Flag of the European Union EU Clinical Trials Register Help

Clinical trials

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

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

    The EU Clinical Trials Register currently displays   43873   clinical trials with a EudraCT protocol, of which   7293   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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

    < Back to search results

    Download PDF

    Clinical Trial Results:
    A Long Term Follow-up Registry for Subjects Who Achieve a Sustained Virologic Response to Treatment in Gilead Sponsored Trials in Subjects with Chronic Hepatitis C Infection

    Summary
    EudraCT number
    		 2011-000945-19
    Trial protocol
    		 DE   GB   FR   CZ   HU   PL   IT   AT   SE   ES   EE   NL   BE  
    Global end of trial date
    08 Jan 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    03 Jan 2019
    First version publication date
    03 Jan 2019
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    GS-US-248-0122
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01457755
    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
    08 Jan 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    08 Jan 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Jan 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the durability of sustained virologic response (SVR) following treatment in a Gilead-sponsored Hepatitis C Study.
    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
    13 Apr 2012
    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
    United States: 4287
    Country: Number of subjects enrolled
    France: 588
    Country: Number of subjects enrolled
    New Zealand: 331
    Country: Number of subjects enrolled
    Germany: 265
    Country: Number of subjects enrolled
    United Kingdom: 261
    Country: Number of subjects enrolled
    Australia: 250
    Country: Number of subjects enrolled
    Canada: 199
    Country: Number of subjects enrolled
    Italy: 172
    Country: Number of subjects enrolled
    Spain: 99
    Country: Number of subjects enrolled
    Poland: 46
    Country: Number of subjects enrolled
    Netherlands: 24
    Country: Number of subjects enrolled
    Sweden: 22
    Country: Number of subjects enrolled
    Belgium: 20
    Country: Number of subjects enrolled
    Czech Republic: 19
    Country: Number of subjects enrolled
    Austria: 11
    Country: Number of subjects enrolled
    Estonia: 8
    Country: Number of subjects enrolled
    Puerto Rico: 5
    Worldwide total number of subjects
    6607
    EEA total number of subjects
    1535
    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)
    5886
    From 65 to 84 years
    721
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Participants were enrolled in North America, Europe, Australia, and New Zealand. The first participant was screened on 13 April 2012. The last study visit occurred on 08 January 2018.

    Pre-assignment
    Screening details
    		 6623 participants were screened.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 SOF+RBV±PEG
    Arm description
    		 Participants previously received sofosbuvir (SOF) + ribavirin (RBV) with or without pegylated interferon (PEG).
    Arm type
    		 Observational

    Investigational medicinal product name
    Sofosbuvir
    Investigational medicinal product code
    Other name
    SOF; Sovaldi®
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    No treatment was administered in this observational study. Participants received sofosbuvir in a previous Gilead-sponsored study.

    Investigational medicinal product name
    Ribavirin
    Investigational medicinal product code
    Other name
    RBV
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    No treatment was administered in this observational study. Participants received RBV in a previous Gilead-sponsored study.

    Investigational medicinal product name
    Pegylated interferon
    Investigational medicinal product code
    Other name
    PEG
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    No treatment was administered in this observational study. Participants received PEG in a previous Gilead-sponsored study.

    Arm title
    		 LDV/SOF±RBV
    Arm description
    		 Participants previously received ledipasvir/sofosbuvir (LDV/SOF) with or without RBV.
    Arm type
    		 Observational

    Investigational medicinal product name
    Ledipasvir/sofosbuvir
    Investigational medicinal product code
    Other name
    LDV/SOF; Harvoni®
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    No treatment was administered in this observational study. Participants received LDV/SOF in a previous Gilead-sponsored study.

    Investigational medicinal product name
    Ribavirin
    Investigational medicinal product code
    Other name
    RBV
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    No treatment was administered in this observational study. Participants received RBV in a previous Gilead-sponsored study.

