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    Clinical Trial Results:
    A Phase 2, Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/Ledipasvir Fixed-Dose Combination in Treatment-Naive and Treatment-Experienced Subjects with Chronic Genotype 4 or 5 HCV Infection

    Summary
    EudraCT number
    		 2013-003978-27
    Trial protocol
    		 FR  
    Global end of trial date
    17 Feb 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    15 May 2016
    First version publication date
    15 May 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    GS-US-337-1119
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02081079
    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
    17 Feb 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    17 Feb 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This study was to evaluate the efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) in participants with chronic genotype 4 or 5 hepatitis C virus (HCV) infection as measured by the proportion of subjects with sustained virologic response (SVR12), defined as HCV RNA < lower limit of quantification (LLOQ) 12 weeks after discontinuation of therapy.
    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 Mar 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
    France: 85
    Worldwide total number of subjects
    85
    EEA total number of subjects
    85
    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)
    62
    From 65 to 84 years
    23
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants were enrolled at study sites in France. The first participant was screened on 07 March 2014. The last study visit occurred on 17 February 2015.

    Pre-assignment
    Screening details
    		 91 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
    		 Genotype 4
    Arm description
    		 LDV/SOF FDC for up to 12 weeks in participants with genotype 4 HCV infection
    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
    Ledipasvir/sofosbuvir (90/400 mg) FDC once daily

    Arm title
    		 Genotype 5
    Arm description
    		 LDV/SOF FDC for up to 12 weeks in participants with genotype 5 HCV infection
    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
    Ledipasvir/sofosbuvir (90/400 mg) FDC once daily

    Number of subjects in period 1
    		Genotype 4 Genotype 5
    Started
    44
    41
    Completed
    40
    39
    Not completed
    4
    2
         Lost to follow-up
    1
    -
         Lack of efficacy
    3
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Genotype 4
    Reporting group description
    		 LDV/SOF FDC for up to 12 weeks in participants with genotype 4 HCV infection

    Reporting group title
    Genotype 5
    Reporting group description
    		 LDV/SOF FDC for up to 12 weeks in participants with genotype 5 HCV infection

    Reporting group values
    		 Genotype 4 Genotype 5 Total
    Number of subjects
    		 44 41 85
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 51 ( 8.9 ) 63 ( 9.6 ) -
    Gender categorical
    Units: Subjects
        Female
    		 16 20 36
        Male
    		 28 21 49
    Race
    Units: Subjects
        Black or African American
    		 8 0 8
        White
    		 36 41 77
    HCV Genotype
    Units: Subjects
        Genotype 4
    		 44 0 44
        Genotype 5
    		 0 41 41
    Cirrhosis Status
    Units: Subjects
        Absence
    		 34 32 66
        Presence
    		 10 9 19
    IL28b Status
    The CC, CT, and TT alleles are different forms of the IL28b gene.
    Units: Subjects
        CC
    		 8 19 27
        CT
    		 27 18 45
        TT
    		 9 4 13
    HCV RNA
    Units: log10 copies/mL
        arithmetic mean (standard deviation)
    		 6.2 ( 0.47 ) 64 ( 0.47 ) -
    Subject analysis sets

    Subject analysis set title
    Genotype 4: Treatment-naive
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    LDV/SOF FDC for up to 12 weeks in treatment-naive participants with genotype 4 HCV infection

    Subject analysis set title
    Genotype 4: Treatment-experienced
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    LDV/SOF FDC for up to 12 weeks in treatment-experienced participants with genotype 4 HCV infection

    Subject analysis set title
    Genotype 5: Treatment-naive
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    LDV/SOF FDC for up to 12 weeks in treatment-naive participants with genotype 5 HCV infection

    Subject analysis set title
    Genotype 5: Treatment-experienced
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    LDV/SOF FDC for up to 12 weeks in treatment-experienced participants with genotype 5 HCV infection

