCP+P/C P/C+MCB Pbo+BCP Pbo/MCB Pbo+P/C+BCP/BCP+P/C
    Started
    25
    20
    13
    Received At least 1 Dose of Study Drug
    25
    20
    12
    Completed
    25
    18
    9
    Not completed
    0
    2
    4
         Participant not dosed
    -
    -
    1
         Consent withdrawn by subject
    -
    -
    2
         Lost to follow-up
    -
    2
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    MCB+BCP+Pegasys/Copegus (P/C)
    Reporting group description
    		 Participants received 24 weeks of therapy with MCB 1000 milligrams (mg) oral tablets twice a day (BID), BCP 800 mg three times a day (TID) oral capsule, Pegasys 180 micrograms per week (μg/week) subcutaneously (SC) and Copegus 1000/1200 mg/day oral tablets for a total treatment duration of 24 weeks, followed by a 24-week treatment-free follow-up period.

    Reporting group title
    MCB+BCP+P/C+BCP+P/C
    Reporting group description
    		 Participants received 24 weeks of therapy with MCB 1000 mg oral tablets BID + BCP 800 mg oral capsule TID + Pegasys 180 μg per week SC injection / Copegus 1000/1200 mg oral tablets followed by 24 weeks of therapy with BCP 800 mg oral capsule TID +Pegasys 180 μg per week SC injection / Copegus 1000/1200 mg oral tablets per day (triple) for a total treatment duration of 48 weeks, followed by a 24-week treatment-free follow-up period.

    Reporting group title
    P/C+MCB Pbo+BCP Pbo/MCB Pbo+P/C+BCP/BCP+P/C
    Reporting group description
    		 Participants received 4 weeks of therapy with MCB placebo (MCB pbo), BCP placebo + Pegasys/Copegus, then 20 weeks of therapy with MCB placebo + boceprevir + Pegasys/Copegus, and then 24 weeks of therapy with BCP + Pegasys/Copegus for a total treatment duration of 48 weeks, followed by a 24-week treatment-free follow-up period.

    Reporting group values
    		 MCB+BCP+Pegasys/Copegus (P/C) MCB+BCP+P/C+BCP+P/C P/C+MCB Pbo+BCP Pbo/MCB Pbo+P/C+BCP/BCP+P/C Total
    Number of subjects
    		 25 20 13 58
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 53.8 ± 8 53.3 ± 10.1 56 ± 8.1 -
    Gender categorical
    Units: Subjects
        Female
    		 8 7 5 20
        Male
    		 17 13 8 38

    End points

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    End points reporting groups
    Reporting group title
    MCB+BCP+Pegasys/Copegus (P/C)
    Reporting group description
    		 Participants received 24 weeks of therapy with MCB 1000 milligrams (mg) oral tablets twice a day (BID), BCP 800 mg three times a day (TID) oral capsule, Pegasys 180 micrograms per week (μg/week) subcutaneously (SC) and Copegus 1000/1200 mg/day oral tablets for a total treatment duration of 24 weeks, followed by a 24-week treatment-free follow-up period.

    Reporting group title
    MCB+BCP+P/C+BCP+P/C
    Reporting group description
    		 Participants received 24 weeks of therapy with MCB 1000 mg oral tablets BID + BCP 800 mg oral capsule TID + Pegasys 180 μg per week SC injection / Copegus 1000/1200 mg oral tablets followed by 24 weeks of therapy with BCP 800 mg oral capsule TID +Pegasys 180 μg per week SC injection / Copegus 1000/1200 mg oral tablets per day (triple) for a total treatment duration of 48 weeks, followed by a 24-week treatment-free follow-up period.

    Reporting group title
    P/C+MCB Pbo+BCP Pbo/MCB Pbo+P/C+BCP/BCP+P/C
    Reporting group description
    		 Participants received 4 weeks of therapy with MCB placebo (MCB pbo), BCP placebo + Pegasys/Copegus, then 20 weeks of therapy with MCB placebo + boceprevir + Pegasys/Copegus, and then 24 weeks of therapy with BCP + Pegasys/Copegus for a total treatment duration of 48 weeks, followed by a 24-week treatment-free follow-up period.

    Subject analysis set title
    P/C+MCB Pbo+BCP Pbo (Up to Week 4)
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Participants received 4 weeks of therapy with MCB placebo, BCP placebo + Pegasys/Copegus.

    Subject analysis set title
    P/C+MCB Pbo+BCP Pbo/MCB Pbo+P/C+BCP/BCP+P/C (After Week 4)
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Of the 13 participants randomized to P/C+MCB Pbo+BCP Pbo/MCB Pbo+P/C+BCP/BCP+P/C group, 5 participants receiving MCB followed Amendment D. For these participants, MCB was initiated at various time points after Week 4, depending on how long participants had been in the study at the time of implementation of amendment, and was given for various durations at the investigator's discretion.