    Arm title
    		 SOF/VEL±RBV
    Arm description
    		 Participants previously received sofosbuvir/velpatasvir (SOF/VEL) with or without RBV.
    Arm type
    		 Observational

    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
    No treatment was administered in this observational study. Participants received SOF/VEL in a previous Gilead-sponsored study.

    Investigational medicinal product name
    Ribavirin
    Investigational medicinal product code
    Other name
    RBV
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    No treatment was administered in this observational study. Participants received RBV in a previous Gilead-sponsored study.

    Arm title
    		 SOF/VEL/VOX
    Arm description
    		 Participants previously received sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX).
    Arm type
    		 Observational

    Investigational medicinal product name
    Sofosbuvir/velpatasvir/voxilaprevir
    Investigational medicinal product code
    Other name
    SOF/VEL/VOX; Vosevi®
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    No treatment was administered in this observational study. Participants received SOF/VEL/VOX in a previous Gilead-sponsored study.

    Arm title
    		 Other
    Arm description
    		 Participants previously received other HCV treatment.
    Arm type
    		 Observational

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		SOF+RBV±PEG LDV/SOF±RBV SOF/VEL±RBV SOF/VEL/VOX Other
    Started
    1724
    2204
    1422
    597
    660
    Completed
    1138
    1278
    302
    0
    163
    Not completed
    586
    926
    1120
    597
    497
         Virologic Relapse
    12
    7
    3
    1
    5
         Study Discontinued
    74
    154
    802
    537
    337
         Subject Withdrew Consent
    174
    177
    87
    16
    46
         Enrolled into HCV SVR Cirrhosis Registry Study
    62
    273
    83
    7
    30
         Death
    8
    20
    6
    2
    4
         Investigator Decision
    15
    16
    6
    2
    2
         Lost to follow-up
    241
    279
    133
    32
    73

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    SOF+RBV±PEG
    Reporting group description
    		 Participants previously received sofosbuvir (SOF) + ribavirin (RBV) with or without pegylated interferon (PEG).

    Reporting group title
    LDV/SOF±RBV
    Reporting group description
    		 Participants previously received ledipasvir/sofosbuvir (LDV/SOF) with or without RBV.

    Reporting group title
    SOF/VEL±RBV
    Reporting group description
    		 Participants previously received sofosbuvir/velpatasvir (SOF/VEL) with or without RBV.

    Reporting group title
    SOF/VEL/VOX
    Reporting group description
    		 Participants previously received sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX).

    Reporting group title
    Other
    Reporting group description
    		 Participants previously received other HCV treatment.

    Reporting group values
    		 SOF+RBV±PEG LDV/SOF±RBV SOF/VEL±RBV SOF/VEL/VOX Other Total
    Number of subjects
    		 1724 2204 1422 597 660 6607
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 52 ± 9.7 55 ± 9.6 55 ± 10.1 56 ± 10.2 51 ± 10.9 -
    Gender categorical
    Units: Subjects
        Female
    		 607 800 578 233 287 2505
        Male
    		 1117 1404 844 364 373 4102
    Race
    Units: Subjects
        Black or African American
    		 112 301 128 73 51 665
        White
    		 1489 1843 1194 486 562 5574
        Asian
    		 71 25 69 31 27 223
        American Indian or Alaska Native
    		 13 6 12 5 6 42
        Native Hawaiian or Pacific Islander
    		 6 8 4 0 2 20
        Other
    		 26 16 14 2 9 67
        Not Disclosed
    		 7 5 1 0 3 16
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 203 217 128 52 69 669
        Not Hispanic or Latino
    		 1508 1978 1292 545 586 5909
        Not Reported
    		 12 9 2 0 5 28
        Missing
    		 1 0 0 0 0 1

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    SOF+RBV±PEG
    Reporting group description
    		 Participants previously received sofosbuvir (SOF) + ribavirin (RBV) with or without pegylated interferon (PEG).

    Reporting group title
    LDV/SOF±RBV
    Reporting group description
    		 Participants previously received ledipasvir/sofosbuvir (LDV/SOF) with or without RBV.