    Subject analysis sets values
    		 Genotype 4: Treatment-naive Genotype 4: Treatment-experienced Genotype 5: Treatment-naive Genotype 5: Treatment-experienced
    Number of subjects
    22
    22
    21
    20
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    52 ( 9.2 )
    50 ( 8.8 )
    61 ( 10.4 )
    64 ( 8.6 )
    Gender categorical
    Units: Subjects
        Female
    11
    5
    10
    10
        Male
    11
    17
    11
    10
    Race
    Units: Subjects
        Black or African American
    3
    5
    0
    0
        White
    19
    17
    21
    20
    HCV Genotype
    Units: Subjects
        Genotype 4
    22
    22
    0
    0
        Genotype 5
    0
    0
    21
    20
    Cirrhosis Status
    Units: Subjects
        Absence
    21
    13
    18
    14
        Presence
    1
    9
    3
    6
    IL28b Status
    The CC, CT, and TT alleles are different forms of the IL28b gene.
    Units: Subjects
        CC
    7
    1
    13
    6
        CT
    11
    16
    7
    11
        TT
    4
    5
    1
    3
    HCV RNA
    Units: log10 copies/mL
        arithmetic mean (standard deviation)
    6 ( 0.4 )
    6.3 ( 0.48 )
    6.2 ( 0.48 )
    6.6 ( 0.39 )

    End points

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    End points reporting groups
    Reporting group title
    Genotype 4
    Reporting group description
    		 LDV/SOF FDC for up to 12 weeks in participants with genotype 4 HCV infection

    Reporting group title
    Genotype 5
    Reporting group description
    		 LDV/SOF FDC for up to 12 weeks in participants with genotype 5 HCV infection

    Subject analysis set title
    Genotype 4: Treatment-naive
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    LDV/SOF FDC for up to 12 weeks in treatment-naive participants with genotype 4 HCV infection

    Subject analysis set title
    Genotype 4: Treatment-experienced
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    LDV/SOF FDC for up to 12 weeks in treatment-experienced participants with genotype 4 HCV infection

    Subject analysis set title
    Genotype 5: Treatment-naive
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    LDV/SOF FDC for up to 12 weeks in treatment-naive participants with genotype 5 HCV infection

    Subject analysis set title
    Genotype 5: Treatment-experienced
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    LDV/SOF FDC for up to 12 weeks in treatment-experienced participants with genotype 5 HCV infection

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

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    End point title
    		 Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) [1]
    End point description
    SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment. Full Analysis Set: participants were enrolled and received at least 1 dose of study drug.
    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 statistical analysis was planned or performed.
    End point values
    		 Genotype 4: Treatment-naive Genotype 4: Treatment-experienced Genotype 5: Treatment-naive Genotype 5: Treatment-experienced
    Number of subjects analysed
    22
    22
    21
    20
    Units: percentage of participants
        number (not applicable)
    95.5
    90.9
    95.2
    95
    No statistical analyses for this end point

    Primary: Percentage of Participants Who Permanently Discontinued LDV/SOF Due to an Adverse Event

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    End point title
    		 Percentage of Participants Who Permanently Discontinued LDV/SOF Due to an Adverse Event [2]
    End point description
    Safety Analysis Set: participants were enrolled and received at least 1 dose of study drug.
    End point type
    Primary
    End point timeframe
    Up to 12 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 analysis was planned or performed.
    End point values
    		 Genotype 4 Genotype 5
    Number of subjects analysed
    44
    41
    Units: percentage of participants
        number (not applicable)
    0
    0
    No statistical analyses for this end point

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

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    End point title
    		 Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
    End point description
    SVR4 and SVR 24 were defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively. Full Analysis Set
    End point type
    Secondary
    End point timeframe
    Posttreatment Weeks 4 and 24
    End point values
    		 Genotype 4: Treatment-naive Genotype 4: Treatment-experienced Genotype 5: Treatment-naive Genotype 5: Treatment-experienced
    Number of subjects analysed
    22
    22
    21
    20
    Units: percentage of participants
    number (not applicable)
        SVR4
    95.5
    90.9
    95.2
    95
        SVR24
    95.5
    90.9
    95.2
    95
    No statistical analyses for this end point

    Secondary: Percentage of Patients With Virologic Failure

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    End point title
    		 Percentage of Patients With Virologic Failure
    End point description
    Virologic failure was defined as either: • On-treatment virologic failure: o Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or o Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or o Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment); OR • Relapse: o HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at end of treatment, 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
    		 Genotype 4: Treatment-naive Genotype 4: Treatment-experienced Genotype 5: Treatment-naive Genotype 5: Treatment-experienced
    Number of subjects analysed
    22
    22
    21
    20
    Units: percentage of participants
    number (not applicable)
        On-treatment Virologic Failure
    0
    0
    0
    0
        Relapse
    4.5
    9.1
    4.8
    5
    No statistical analyses for this end point

    Secondary: Change From Baseline in HCV RNA at Weeks 2, 4, 8, and 12

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    End point title
    		 Change From Baseline in HCV RNA at Weeks 2, 4, 8, and 12
    End point description
    Full Analysis Set
    End point type
    Secondary
    End point timeframe
    Baseline; Weeks 2, 4, 8, and 12
    End point values
    		 Genotype 4: Treatment-naive Genotype 4: Treatment-experienced Genotype 5: Treatment-naive Genotype 5: Treatment-experienced
    Number of subjects analysed
    22
    22
    21
    20
    Units: log10 IU/mL
    arithmetic mean (standard deviation)
        Change at Week 2
    -4.65 ( 0.397 )
    -4.77 ( 0.495 )
    -4.97 ( 0.479 )
    -4.94 ( 0.477 )
        Change at Week 4
    -4.86 ( 0.396 )
    -5.17 ( 0.49 )
    -5.07 ( 0.474 )
    -5.39 ( 0.381 )
        Change at Week 8
    -4.88 ( 0.401 )
    -5.18 ( 0.484 )
    -5.07 ( 0.474 )
    -5.45 ( 0.387 )
        Change at Week 12
    -4.88 ( 0.401 )
    -5.18 ( 0.484 )
    -5.07 ( 0.474 )
    -5.45 ( 0.387 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 12 weeks plus 30 days
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    Genotype 4
    Reporting group description
    		 Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) for up to 12 weeks in participants with genotype 4 hepatitis C virus (HCV) infection

    Reporting group title
    Genotype 5
    Reporting group description
    		 LDV/SOF (90/400 mg) FDC for up to 12 weeks in participants with genotype 5 HCV infection

    Serious adverse events
    		 Genotype 4 Genotype 5
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 44 (0.00%)
    1 / 41 (2.44%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Psychiatric disorders
    Depression
         subjects affected / exposed
    0 / 44 (0.00%)
    1 / 41 (2.44%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Genotype 4 Genotype 5
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    31 / 44 (70.45%)
    31 / 41 (75.61%)
    Injury, poisoning and procedural complications
    Wound
         subjects affected / exposed
    3 / 44 (6.82%)
    0 / 41 (0.00%)
         occurrences all number
    3
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    11 / 44 (25.00%)
    11 / 41 (26.83%)
         occurrences all number
    14
    13
    Dizziness
         subjects affected / exposed
    0 / 44 (0.00%)
    3 / 41 (7.32%)
         occurrences all number
    0
    3
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    10 / 44 (22.73%)
    16 / 41 (39.02%)
         occurrences all number
    10
    18
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    3 / 44 (6.82%)
    1 / 41 (2.44%)
         occurrences all number
    3
    1
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    4 / 44 (9.09%)
    3 / 41 (7.32%)
         occurrences all number
    4
    3
    Nausea
         subjects affected / exposed
    4 / 44 (9.09%)
    1 / 41 (2.44%)
         occurrences all number
    4
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    4 / 44 (9.09%)
    2 / 41 (4.88%)
         occurrences all number
    4
    2
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    4 / 44 (9.09%)
    1 / 41 (2.44%)
         occurrences all number
    4
    1
    Arthralgia
         subjects affected / exposed
    1 / 44 (2.27%)
    3 / 41 (7.32%)
         occurrences all number
    1
    3
    Myalgia
         subjects affected / exposed
    1 / 44 (2.27%)
    3 / 41 (7.32%)
         occurrences all number
    1
    3
    Musculoskeletal pain
         subjects affected / exposed
    0 / 44 (0.00%)
    3 / 41 (7.32%)
         occurrences all number
    0
    3
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    0 / 44 (0.00%)
    3 / 41 (7.32%)
         occurrences all number
    0
    3
    Urinary tract infection
         subjects affected / exposed
    0 / 44 (0.00%)
    3 / 41 (7.32%)
         occurrences all number
    0
    3

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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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