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    Clinical Trial Results:
    A Phase 2, Multicenter, Randomized, Open-Label Study to Evaluate the Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed Dose Combination (FDC) and Sofosbuvir/Velpatasvir FDC and Ribavirin in Subjects with Chronic Genotype 3 HCV Infection and Cirrhosis

    Summary
    EudraCT number
    		 2016-000417-73
    Trial protocol
    		 ES  
    Global end of trial date
    27 Oct 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    26 Oct 2018
    First version publication date
    26 Oct 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    GS-US-342-2097
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02781558
    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
    27 Oct 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    06 Oct 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    27 Oct 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) and SOF/VEL FDC and ribavirin (RBV) for 12 weeks in participants with chronic genotype 3 hepatitis C virus (HCV) infection and compensated cirrhosis.
    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
    29 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: 204
    Worldwide total number of subjects
    204
    EEA total number of subjects
    204
    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)
    199
    From 65 to 84 years
    4
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants were enrolled at study sites in Spain. The first participant was screened on 29 July 2016. The last study visit occurred on 27 October 2017.

    Pre-assignment
    Screening details
    		 269 participants were screened.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 SOF/VEL
    Arm description
    		 SOF/VEL for 12 weeks
    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 FDC administered once daily

    Arm title
    		 SOF/VEL + RBV
    Arm description
    		 SOF/VEL + RBV for 12 weeks
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ribavirin
    Investigational medicinal product code
    Other name
    RBV
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1000 or 1200 mg daily based on weight (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)

    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 FDC administered once daily

    Number of subjects in period 1
    		SOF/VEL SOF/VEL + RBV
    Started
    101
    103
    Completed
    98
    101
    Not completed
    3
    2
         Adverse event, non-fatal
    1
    -
         Lost to follow-up
    2
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    SOF/VEL
    Reporting group description
    		 SOF/VEL for 12 weeks

    Reporting group title
    SOF/VEL + RBV
    Reporting group description
    		 SOF/VEL + RBV for 12 weeks

    Reporting group values
    		 SOF/VEL SOF/VEL + RBV Total
    Number of subjects
    		 101 103 204
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 51 ± 7.3 51 ± 7.6 -
    Gender categorical
    Units: Subjects
        Female
    		 26 16 42
        Male
    		 75 87 162
    Race
    Units: Subjects
        White
    		 84 95 179
        Asian
    		 17 8 25
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 9 10 19
        Not Hispanic or Latino
    		 92 93 185
    IL28B
    The CC, CT, and TT alleles are different forms of the IL28b gene.
    Units: Subjects
        CC
    		 64 53 117
        Non-CC
    		 36 50 86
        Missing
    		 1 0 1
    HCV RNA Category
    Units: Subjects
        < 800,000 IU/mL
    		 32 24 56
        ≥ 800,000 IU/mL
    		 69 79 148
    HCV RNA
    Units: log10 IU/mL
        arithmetic mean (standard deviation)
    		 6.2 ± 0.64 6.3 ± 0.56 -

    End points

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    End points reporting groups
    Reporting group title
    SOF/VEL
    Reporting group description
    		 SOF/VEL for 12 weeks

    Reporting group title
    SOF/VEL + RBV
    Reporting group description
    		 SOF/VEL + RBV for 12 weeks

    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; ie, 15 IU/mL) at 12 weeks after stopping study treatment. Participants in the Full Analysis Set (all randomized participants who took at least 1 dose of any 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 SOF/VEL + RBV
    Number of subjects analysed
    101
    103
    Units: percentage of participants
        number (confidence interval 95%)
    91.1 (83.8 to 95.8)
    96.1 (90.4 to 98.9)
    No statistical analyses for this end point

    Secondary: Percentage of Participants Who Permanently Discontinued Any Study Drug (Which Included SOF/VEL and RBV) Due to Any Adverse Event

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    End point title
    		 Percentage of Participants Who Permanently Discontinued Any Study Drug (Which Included SOF/VEL and RBV) Due to Any Adverse Event
    End point description
    Participants in the Safety Analysis Set (participants who took at least 1 dose of any study drug (which included SOF/VEL and RBV)) were analyzed.
    End point type
    Secondary
    End point timeframe
    Posttreatment Week 12
    End point values
    		 SOF/VEL SOF/VEL + RBV
    Number of subjects analysed
    101
    103
    Units: percentage of participants
        number (not applicable)
    1.0
    1.9
    No statistical analyses for this end point

    Secondary: Percentage of Participants Who Attain Sustained Virologic Response at 4 Weeks After Cessation of the Study Treatment Regimen (SVR4)

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    End point title
    		 Percentage of Participants Who Attain Sustained Virologic Response at 4 Weeks After Cessation of the Study Treatment Regimen (SVR4)
    End point description
    SVR4 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 4 weeks after stopping study treatment. Participants on the Full Analysis Set were analyzed.
    End point type
    Secondary
    End point timeframe
    Posttreatment Week 4
    End point values
    		 SOF/VEL SOF/VEL + RBV
    Number of subjects analysed
    101
    103
    Units: percentage of participants
        number (confidence interval 95%)
    93.1 (86.2 to 97.2)
    97.1 (91.7 to 99.4)
    No statistical analyses for this end point