    Reporting group title
    SOF/VEL±RBV
    Reporting group description
    		 Participants previously received sofosbuvir/velpatasvir (SOF/VEL) with or without RBV.

    Reporting group title
    SOF/VEL/VOX
    Reporting group description
    		 Participants previously received sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX).

    Reporting group title
    Other
    Reporting group description
    		 Participants previously received other HCV treatment.

    Primary: Percentage of Participants Maintaining Sustained Virologic Response (SVR) at Week 144

    		 Close Top of page
    End point title
    		 Percentage of Participants Maintaining Sustained Virologic Response (SVR) at Week 144 [1]
    End point description
    Participants in the Full Analysis Set (all participants with at least one post-enrollment visit who have previously participated in a Gilead-sponsored HCV study, received at least 1 Gilead OAV and achieved SVR, as defined in the original treatment protocol) with available data were analyzed.
    End point type
    Primary
    End point timeframe
    At Week 144
    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 in this observational study.
    End point values
    		 SOF+RBV±PEG LDV/SOF±RBV SOF/VEL±RBV SOF/VEL/VOX Other
    Number of subjects analysed
    1721 [2]
    2204
    1422
    597
    659 [3]
    Units: Percentage of Participants
        number (not applicable)
    98.8
    99.6
    99.7
    99.8
    99.2
    Notes
    [2] - 3 out of 1724 participants had missing HCV RNA data
    [3] - 1 out of 660 participants had missing HCV RNA data
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information [1]
    Timeframe for reporting adverse events
    Participants were not provided study drug in this registry study. There were no treatment-emergent adverse events (AEs) or serious adverse events (SAEs).
    Adverse event reporting additional description
    Safety Analysis Set included all participants with at least one post-enrollment visit who have previously participated in a Gilead-sponsored HCV study, received at least 1 Gilead OAV and achieved SVR, as defined in the original treatment protocol.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.1
    Reporting groups
    Reporting group title
    SOF+RBV±PEG
    Reporting group description
    		 Participants previously received sofosbuvir (SOF) + ribavirin (RBV) with or without pegylated interferon (PEG).

    Reporting group title
    LDV/SOF±RBV
    Reporting group description
    		 Participants previously received ledipasvir/sofosbuvir (LDV/SOF) with or without RBV.

    Reporting group title
    SOF/VEL±RBV
    Reporting group description
    		 Participants previously received sofosbuvir/velpatasvir (SOF/VEL) with or without RBV.

    Reporting group title
    SOF/VEL/VOX
    Reporting group description
    		 Participants previously received sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX).

    Reporting group title
    Other
    Reporting group description
    		 Participants previously received other HCV treatment.

    Serious adverse events
    		 SOF+RBV±PEG LDV/SOF±RBV SOF/VEL±RBV SOF/VEL/VOX Other
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 1724 (0.00%)
    0 / 2204 (0.00%)
    0 / 1422 (0.00%)
    0 / 597 (0.00%)
    0 / 660 (0.00%)
         number of deaths (all causes)
    8
    20
    6
    2
    4
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 SOF+RBV±PEG LDV/SOF±RBV SOF/VEL±RBV SOF/VEL/VOX Other
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 1724 (0.00%)
    0 / 2204 (0.00%)
    0 / 1422 (0.00%)
    0 / 597 (0.00%)
    0 / 660 (0.00%)
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: Participants were not provided study drug in this registry study. There were no treatment-emergent AEs or SAEs.

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    19 Jun 2012
    A quality of life survey added to all study visits in GS-US-248-0122. The window for rolling a patient over from the treatment protocol increased from 60 days to 90 days for scheduling flexibility.
    02 Dec 2014
    The purpose of this Amendment was to revise the protocol text that individual participants may be discontinued at the Sponsor’s discretion. The current protocol language implies that Gilead may only discontinue the entire Registry Study. This amendment clarifies that Gilead may discontinue individual participants in the Registry Study once regulatory requirements are met.

    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.

    European Medicines Agency © 1995-Tue May 07 23:30:04 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA