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    Clinical Trial Results:
    A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Trial Comparing 24 or 48 Weeks of GS-9190, in Combination with Peginterferon Alfa 2a and Ribavirin, to 48 Weeks of Peginterferon Alfa 2a and Ribavirin for the Treatment of Genotype-1 Chronic Hepatitis C Virus (HCV) Infection (GS-US-196-0103)

    Summary
    EudraCT number
    		 2008-004527-31
    Trial protocol
    		 IE   GB   DE   BE  
    Global end of trial date
    05 Sep 2013

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

    Trial information

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    Trial identification
    Sponsor protocol code
    GS-US-196-0103
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00743795
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Gilead Sciences
    Sponsor organisation address
    333 Lakeside Drive, Foster City, CA, United States, 94404
    Public contact
    Clinical Trial Mailbox, Gilead Sciences International Ltd, ClinicalTrialDisclosures@gilead.com
    Scientific contact
    Clinical Trial Mailbox, Gilead Sciences International Ltd, ClinicalTrialDisclosures@gilead.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
    05 Sep 2013
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    05 Sep 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This study compared the antiviral activity, safety, and tolerability of tegobuvir (TGV; formerly GS-9190) versus placebo, in combination with peginterferon alfa 2a (PEG) and ribavirin (RBV) for the treatment of chronic genotype 1 hepatitis C virus (HCV) infection.
    Protection of trial subjects
    The protocol and consent/assent forms were submitted by each investigator to a duly constituted Independent Ethics Committee (IEC) or Institutional Review Board (IRB) for review and approval before study initiation. All revisions to the consent/assent forms (if applicable) after initial IEC/IRB approval were submitted by the investigator to the IEC/IRB for review and approval before implementation in accordance with regulatory requirements. This study was conducted in accordance with recognized international scientific and ethical standards, including but not limited to the International Conference on Harmonization guideline for Good Clinical Practice (ICH GCP) and the original principles embodied in the Declaration of Helsinki.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    07 Oct 2008
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Efficacy
    Long term follow-up duration
    		 3 Years
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Poland: 31
    Country: Number of subjects enrolled
    United Kingdom: 3
    Country: Number of subjects enrolled
    Belgium: 8
    Country: Number of subjects enrolled
    Germany: 11
    Country: Number of subjects enrolled
    Ireland: 5
    Country: Number of subjects enrolled
    Puerto Rico: 8
    Country: Number of subjects enrolled
    United States: 186
    Worldwide total number of subjects
    252
    EEA total number of subjects
    58
    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)
    249
    From 65 to 84 years
    3
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants were enrolled at study sites in the United States and Europe. The first participant was screened on 07 October 2008. The last study visit occurred on 05 September 2013.

    Pre-assignment
    Screening details
    		 Participants were evaluated at a screening visit, and eligible participants were randomized at a 1:2:1 ratio into 1 of 3 treatment groups.

    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, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo (Group 1)
    Arm description
    		 Placebo to match tegobuvir (TGV) + peginterferon alfa 2a (PEG) + ribavirin (RBV) for 48 weeks
    Arm type
    		 Placebo

    Investigational medicinal product name
    Tegobuvir placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo to match tegobuvir capsules administered orally twice daily

    Investigational medicinal product name
    Peginterferon alfa 2a
    Investigational medicinal product code
    Other name
    Pegasys®
    Pharmaceutical forms
    Suspension for injection in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Peginterferon alfa 2a (PEG) 180 μg administered subcutaneously weekly as 180 μg/0.5 mL prefilled syringes

    Investigational medicinal product name
    Ribavirin
    Investigational medicinal product code
    Other name
    Copegus®
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Ribavirin (RBV) 200 mg tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)

    Arm title
    		 TGV (Group 2)
    Arm description
    		 TGV+PEG+RBV for 48 weeks
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tegobuvir
    Investigational medicinal product code
    Other name
    GS-9190
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Tegobuvir (TGV) 40 mg capsules administered orally twice daily