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

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    End point title
    		 Percentage of Participants Who Have HCV RNA < LLOQ 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 SOF/VEL + RBV
    Number of subjects analysed
    100
    103
    Units: percentage of participants
        number (confidence interval 95%)
    51.0 (40.8 to 61.1)
    44.7 (34.9 to 54.8)
    No statistical analyses for this end point

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

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    End point title
    		 Percentage of Participants Who Have 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 SOF/VEL + RBV
    Number of subjects analysed
    100
    103
    Units: percentage of participants
        number (confidence interval 95%)
    85.0 (76.5 to 91.4)
    90.3 (82.9 to 95.2)
    No statistical analyses for this end point

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

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    End point title
    		 Percentage of Participants Who Have 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 SOF/VEL + RBV
    Number of subjects analysed
    100
    102
    Units: Percentage of participants
        number (confidence interval 95%)
    99.0 (94.6 to 100.0)
    100.0 (96.4 to 100.0)
    No statistical analyses for this end point

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

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    End point title
    		 Percentage of Participants Who Have 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 SOF/VEL + RBV
    Number of subjects analysed
    100
    101
    Units: percentage of participants
        number (confidence interval 95%)
    99.0 (94.6 to 100.0)
    100.0 (96.4 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 SOF/VEL + RBV
    Number of subjects analysed
    97
    102
    Units: log10 IU/mL
        arithmetic mean (standard deviation)
    1.52 ± 0.513
    1.47 ± 0.413
    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 SOF/VEL + RBV
    Number of subjects analysed
    100
    103
    Units: log10 IU/mL
        arithmetic mean (standard deviation)
    1.22 ± 0.257
    1.19 ± 0.152
    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 SOF/VEL + RBV
    Number of subjects analysed
    100
    102
    Units: log10 IU/mL
        arithmetic mean (standard deviation)
    1.15 ± 0.040
    1.15 ± 0.000
    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 SOF/VEL + RBV
    Number of subjects analysed
    100
    101
    Units: log10 IU/mL
        arithmetic mean (standard deviation)
    1.15 ± 0.018
    1.15 ± 0.000
    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 SOF/VEL + RBV
    Number of subjects analysed
    97
    102
    Units: log10 IU/mL
        arithmetic mean (standard deviation)
    -4.67 ± 0.627
    -4.80 ± 0.580
    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 SOF/VEL + RBV
    Number of subjects analysed
    100
    103
    Units: log10 IU/mL
        arithmetic mean (standard deviation)
    -4.96 ± 0.641
    -5.09 ± 0.559
    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 SOF/VEL + RBV
    Number of subjects analysed
    100
    102
    Units: log10 IU/mL
        arithmetic mean (standard deviation)
    -5.04 ± 0.638
    -5.13 ± 0.565
    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 SOF/VEL + RBV
    Number of subjects analysed
    100
    101
    Units: log10 IU/mL
        arithmetic mean (standard deviation)
    -5.04 ± 0.640
    -5.13 ± 0.568
    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: 1) On-treatment virologic failure: a) Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or b) Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or c) Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment), or 2) Virologic relapse: Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last ontreatment visit. 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 SOF/VEL + RBV
    Number of subjects analysed
    101
    103
    Units: percentage of participants2
        number (not applicable)
    5.9
    1.9
    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
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.0
    Reporting groups
    Reporting group title
    SOF/VEL
    Reporting group description
    		 SOF/VEL for 12 weeks

    Reporting group title
    SOF/VEL + RBV
    Reporting group description
    		 SOF/VEL + RBV for 12 weeks

    Serious adverse events
    		 SOF/VEL SOF/VEL + RBV
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 101 (3.96%)
    2 / 103 (1.94%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Hepatic cancer
         subjects affected / exposed
    0 / 101 (0.00%)
    1 / 103 (0.97%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatocellular carcinoma
         subjects affected / exposed
    1 / 101 (0.99%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Non-small cell lung cancer
         subjects affected / exposed
    0 / 101 (0.00%)
    1 / 103 (0.97%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Accident at work
         subjects affected / exposed
    1 / 101 (0.99%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Limb injury
         subjects affected / exposed
    1 / 101 (0.99%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Pharyngotonsillitis
         subjects affected / exposed
    1 / 101 (0.99%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    1 / 101 (0.99%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 SOF/VEL SOF/VEL + RBV
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    24 / 101 (23.76%)
    55 / 103 (53.40%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    8 / 101 (7.92%)
    25 / 103 (24.27%)
         occurrences all number
    12
    29
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    12 / 101 (11.88%)
    28 / 103 (27.18%)
         occurrences all number
    13
    30
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    2 / 101 (1.98%)
    6 / 103 (5.83%)
         occurrences all number
    2
    6
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    2 / 101 (1.98%)
    9 / 103 (8.74%)
         occurrences all number
    2
    9
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    1 / 101 (0.99%)
    12 / 103 (11.65%)
         occurrences all number
    1
    12
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    7 / 101 (6.93%)
    4 / 103 (3.88%)
         occurrences all number
    7
    4

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    04 Apr 2016
    • Clarified that subjects who did not have definitive genotype 3 HCV at screening were not eligible for study participation • The calculation of Child-Pugh-Turcotte (CPT) score was removed from the posttreatment assessments.

    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
    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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