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    Clinical Trial Results:
    An open-Label, multicenter study to evaluate the efficacy and safety of sofosbuvir/ledipasvir fixed-dose combination ± ribavirin for 12 or 24 weeks in chronic genotype 1 HCV infected subjects who participated in a prior gilead-sponsored HCV treatment study

    Summary
    EudraCT number
    		 2014-001245-24
    Trial protocol
    		 ES  
    Global end of trial date
    12 Nov 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    28 Nov 2016
    First version publication date
    28 Nov 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    GS-US-337-1118
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01987453
    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
    12 Nov 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    12 Nov 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) with or without ribavirin (RBV) in participants with chronic genotype 1 hepatitis C virus (HCV) infection who have participated in a prior Gilead-sponsored HCV treatment study, and who did not achieve sustained virologic response (SVR24), defined as HCV RNA < lower limit of quantification (LLOQ) 24 weeks after last dose of study drug (SVR24).
    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
    30 Jul 2014
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Spain: 3
    Country: Number of subjects enrolled
    United States: 96
    Country: Number of subjects enrolled
    Australia: 1
    Worldwide total number of subjects
    100
    EEA total number of subjects
    3
    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)
    85
    From 65 to 84 years
    15
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants were enrolled at study sites in the US, Australia, and Spain. The first participant was screened on 30 July 2014. The last study visit occurred on 12 November 2015.

    Pre-assignment
    Screening details
    		 101 participants were screened.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 LDV/SOF + RBV 12 weeks (Group 1)
    Arm description
    		 Participants who failed a prior sofosbuvir (SOF) + ribavirin (RBV) ± pegylated interferon (Peg-IFN) regimen received LDV/SOF + RBV for 12 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ledipasvir/sofosbuvir
    Investigational medicinal product code
    Other name
    Harvoni®; GS-5885/GS-7977
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    90/400 mg FDC administered once daily

    Investigational medicinal product name
    Ribavirin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1000 or 1200 mg daily based on weight for 12 weeks

    Arm title
    		 LDV/SOF 24 weeks (Group 2)
    Arm description
    		 Participants who failed a prior LDV/SOF±RBV regimen received LDV/SOF for 24 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ledipasvir/sofosbuvir
    Investigational medicinal product code
    Other name
    Harvoni®; GS-5885/GS-7977
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    90/400 mg FDC administered once daily

    Arm title
    		 LDV/SOF + RBV 24 weeks (Group 3)
    Arm description
    		 Participants with advanced compensated or decompensated cirrhosis who failed a prior SOF+RBV regimen received LDV/SOF + RBV for 24 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ledipasvir/sofosbuvir
    Investigational medicinal product code
    Other name
    Harvoni®; GS-5885/GS-7977
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    90/400 mg FDC administered once daily

    Investigational medicinal product name
    Ribavirin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Ribavirin (dose adjusted according to hemoglobin and renal status) administered for 24 weeks

    Number of subjects in period 1
    		LDV/SOF + RBV 12 weeks (Group 1) LDV/SOF 24 weeks (Group 2) LDV/SOF + RBV 24 weeks (Group 3)
    Started
    51
    41
    8
    Completed
    50
    29
    7
    Not completed
    1
    12
    1
         Death
    -
    -
    1
         Lack of efficacy
    1
    12
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    LDV/SOF + RBV 12 weeks (Group 1)
    Reporting group description
    		 Participants who failed a prior sofosbuvir (SOF) + ribavirin (RBV) ± pegylated interferon (Peg-IFN) regimen received LDV/SOF + RBV for 12 weeks.

    Reporting group title
    LDV/SOF 24 weeks (Group 2)
    Reporting group description
    		 Participants who failed a prior LDV/SOF±RBV regimen received LDV/SOF for 24 weeks.

    Reporting group title
    LDV/SOF + RBV 24 weeks (Group 3)
    Reporting group description
    		 Participants with advanced compensated or decompensated cirrhosis who failed a prior SOF+RBV regimen received LDV/SOF + RBV for 24 weeks.