    Investigational medicinal product name
    Peginterferon alfa 2a
    Investigational medicinal product code
    Other name
    Pegasys®
    Pharmaceutical forms
    Suspension for injection in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Peginterferon alfa 2a (PEG) 180 μg administered subcutaneously weekly as 180 μg/0.5 mL prefilled syringes

    Investigational medicinal product name
    Ribavirin
    Investigational medicinal product code
    Other name
    Copegus®
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Ribavirin (RBV) 200 mg tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)

    Arm title
    		 TGV Response-Guided Therapy (Group 3)
    Arm description
    		 TGV+PEG+RBV for 24 or 48 weeks; Participants who had HCV RNA < 25 IU/mL at Week 4 and undetectable HCV RNA (< 10 IU/mL) at Week 12 through Week 24 stopped all study drugs at Week 24.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tegobuvir
    Investigational medicinal product code
    Other name
    GS-9190
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Tegobuvir (TGV) 40 mg capsules administered orally twice daily

    Investigational medicinal product name
    Peginterferon alfa 2a
    Investigational medicinal product code
    Other name
    Pegasys®
    Pharmaceutical forms
    Suspension for injection in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Peginterferon alfa 2a (PEG) 180 μg administered subcutaneously weekly as 180 μg/0.5 mL prefilled syringes

    Investigational medicinal product name
    Ribavirin
    Investigational medicinal product code
    Other name
    Copegus®
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Ribavirin (RBV) 200 mg tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)

    Number of subjects in period 1
    		Placebo (Group 1) TGV (Group 2) TGV Response-Guided Therapy (Group 3)
    Started
    64
    126
    62
    Completed
    34
    63
    32
    Not completed
    30
    63
    30
         Safety, tolerability, or efficacy reasons
    26
    53
    25
         Lost to follow-up
    2
    4
    3
         Withdrew consent
    1
    5
    1
         Investigator's discretion
    1
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall study
    Reporting group description
    		 -

    Reporting group values
    		 Overall study Total
    Number of subjects
    		 252 252
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 47 ± 10.3 -
    Gender categorical
    Units: Subjects
        Female
    		 100 100
        Male
    		 152 152
    Race
    Units: Subjects
        White
    		 215 215
        Black
    		 20 20
        Asian
    		 6 6
        Other
    		 6 6
        American Indian or Alaska Native
    		 4 4
        Native Hawaiian or Pacific Islander
    		 1 1
    Ethnicity
    Units: Subjects
        Non-Hispanic/Latino
    		 210 210
        Hispanic/Latino
    		 42 42
    Genotype
    Units: Subjects
        1a
    		 143 143
        1b
    		 108 108
        6e
    		 1 1
    HCV RNA
    Units: log10 IU/mL
        arithmetic mean (standard deviation)
    		 6.3 ± 0.73 -
    Subject analysis sets

    Subject analysis set title
    TGV
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Participants in Groups 2 and 3 who received TGV+PEG+RBV for 24 or 48 weeks were included.

    Subject analysis set title
    Placebo
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Participants in Group 1 who received placebo to match TGV+PEG+RBV for 48 weeks were included.

    Subject analysis sets values
    		 TGV Placebo
    Number of subjects
    188
    64
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    47 ± 10.4
    47 ± 10
    Gender categorical
    Units: Subjects
        Female
    69
    31
        Male
    119
    33
    Race
    Units: Subjects
        White
    160
    55
        Black
    15
    5
        Asian
    5
    1
        Other
    4
    2
        American Indian or Alaska Native
    4
    0
        Native Hawaiian or Pacific Islander
    0
    1
    Ethnicity
    Units: Subjects
        Non-Hispanic/Latino
    156
    54
        Hispanic/Latino
    32
    10
    Genotype
    Units: Subjects
        1a
    106
    37
        1b
    81
    27
        6e
    1
    0
    HCV RNA
    Units: log10 IU/mL
        arithmetic mean (standard deviation)
    6.3 ± 0.73
    6.3 ± 0.73

