Flag of the European Union EU Clinical Trials Register Help

Clinical trials

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

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


    The EU Clinical Trials Register currently displays   43862   clinical trials with a EudraCT protocol, of which   7285   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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

    < Back to search results

    Download PDF

    Clinical Trial Results:
    A Phase 3, Multicenter, Randomized, Double-Blind, Placebo Controlled Study to Investigate the Efficacy and Safety of GS-7977 + Ribavirin for 12 Weeks in Treatment Naïve and Treatment Experienced Subjects with Chronic Genotype 2 or 3 HCV Infection

    Summary
    EudraCT number
    2012-001942-16
    Trial protocol
    EE   AT   NL   DE   GB   SE   ES   PL  
    Global end of trial date
    08 Jan 2014

    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

    Close Top of page
    Trial identification
    Sponsor protocol code
    GS-US-334-0133
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01682720
    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
    08 Jan 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Jan 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This study evaluated the safety, tolerability, and antiviral efficacy of sofosbuvir (SOF; GS-7977) with ribavirin (RBV) in participants with genotype 2 or 3 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
    19 Sep 2012
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Netherlands: 25
    Country: Number of subjects enrolled
    Poland: 22
    Country: Number of subjects enrolled
    Spain: 48
    Country: Number of subjects enrolled
    Sweden: 24
    Country: Number of subjects enrolled
    United Kingdom: 55
    Country: Number of subjects enrolled
    Austria: 18
    Country: Number of subjects enrolled
    Estonia: 15
    Country: Number of subjects enrolled
    Germany: 69
    Country: Number of subjects enrolled
    Italy: 62
    Country: Number of subjects enrolled
    France: 81
    Worldwide total number of subjects
    419
    EEA total number of subjects
    419
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    386
    From 65 to 84 years
    33
    85 years and over
    0

    Subject disposition

    Close Top of page
    Recruitment
    Recruitment details
    Participants were enrolled at a total of 77 study sites in Europe. The first participant was screened on 19 September 2012. The last participant observation occurred on 08 January 2014.

    Pre-assignment
    Screening details
    475 participants were screened and 421 were randomized. 419 participants were randomized and received at least 1 dose of study drug (Safety Analysis Set). 344 participants with genotype 2 or 3 HCV infection were randomized and received at least 1 dose of sofosbuvir (Full Analysis Set).

    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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Placebo 12 Weeks (GT2/3)
    Arm description
    Placebo to match sofosbuvir (SOF) + placebo to match ribavirin (RBV) for 12 weeks in participants with genotype (GT) 2 or 3 HCV infection
    Arm type
    Placebo

    Investigational medicinal product name
    SOF Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo to match SOF administered orally once daily

    Investigational medicinal product name
    RBV Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo to match RBV administered orally in a divided daily dose

    Arm title
    SOF + RBV 12 Weeks (GT2)
    Arm description
    SOF + RBV for 12 weeks in participants with genotype 2 HCV infection
    Arm type
    Experimental

    Investigational medicinal product name
    SOF
    Investigational medicinal product code
    Other name
    Sovaldi®, GS-7977, PSI-7977
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    SOF 400 mg tablet administered orally once daily

    Investigational medicinal product name
    RBV
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    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
    SOF + RBV 12 Weeks (GT3)
    Arm description
    SOF + RBV for 12 weeks in participants with genotype 3 HCV infection
    Arm type
    Experimental

    Investigational medicinal product name
    SOF
    Investigational medicinal product code
    Other name
    Sovaldi®, GS-7977, PSI-7977
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    SOF 400 mg tablet administered orally once daily

    Investigational medicinal product name
    RBV
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    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
    SOF + RBV 24 Weeks (GT3)
    Arm description
    SOF + RBV for 24 weeks in participants with genotype 3 HCV infection
    Arm type
    Experimental

    Investigational medicinal product name
    SOF
    Investigational medicinal product code
    Other name
    Sovaldi®, GS-7977, PSI-7977
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    SOF 400 mg tablet administered orally once daily

    Investigational medicinal product name
    RBV
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    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 12 Weeks (GT2/3) SOF + RBV 12 Weeks (GT2) SOF + RBV 12 Weeks (GT3) SOF + RBV 24 Weeks (GT3)
    Started
    85
    73
    11
    250
    Completed
    0
    69
    5
    211
    Not completed
    85
    4
    6
    39
         Efficacy failure
    -
    3
    3
    -
         Consent withdrawn by subject
    -
    -
    2
    2
         Adverse event, non-fatal
    1
    -
    1
    1
         Terminated by sponsor
    83
    -
    -
    -
         Lost to follow-up
    1
    1
    -
    6
         Efficacy faiure
    -
    -
    -
    30

