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    Clinical Trial Results:
    A Registry for Subjects With Cirrhosis Who Achieve a Sustained Virologic Response Following Treatment With a Sofosbuvir- Based Regimen Without Interferon for Chronic Hepatitis C Infection

    Summary
    EudraCT number
    		 2014-001249-26
    Trial protocol
    		 DE   ES   GB   IT  
    Global end of trial date
    31 Dec 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    21 Dec 2022
    First version publication date
    21 Dec 2022
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    GS-US-337-1431
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02292706
    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
    31 Dec 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    31 Dec 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Dec 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this registry study was to assess the durability of sustained virologic response (SVR) and clinical progression or regression of liver disease including the incidence of hepatocellular carcinoma following SVR in participants with cirrhosis after treatment with a sofosbuvir-based regimen for Hepatitis C virus infection.
    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 Dec 2014
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Regulatory reason
    Long term follow-up duration
    		 5 Years
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Spain: 54
    Country: Number of subjects enrolled
    United Kingdom: 51
    Country: Number of subjects enrolled
    France: 122
    Country: Number of subjects enrolled
    Germany: 27
    Country: Number of subjects enrolled
    Italy: 26
    Country: Number of subjects enrolled
    United States: 1136
    Country: Number of subjects enrolled
    New Zealand: 70
    Country: Number of subjects enrolled
    Australia: 69
    Country: Number of subjects enrolled
    Canada: 54
    Worldwide total number of subjects
    1609
    EEA total number of subjects
    229
    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)
    1295
    From 65 to 84 years
    312
    85 years and over
    2

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Participants were enrolled at study sites in Australia, Canada, France, Germany, Italy, New Zealand, Spain, the United Kingdom, and the United States.

    Pre-assignment
    Screening details
    		 1609 participants were enrolled in the registry. Of the 1609 enrolled participants, 1573 participants met eligibility criteria and were included in the analysis.

    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
    Arm description
    		 Participants who were previously treated with sofosbuvir (SOF) along with ribavirin (RBV) were followed up to 5 years.
    Arm type
    		 Observational

    Investigational medicinal product name
    Sofosbuvir
    Investigational medicinal product code
    Other name
    SOF, GS-7977, PSI-7977, Sovaldi®
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    No treatment was administered in this study. Participants received SOF in a previous Gilead-sponsored study or at a subset of sites preselected by Gilead, who have previously received an all-oral SOF-based regimen outside a clinical 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 study. Participants received RBV in a previous Gilead-sponsored study or at a subset of sites preselected by Gilead, who have previously received an all-oral SOF-based regimen outside a clinical study.

    Arm title
    		 LDV/SOF
    Arm description
    		 Participants who were previously treated with ledipasvir (LDV)/SOF were followed up to 5 years.
    Arm type
    		 Observational

    Investigational medicinal product name
    Ledipasvir/sofosbuvir
    Investigational medicinal product code
    Other name
    LDV/SOF; Harvoni®
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    No treatment was administered in this study. Participants received LDV/SOF in a previous Gilead-sponsored study or at a subset of sites preselected by Gilead, who have previously received an all-oral SOF-based regimen outside a clinical study.

    Arm title
    		 LDV/SOF+RBV
    Arm description
    		 Participants who were previously treated with LDV/SOF along with RBV were followed up to 5 years.
    Arm type
    		 Observational

    Investigational medicinal product name
    Ledipasvir/sofosbuvir
    Investigational medicinal product code
    Other name
    LDV/SOF; Harvoni®
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    No treatment was administered in this study. Participants received LDV/SOF in a previous Gilead-sponsored study or at a subset of sites preselected by Gilead, who have previously received an all-oral SOF-based regimen outside a clinical 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 study. Participants received RBV in a previous Gilead-sponsored study or at a subset of sites preselected by Gilead, who have previously received an all-oral SOF-based regimen outside a clinical study.