    Primary: Percentage of Participants With a Sustained Virological Response at Week 12 After Treatment (SVR-12)

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    End point title
    		 Percentage of Participants With a Sustained Virological Response at Week 12 After Treatment (SVR-12) [1]
    End point description
    SVR-12 (actual) outcome was defined as an unquantifiable (less than the lower limit of quantification [LLOQ]; less than [<]25 international units per milliliter [IU/mL]) serum hepatitis C virus ribonucleic acid (HCV RNA) 12 weeks after the actual end of treatment (a single last unquantifiable HCV RNA within 8-20 weeks after the last dose of study drug administration). Analysis population: Treated population; All randomized participants who received at least 1 dose of study drug. Participants were analyzed according to the treatment group they were randomized.
    End point type
    Primary
    End point timeframe
    Week 12
    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: This study was of an explorative nature; therefore only descriptive statistics were applied, and no statistical hypothesis testing was carried out.
    End point values
    		 MCB+BCP+Pegasys/Copegus (P/C) MCB+BCP+P/C+BCP+P/C P/C+MCB Pbo+BCP Pbo/MCB Pbo+P/C+BCP/BCP+P/C
    Number of subjects analysed
    25
    20
    12
    Units: percentage of participants
        number (confidence interval 95%)
    60 (40.7 to 76.6)
    70 (48.1 to 85.5)
    33.3 (13.8 to 60.9)
    No statistical analyses for this end point

    Secondary: Percentage of Participants With a Sustained Virological Response At Week 24 After Treatment (SVR-24)

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    End point title
    		 Percentage of Participants With a Sustained Virological Response At Week 24 After Treatment (SVR-24)
    End point description
    SVR-24 (actual) outcome was defined as unquantifiable (less than the LLOQ [<25 IU/mL]) serum HCV RNA response outcome greater than or equal to 20 weeks after the last dose of study drug administration. Analysis population: Treated population; All randomized participants who received at least 1 dose of study drug. Participants were analyzed according to the treatment group they were randomized.
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    		 MCB+BCP+Pegasys/Copegus (P/C) MCB+BCP+P/C+BCP+P/C P/C+MCB Pbo+BCP Pbo/MCB Pbo+P/C+BCP/BCP+P/C
    Number of subjects analysed
    25
    20
    12
    Units: percentage of participants
        number (confidence interval 95%)
    60 (40.7 to 76.6)
    70 (48.1 to 85.5)
    33.3 (13.8 to 60.9)
    No statistical analyses for this end point

    Secondary: Percentage of Participants With a Sustained Virological Response at Week 4 After Treatment (SVR-4)

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    End point title
    		 Percentage of Participants With a Sustained Virological Response at Week 4 After Treatment (SVR-4)
    End point description
    SVR-4 (actual) outcome was defined as unquantifiable (less than the LLOQ [<25 IU/mL]) serum HCV RNA response outcome within 2–8 weeks after the last day of study drug administration. Analysis population: Treated population; All randomized participants who received at least 1 dose of study drug. Participants were analyzed according to the treatment group they were randomized.
    End point type
    Secondary
    End point timeframe
    Week 4
    End point values
    		 MCB+BCP+Pegasys/Copegus (P/C) MCB+BCP+P/C+BCP+P/C P/C+MCB Pbo+BCP Pbo/MCB Pbo+P/C+BCP/BCP+P/C
    Number of subjects analysed
    25
    20
    12
    Units: percentage of participants
        number (confidence interval 95%)
    60 (40.7 to 76.6)
    75 (53.1 to 88.8)
    33.3 (13.8 to 60.9)
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Virological Response by Week

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    End point title
    		 Percentage of Participants With Virological Response by Week
    End point description
    Virological response was defined as unquantifiable HCV RNA level <25 IU/mL. Analysis population: Treated population; All randomized participants who received at least 1 dose of study drug. Participants were analyzed according to the treatment group they were randomized. Here, N = number of participants analyzed for this end point and n (number) = number of participants with available data at specified time point. For Week 48, Arm A: "99999" signifies that the data was not possible to calculate since the treatment period was up to Week 24 only.
    End point type
    Secondary
    End point timeframe
    Weeks 2, 4, 12, 24, and 48
    End point values
    		 MCB+BCP+Pegasys/Copegus (P/C) MCB+BCP+P/C+BCP+P/C P/C+MCB Pbo+BCP Pbo/MCB Pbo+P/C+BCP/BCP+P/C
    Number of subjects analysed
    25
    20
    12
    Units: percentage of participants
    number (confidence interval 95%)
        Week 2 (n= 25, 20, 12)
    76 (56.5 to 88.5)
    55 (34.2 to 74.2)
    0 (0 to 24.3)
        Week 4 (n= 25, 20, 12)
    84 (65.3 to 93.6)
    100 (83.9 to 100)
    8.3 (1.5 to 35.4)
        Week 12 (n= 25, 20, 12)
    84 (65.3 to 93.6)
    100 (83.9 to 100)
    75 (46.8 to 91.1)
        Week 24 (n= 25, 20, 12)
    84 (65.3 to 93.6)
    95 (76.4 to 99.1)
    58.3 (32 to 80.7)
        Week 48 (n= 0, 20, 12)
    99999 (99999 to 99999)
    70 (48.1 to 85.5)
    50 (25.4 to 74.6)
    No statistical analyses for this end point