    Reporting group values
    		 LDV/SOF + RBV 12 weeks (Group 1) LDV/SOF 24 weeks (Group 2) LDV/SOF + RBV 24 weeks (Group 3) Total
    Number of subjects
    		 51 41 8 100
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 54 ( 8.7 ) 58 ( 6.9 ) 61 ( 6.7 ) -
    Gender categorical
    Units: Subjects
        Female
    		 20 7 1 28
        Male
    		 31 34 7 72
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 4 5 0 9
        Not Hispanic or Latino
    		 47 36 8 91
    Race
    Units: Subjects
        Black or African American
    		 8 10 1 19
        White
    		 43 31 7 81
    Prior HCV Treatment Experience
    Units: Subjects
        SOF+PEG+RBV
    		 25 0 0 25
        SOF+RBV
    		 20 0 8 28
        LDV/SOF
    		 0 18 0 18
        LDV/SOF+RBV
    		 0 15 0 15
        LDV/SOF+GS-9669
    		 0 8 0 8
        Without SOF
    		 6 0 0 6
    IL28B
    The CC, CT, and TT alleles are different forms of the IL28b gene.
    Units: Subjects
        CC
    		 4 3 0 7
        CT
    		 33 27 7 67
        TT
    		 14 11 1 26
    HCV RNA Category
    Units: Subjects
        < 800,000 IU/mL
    		 13 11 6 30
        >= 800,000 IU/mL
    		 38 30 2 70
    HCV RNA
    Units: log10 IU/mL
        arithmetic mean (standard deviation)
    		 6.2 ( 0.58 ) 6.2 ( 0.62 ) 5.6 ( 0.44 ) -

    End points

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    End points reporting groups
    Reporting group title
    LDV/SOF + RBV 12 weeks (Group 1)
    Reporting group description
    		 Participants who failed a prior sofosbuvir (SOF) + ribavirin (RBV) ± pegylated interferon (Peg-IFN) regimen received LDV/SOF + RBV for 12 weeks.

    Reporting group title
    LDV/SOF 24 weeks (Group 2)
    Reporting group description
    		 Participants who failed a prior LDV/SOF±RBV regimen received LDV/SOF for 24 weeks.

    Reporting group title
    LDV/SOF + RBV 24 weeks (Group 3)
    Reporting group description
    		 Participants with advanced compensated or decompensated cirrhosis who failed a prior SOF+RBV regimen received LDV/SOF + RBV for 24 weeks.

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

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    End point title
    		 Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12) [1]
    End point description
    SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study treatment. Full Analysis Set: participants enrolled into the study and received at least 1 dose of study drug
    End point type
    Primary
    End point timeframe
    Post-treatment 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 statistical comparison was planned or performed.
    End point values
    		 LDV/SOF + RBV 12 weeks (Group 1) LDV/SOF 24 weeks (Group 2) LDV/SOF + RBV 24 weeks (Group 3)
    Number of subjects analysed
    51
    41
    8
    Units: percentage of participants
        number (not applicable)
    98
    70.7
    100
    No statistical analyses for this end point

    Primary: Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event

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    End point title
    		 Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event [2]
    End point description
    Safety Analysis Set: participants who received at least 1 dose of study drug
    End point type
    Primary
    End point timeframe
    Up to 24 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 comparison was planned or performed.
    End point values
    		 LDV/SOF + RBV 12 weeks (Group 1) LDV/SOF 24 weeks (Group 2) LDV/SOF + RBV 24 weeks (Group 3)
    Number of subjects analysed
    51
    41
    8
    Units: percentage of participants
        number (not applicable)
    5.9
    0
    0
    No statistical analyses for this end point

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

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    End point title
    		 Percentage of Participants With Sustained Virologic Response (SVR) at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
    End point description
    SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study treatment, respectively. Full Analysis set
    End point type
    Secondary
    End point timeframe
    Posttreatment Weeks 4 and 24
    End point values
    		 LDV/SOF + RBV 12 weeks (Group 1) LDV/SOF 24 weeks (Group 2) LDV/SOF + RBV 24 weeks (Group 3)
    Number of subjects analysed
    51
    41
    8
    Units: percentage of participants
    number (not applicable)
        SVR4
    98
    73.2
    100
        SVR24
    98
    70.7
    100
    No statistical analyses for this end point

    Secondary: Percentage of Participants With HCV RNA < LLOQ While on Treatment

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    End point title
    		 Percentage of Participants With HCV RNA < LLOQ While on Treatment
    End point description
    Full Analysis Set
    End point type
    Secondary
    End point timeframe
    Baseline to Week 24
    End point values
    		 LDV/SOF + RBV 12 weeks (Group 1) LDV/SOF 24 weeks (Group 2) LDV/SOF + RBV 24 weeks (Group 3)
    Number of subjects analysed
    51
    41
    8
    Units: percentage of participants
    number (not applicable)
        Week 1
    23.5
    31.7
    0
        Week 4
    98
    95.1
    100
        Week 8
    100
    100
    100
        Week 12
    100
    100
    100
        Week 16
    999
    97.6
    100
        Week 20
    999
    97.6
    100
        Week 24
    999
    100
    100
    No statistical analyses for this end point