    Arm title
    		 SOF/VEL
    Arm description
    		 Participants who were previously treated with SOF/velpatasvir (VEL) were followed up to 5 years.
    Arm type
    		 Observational

    Investigational medicinal product name
    Sofosbuvir/velpatasvir
    Investigational medicinal product code
    Other name
    SOF/VEL; Epclusa®
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    No treatment was administered in this study. Participants received SOF/VEL in a previous Gilead-sponsored study or at a subset of sites preselected by Gilead, who have previously received an all-oral SOF-based regimen outside a clinical study.

    Arm title
    		 SOF/VEL+RBV
    Arm description
    		 Participants who were previously treated with SOF/VEL along with RBV were followed up to 5 years.
    Arm type
    		 Observational

    Investigational medicinal product name
    Sofosbuvir/velpatasvir
    Investigational medicinal product code
    Other name
    SOF/VEL; Epclusa®
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    No treatment was administered in this study. Participants received SOF/VEL in a previous Gilead-sponsored study or at a subset of sites preselected by Gilead, who have previously received an all-oral SOF-based regimen outside a clinical 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 study. Participants received RBV in a previous Gilead-sponsored study or at a subset of sites preselected by Gilead, who have previously received an all-oral SOF-based regimen outside a clinical study.

    Arm title
    		 SOF/VEL/VOX
    Arm description
    		 Participants who were previously treated with SOF/VEL/voxilaprevir (VOX) with or without RBV were followed up to 5 years.
    Arm type
    		 Observational

    Investigational medicinal product name
    Sofosbuvir/velpatasvir/voxilaprevir
    Investigational medicinal product code
    Other name
    SOF/VEL/VOX; Vosevi®
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    No treatment was administered in this study. Participants received SOF/VEL/VOX with or without RBV in a previous Gilead-sponsored study or at a subset of sites preselected by Gilead, who have previously received an all-oral SOF-based regimen outside a clinical study.

    Arm title
    		 Other SOF-Based
    Arm description
    		 Participants who previously received other SOF based regimen were followed up to 5 years. The other SOF-based regimens may have included the following BMS-790052 (Daclatasvir) + GS-7977 (SOF) with or without RBV, LDV/SOF + GS-9669, GS-7977 (SOF) + with or without RBV + TMC-435 (Simeprevir), LDV/SOF + Vedroprevir (VDV), LDV/SOF + GS-9669 (250 mg and 500 mg), LDV/SOF + VDV + RBV, Simeprevir+ SOF, and TMC-435 (Simeprevir) +VEL/SOF.
    Arm type
    		 Observational

    Investigational medicinal product name
    Sofosbuvir
    Investigational medicinal product code
    Other name
    SOF, GS-7977, PSI-7977, Sovaldi®
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    No treatment was administered in this study. Participants received other SOF-based regimens in a previous Gilead-sponsored study or at a subset of sites preselected by Gilead, who have previously received an all-oral SOF-based regimen outside a clinical study.

    Number of subjects in period 1 [1]
    		SOF+RBV LDV/SOF LDV/SOF+RBV SOF/VEL SOF/VEL+RBV SOF/VEL/VOX Other SOF-Based
    Started
    94
    275
    263
    372
    98
    332
    139
    Completed
    49
    145
    157
    201
    35
    181
    82
    Not completed
    45
    130
    106
    171
    63
    151
    57
         Virologic relapse or reinfection
    1
    -
    -
    1
    -
    1
    -
         Subject terminated by sponsor
    1
    -
    -
    2
    1
    -
    -
         Death
    3
    11
    16
    22
    8
    17
    3
         Liver transplant
    1
    1
    11
    16
    5
    6
    5
         Study terminated by sponsor
    -
    9
    4
    21
    11
    13
    3
         Lost to follow-up
    20
    44
    24
    61
    21
    52
    25
         Withdrew consent
    15
    56
    43
    36
    13
    51
    20
         Investigator's discretion
    4
    9
    7
    11
    4
    10
    1
         Missing
    -
    -
    1
    1
    -
    1
    -
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: Thirty-six participants who were enrolled but did not meet the eligibility criteria were not included in the Safety Analysis Set reported in the above table.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    SOF+RBV
    Reporting group description
    		 Participants who were previously treated with sofosbuvir (SOF) along with ribavirin (RBV) were followed up to 5 years.

    Reporting group title
    LDV/SOF
    Reporting group description
    		 Participants who were previously treated with ledipasvir (LDV)/SOF were followed up to 5 years.

    Reporting group title
    LDV/SOF+RBV
    Reporting group description
    		 Participants who were previously treated with LDV/SOF along with RBV were followed up to 5 years.

    Reporting group title
    SOF/VEL
    Reporting group description
    		 Participants who were previously treated with SOF/velpatasvir (VEL) were followed up to 5 years.

    Reporting group title
    SOF/VEL+RBV
    Reporting group description
    		 Participants who were previously treated with SOF/VEL along with RBV were followed up to 5 years.

    Reporting group title
    SOF/VEL/VOX
    Reporting group description
    		 Participants who were previously treated with SOF/VEL/voxilaprevir (VOX) with or without RBV were followed up to 5 years.

    Reporting group title
    Other SOF-Based
    Reporting group description
    		 Participants who previously received other SOF based regimen were followed up to 5 years. The other SOF-based regimens may have included the following BMS-790052 (Daclatasvir) + GS-7977 (SOF) with or without RBV, LDV/SOF + GS-9669, GS-7977 (SOF) + with or without RBV + TMC-435 (Simeprevir), LDV/SOF + Vedroprevir (VDV), LDV/SOF + GS-9669 (250 mg and 500 mg), LDV/SOF + VDV + RBV, Simeprevir+ SOF, and TMC-435 (Simeprevir) +VEL/SOF.

    Reporting group values
    		 SOF+RBV LDV/SOF LDV/SOF+RBV SOF/VEL SOF/VEL+RBV SOF/VEL/VOX Other SOF-Based Total
    Number of subjects
    		 94 275 263 372 98 332 139 1573
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 56 ± 7.4 60 ± 7.8 60 ± 7.2 58 ± 7.3 58 ± 6.9 59 ± 7.6 59 ± 8.1 -
    Gender categorical
    Units: Subjects
        Female
    		 35 94 83 115 28 87 55 497
        Male
    		 59 181 180 257 70 245 84 1076
    Race
    Units: Subjects
        White
    		 82 230 234 324 86 292 117 1365
        Black
    		 3 40 19 25 5 26 20 138
        Asian
    		 7 3 4 17 5 8 0 44
        American Indian or Alaska Native
    		 1 0 2 4 0 1 1 9
        Unknown or Not Reported
    		 0 2 2 2 0 2 1 9
        Native Hawaiian or Other Pacific Islander
    		 1 0 1 0 1 2 0 5
        Other
    		 0 0 1 0 1 1 0 3
    Ethnicity
    Units: Subjects
        Not Hispanic or Latino
    		 87 239 219 331 90 281 117 1364
        Hispanic or Latino
    		 7 34 41 35 8 49 22 196
        Unknown or Not Reported
    		 0 2 3 6 0 2 0 13

    End points

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    End points reporting groups
    Reporting group title
    SOF+RBV
    Reporting group description
    		 Participants who were previously treated with sofosbuvir (SOF) along with ribavirin (RBV) were followed up to 5 years.

    Reporting group title
    LDV/SOF
    Reporting group description
    		 Participants who were previously treated with ledipasvir (LDV)/SOF were followed up to 5 years.

    Reporting group title
    LDV/SOF+RBV
    Reporting group description
    		 Participants who were previously treated with LDV/SOF along with RBV were followed up to 5 years.

    Reporting group title
    SOF/VEL
    Reporting group description
    		 Participants who were previously treated with SOF/velpatasvir (VEL) were followed up to 5 years.

    Reporting group title
    SOF/VEL+RBV
    Reporting group description
    		 Participants who were previously treated with SOF/VEL along with RBV were followed up to 5 years.

    Reporting group title
    SOF/VEL/VOX
    Reporting group description
    		 Participants who were previously treated with SOF/VEL/voxilaprevir (VOX) with or without RBV were followed up to 5 years.