    Secondary: Number of Participants With Documented Direct-Acting Antiviral (DAA) Resistance

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    End point title
    		 Number of Participants With Documented Direct-Acting Antiviral (DAA) Resistance
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) and Weeks 1, 2, 4, 8, 12, 16, 20, 24, 30, 36, 42, 48, and at weeks 4, 12, and 24 during treatment-free follow-up
    End point values
    		 MCB+BCP+Pegasys/Copegus (P/C) MCB+BCP+P/C+BCP+P/C P/C+MCB Pbo+BCP Pbo/MCB Pbo+P/C+BCP/BCP+P/C
    Number of subjects analysed
    25
    20
    12
    Units: participants
        number (not applicable)
    4
    4
    3
    No statistical analyses for this end point

    Secondary: Change from Baseline to Week 24 in HCV RNA

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    End point title
    		 Change from Baseline to Week 24 in HCV RNA
    End point description
    Serum HCV RNA was assessed by polymerase chain reaction (PCR) techniques using the Roche COBAS TaqMan HCV v2.0 Test (less than the LLOQ; < 25 IU/mL). Analysis population: Treated population; All randomized participants who received at least 1 dose of study drug. Participants were analyzed according to the treatment group they were randomized. Here, N= number of participants analyzed for this end point, and n= number of participants with available data for this end point.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 24
    End point values
    		 MCB+BCP+Pegasys/Copegus (P/C) MCB+BCP+P/C+BCP+P/C P/C+MCB Pbo+BCP Pbo/MCB Pbo+P/C+BCP/BCP+P/C
    Number of subjects analysed
    25
    20
    12
    Units: international unit(s)/millilitre
    arithmetic mean (standard deviation)
        Baseline (n= 25, 20, 12)
    6.51 ± 0.52
    6.65 ± 0.37
    6.63 ± 0.42
        Change at Week 24 (n= 21, 19, 7)
    -5.44 ± 0.44
    -5.45 ± 0.37
    -5.32 ± 0.45
    No statistical analyses for this end point

    Secondary: Trough Concentration of RO4995855 by Week 0 and Week 8

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    End point title
    		 Trough Concentration of RO4995855 by Week 0 and Week 8 [2]
    End point description
    RO4995855 is the parent drug of MCB (RO5024048). Trough concentration is the minimum observed drug concentration during a dosing interval. "9999" at Week 0 for MCB+BCP+P/C, MCB+BCP+P/C+BCP+P/C, P/C+MCB Pbo +BCP Pbo (up to Week 4) signifies that the geometric coefficient of variation was not calculable as the mean concentration was zero for all the participants. Participants in P/C+MCB Pbo +BCP Pbo/MCB Pbo+P/C+BCP/BCP+P/C (after Week 4) group received MCB following Amendment D and "9999 and 99999" for Week 0 signifies that the data was not possible to calculate since the treatment period started after Week 4. Analysis population: Treated population; All randomized participants who received at least 1 dose of study drug. Participants were analyzed according to the treatment group they were randomized. Here, N = number of participants analyzed for this end point and n= number of participants with available data at specified time point.
    End point type
    Secondary
    End point timeframe
    Week 0 and 8
    Notes
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Of the 13 participants randomized to P/C+MCB Pbo+BCP Pbo/MCB Pbo+P/C+BCP/BCP+P/C, 5 participants received MCB following Amendment D. For these participants, MCB was initiated at various time points after Week 4 and was given for various durations at the Investigator’s discretion. This created reporting data to 2 groups.
    End point values
    		 MCB+BCP+Pegasys/Copegus (P/C) MCB+BCP+P/C+BCP+P/C P/C+MCB Pbo+BCP Pbo (Up to Week 4) P/C+MCB Pbo+BCP Pbo/MCB Pbo+P/C+BCP/BCP+P/C (After Week 4)
    Number of subjects analysed
    21
    19
    11
    6
    Units: nanogram(s) per milliliter
    geometric mean (geometric coefficient of variation)
        Week 0 (n= 21, 16, 11)
    0 ± 9999
    0 ± 9999
    0 ± 9999
    9999 ± 99999
        Week 8 (n= 21, 19, 3, 6)
    2967.62 ± 56.92
    3058.42 ± 67.6
    516.7 ± 173.2
    28.33 ± 244.9
    No statistical analyses for this end point

    Secondary: Trough Concentration of RO5012433 by Week 0 and Week 8

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    End point title
    		 Trough Concentration of RO5012433 by Week 0 and Week 8 [3]
    End point description
    RO5012433 is the metabolite of RO4995855. Trough concentration is the minimum observed drug concentration during a dosing interval. "9999" at Week 0 for MCB+BCP+P/C, MCB+BCP+P/C+BCP+P/C, P/C+MCB Pbo +BCP Pbo (up to Week 4) signifies that the geometric coefficient of variation was not calculable as the mean concentration was zero for all the participants. Participants in P/C+MCB Pbo +BCP Pbo/MCB Pbo+P/C+BCP/BCP+P/C (after Week 4) group received MCB following Amendment D and "9999 and 99999" for Week 0 signifies that the data was not possible to calculate since the treatment period started after Week 4. Analysis population: Treated population; All randomized participants who received at least 1 dose of study drug. Participants were analyzed according to the treatment group they were randomized. Here, N= number of participants analyzed for this end point and n= number of participants with available data at specified time point.
    End point type
    Secondary
    End point timeframe
    Week 0 and Week 8
    Notes
    [3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Of the 13 participants randomized to P/C+MCB Pbo+BCP Pbo/MCB Pbo+P/C+BCP/BCP+P/C, 5 participants received MCB following Amendment D. For these participants, MCB was initiated at various time points after Week 4 and was given for various durations at the Investigator’s discretion. This created reporting data to 2 groups.
    End point values
    		 MCB+BCP+Pegasys/Copegus (P/C) MCB+BCP+P/C+BCP+P/C P/C+MCB Pbo+BCP Pbo (Up to Week 4) P/C+MCB Pbo+BCP Pbo/MCB Pbo+P/C+BCP/BCP+P/C (After Week 4)
    Number of subjects analysed
    21
    19
    11
    9
    Units: nanogram(s) per milliliter
    geometric mean (geometric coefficient of variation)
        Week 0 (n= 21, 16, 11)
    0 ± 9999
    0 ± 9999
    0 ± 9999
    9999 ± 99999
        Week 8 (n= 21, 19, 9, 9)
    523.05 ± 38.31
    599.16 ± 65.7
    120.7 ± 173.2
    47 ± 244.9
    No statistical analyses for this end point

    Secondary: Trough Concentration of Boceprevir by Week 0 and Week 8

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    End point title
    		 Trough Concentration of Boceprevir by Week 0 and Week 8 [4]
    End point description
    Trough concentration is the minimum observed drug concentration during a dosing interval. "9999" at Week 0 for MCB+BCP+P/C, MCB+BCP+P/C+BCP+P/C, P/C+MCB Pbo +BCP Pbo (up to Week 4) signifies that the geometric coefficient of variation was not calculable as the mean concentration was zero for all the participants. Participants in P/C+MCB Pbo +BCP Pbo/MCB Pbo+P/C+BCP/BCP+P/C (after Week 4) group received MCB following Amendment D and "9999 and 99999" for Week 0 signifies that the data was not possible to calculate since the treatment period started after Week 4. Analysis population: Treated population; All randomized participants who received at least 1 dose of study drug. Participants were analyzed according to the treatment group they were randomized. Here, N = number of participants analyzed for this end point and n= number of participants with available data at specified time point.
    End point type
    Secondary
    End point timeframe
    Week 0 and Week 8
    Notes
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Of the 13 participants randomized to P/C+MCB Pbo+BCP Pbo/MCB Pbo+P/C+BCP/BCP+P/C, 5 participants received MCB following Amendment D. For these participants, MCB was initiated at various time points after Week 4 and was given for various durations at the Investigator’s discretion. This created reporting data to 2 groups.
    End point values
    		 MCB+BCP+Pegasys/Copegus (P/C) MCB+BCP+P/C+BCP+P/C P/C+MCB Pbo+BCP Pbo (Up to Week 4) P/C+MCB Pbo+BCP Pbo/MCB Pbo+P/C+BCP/BCP+P/C (After Week 4)
    Number of subjects analysed
    22
    19
    11
    9
    Units: nanogram(s) per milliliter
    geometric mean (geometric coefficient of variation)
        Week 0 (n= 22, 18, 11)
    0 ± 9999
    0 ± 9999
    0 ± 9999
    9999 ± 99999
        Week 8 (n= 21, 19, 9, 9)
    390.41 ± 175.1
    349.75 ± 187.6
    133.38 ± 97.01
    133.38 ± 97.01
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse Events (AEs) were recorded from Baseline through the end of 24-week treatment free follow-up period (up to a maximum of 72 weeks)
    Adverse event reporting additional description
    All randomized participants who received at least one dose of study drug and had at least one post-baseline safety assessment.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.1
    Reporting groups
    Reporting group title
    MCB+BCP+Pegasys/Copegus (P/C)
    Reporting group description
    		 Participants received 24 weeks of therapy with MCB 1000 mg oral tablets BID, BCP 800 mg TID oral capsule, Pegasys 180 μg/week SC and Copegus 1000/1200 mg/day oral tablets for a total treatment duration of 24 weeks, followed by a 24-week treatment-free follow-up period.