    End points

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    End points reporting groups
    Reporting group title
    Placebo (Group 1)
    Reporting group description
    		 Placebo to match tegobuvir (TGV) + peginterferon alfa 2a (PEG) + ribavirin (RBV) for 48 weeks

    Reporting group title
    TGV (Group 2)
    Reporting group description
    		 TGV+PEG+RBV for 48 weeks

    Reporting group title
    TGV Response-Guided Therapy (Group 3)
    Reporting group description
    		 TGV+PEG+RBV for 24 or 48 weeks; Participants who had HCV RNA < 25 IU/mL at Week 4 and undetectable HCV RNA (< 10 IU/mL) at Week 12 through Week 24 stopped all study drugs at Week 24.

    Subject analysis set title
    TGV
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Participants in Groups 2 and 3 who received TGV+PEG+RBV for 24 or 48 weeks were included.

    Subject analysis set title
    Placebo
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Participants in Group 1 who received placebo to match TGV+PEG+RBV for 48 weeks were included.

    Primary: Percentage of participants with complete early virologic response (cEVR)

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    End point title
    		 Percentage of participants with complete early virologic response (cEVR)
    End point description
    cEVR was defined as undetectable HCV RNA at Week 12.
    End point type
    Primary
    End point timeframe
    Week 12
    End point values
    		 TGV Placebo
    Number of subjects analysed
    187
    64
    Units: percentage of participants
        number (not applicable)
    66.8
    46.9
    Statistical analysis title
    		 P-value between TGV vs placebo
    Comparison groups
    TGV v Placebo
    Number of subjects included in analysis
    251
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.002 [1]
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Notes
    [1] - P-value was determined from the Cochran-Mantel-Haenszel (CMH) test statistic for stratified proportions. Stratification was based on plasma HCV RNA level (< or ≥ 400,000 IU/mL at screening).

    Primary: Percentage of participants who discontinued study drug due to an adverse event

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    End point title
    		 Percentage of participants who discontinued study drug due to an adverse event [2]
    End point description
    End point type
    Primary
    End point timeframe
    Up to 48 weeks
    Notes
    [2] - 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 statistical hypothesis testing was planned or performed for this endpoint.
    End point values
    		 TGV Placebo
    Number of subjects analysed
    188
    64
    Units: percentage of participants
        number (not applicable)
    16.5
    15.6
    No statistical analyses for this end point

    Secondary: Percentage of participants with rapid virologic response (RVR) at Week 4

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    End point title
    		 Percentage of participants with rapid virologic response (RVR) at Week 4
    End point description
    RVR was defined as HCV RNA < 25 IU/mL.
    End point type
    Secondary
    End point timeframe
    Week 4
    End point values
    		 TGV Placebo
    Number of subjects analysed
    187
    64
    Units: percentage of participants
        number (not applicable)
    54.5
    20.3
    No statistical analyses for this end point

    Secondary: Percentage of participants with complete rapid virologic response (cRVR)

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    End point title
    		 Percentage of participants with complete rapid virologic response (cRVR)
    End point description
    cRVR was defined as HCV RNA < 25 IU/mL at Week 4 and < 10 IU/mL at Weeks 12, 20, and 24.
    End point type
    Secondary
    End point timeframe
    Up to 24 weeks
    End point values
    		 TGV Placebo
    Number of subjects analysed
    187
    64
    Units: percentage of participants
        number (not applicable)
    46.5
    18.8
    No statistical analyses for this end point

    Secondary: Percentage of participants with virological suppression below the limit of assay detection (ie, HCV RNA < 10 IU/mL) at Weeks 24 and 48

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    End point title
    		 Percentage of participants with virological suppression below the limit of assay detection (ie, HCV RNA < 10 IU/mL) at Weeks 24 and 48
    End point description
    End point type
    Secondary
    End point timeframe
    Weeks 24 and 48
    End point values
    		 TGV Placebo
    Number of subjects analysed
    187
    64
    Units: percentage of participants
    number (not applicable)
        Week 24
    67.9
    70.3
        Week 48
    63.1
    65.6
    No statistical analyses for this end point