    Reporting group title
    Other SOF-Based
    Reporting group description
    		 Participants who previously received other SOF based regimen were followed up to 5 years. The other SOF-based regimens may have included the following BMS-790052 (Daclatasvir) + GS-7977 (SOF) with or without RBV, LDV/SOF + GS-9669, GS-7977 (SOF) + with or without RBV + TMC-435 (Simeprevir), LDV/SOF + Vedroprevir (VDV), LDV/SOF + GS-9669 (250 mg and 500 mg), LDV/SOF + VDV + RBV, Simeprevir+ SOF, and TMC-435 (Simeprevir) +VEL/SOF.

    Primary: Percentage of Participants Maintaining Sustained Virologic Response (SVR) at Week 240

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    End point title
    		 Percentage of Participants Maintaining Sustained Virologic Response (SVR) at Week 240 [1]
    End point description
    SVR at Week 240 was defined as HCV RNA< lower limit of quantification (LLOQ i.e., 15 or 25 International Units Per Milliliter [IU/mL]) or last available HCV RNA< LLOQ with no subsequent follow-up values at Week 240 after enrollment in this registry study. Full Analysis Set included all participants who met all inclusion criteria and did not meet any of the exclusion criteria, and with at least one post-enrollment visit measurement available.
    End point type
    Primary
    End point timeframe
    Week 240
    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: Percentage of participants who maintained SVR at Week 240 was estimated using a Kaplan-Meier model.
    End point values
    		 SOF+RBV LDV/SOF LDV/SOF+RBV SOF/VEL SOF/VEL+RBV SOF/VEL/VOX Other SOF-Based
    Number of subjects analysed
    94
    275
    263
    372
    98
    332
    139
    Units: percentage of participants
        number (not applicable)
    98.9
    100
    99.6
    99.7
    100
    99.6
    100
    No statistical analyses for this end point

    Primary: Percentage of Participants With Any Liver-Associated Events

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    End point title
    		 Percentage of Participants With Any Liver-Associated Events [2]
    End point description
    Participants in Full Analysis Set who did not develop liver-associated event prior to entering the registry study were analyzed.
    End point type
    Primary
    End point timeframe
    Enrollment up to 240 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: Percentages of participants with any liver-associated events since registry start (Enrollment) through Week 240 was estimated using a Kaplan Meier model.
    End point values
    		 SOF+RBV LDV/SOF LDV/SOF+RBV SOF/VEL SOF/VEL+RBV SOF/VEL/VOX Other SOF-Based
    Number of subjects analysed
    89
    259
    254
    350
    81
    326
    133
    Units: percentage of participants
        number (not applicable)
    18.7
    15.0
    24.8
    18.1
    37.6
    16.1
    18.2
    No statistical analyses for this end point

    Primary: Percentage of Participants Who Developed Hepatocellular Carcinoma (HCC) Through Week 240

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    End point title
    		 Percentage of Participants Who Developed Hepatocellular Carcinoma (HCC) Through Week 240 [3]
    End point description
    Participants with de novo HCC since registry start were defined as participants who had not been identified with HCC prior to registry start and only had HCC since registry start. Participants in the Full Analysis Set with no HCC prior to this registry study were analyzed.
    End point type
    Primary
    End point timeframe
    Enrollment up to 240 weeks
    Notes
    [3] - 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: Percentage of participants who developed de novo HCC through Week 240 was estimated using a Kaplan-Meier model.
    End point values
    		 SOF+RBV LDV/SOF LDV/SOF+RBV SOF/VEL SOF/VEL+RBV SOF/VEL/VOX Other SOF-Based
    Number of subjects analysed
    92
    273
    259
    367
    98
    330
    138
    Units: percentage of participants
        number (not applicable)
    11.8
    5.01
    10.8
    10.8
    15.3
    12.4
    11.2
    No statistical analyses for this end point

    Secondary: Number of Participants With Detectable HCV RNA Due to Re-emergence of Pre-existing Virus Through Week 240