    Reporting group title
    P/C+MCB Pbo+BCP Pbo/MCB Pbo+P/C+BCP/BCP+P/C
    Reporting group description
    		 Participants received 4 weeks of therapy with MCB placebo, BCP placebo + Pegasys/Copegus, then 20 weeks of therapy with MCB placebo + BCP + Pegasys/Copegus, and then 24 weeks of therapy with BCP + Pegasys/Copegus for a total treatment duration of 48 weeks, followed by a 24-week treatment-free follow-up period.

    Reporting group title
    MCB+BCP+P/C+BCP+P/C
    Reporting group description
    		 Participants received 24 weeks of therapy with MCB 1000 mg oral tablets BID +BCP 800 mg oral capsule TID + Pegasys 180 μg per week SC injection / Copegus 1000/1200 mg oral tablets followed by 24 weeks of therapy with BCP 800 mg oral capsule TID +Pegasys 180 μg per week SC injection /Copegus 1000/1200 mg oral tablets per day (triple) for a total treatment duration of 48 weeks, followed by a 24-week treatment-free follow-up period.

    Serious adverse events
    		 MCB+BCP+Pegasys/Copegus (P/C) P/C+MCB Pbo+BCP Pbo/MCB Pbo+P/C+BCP/BCP+P/C MCB+BCP+P/C+BCP+P/C
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 25 (4.00%)
    2 / 12 (16.67%)
    3 / 20 (15.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    Cardiac disorders
    Acute coronary syndrome
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 12 (0.00%)
    0 / 20 (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
    Myocardial infarction
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 12 (0.00%)
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 12 (8.33%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 12 (0.00%)
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 12 (8.33%)
    0 / 20 (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
    Renal and urinary disorders
    Renal failure acute
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 12 (0.00%)
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         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
    		 MCB+BCP+Pegasys/Copegus (P/C) P/C+MCB Pbo+BCP Pbo/MCB Pbo+P/C+BCP/BCP+P/C MCB+BCP+P/C+BCP+P/C
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    25 / 25 (100.00%)
    12 / 12 (100.00%)
    20 / 20 (100.00%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Melanocytic naevus
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 12 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    1
    Vascular disorders
    Hypotension
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 12 (8.33%)
    0 / 20 (0.00%)
         occurrences all number
    0
    1
    0
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    8 / 25 (32.00%)
    4 / 12 (33.33%)
    8 / 20 (40.00%)
         occurrences all number
    8
    4
    9
    Asthenia
         subjects affected / exposed
    7 / 25 (28.00%)
    4 / 12 (33.33%)
    6 / 20 (30.00%)
         occurrences all number
    8
    4
    7
    Chills
         subjects affected / exposed
    3 / 25 (12.00%)
    4 / 12 (33.33%)
    6 / 20 (30.00%)
         occurrences all number
    3
    4
    7
    Pyrexia
         subjects affected / exposed
    3 / 25 (12.00%)
    4 / 12 (33.33%)
    5 / 20 (25.00%)
         occurrences all number
    4
    8
    6
    Irritability
         subjects affected / exposed
    5 / 25 (20.00%)
    1 / 12 (8.33%)
    3 / 20 (15.00%)
         occurrences all number
    6
    1
    4
    Influenza like illness
         subjects affected / exposed
    2 / 25 (8.00%)
    0 / 12 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    2
    0
    1
    Malaise
         subjects affected / exposed
    2 / 25 (8.00%)
    0 / 12 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    2
    0
    1
    Chest pain
         subjects affected / exposed
    1 / 25 (4.00%)
    1 / 12 (8.33%)
    0 / 20 (0.00%)
         occurrences all number
    1
    1
    0
    Injection site erythema
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 12 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    1
    0
    1
    Feeling abnormal
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 12 (8.33%)
    0 / 20 (0.00%)
         occurrences all number
    0
    1
    0
    Feeling cold
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 12 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    1
    Injection site pain
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 12 (8.33%)
    0 / 20 (0.00%)
         occurrences all number
    0
    1
    0
    Local swelling
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 12 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    1
    Mucosal dryness
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 12 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    1
    Oedema peripheral
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 12 (8.33%)
    0 / 20 (0.00%)
         occurrences all number
    0
    1
    0
    Thirst
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 12 (8.33%)
    0 / 20 (0.00%)
         occurrences all number
    0
    1
    0
    Immune system disorders
    Hypersensitivity
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 12 (8.33%)
    0 / 20 (0.00%)
         occurrences all number
    0
    1
    0
    Reproductive system and breast disorders
    Epididymitis
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 12 (8.33%)
    0 / 20 (0.00%)
         occurrences all number
    0
    1
    0
    Prostatitis
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 12 (8.33%)
    0 / 20 (0.00%)
         occurrences all number
    0
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    6 / 25 (24.00%)
    4 / 12 (33.33%)
    5 / 20 (25.00%)
         occurrences all number
    7
    5
    6
    Dyspnoea exertional
         subjects affected / exposed
    5 / 25 (20.00%)
    0 / 12 (0.00%)
    6 / 20 (30.00%)
         occurrences all number
    5
    0
    7
    Oropharyngeal pain
         subjects affected / exposed
    3 / 25 (12.00%)
    2 / 12 (16.67%)
    2 / 20 (10.00%)
         occurrences all number
    5
    2
    2
    Dyspnoea
         subjects affected / exposed
    2 / 25 (8.00%)
    1 / 12 (8.33%)
    1 / 20 (5.00%)
         occurrences all number
    2
    1
    3
    Productive cough
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 12 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    1
    Respiratory tract congestion
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 12 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    1
    Sinus congestion
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 12 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    1
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    4 / 25 (16.00%)
    0 / 12 (0.00%)
    3 / 20 (15.00%)
         occurrences all number
    5
    0
    3
    Anxiety
         subjects affected / exposed
    3 / 25 (12.00%)
    1 / 12 (8.33%)
    1 / 20 (5.00%)
         occurrences all number
    3
    1
    1
    Depressed mood
         subjects affected / exposed
    1 / 25 (4.00%)