    Secondary: Percentage of participants with sustained virologic response (SVR)

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    End point title
    		 Percentage of participants with sustained virologic response (SVR)
    End point description
    SVR was defined as HCV RNA < 10 IU/mL 24 weeks following the last dose of study drug.
    End point type
    Secondary
    End point timeframe
    Posttreatment Week 24
    End point values
    		 TGV Placebo
    Number of subjects analysed
    187
    64
    Units: percentage of participants
        number (not applicable)
    55.6
    56.3
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 48 weeks plus 30 days
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10
    Reporting groups
    Reporting group title
    Placebo (Group 1)
    Reporting group description
    		 Placebo to match TGV+PEG+RBV for 48 weeks

    Reporting group title
    TGV (Group 2)
    Reporting group description
    		 TGV+PEG+RBV for 48 weeks

    Reporting group title
    TGV (Group 3, 48 weeks)
    Reporting group description
    		 TGV+PEG+RBV for 48 weeks

    Reporting group title
    TGV (Group 3, 24 weeks)
    Reporting group description
    		 TGV+PEG+RBV for 24 weeks; Participants in Group 3 who had HCV RNA < 25 IU/mL at Week 4 and undetectable HCV RNA (< 10 IU/mL) at Week 12 through Week 24 stopped all study drugs at Week 24.