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    End point title
    		 Number of Participants With Detectable HCV RNA Due to Re-emergence of Pre-existing Virus Through Week 240
    End point description
    Participants in Full Analysis Set were analyzed.
    End point type
    Secondary
    End point timeframe
    Enrollment up to 240 weeks
    End point values
    		 SOF+RBV LDV/SOF LDV/SOF+RBV SOF/VEL SOF/VEL+RBV SOF/VEL/VOX Other SOF-Based
    Number of subjects analysed
    94
    275
    263
    372
    98
    332
    139
    Units: participants
    0
    0
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of Participants With Detectable HCV Resistance Mutations Through Week 240

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    End point title
    		 Number of Participants With Detectable HCV Resistance Mutations Through Week 240
    End point description
    Participants in Full Analysis Set were analyzed.
    End point type
    Secondary
    End point timeframe
    Enrollment up to 240 weeks
    End point values
    		 SOF+RBV LDV/SOF LDV/SOF+RBV SOF/VEL SOF/VEL+RBV SOF/VEL/VOX Other SOF-Based
    Number of subjects analysed
    94
    275
    263
    372
    98
    332
    139
    Units: participants
    0
    0
    1
    0
    0
    1
    0
    No statistical analyses for this end point

    Secondary: Number of Participants With Detectable HCV RNA Due to Re-infection Through Week 240

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    End point title
    		 Number of Participants With Detectable HCV RNA Due to Re-infection Through Week 240
    End point description
    Reinfection was defined as HCV RNA > LLOQ on 2 samples collected at least 1 week apart with a different virus than that present prior to treatment baseline in the parent study. Participants in Full Analysis Set were analyzed.
    End point type
    Secondary
    End point timeframe
    Enrollment up to 240 weeks
    End point values
    		 SOF+RBV LDV/SOF LDV/SOF+RBV SOF/VEL SOF/VEL+RBV SOF/VEL/VOX Other SOF-Based
    Number of subjects analysed
    94
    275
    263
    372
    98
    332
    139
    Units: participants
    0
    0
    0
    1
    0
    1
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All-Cause Mortality and Adverse Events: From enrollment up to a maximum duration of 5 years No study treatments were given to study participants; thus, reported adverse events refer to AEs related to study procedures.
    Adverse event reporting additional description
    All-Cause Mortality:Included participants who signed informed consent and enrolled into study. No deaths among participants who were enrolled but did not meet eligibility criteria.AEs:Included all participants who met all inclusion criteria and did not meet any of exclusion criteria,and with at least one post-enrollment visit measurement available.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.1
    Reporting groups
    Reporting group title
    SOF+RBV
    Reporting group description
    		 Participants who were previously treated with SOF along with RBV were followed up to 5 years.

    Reporting group title
    LDV/SOF
    Reporting group description
    		 Participants who were previously treated with LDV/SOF were followed up to 5 years.

    Reporting group title
    LDV/SOF+RBV
    Reporting group description
    		 Participants who were previously treated with LDV/SOF along with RBV were followed up to 5 years.

    Reporting group title
    SOF/VEL
    Reporting group description
    		 Participants who were previously treated with SOF/VEL were followed up to 5 years.

    Reporting group title
    SOF/VEL+RBV
    Reporting group description
    		 Participants who were previously treated with SOF/VEL along with RBV were followed up to 5 years.

    Reporting group title
    SOF/VEL/VOX
    Reporting group description
    		 Participants who were previously treated with SOF/VEL/VOX with or without RBV were followed up to 5 years.

    Reporting group title
    Other SOF-Based
    Reporting group description
    		 Participants who previously received other SOF based regimen were followed up to 5 years.

    Serious adverse events
    		 SOF+RBV LDV/SOF LDV/SOF+RBV SOF/VEL SOF/VEL+RBV SOF/VEL/VOX Other SOF-Based
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 94 (0.00%)
    0 / 275 (0.00%)
    0 / 263 (0.00%)
    0 / 372 (0.00%)
    0 / 98 (0.00%)
    0 / 332 (0.00%)
    0 / 139 (0.00%)
         number of deaths (all causes)
    3
    11
    16
    22
    8
    17
    3
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 SOF+RBV LDV/SOF LDV/SOF+RBV SOF/VEL SOF/VEL+RBV SOF/VEL/VOX Other SOF-Based
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 94 (0.00%)
    4 / 275 (1.45%)
    1 / 263 (0.38%)
    1 / 372 (0.27%)
    0 / 98 (0.00%)
    1 / 332 (0.30%)
    1 / 139 (0.72%)
    Injury, poisoning and procedural complications
    Incision site rash
         subjects affected / exposed
    0 / 94 (0.00%)
    0 / 275 (0.00%)
    0 / 263 (0.00%)
    0 / 372 (0.00%)
    0 / 98 (0.00%)
    1 / 332 (0.30%)
    0 / 139 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    Post procedural complication
         subjects affected / exposed
    0 / 94 (0.00%)
    0 / 275 (0.00%)
    1 / 263 (0.38%)
    0 / 372 (0.00%)
    0 / 98 (0.00%)
    0 / 332 (0.00%)
    0 / 139 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Procedural complication
         subjects affected / exposed
    0 / 94 (0.00%)
    1 / 275 (0.36%)
    0 / 263 (0.00%)
    0 / 372 (0.00%)
    0 / 98 (0.00%)
    0 / 332 (0.00%)
    0 / 139 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    Procedural dizziness
         subjects affected / exposed
    0 / 94 (0.00%)
    1 / 275 (0.36%)
    0 / 263 (0.00%)
    0 / 372 (0.00%)
    0 / 98 (0.00%)
    0 / 332 (0.00%)
    0 / 139 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    Procedural pain
         subjects affected / exposed
    0 / 94 (0.00%)
    0 / 275 (0.00%)
    0 / 263 (0.00%)
    0 / 372 (0.00%)
    0 / 98 (0.00%)
    1 / 332 (0.30%)
    0 / 139 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    Nervous system disorders
    Paraesthesia
         subjects affected / exposed
    0 / 94 (0.00%)
    0 / 275 (0.00%)
    0 / 263 (0.00%)
    1 / 372 (0.27%)
    0 / 98 (0.00%)
    0 / 332 (0.00%)
    0 / 139 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    Presyncope
         subjects affected / exposed
    0 / 94 (0.00%)
    0 / 275 (0.00%)
    0 / 263 (0.00%)
    1 / 372 (0.27%)
    0 / 98 (0.00%)
    0 / 332 (0.00%)
    0 / 139 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    General disorders and administration site conditions
    Vessel puncture site haematoma
         subjects affected / exposed
    0 / 94 (0.00%)
    2 / 275 (0.73%)
    0 / 263 (0.00%)
    0 / 372 (0.00%)
    0 / 98 (0.00%)
    0 / 332 (0.00%)
    1 / 139 (0.72%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    17 Oct 2014
    • The purpose of this amendment was to clarify clinical laboratory and liver disease assessments. In addition, language was added to clarify the study conduct and patient enrollment of the Cirrhosis SVR Registry Study • The Gilead Study Director and Medical Monitor were changed • Reference to a Baseline visit was removed throughout. This was officially known as Day 1 • Minor wording changes were made to correct grammar and for clarity • Typographical edits were incorporated to ensure consistency and for clarification as needed.
    17 Aug 2015
    The purpose of this Amendment was to expand the inclusion criteria to allow cirrhotic subjects successfully achieved SVR after having been treated with commercial all-oral SOF-based regimen to participate in this Registry Study at pre-selected Gilead sites. Relevant sections of the protocol were updated to reflect this change as detailed below. This amendment also increased the window from the date of the final visit in the Gilead sponsored treatment study to entry into this Registry Study (Day 1 Assessment) from 48 to 60 weeks for those subjects who were previously treated in a Gilead sponsored study. Subjects who were enrolled in this registry from the Gilead HCV development programs continued in this registry as appropriate.
    01 Jun 2017
    • An optional whole blood sample collection for genetic analysis was added at Day 1, Week 96, and the final study visit, i.e., Week 240 or Early Termination for subjects who consented • The Study Director/Medical Monitor information was updated.

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/32707225
    http://www.ncbi.nlm.nih.gov/pubmed/33493697
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