    Baseline characteristics

    Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Placebo 12 Weeks (GT2/3)
    Reporting group description
    Placebo to match sofosbuvir (SOF) + placebo to match ribavirin (RBV) for 12 weeks in participants with genotype (GT) 2 or 3 HCV infection

    Reporting group title
    SOF + RBV 12 Weeks (GT2)
    Reporting group description
    SOF + RBV for 12 weeks in participants with genotype 2 HCV infection

    Reporting group title
    SOF + RBV 12 Weeks (GT3)
    Reporting group description
    SOF + RBV for 12 weeks in participants with genotype 3 HCV infection

    Reporting group title
    SOF + RBV 24 Weeks (GT3)
    Reporting group description
    SOF + RBV for 24 weeks in participants with genotype 3 HCV infection

    Reporting group values
    Placebo 12 Weeks (GT2/3) SOF + RBV 12 Weeks (GT2) SOF + RBV 12 Weeks (GT3) SOF + RBV 24 Weeks (GT3) Total
    Number of subjects
    85 73 11 250 419
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    49 ± 10.5 58 ± 10.1 46 ± 8.8 48 ± 10.1 -
    Gender categorical
    Units: Subjects
        Female
    36 33 5 95 169
        Male
    49 40 6 155 250
    HCV Genotype
    Units: Subjects
        Genotype 2
    18 73 0 0 91
        Genotype 3
    67 0 11 250 328
    Liver cirrhosis
    Units: Subjects
        No
    68 62 9 190 329
        Yes
    17 11 2 60 90
    HCV RNA category
    Units: Subjects
        < 6 log10 IU/mL
    21 16 4 72 113
        ≥ 6 log10 IU/mL
    64 57 7 178 306
    Prior HCV treatment experience
    Units: Subjects
        Experienced
    50 41 9 145 245
        Naive
    35 32 2 105 174
    Response to prior HCV treatment
    Units: Subjects
        Interferon intolerant
    0 3 0 10 13
        Nonresponse
    18 10 4 41 73
        Relapse/breakthrough
    32 28 5 94 159
        N/A (treatment-naive)
    35 32 2 105 174
    Interferon eligibility
    Units: Subjects
        Interferon eligible
    30 27 2 94 153
        Interferon ineligible
    5 5 0 11 21
        N/A (treatment-experienced)
    50 41 9 145 245
    Race
    Units: Subjects
        Black or African American
    1 5 0 0 6
        White
    81 65 11 236 393
        Asian
    3 1 0 9 13
        Not permitted
    0 2 0 5 7
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    10 6 1 36 53
        Not Hispanic or Latino
    71 65 10 203 349
        Not permitted
    4 2 0 11 17
    HCV RNA
    Units: log10 IU/mL
        arithmetic mean (standard deviation)
    6.5 ± 0.69 6.5 ± 0.7 6.2 ± 0.77 6.3 ± 0.74 -

    End points

    Close Top of page
    End points reporting groups
    Reporting group title
    Placebo 12 Weeks (GT2/3)
    Reporting group description
    Placebo to match sofosbuvir (SOF) + placebo to match ribavirin (RBV) for 12 weeks in participants with genotype (GT) 2 or 3 HCV infection

    Reporting group title
    SOF + RBV 12 Weeks (GT2)
    Reporting group description
    SOF + RBV for 12 weeks in participants with genotype 2 HCV infection

    Reporting group title
    SOF + RBV 12 Weeks (GT3)
    Reporting group description
    SOF + RBV for 12 weeks in participants with genotype 3 HCV infection

    Reporting group title
    SOF + RBV 24 Weeks (GT3)
    Reporting group description
    SOF + RBV for 24 weeks in participants with genotype 3 HCV infection

    Subject analysis set title
    SOF + RBV 12 Weeks (GT2/3)
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    SOF + RBV for 12 weeks in participants with genotype 2 or 3 HCV infection

    Primary: Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)

    Close Top of page
    End point title
    Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12) [1] [2]
    End point description
    SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ, ie, < 25 IU/mL) 12 weeks following the last dose of study drug. SVR data was not collected for the Placebo 12 Weeks (GT2/3) group. Full Analysis Set: participants with genotype 2 or 3 HCV infection were randomized and received at least 1 dose of SOF.
    End point type
    Primary
    End point timeframe
    Posttreatment 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: No intergroup comparison was performed because the GT2 12 week and GT3 24 week groups were distinct in demographics and treatment.
    [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: Consistent with the termination of study by sponsor provided for in Protocol Amendment 2, and because participants in the placebo group did not receive active treatment, no data for sustained virologic response was collected for the Placebo 12 Weeks (GT2/3) group.
    End point values
    SOF + RBV 12 Weeks (GT2) SOF + RBV 12 Weeks (GT3) SOF + RBV 24 Weeks (GT3)
    Number of subjects analysed
    73
    11
    250
    Units: percentage of participants
        number (not applicable)
    93.2
    27.3
    85.2
    No statistical analyses for this end point