    1 / 12 (8.33%)
    2 / 20 (10.00%)
         occurrences all number
    1
    1
    2
    Depression
         subjects affected / exposed
    2 / 25 (8.00%)
    0 / 12 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    2
    0
    0
    Sleep disorder
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 12 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    1
    0
    1
    Apathy
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 12 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    1
    Mood swings
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 12 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    1
    Investigations
    Creatinine renal clearance decreased
         subjects affected / exposed
    1 / 25 (4.00%)
    1 / 12 (8.33%)
    1 / 20 (5.00%)
         occurrences all number
    1
    1
    1
    Neutrophil count decreased
         subjects affected / exposed
    3 / 25 (12.00%)
    0 / 12 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    3
    0
    0
    Body temperature increased
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 12 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    1
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 12 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    1
    0
    1
    Burn oesophageal
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 12 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    1
    Ligament rupture
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 12 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    1
    Procedural pain
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 12 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    1
    Cardiac disorders
    Tachycardia
         subjects affected / exposed
    1 / 25 (4.00%)
    1 / 12 (8.33%)
    1 / 20 (5.00%)
         occurrences all number
    1
    2
    1
    Palpitations
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 12 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    1
    Nervous system disorders
    Dysgeusia
         subjects affected / exposed
    11 / 25 (44.00%)
    0 / 12 (0.00%)
    11 / 20 (55.00%)
         occurrences all number
    11
    0
    11
    Headache
         subjects affected / exposed
    7 / 25 (28.00%)
    6 / 12 (50.00%)
    7 / 20 (35.00%)
         occurrences all number
    7
    15
    8
    Dizziness
         subjects affected / exposed
    5 / 25 (20.00%)
    1 / 12 (8.33%)
    5 / 20 (25.00%)
         occurrences all number
    8
    1
    5
    Loss of consciousness
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 12 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    1
    Memory impairment
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 12 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    1
    Poor quality sleep
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 12 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    1
    Syncope
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 12 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    1
    Tremor
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 12 (8.33%)
    0 / 20 (0.00%)
         occurrences all number
    0
    1
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    10 / 25 (40.00%)
    6 / 12 (50.00%)
    13 / 20 (65.00%)
         occurrences all number
    10
    6
    17
    Neutropenia
         subjects affected / exposed
    3 / 25 (12.00%)
    3 / 12 (25.00%)
    6 / 20 (30.00%)
         occurrences all number
    3
    4
    6
    Thrombocytopenia
         subjects affected / exposed
    2 / 25 (8.00%)
    3 / 12 (25.00%)
    6 / 20 (30.00%)
         occurrences all number
    2
    3
    6
    Ear and labyrinth disorders
    Tinnitus
         subjects affected / exposed
    2 / 25 (8.00%)
    0 / 12 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    2
    0
    0
    Vertigo
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 12 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    1
    0
    1
    Eye disorders
    Vision blurred
         subjects affected / exposed
    3 / 25 (12.00%)
    0 / 12 (0.00%)
    2 / 20 (10.00%)
         occurrences all number
    3
    0
    2
    Dry eye
         subjects affected / exposed
    3 / 25 (12.00%)
    0 / 12 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    3
    0
    1
    Eye pain
         subjects affected / exposed
    1 / 25 (4.00%)
    1 / 12 (8.33%)
    0 / 20 (0.00%)
         occurrences all number
    1
    1
    0
    Visual acuity reduced
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 12 (8.33%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    1
    Conjunctival haemorrhage
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 12 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    1
    Eczema eyelids
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 12 (8.33%)
    0 / 20 (0.00%)
         occurrences all number
    0
    1
    0
    Erythema of eyelid
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 12 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    1
    Periorbital oedema
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 12 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    1
    Retinal artery embolism
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 12 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    1
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    9 / 25 (36.00%)
    6 / 12 (50.00%)
    8 / 20 (40.00%)
         occurrences all number
    9
    9
    11
    Diarrhoea
         subjects affected / exposed
    6 / 25 (24.00%)
    3 / 12 (25.00%)
    3 / 20 (15.00%)
         occurrences all number
    8
    7
    3
    Vomiting
         subjects affected / exposed
    5 / 25 (20.00%)
    2 / 12 (16.67%)
    5 / 20 (25.00%)
         occurrences all number
    6
    4
    7
    Abdominal pain
         subjects affected / exposed
    2 / 25 (8.00%)
    1 / 12 (8.33%)
    1 / 20 (5.00%)
         occurrences all number
    2
    1
    1
    Constipation
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 12 (0.00%)
    4 / 20 (20.00%)
         occurrences all number
    0
    0
    4
    Abdominal discomfort
         subjects affected / exposed
    1 / 25 (4.00%)
    1 / 12 (8.33%)
    1 / 20 (5.00%)
         occurrences all number
    1
    1
    1
    Abdominal distension
         subjects affected / exposed
    1 / 25 (4.00%)
    1 / 12 (8.33%)
    1 / 20 (5.00%)
         occurrences all number
    1
    1
    1
    Abdominal pain upper
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 12 (0.00%)
    2 / 20 (10.00%)
         occurrences all number
    2
    0
    2
    Dyspepsia
         subjects affected / exposed
    2 / 25 (8.00%)
    0 / 12 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    3
    0
    1
    Gastrooesophageal reflux disease
         subjects affected / exposed
    1 / 25 (4.00%)
    2 / 12 (16.67%)
    0 / 20 (0.00%)
         occurrences all number
    1
    2