    Serious adverse events
    		 Placebo (Group 1) TGV (Group 2) TGV (Group 3, 48 weeks) TGV (Group 3, 24 weeks)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 64 (4.69%)
    5 / 126 (3.97%)
    4 / 37 (10.81%)
    0 / 25 (0.00%)
         number of deaths (all causes)
    0
    1
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Lung neoplasm malignant
         subjects affected / exposed
    0 / 64 (0.00%)
    0 / 126 (0.00%)
    1 / 37 (2.70%)
    0 / 25 (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
    Injury, poisoning and procedural complications
    Crush injury
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 126 (0.79%)
    0 / 37 (0.00%)
    0 / 25 (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
    Femur fracture
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 126 (0.00%)
    0 / 37 (0.00%)
    0 / 25 (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
    Vascular disorders
    Circulatory collapse
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 126 (0.79%)
    0 / 37 (0.00%)
    0 / 25 (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 / 1
    0 / 0
    0 / 0
    Nervous system disorders
    Convulsion
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 126 (0.79%)
    0 / 37 (0.00%)
    0 / 25 (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
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 126 (0.00%)
    0 / 37 (0.00%)
    0 / 25 (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
    Systemic inflammatory response syndrome
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 126 (0.79%)
    0 / 37 (0.00%)
    0 / 25 (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
    Retinal vein occlusion
         subjects affected / exposed
    0 / 64 (0.00%)
    0 / 126 (0.00%)
    1 / 37 (2.70%)
    0 / 25 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Social circumstances
    Drug abuser
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 126 (0.00%)
    0 / 37 (0.00%)
    0 / 25 (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
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 126 (0.79%)
    0 / 37 (0.00%)
    0 / 25 (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
    Psychiatric disorders
    Disorientation
         subjects affected / exposed
    0 / 64 (0.00%)
    0 / 126 (0.00%)
    1 / 37 (2.70%)
    0 / 25 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Suicidal ideation
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 126 (0.00%)
    0 / 37 (0.00%)
    0 / 25 (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
    Musculoskeletal and connective tissue disorders
    Muscular weakness
         subjects affected / exposed
    0 / 64 (0.00%)
    0 / 126 (0.00%)
    1 / 37 (2.70%)
    0 / 25 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 126 (0.79%)
    0 / 37 (0.00%)
    0 / 25 (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
    Pneumonia
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 126 (0.79%)
    0 / 37 (0.00%)
    0 / 25 (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
    Viral infection
         subjects affected / exposed
    0 / 64 (0.00%)
    0 / 126 (0.00%)
    1 / 37 (2.70%)
    0 / 25 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 126 (0.00%)
    0 / 37 (0.00%)
    0 / 25 (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
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo (Group 1) TGV (Group 2) TGV (Group 3, 48 weeks) TGV (Group 3, 24 weeks)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    60 / 64 (93.75%)
    120 / 126 (95.24%)
    35 / 37 (94.59%)
    23 / 25 (92.00%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    5 / 64 (7.81%)
    10 / 126 (7.94%)
    1 / 37 (2.70%)
    2 / 25 (8.00%)
         occurrences all number
    5
    10
    1
    3
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    27 / 64 (42.19%)
    52 / 126 (41.27%)
    17 / 37 (45.95%)
    10 / 25 (40.00%)
         occurrences all number
    27
    56
    17
    11
    Influenza like illness
         subjects affected / exposed
    13 / 64 (20.31%)
    34 / 126 (26.98%)
    2 / 37 (5.41%)
    7 / 25 (28.00%)
         occurrences all number
    14
    39
    2
    8
    Pyrexia