    Primary: Adverse Events Leading to Permanent Discontinuation of Study Drug(s)

    Close Top of page
    End point title
    Adverse Events Leading to Permanent Discontinuation of Study Drug(s) [3] [4]
    End point description
    The percentage of participants experiencing an adverse event leading to permanent discontinuation of study drug(s) was analyzed. Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
    End point type
    Primary
    End point timeframe
    Up to 24 weeks
    Notes
    [3] - 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 intergroup comparison was performed because the various groups were distinct in demographics and treatment.
    [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: Adverse events for the SOF 12 Weeks (GT2) SOF 12 Weeks (GT3) groups were collected and are reported as the SOF 12 Weeks (GT2/3) group.
    End point values
    Placebo 12 Weeks (GT2/3) SOF + RBV 24 Weeks (GT3) SOF + RBV 12 Weeks (GT2/3)
    Number of subjects analysed
    85
    250
    84
    Units: percentage of participants
        number (not applicable)
    1.2
    0.4
    1.2
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)

    Close Top of page
    End point title
    Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) [5]
    End point description
    SVR4 and SVR24 was defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively. SVR data was not collected for the Placebo 12 Weeks (GT2/3) group. Full Analysis Set
    End point type
    Secondary
    End point timeframe
    Posttreatment Weeks 4 and 24
    Notes
    [5] - 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: Consistent with the termination of study by sponsor provided for in Protocol Amendment 2, and because participants in the placebo group did not receive active treatment, no data for sustained virologic response was collected for the Placebo 12 Weeks (GT2/3) group.
    End point values
    SOF + RBV 12 Weeks (GT2) SOF + RBV 12 Weeks (GT3) SOF + RBV 24 Weeks (GT3)
    Number of subjects analysed
    73
    11
    250
    Units: percentage of participants
    number (not applicable)
        SVR4
    93.2
    45.5
    87.2
        SVR24
    93.2
    27.3
    84.4
    No statistical analyses for this end point

    Secondary: Percentage of Participants Experiencing Viral Breakthrough or Viral Relapse

    Close Top of page
    End point title
    Percentage of Participants Experiencing Viral Breakthrough or Viral Relapse [6]
    End point description
    Viral breakthrough was defined as having confirmed detectable HCV RNA levels (HCV RNA > LLOQ) after having previously had undetectable HCV RNA levels (HCV RNA < LLOQ) while on treatment. Viral relapse was defined as having achieved undetectable HCV RNA levels (HCV RNA < LLOQ) at end of treatment, but did not achieve an SVR. Data was not collected for the Placebo 12 Weeks (GT2/3) group. Full Analysis Set
    End point type
    Secondary
    End point timeframe
    Up to Posttreatment Week 24
    Notes
    [6] - 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: Consistent with the termination of study by sponsor provided for in Protocol Amendment 2, and because participants in the placebo group did not receive active treatment, no data for viral breakthrough or viral relapse was collected for the Placebo 12 Weeks (GT2/3) group.
    End point values
    SOF + RBV 12 Weeks (GT2) SOF + RBV 12 Weeks (GT3) SOF + RBV 24 Weeks (GT3)
    Number of subjects analysed
    73
    11
    250
    Units: percentage of participants
    number (not applicable)
        Viral breakthrough
    0
    0
    0.4
        Viral relapse
    6.8
    54.5
    14
    No statistical analyses for this end point

    Adverse events

    Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Baseline up to Week 24 plus 30 days
    Adverse event reporting additional description
    Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    16.1
    Reporting groups
    Reporting group title
    Placebo 12 Weeks (GT2/3)
    Reporting group description
    Placebo to match SOF + placebo to match RBV for 12 weeks in participants with genotype 2 or 3 HCV infection

    Reporting group title
    SOF + RBV 12 Weeks (GT2/3)
    Reporting group description
    SOF + RBV for 12 weeks in participants with genotype 2 or 3 HCV infection

    Reporting group title
    SOF + RBV 24 Weeks (GT3)
    Reporting group description
    SOF + RBV for 24 weeks in participants with genotype 3 HCV infection