    0
    Anal pruritus
         subjects affected / exposed
    2 / 25 (8.00%)
    0 / 12 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    2
    0
    0
    Dysphagia
         subjects affected / exposed
    2 / 25 (8.00%)
    0 / 12 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    2
    0
    0
    Rectal haemorrhage
         subjects affected / exposed
    1 / 25 (4.00%)
    1 / 12 (8.33%)
    0 / 20 (0.00%)
         occurrences all number
    1
    2
    0
    Change of bowel habit
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 12 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    1
    Chapped lips
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 12 (8.33%)
    0 / 20 (0.00%)
         occurrences all number
    0
    1
    0
    Dry mouth
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 12 (8.33%)
    0 / 20 (0.00%)
         occurrences all number
    0
    1
    0
    Frequent bowel movements
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 12 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    1
    Haematochezia
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 12 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    1
    Melaena
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 12 (8.33%)
    0 / 20 (0.00%)
         occurrences all number
    0
    1
    0
    Mouth ulceration
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 12 (8.33%)
    0 / 20 (0.00%)
         occurrences all number
    0
    1
    0
    Proctalgia
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 12 (8.33%)
    0 / 20 (0.00%)
         occurrences all number
    0
    1
    0
    Toothache
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 12 (8.33%)
    0 / 20 (0.00%)
         occurrences all number
    0
    1
    0
    Hepatobiliary disorders
    Hepatic pain
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 12 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    1
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    8 / 25 (32.00%)
    3 / 12 (25.00%)
    7 / 20 (35.00%)
         occurrences all number
    8
    3
    9
    Dry skin
         subjects affected / exposed
    4 / 25 (16.00%)
    2 / 12 (16.67%)
    5 / 20 (25.00%)
         occurrences all number
    4
    2
    5
    Rash
         subjects affected / exposed
    5 / 25 (20.00%)
    1 / 12 (8.33%)
    3 / 20 (15.00%)
         occurrences all number
    8
    2
    4
    Alopecia
         subjects affected / exposed
    2 / 25 (8.00%)
    1 / 12 (8.33%)
    4 / 20 (20.00%)
         occurrences all number
    2
    1
    4
    Eczema
         subjects affected / exposed
    4 / 25 (16.00%)
    1 / 12 (8.33%)
    1 / 20 (5.00%)
         occurrences all number
    4
    1
    1
    Erythema
         subjects affected / exposed
    2 / 25 (8.00%)
    0 / 12 (0.00%)
    2 / 20 (10.00%)
         occurrences all number
    4
    0
    2
    Pruritus generalised
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 12 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    1
    Rash erythematous
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 12 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    1
    Rash maculo-papular
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 12 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    1
    Rash papular
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 12 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    1
    Renal and urinary disorders
    Renal failure
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 12 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    1
    Endocrine disorders
    Hypothyroidism
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 12 (8.33%)
    0 / 20 (0.00%)
         occurrences all number
    0
    1
    0
    Musculoskeletal and connective tissue disorders
    Myalgia
         subjects affected / exposed
    5 / 25 (20.00%)
    3 / 12 (25.00%)
    6 / 20 (30.00%)
         occurrences all number
    6
    4
    7
    Arthralgia
         subjects affected / exposed
    6 / 25 (24.00%)
    0 / 12 (0.00%)
    6 / 20 (30.00%)
         occurrences all number
    8
    0
    7
    Back pain
         subjects affected / exposed
    2 / 25 (8.00%)
    0 / 12 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    2
    0
    1
    Musculoskeletal pain
         subjects affected / exposed
    1 / 25 (4.00%)
    1 / 12 (8.33%)
    1 / 20 (5.00%)
         occurrences all number
    1
    1
    1
    Pain in extremity
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 12 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    1
    0
    1
    Muscular weakness
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 12 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    1
    Torticollis
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 12 (8.33%)
    0 / 20 (0.00%)
         occurrences all number
    0
    1
    0
    Trigger finger
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 12 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    1
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    2 / 25 (8.00%)
    3 / 12 (25.00%)
    1 / 20 (5.00%)
         occurrences all number
    3
    3
    1
    Gingival abscess
         subjects affected / exposed
    2 / 25 (8.00%)
    0 / 12 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    3
    0
    1
    Influenza
         subjects affected / exposed
    2 / 25 (8.00%)
    0 / 12 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    3
    0
    0
    Bronchitis
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 12 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    1
    Cellulitis
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 12 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    1
    Ear infection fungal
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 12 (8.33%)
    0 / 20 (0.00%)
         occurrences all number
    0
    1
    0
    Laryngitis
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 12 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    1
    Oesophageal candidiasis
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 12 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    1
    Subcutaneous abscess
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 12 (8.33%)
    0 / 20 (0.00%)
         occurrences all number
    0
    1
    0
    Tooth abscess
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 12 (8.33%)
    0 / 20 (0.00%)
         occurrences all number
    0
    1
    0
    Urinary tract infection
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 12 (8.33%)
    0 / 20 (0.00%)
         occurrences all number
    0
    1
    0
    Vulvovaginal mycotic infection
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 12 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    2
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    4 / 25 (16.00%)
    2 / 12 (16.67%)
    5 / 20 (25.00%)
         occurrences all number
    4
    2
    5