         subjects affected / exposed
    4 / 64 (6.25%)
    36 / 126 (28.57%)
    10 / 37 (27.03%)
    5 / 25 (20.00%)
         occurrences all number
    5
    43
    11
    6
    Irritability
         subjects affected / exposed
    13 / 64 (20.31%)
    24 / 126 (19.05%)
    10 / 37 (27.03%)
    3 / 25 (12.00%)
         occurrences all number
    15
    24
    11
    4
    Chills
         subjects affected / exposed
    7 / 64 (10.94%)
    15 / 126 (11.90%)
    13 / 37 (35.14%)
    2 / 25 (8.00%)
         occurrences all number
    9
    16
    14
    2
    Asthenia
         subjects affected / exposed
    2 / 64 (3.13%)
    18 / 126 (14.29%)
    2 / 37 (5.41%)
    4 / 25 (16.00%)
         occurrences all number
    2
    20
    3
    4
    Pain
         subjects affected / exposed
    6 / 64 (9.38%)
    11 / 126 (8.73%)
    4 / 37 (10.81%)
    1 / 25 (4.00%)
         occurrences all number
    6
    11
    4
    1
    Injection site erythema
         subjects affected / exposed
    2 / 64 (3.13%)
    8 / 126 (6.35%)
    8 / 37 (21.62%)
    3 / 25 (12.00%)
         occurrences all number
    2
    8
    8
    3
    Injection site reaction
         subjects affected / exposed
    3 / 64 (4.69%)
    8 / 126 (6.35%)
    1 / 37 (2.70%)
    0 / 25 (0.00%)
         occurrences all number
    3
    9
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    7 / 64 (10.94%)
    25 / 126 (19.84%)
    8 / 37 (21.62%)
    10 / 25 (40.00%)
         occurrences all number
    7
    25
    9
    10
    Dyspnoea
         subjects affected / exposed
    11 / 64 (17.19%)
    16 / 126 (12.70%)
    4 / 37 (10.81%)
    3 / 25 (12.00%)
         occurrences all number
    11
    16
    4
    3
    Dyspnoea exertional
         subjects affected / exposed
    4 / 64 (6.25%)
    12 / 126 (9.52%)
    2 / 37 (5.41%)
    1 / 25 (4.00%)
         occurrences all number
    4
    12
    2
    1
    Pharyngolaryngeal pain
         subjects affected / exposed
    3 / 64 (4.69%)
    10 / 126 (7.94%)
    2 / 37 (5.41%)
    3 / 25 (12.00%)
         occurrences all number
    3
    10
    2
    3
    Productive cough
         subjects affected / exposed
    3 / 64 (4.69%)
    8 / 126 (6.35%)
    2 / 37 (5.41%)
    0 / 25 (0.00%)
         occurrences all number
    3
    8
    2
    0
    Nasal congestion
         subjects affected / exposed
    1 / 64 (1.56%)
    7 / 126 (5.56%)
    0 / 37 (0.00%)
    0 / 25 (0.00%)
         occurrences all number
    1
    7
    0
    0
    Respiratory tract congestion
         subjects affected / exposed
    1 / 64 (1.56%)
    3 / 126 (2.38%)
    2 / 37 (5.41%)
    0 / 25 (0.00%)
         occurrences all number
    1
    3
    2
    0
    Increased upper airway secretion
         subjects affected / exposed
    0 / 64 (0.00%)
    0 / 126 (0.00%)
    2 / 37 (5.41%)
    0 / 25 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    20 / 64 (31.25%)
    38 / 126 (30.16%)
    13 / 37 (35.14%)
    5 / 25 (20.00%)
         occurrences all number
    20
    40
    14
    5
    Depression
         subjects affected / exposed
    13 / 64 (20.31%)
    28 / 126 (22.22%)
    9 / 37 (24.32%)
    2 / 25 (8.00%)
         occurrences all number
    13
    29
    9
    2
    Anxiety
         subjects affected / exposed
    12 / 64 (18.75%)
    20 / 126 (15.87%)
    5 / 37 (13.51%)
    0 / 25 (0.00%)
         occurrences all number
    13
    21
    5
    0
    Investigations
    Weight decreased
         subjects affected / exposed
    7 / 64 (10.94%)
    12 / 126 (9.52%)
    3 / 37 (8.11%)
    4 / 25 (16.00%)
         occurrences all number
    7
    12
    3
    4
    Nervous system disorders
    Headache
         subjects affected / exposed
    20 / 64 (31.25%)
    56 / 126 (44.44%)
    15 / 37 (40.54%)
    9 / 25 (36.00%)
         occurrences all number
    25
    64
    31
    11
    Dizziness
         subjects affected / exposed
    6 / 64 (9.38%)
    12 / 126 (9.52%)
    6 / 37 (16.22%)
    3 / 25 (12.00%)
         occurrences all number
    6
    14
    7
    3
    Dysgeusia
         subjects affected / exposed
    2 / 64 (3.13%)
    12 / 126 (9.52%)
    1 / 37 (2.70%)
    1 / 25 (4.00%)
         occurrences all number
    2
    12
    1
    1
    Migraine