    Serious adverse events
    Placebo 12 Weeks (GT2/3) SOF + RBV 12 Weeks (GT2/3) SOF + RBV 24 Weeks (GT3)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 85 (2.35%)
    0 / 84 (0.00%)
    10 / 250 (4.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Investigations
    Amylase increased
         subjects affected / exposed
    0 / 85 (0.00%)
    0 / 84 (0.00%)
    1 / 250 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lipase increased
         subjects affected / exposed
    0 / 85 (0.00%)
    0 / 84 (0.00%)
    1 / 250 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Hepatocellular carcinoma
         subjects affected / exposed
    0 / 85 (0.00%)
    0 / 84 (0.00%)
    1 / 250 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Invasive ductal breast carcinoma
         subjects affected / exposed
    0 / 85 (0.00%)
    0 / 84 (0.00%)
    1 / 250 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Road traffic accident
         subjects affected / exposed
    0 / 85 (0.00%)
    0 / 84 (0.00%)
    1 / 250 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Arrhythmia
         subjects affected / exposed
    0 / 85 (0.00%)
    0 / 84 (0.00%)
    1 / 250 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Complex regional pain syndrome
         subjects affected / exposed
    0 / 85 (0.00%)
    0 / 84 (0.00%)
    1 / 250 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Adenocarcinoma of colon
         subjects affected / exposed
    1 / 85 (1.18%)
    0 / 84 (0.00%)
    0 / 250 (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
    Haemorrhoidal haemorrhage
         subjects affected / exposed
    0 / 85 (0.00%)
    0 / 84 (0.00%)
    1 / 250 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Biliary colic
         subjects affected / exposed
    0 / 85 (0.00%)
    0 / 84 (0.00%)
    1 / 250 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Suicide attempt
         subjects affected / exposed
    0 / 85 (0.00%)
    0 / 84 (0.00%)
    1 / 250 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Gastroenteritis
         subjects affected / exposed
    1 / 85 (1.18%)
    0 / 84 (0.00%)
    0 / 250 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hyperglycaemia
         subjects affected / exposed
    0 / 85 (0.00%)
    0 / 84 (0.00%)
    1 / 250 (0.40%)
         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
    Placebo 12 Weeks (GT2/3) SOF + RBV 12 Weeks (GT2/3) SOF + RBV 24 Weeks (GT3)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    54 / 85 (63.53%)
    69 / 84 (82.14%)
    212 / 250 (84.80%)
    Nervous system disorders
    Disturbance in attention
         subjects affected / exposed
    2 / 85 (2.35%)
    1 / 84 (1.19%)
    15 / 250 (6.00%)
         occurrences all number
    2
    1
    15
    Dizziness
         subjects affected / exposed
    2 / 85 (2.35%)
    5 / 84 (5.95%)
    19 / 250 (7.60%)
         occurrences all number
    2
    5
    20
    Headache
         subjects affected / exposed
    23 / 85 (27.06%)
    24 / 84 (28.57%)
    74 / 250 (29.60%)
         occurrences all number
    25
    29
    101
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 85 (1.18%)
    6 / 84 (7.14%)
    17 / 250 (6.80%)
         occurrences all number
    1
    6
    18
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    4 / 85 (4.71%)
    21 / 84 (25.00%)
    53 / 250 (21.20%)
         occurrences all number
    4
    24
    60
    Chest pain
         subjects affected / exposed
    0 / 85 (0.00%)
    5 / 84 (5.95%)
    5 / 250 (2.00%)
         occurrences all number
    0
    5
    5
    Fatigue
         subjects affected / exposed
    16 / 85 (18.82%)
    19 / 84 (22.62%)
    75 / 250 (30.00%)
         occurrences all number
    18
    19
    78
    Influenza like illness
         subjects affected / exposed
    5 / 85 (5.88%)
    1 / 84 (1.19%)
    16 / 250 (6.40%)
         occurrences all number
    6
    1
    17
    Irritability
         subjects affected / exposed
    3 / 85 (3.53%)
    4 / 84 (4.76%)
    26 / 250 (10.40%)
         occurrences all number
    3
    4
    28
    Pyrexia
         subjects affected / exposed
    2 / 85 (2.35%)
    7 / 84 (8.33%)
    9 / 250 (3.60%)
         occurrences all number
    2
    9
    9
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    4 / 85 (4.71%)
    1 / 84 (1.19%)
    21 / 250 (8.40%)
         occurrences all number
    5
    1
    23
    Abdominal pain upper