    Secondary: Change in HCV RNA From Baseline

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    End point title
    		 Change in HCV RNA From Baseline
    End point description
    Full Analysis Set
    End point type
    Secondary
    End point timeframe
    Baseline to Week 8
    End point values
    		 LDV/SOF + RBV 12 weeks (Group 1) LDV/SOF 24 weeks (Group 2) LDV/SOF + RBV 24 weeks (Group 3)
    Number of subjects analysed
    51
    41
    8
    Units: log10 IU/mL
    arithmetic mean (standard deviation)
        Change at Week 1
    -4.47 ( 0.5 )
    -4.4 ( 0.535 )
    -3.75 ( 0.878 )
        Change at Week 4
    -5.07 ( 0.565 )
    -5.06 ( 0.6 )
    -4.47 ( 0.441 )
        Change at Week 8
    -5.09 ( 0.583 )
    -5.08 ( 0.617 )
    -4.47 ( 0.441 )
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Virologic Failure

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    End point title
    		 Percentage of Participants With Virologic Failure
    End point description
    Virologic failure was defined as: • On-treatment virologic failure: • Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or • Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or • Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment) • Virologic relapse: • Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last ontreatment visit confirmed with 2 consecutive values or last available posttreatment measurement Full Analysis Set
    End point type
    Secondary
    End point timeframe
    Up to posttreatment Week 24
    End point values
    		 LDV/SOF + RBV 12 weeks (Group 1) LDV/SOF 24 weeks (Group 2) LDV/SOF + RBV 24 weeks (Group 3)
    Number of subjects analysed
    51
    41
    8
    Units: percentage of participants
    number (not applicable)
        On treatment Virologic Failure
    0
    2.4
    0
        Relapse
    2
    27.5
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 24 weeks plus 30 days
    Adverse event reporting additional description
    Safety Analysis Set: participants who received at least 1 dose of study drug
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.1
    Reporting groups
    Reporting group title
    LDV/SOF + RBV 12 (Group 1)
    Reporting group description
    		 Participants who failed a prior sofosbuvir (SOF) + ribavirin (RBV) ± pegylated interferon (Peg-IFN) regimen received LDV/SOF + RBV for 12 weeks. .

    Reporting group title
    LDV/SOF 24 Week (Group 2)
    Reporting group description
    		 Participants who failed a prior LDV/SOF±RBV regimen received LDV/SOF for 24 weeks.

    Reporting group title
    LDV/SOF + RBV (Group 2)
    Reporting group description
    		 Participants with advanced compensated or decompensated cirrhosis who failed a prior SOF+RBV regimen received LDV/SOF + RBV for 24 weeks.

    Serious adverse events
    		 LDV/SOF + RBV 12 (Group 1) LDV/SOF 24 Week (Group 2) LDV/SOF + RBV (Group 2)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 51 (3.92%)
    2 / 41 (4.88%)
    2 / 8 (25.00%)
         number of deaths (all causes)
    0
    0
    1
         number of deaths resulting from adverse events
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Hepatocellular carcinoma
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 41 (2.44%)
    0 / 8 (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
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Oedema genital
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 41 (0.00%)
    1 / 8 (12.50%)
         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
    Bipolar disorder
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 41 (0.00%)
    0 / 8 (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
    Renal and urinary disorders
    Renal failure
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 41 (0.00%)
    1 / 8 (12.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Musculoskeletal and connective tissue disorders
    Intervertebral disc protrusion
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 41 (2.44%)
    0 / 8 (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
    Infections and infestations
    Anal abscess
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 41 (0.00%)
    1 / 8 (12.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cholecystitis infective
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 41 (0.00%)
    0 / 8 (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
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 LDV/SOF + RBV 12 (Group 1) LDV/SOF 24 Week (Group 2) LDV/SOF + RBV (Group 2)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    37 / 51 (72.55%)
    16 / 41 (39.02%)
    7 / 8 (87.50%)
    Investigations
    Haemoglobin decreased
         subjects affected / exposed
    2 / 51 (3.92%)
    0 / 41 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    2
    0
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    11 / 51 (21.57%)
    6 / 41 (14.63%)
    0 / 8 (0.00%)
         occurrences all number
    11
    6
    0
    Encephalopathy
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 41 (0.00%)
    2 / 8 (25.00%)
         occurrences all number
    0
    0
    2
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    13 / 51 (25.49%)
    4 / 41 (9.76%)
    3 / 8 (37.50%)
         occurrences all number
    13
    4
    3
    Pyrexia
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 41 (0.00%)
    2 / 8 (25.00%)
         occurrences all number
    1
    0
    2
    Oedema
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 41 (0.00%)
    2 / 8 (25.00%)
         occurrences all number
    0
    0
    2
    Odema Peripheral
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 41 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    0
    1
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    7 / 51 (13.73%)
    2 / 41 (4.88%)
    2 / 8 (25.00%)
         occurrences all number
    8
    2
    2
    Nausea
         subjects affected / exposed
    5 / 51 (9.80%)
    1 / 41 (2.44%)
    2 / 8 (25.00%)
         occurrences all number
    6
    1
    3
    Constipation
         subjects affected / exposed
    4 / 51 (7.84%)
    1 / 41 (2.44%)
    0 / 8 (0.00%)
         occurrences all number
    4
    1
    0
    Vomiting
         subjects affected / exposed
    3 / 51 (5.88%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    3
    0
    0
    Abdominal pain upper
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 41 (0.00%)
    2 / 8 (25.00%)
         occurrences all number
    0
    0
    2
    Abdominal pain
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 41 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    1
    0
    1
    Ascites
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 41 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    0
    1
    Oesophagitis
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 41 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 51 (1.96%)
    2 / 41 (4.88%)
    1 / 8 (12.50%)
         occurrences all number
    1
    2
    1
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    6 / 51 (11.76%)
    1 / 41 (2.44%)
    0 / 8 (0.00%)
         occurrences all number
    7
    1
    0
    Pruritus
         subjects affected / exposed
    3 / 51 (5.88%)
    0 / 41 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    3
    0
    2
    Rash maculo-papular
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 41 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    0
    1
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    6 / 51 (11.76%)
    3 / 41 (7.32%)
    2 / 8 (25.00%)
         occurrences all number
    6
    3
    2
    Depression
         subjects affected / exposed
    3 / 51 (5.88%)
    1 / 41 (2.44%)
    0 / 8 (0.00%)
         occurrences all number
    3
    1
    0
    Irritability
         subjects affected / exposed
    3 / 51 (5.88%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    3
    0
    0
    Infections and infestations
    Influenza
         subjects affected / exposed
    3 / 51 (5.88%)
    0 / 41 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    3
    0
    1
    Sinusitis
         subjects affected / exposed
    3 / 51 (5.88%)
    1 / 41 (2.44%)
    0 / 8 (0.00%)
         occurrences all number
    3
    1
    0
    Upper respiratory tract infection'
         subjects affected / exposed
    1 / 51 (1.96%)
    1 / 41 (2.44%)
    1 / 8 (12.50%)
         occurrences all number
    1
    1
    1
    Anal abscess
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 41 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    0
    2
    Conjunctivitis
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 41 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    0
    1
    Respiratory tract infection
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 41 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    0
    1
    Viral infection
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 41 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    0
    1
    Metabolism and nutrition disorders
    Arthralgia
         subjects affected / exposed
    3 / 51 (5.88%)
    2 / 41 (4.88%)
    0 / 8 (0.00%)
         occurrences all number
    1
    2
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    06 Jan 2014
    Protocol title was updated to reflect additional treatment arm. Duration of treatment was extended as a result of Group 2 treatment length. Objectives were updated to reflect Group 2 Arm which didn't include ribavirin. Study design was revised to detail about stratification of subjects into different treatment groups. Study procedure and frequency sections were updated to account for additional visits for Group 2 subjects on 24 week regimen. Statistical methods were updated as a result of additional group. Updated rational of the current study and risk/benefit assessment to account for inclusion of Group 2 subjects.
    09 Apr 2014
    Duration of treatment was updated to include Group 3 treatment arm of 24 weeks. Study design was updated to detail about stratification of subjects into different treatment groups. Updated eligibility criteria for inclusion of Group 3 subjects. Revised study procedures/frequency to include additional assessments required by Group 3 subjects. Updated test product, dose and mode of administration specific to inclusion of Group 3 subjects

    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/25846014
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