         subjects affected / exposed
    2 / 64 (3.13%)
    4 / 126 (3.17%)
    1 / 37 (2.70%)
    2 / 25 (8.00%)
         occurrences all number
    2
    4
    1
    2
    Hypoaesthesia
         subjects affected / exposed
    1 / 64 (1.56%)
    3 / 126 (2.38%)
    2 / 37 (5.41%)
    0 / 25 (0.00%)
         occurrences all number
    1
    3
    2
    0
    Paraesthesia
         subjects affected / exposed
    1 / 64 (1.56%)
    2 / 126 (1.59%)
    0 / 37 (0.00%)
    2 / 25 (8.00%)
         occurrences all number
    1
    3
    0
    2
    Blood and lymphatic system disorders
    Neutropenia
         subjects affected / exposed
    19 / 64 (29.69%)
    40 / 126 (31.75%)
    8 / 37 (21.62%)
    6 / 25 (24.00%)
         occurrences all number
    23
    58
    12
    6
    Anaemia
         subjects affected / exposed
    20 / 64 (31.25%)
    33 / 126 (26.19%)
    6 / 37 (16.22%)
    5 / 25 (20.00%)
         occurrences all number
    25
    36
    6
    6
    Lymphopenia
         subjects affected / exposed
    1 / 64 (1.56%)
    4 / 126 (3.17%)
    2 / 37 (5.41%)
    0 / 25 (0.00%)
         occurrences all number
    1
    4
    2
    0
    Eye disorders
    Vision blurred
         subjects affected / exposed
    1 / 64 (1.56%)
    4 / 126 (3.17%)
    2 / 37 (5.41%)
    1 / 25 (4.00%)
         occurrences all number
    1
    4
    2
    1
    Eye pain
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 126 (0.79%)
    3 / 37 (8.11%)
    1 / 25 (4.00%)
         occurrences all number
    0
    1
    4
    1
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    14 / 64 (21.88%)
    27 / 126 (21.43%)
    15 / 37 (40.54%)
    9 / 25 (36.00%)
         occurrences all number
    17
    27
    16
    13
    Diarrhoea
         subjects affected / exposed
    10 / 64 (15.63%)
    25 / 126 (19.84%)
    8 / 37 (21.62%)
    4 / 25 (16.00%)
         occurrences all number
    10
    28
    9
    7
    Dyspepsia
         subjects affected / exposed
    8 / 64 (12.50%)
    7 / 126 (5.56%)
    2 / 37 (5.41%)
    2 / 25 (8.00%)
         occurrences all number
    10
    8
    2
    2
    Vomiting
         subjects affected / exposed
    2 / 64 (3.13%)
    8 / 126 (6.35%)
    5 / 37 (13.51%)
    3 / 25 (12.00%)
         occurrences all number
    2
    10
    6
    3
    Abdominal pain upper
         subjects affected / exposed
    3 / 64 (4.69%)
    9 / 126 (7.14%)
    2 / 37 (5.41%)
    1 / 25 (4.00%)
         occurrences all number
    3
    10
    2
    1
    Constipation
         subjects affected / exposed
    3 / 64 (4.69%)
    7 / 126 (5.56%)
    3 / 37 (8.11%)
    1 / 25 (4.00%)
         occurrences all number
    3
    7
    3
    1
    Dry mouth
         subjects affected / exposed
    2 / 64 (3.13%)
    8 / 126 (6.35%)
    2 / 37 (5.41%)
    1 / 25 (4.00%)
         occurrences all number
    2
    8
    2
    1
    Gastroesophageal reflux disease
         subjects affected / exposed
    2 / 64 (3.13%)
    8 / 126 (6.35%)
    3 / 37 (8.11%)
    0 / 25 (0.00%)
         occurrences all number
    2
    8
    3
    0
    Abdominal pain
         subjects affected / exposed
    2 / 64 (3.13%)
    4 / 126 (3.17%)
    3 / 37 (8.11%)
    3 / 25 (12.00%)
         occurrences all number
    2
    4
    3
    4
    Stomatitis
         subjects affected / exposed
    2 / 64 (3.13%)
    5 / 126 (3.97%)
    2 / 37 (5.41%)
    1 / 25 (4.00%)
         occurrences all number
    2
    5
    2
    1
    Cheilitis
         subjects affected / exposed
    0 / 64 (0.00%)
    2 / 126 (1.59%)
    2 / 37 (5.41%)
    0 / 25 (0.00%)
         occurrences all number
    0
    2
    2
    0
    Tongue discolouration
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 126 (0.79%)
    2 / 37 (5.41%)
    0 / 25 (0.00%)
         occurrences all number
    0
    1
    2
    0
    Pruritus ani
         subjects affected / exposed
    0 / 64 (0.00%)
    0 / 126 (0.00%)
    2 / 37 (5.41%)
    0 / 25 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    10 / 64 (15.63%)
    34 / 126 (26.98%)
    11 / 37 (29.73%)
    9 / 25 (36.00%)
         occurrences all number
    11
    34
    11
    9
    Pruritus
         subjects affected / exposed
    11 / 64 (17.19%)
    29 / 126 (23.02%)
    10 / 37 (27.03%)
    6 / 25 (24.00%)
         occurrences all number
    11
    32
    10
    6
    Rash
         subjects affected / exposed
    11 / 64 (17.19%)
    24 / 126 (19.05%)
    10 / 37 (27.03%)
    3 / 25 (12.00%)
         occurrences all number
    12
    31
    11
    3
    Dry skin
         subjects affected / exposed
    6 / 64 (9.38%)
    13 / 126 (10.32%)
    3 / 37 (8.11%)
    2 / 25 (8.00%)
         occurrences all number
    6
    13
    3
    2
    Eczema
         subjects affected / exposed
    3 / 64 (4.69%)
    7 / 126 (5.56%)
    1 / 37 (2.70%)
    2 / 25 (8.00%)
         occurrences all number
    3
    7
    1
    2
    Night sweats
         subjects affected / exposed
    4 / 64 (6.25%)
    2 / 126 (1.59%)
    1 / 37 (2.70%)
    1 / 25 (4.00%)
         occurrences all number
    4
    2
    1
    1
    Rash generalised
         subjects affected / exposed
    4 / 64 (6.25%)
    0 / 126 (0.00%)
    1 / 37 (2.70%)
    0 / 25 (0.00%)
         occurrences all number
    4
    0
    1
    0
    Musculoskeletal and connective tissue disorders
    Myalgia
         subjects affected / exposed
    6 / 64 (9.38%)
    27 / 126 (21.43%)
    7 / 37 (18.92%)
    7 / 25 (28.00%)
         occurrences all number
    6
    28
    10
    8
    Arthralgia
         subjects affected / exposed
    5 / 64 (7.81%)
    20 / 126 (15.87%)
    5 / 37 (13.51%)
    2 / 25 (8.00%)
         occurrences all number
    5
    21
    7
    3
    Back pain
         subjects affected / exposed
    5 / 64 (7.81%)
    19 / 126 (15.08%)
    2 / 37 (5.41%)
    2 / 25 (8.00%)
         occurrences all number
    5
    20
    2
    2
    Muscle spasms
         subjects affected / exposed
    3 / 64 (4.69%)
    8 / 126 (6.35%)
    3 / 37 (8.11%)
    3 / 25 (12.00%)
         occurrences all number
    3
    8
    4
    4
    Muscular weakness
         subjects affected / exposed
    0 / 64 (0.00%)
    2 / 126 (1.59%)
    1 / 37 (2.70%)
    2 / 25 (8.00%)
         occurrences all number
    0
    2
    1
    2
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    2 / 64 (3.13%)
    6 / 126 (4.76%)
    5 / 37 (13.51%)
    0 / 25 (0.00%)
         occurrences all number
    3
    6
    5
    0
    Urinary tract infection
         subjects affected / exposed
    3 / 64 (4.69%)
    6 / 126 (4.76%)
    4 / 37 (10.81%)
    0 / 25 (0.00%)
         occurrences all number
    3
    7
    4
    0
    Bronchitis
         subjects affected / exposed
    2 / 64 (3.13%)
    5 / 126 (3.97%)
    2 / 37 (5.41%)
    1 / 25 (4.00%)
         occurrences all number
    2
    6
    2
    1
    Metabolism and nutrition disorders
    Anorexia
         subjects affected / exposed
    8 / 64 (12.50%)
    14 / 126 (11.11%)
    2 / 37 (5.41%)
    5 / 25 (20.00%)
         occurrences all number
    8
    16
    2
    5
    Decreased appetite
         subjects affected / exposed
    2 / 64 (3.13%)
    4 / 126 (3.17%)
    3 / 37 (8.11%)
    2 / 25 (8.00%)
         occurrences all number
    2
    4
    3
    2

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    23 Oct 2008
    Subjects up to 70 years of age were allowed to enroll if all other eligibility criteria were met, sample size calculation was revised based on updated assumptions, and sustained virologic response (SVR) was removed as a coprimary endpoint and added as a secondary endpoint to better reflect the objectives of the study.
    20 Mar 2009
    The study exceeded the initial planned enrollment by approximately 25% and the protocol was amended to allow enrollment of 248 subjects.
    29 Apr 2009
    The HCV RNA stopping criteria for subjects in Arm 3 was updated to avoid ambiguity since there were some inconsistencies historically on the lower limit of detection reported for rapid virologic response (RVR). Subjects in Arm 3 stopped all therapy at Week 24 if they had HCV RNA < 25 IU/mL at Week 4 and undetectable HCV RNA (< 10 IU/mL) at Week 12 and maintained through Week 24.

    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.
    There were no limitations affecting the analysis or results.
    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.

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