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    08 Mar 2012
    The primary reasons for the amendment were A. The study was changed from active control to placebo control. B. Several changes were made in response to feedback from the Food and Drug Administration (FDA): – addition of urine protein analysis assessments; – revision of the definition of additional primary efficacy analysis population; – specification of SVR-24 and SVR-4 as secondary efficacy objectives; – clarification of safety follow-up measures; – update of drug-stopping rules.
    27 Jul 2012
    The primary reasons for the amendment were as follows: A. Removal of control P/C+MCB Pbo+BCP Pbo/MCB Pbo+P/C+BCP/BCP+P/C(MCB free arm). Participants enrolled to this arm were offered the option to receive MCB in addition to their current medications. B. The sample size was decreased from 100 to 60 participants. C.Intensive pharmacokinetic (PK)/pharmacodynamic (PD) sampling was deleted. Sparse PK sampling from all participants (Week 8 trough concentration) was scheduled to enable the measurement of drug exposure. D.IP-10 samples were collected only at baseline. E.The SVR-24 analysis was removed and treatment-free follow-up was decreased from 24 to 12 weeks. F.Serious adverse event reporting window was reduced from 1 working day to immediately (i.e., within 24 hours).
    28 Nov 2012
    The primary reason for the amendment was to address FDA concerns about the possibility of late virologic relapse: A. SVR-24 was added as the secondary endpoint. B. 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
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