         subjects affected / exposed
    6 / 85 (7.06%)
    7 / 84 (8.33%)
    15 / 250 (6.00%)
         occurrences all number
    6
    10
    16
    Constipation
         subjects affected / exposed
    1 / 85 (1.18%)
    2 / 84 (2.38%)
    13 / 250 (5.20%)
         occurrences all number
    1
    4
    17
    Diarrhoea
         subjects affected / exposed
    4 / 85 (4.71%)
    4 / 84 (4.76%)
    30 / 250 (12.00%)
         occurrences all number
    4
    4
    33
    Dyspepsia
         subjects affected / exposed
    0 / 85 (0.00%)
    3 / 84 (3.57%)
    15 / 250 (6.00%)
         occurrences all number
    0
    4
    21
    Nausea
         subjects affected / exposed
    9 / 85 (10.59%)
    26 / 84 (30.95%)
    33 / 250 (13.20%)
         occurrences all number
    9
    27
    38
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    4 / 85 (4.71%)
    8 / 84 (9.52%)
    27 / 250 (10.80%)
         occurrences all number
    4
    8
    29
    Dyspnoea
         subjects affected / exposed
    1 / 85 (1.18%)
    12 / 84 (14.29%)
    27 / 250 (10.80%)
         occurrences all number
    1
    12
    29
    Dyspnoea exertional
         subjects affected / exposed
    0 / 85 (0.00%)
    6 / 84 (7.14%)
    9 / 250 (3.60%)
         occurrences all number
    0
    6
    9
    Skin and subcutaneous tissue disorders
    Dry skin
         subjects affected / exposed
    5 / 85 (5.88%)
    8 / 84 (9.52%)
    31 / 250 (12.40%)
         occurrences all number
    5
    8
    34
    Eczema
         subjects affected / exposed
    0 / 85 (0.00%)
    3 / 84 (3.57%)
    14 / 250 (5.60%)
         occurrences all number
    0
    3
    15
    Pruritus
         subjects affected / exposed
    8 / 85 (9.41%)
    20 / 84 (23.81%)
    67 / 250 (26.80%)
         occurrences all number
    8
    23
    74
    Rash
         subjects affected / exposed
    2 / 85 (2.35%)
    1 / 84 (1.19%)
    24 / 250 (9.60%)
         occurrences all number
    2
    1
    25
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    2 / 85 (2.35%)
    1 / 84 (1.19%)
    13 / 250 (5.20%)
         occurrences all number
    2
    1
    15
    Depressed mood
         subjects affected / exposed
    2 / 85 (2.35%)
    1 / 84 (1.19%)
    13 / 250 (5.20%)
         occurrences all number
    2
    1
    13
    Insomnia
         subjects affected / exposed
    2 / 85 (2.35%)
    9 / 84 (10.71%)
    41 / 250 (16.40%)
         occurrences all number
    2
    9
    45
    Sleep disorder
         subjects affected / exposed
    4 / 85 (4.71%)
    4 / 84 (4.76%)
    23 / 250 (9.20%)
         occurrences all number
    4
    4
    24
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    6 / 85 (7.06%)
    3 / 84 (3.57%)
    25 / 250 (10.00%)
         occurrences all number
    6
    3
    28
    Back pain
         subjects affected / exposed
    5 / 85 (5.88%)
    5 / 84 (5.95%)
    15 / 250 (6.00%)
         occurrences all number
    5
    5
    17
    Myalgia
         subjects affected / exposed
    1 / 85 (1.18%)
    4 / 84 (4.76%)
    22 / 250 (8.80%)
         occurrences all number
    1
    5
    22
    Pain in extremity
         subjects affected / exposed
    1 / 85 (1.18%)
    0 / 84 (0.00%)
    13 / 250 (5.20%)
         occurrences all number
    1
    0
    15
    Infections and infestations
    Influenza
         subjects affected / exposed
    0 / 85 (0.00%)
    6 / 84 (7.14%)
    12 / 250 (4.80%)
         occurrences all number
    0
    6
    12
    Nasopharyngitis
         subjects affected / exposed
    9 / 85 (10.59%)
    4 / 84 (4.76%)
    36 / 250 (14.40%)
         occurrences all number
    9
    4
    41
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    4 / 85 (4.71%)
    5 / 84 (5.95%)
    16 / 250 (6.40%)
         occurrences all number
    4
    6
    16

    More information

    Close Top of page

    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    05 Jul 2012
    Addressed comments received from the Voluntary Harmonisation Procedure (VHP).
    06 Feb 2013
    Provided extended treatment duration (to 24 weeks) for participants with genotype 3 HCV infection and for early termination of treatment for placebo recipients.

    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.

    Online references

    http://www.ncbi.nlm.nih.gov/pubmed/24795201
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Fri Apr 26 13:13:25 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA