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    Clinical Trial Results:
    A Phase 2, Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed Dose Combination in Subjects with Chronic HCV Infection who have Received a Liver Transplant

    Summary
    EudraCT number
    2016-000416-15
    Trial protocol
    GB  
    Global end of trial date
    28 Jul 2017

    Results information
    Results version number
    v1(current)
    This version publication date
    10 Aug 2018
    First version publication date
    10 Aug 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    GS-US-342-2104
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02781571
    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
    Gilead Clinical Study Information Center, Gilead Sciences, GileadClinicalTrials@gilead.com
    Scientific contact
    Gilead Clinical Study Information Center, Gilead Sciences, GileadClinicalTrials@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
    28 Jul 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    28 Jul 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    28 Jul 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objectives of this study were to evaluate the efficacy, safety, and tolerability of sofosbuvir /velpatasvir (SOF/VEL) fixed-dose combination (FDC) in participants with chronic hepatitis C virus (HCV) who have received a liver transplant.
    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
    27 Jul 2016
    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: 31
    Country: Number of subjects enrolled
    United Kingdom: 41
    Country: Number of subjects enrolled
    Switzerland: 7
    Worldwide total number of subjects
    79
    EEA total number of subjects
    72
    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)
    47
    From 65 to 84 years
    32
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Participants were enrolled at study sites in Spain, Switzerland, and the United Kingdom. The first participant was screened on 27 July 2016. The last study visit occurred on 28 July 2017.

    Pre-assignment
    Screening details
    85 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
    Arm title
    SOF/VEL
    Arm description
    SOF/VEL in participants with chronic HCV infection who received a liver transplant
    Arm type
    Experimental

    Investigational medicinal product name
    Sofosbuvir/Velpatasvir
    Investigational medicinal product code
    Other name
    SOF/VEL; Epclusa®
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    400/100 mg FDC once daily for 12 weeks

    Number of subjects in period 1
    SOF/VEL
    Started
    79
    Completed
    79

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall Study
    Reporting group description
    Safety Analysis Set: participants who took at least 1 dose of the study drug.

    Reporting group values
    Overall Study Total
    Number of subjects
    79 79
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    62 ± 8.7 -
    Gender categorical
    Units: Subjects
        Female
    15 15
        Male
    64 64
    Race
    Units: Subjects
        Black or African American
    2 2
        White
    65 65
        Asian
    12 12
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    2 2
        Not Hispanic or Latino
    77 77
    IL28b Status
    The CC, CT, and TT alleles are different forms of the IL28b gene.
    Units: Subjects
        CC
    39 39
        CT
    34 34
        TT
    6 6
    HCV Genotype
    Units: Subjects
        Genotype 1
    37 37
        Genotype 2
    3 3
        Genotype 3
    35 35
        Genotype 4
    4 4
    HCV RNA Category
    Units: Subjects
        < 800,000 IU/mL
    18 18
        ≥ 800,000 IU/mL
    61 61
    HCV RNA
    Units: log10 IU/mL
        arithmetic mean (standard deviation)
    6.4 ± 0.55 -

    End points

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    End points reporting groups
    Reporting group title
    SOF/VEL
    Reporting group description
    SOF/VEL in participants with chronic HCV infection who received a liver transplant

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

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    End point title
    Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Cessation of Therapy (SVR12) [1]
    End point description
    SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) at 12 weeks after stopping study treatment. Participants in the Full Analysis Set (all enrolled participants who took at least 1 dose of the study drug) were analyzed.
    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 comparison was planned or performed.
    End point values
    SOF/VEL
    Number of subjects analysed
    79
    Units: percentage of participants
        number (confidence interval 95%)
    96.2 (89.3 to 99.2)
    No statistical analyses for this end point

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

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    End point title
    Percentage of Participants Who Permanently Discontinued Study Drug Due to Any Adverse Event [2]
    End point description
    Safety Analysis Set: participants who took at least 1 dose if the 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 comparison was planned or performed.
    End point values
    SOF/VEL
    Number of subjects analysed
    79
    Units: percentage of participants
        number (not applicable)
    1.3
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Sustained Virologic Response 4 Weeks After Cessation of Therapy (SVR4)

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    End point title
    Percentage of Participants With Sustained Virologic Response 4 Weeks After Cessation of Therapy (SVR4)
    End point description
    SVR4 was defined as HCV RNA < LLOQ at 4 weeks after stopping study treatment. Participants in the Full Analysis Set were analyzed.
    End point type
    Secondary
    End point timeframe
    Posttreatment Week 4
    End point values
    SOF/VEL
    Number of subjects analysed
    79
    Units: percentage of participants
        number (confidence interval 95%)
    97.5 (91.2 to 99.7)
    No statistical analyses for this end point

    Secondary: Percentage of Participants With HCV RNA < LLOQ at Week 2

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    End point title
    Percentage of Participants With HCV RNA < LLOQ at Week 2
    End point description
    Participants in the Full Analysis Set were analyzed.
    End point type
    Secondary
    End point timeframe
    Week 2
    End point values
    SOF/VEL
    Number of subjects analysed
    79
    Units: Percentage of participants
        number (confidence interval 95%)
    40.5 (29.6 to 52.1)
    No statistical analyses for this end point

    Secondary: Percentage of Participants With HCV RNA < LLOQ at Week 4

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    End point title
    Percentage of Participants With HCV RNA < LLOQ at Week 4
    End point description
    Participants in the Full Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Week 4
    End point values
    SOF/VEL
    Number of subjects analysed
    78
    Units: percentage of participants
        number (confidence interval 95%)
    85.9 (76.2 to 92.7)
    No statistical analyses for this end point

    Secondary: Percentage of Participants With HCV RNA < LLOQ at Week 8

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    End point title
    Percentage of Participants With HCV RNA < LLOQ at Week 8
    End point description
    Participants in the Full Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Week 8
    End point values
    SOF/VEL
    Number of subjects analysed
    78
    Units: percentage of participants
        number (confidence interval 95%)
    98.7 (93.1 to 100.0)
    No statistical analyses for this end point

    Secondary: Percentage of Participants With HCV RNA < LLOQ at Week 12

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    End point title
    Percentage of Participants With HCV RNA < LLOQ at Week 12
    End point description
    Participants in the Full Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    SOF/VEL
    Number of subjects analysed
    78
    Units: percentage of participants
        number (confidence interval 95%)
    100.0 (95.4 to 100.0)
    No statistical analyses for this end point

    Secondary: HCV RNA at Week 2

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    End point title
    HCV RNA at Week 2
    End point description
    Participants in the Full Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Week 2
    End point values
    SOF/VEL
    Number of subjects analysed
    75
    Units: log10 IU/mL
        arithmetic mean (standard deviation)
    1.59 ± 0.596
    No statistical analyses for this end point

    Secondary: HCV RNA at Week 4

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    End point title
    HCV RNA at Week 4
    End point description
    Participants in the Full Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Week 4
    End point values
    SOF/VEL
    Number of subjects analysed
    78
    Units: log10 IU/mL
        arithmetic mean (standard deviation)
    1.23 ± 0.251
    No statistical analyses for this end point

    Secondary: HCV RNA at Week 8

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    End point title
    HCV RNA at Week 8
    End point description
    Participants in the Full Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Week 8
    End point values
    SOF/VEL
    Number of subjects analysed
    77
    Units: log10 IU/mL
        arithmetic mean (standard deviation)
    1.15 ± 0.00
    No statistical analyses for this end point

    Secondary: HCV RNA at Week 12

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    End point title
    HCV RNA at Week 12
    End point description
    Participants in the Full Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    SOF/VEL
    Number of subjects analysed
    78
    Units: log10 IU/mL
        arithmetic mean (standard deviation)
    1.15 ± 0.00
    No statistical analyses for this end point

    Secondary: Change From Baseline in HCV RNA at Week 2

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    End point title
    Change From Baseline in HCV RNA at Week 2
    End point description
    Participants in the Full Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline; Week 2
    End point values
    SOF/VEL
    Number of subjects analysed
    75
    Units: log10 IU/mL
        arithmetic mean (standard deviation)
    -4.75 ± 0.635
    No statistical analyses for this end point

    Secondary: Change From Baseline in HCV RNA at Week 4

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    End point title
    Change From Baseline in HCV RNA at Week 4
    End point description
    Participants in the Full Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline; Week 4
    End point values
    SOF/VEL
    Number of subjects analysed
    78
    Units: log10 IU/mL
        arithmetic mean (standard deviation)
    -5.13 ± 0.551
    No statistical analyses for this end point

    Secondary: Change From Baseline in HCV RNA at Week 8

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    End point title
    Change From Baseline in HCV RNA at Week 8
    End point description
    Participants in the Full Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline; Week 8
    End point values
    SOF/VEL
    Number of subjects analysed
    77
    Units: log10 IU/mL
        arithmetic mean (standard deviation)
    -5.20 ± 0.548
    No statistical analyses for this end point

    Secondary: Change From Baseline in HCV RNA at Week 12

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    End point title
    Change From Baseline in HCV RNA at Week 12
    End point description
    Participants in the Full Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline; Week 12
    End point values
    SOF/VEL
    Number of subjects analysed
    78
    Units: log10 IU/mL
        arithmetic mean (standard deviation)
    -5.22 ± 0.554
    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 on 2 consecutive measurements 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 12 weeks of treatment) • Virologic relapse: HCV RNA ≥ LLOQ during the post-treatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available post-treatment measurement. Participants in the Full Analysis Set were analyzed.
    End point type
    Secondary
    End point timeframe
    Up to Posttreatment Week 12
    End point values
    SOF/VEL
    Number of subjects analysed
    79
    Units: Percentage of Participants
        number (not applicable)
    2.5
    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
    Adverse event reporting additional description
    Safety Analysis Set: participants who took at least 1 dose of the study drug.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    20
    Reporting groups
    Reporting group title
    SOF/VEL
    Reporting group description
    SOF/VEL in participants with chronic HCV infection who received a liver transplant

    Serious adverse events
    SOF/VEL
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 79 (3.80%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Hepatocellular carcinoma
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal and connective tissue disorders
    Joint swelling
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Pneumonia klebsiella
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    SOF/VEL
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    42 / 79 (53.16%)
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    8 / 79 (10.13%)
         occurrences all number
    8
    Nervous system disorders
    Headache
         subjects affected / exposed
    19 / 79 (24.05%)
         occurrences all number
    19
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    16 / 79 (20.25%)
         occurrences all number
    16
    Asthenia
         subjects affected / exposed
    5 / 79 (6.33%)
         occurrences all number
    5
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    6 / 79 (7.59%)
         occurrences all number
    6
    Nausea
         subjects affected / exposed
    6 / 79 (7.59%)
         occurrences all number
    6
    Musculoskeletal and connective tissue disorders
    Myalgia
         subjects affected / exposed
    4 / 79 (5.06%)
         occurrences all number
    5
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    4 / 79 (5.06%)
         occurrences all number
    4
    Infections and infestations
    Influenza
         subjects affected / exposed
    5 / 79 (6.33%)
         occurrences all number
    6
    Viral upper respiratory tract infection
         subjects affected / exposed
    5 / 79 (6.33%)
         occurrences all number
    5

    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.
    None reported
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