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    Clinical Trial Results:
    A Long Term Follow-up Registry for Adolescent and Pediatric Subjects Who Received a Gilead Hepatitis C Virus Direct Acting Antiviral (DAA) in Gilead- Sponsored Chronic Hepatitis C Infection Trials

    Summary
    EudraCT number
    		 2014-004674-42
    Trial protocol
    		 GB   DE   BE   PL   IT  
    Global end of trial date
    06 Jan 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    21 Jun 2023
    First version publication date
    21 Jun 2023
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    GS-US-334-1113
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02510300
    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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    06 Jan 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    06 Jan 2023
    Global end of trial reached?
    Yes
    Global end of trial date
    06 Jan 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this registry was to evaluate the long-term safety of anti-HCV regimens in the pediatric population as determined by assessments of growth and development.
    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
    21 Oct 2015
    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?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 38
    Country: Number of subjects enrolled
    Poland: 3
    Country: Number of subjects enrolled
    Belgium: 7
    Country: Number of subjects enrolled
    Germany: 7
    Country: Number of subjects enrolled
    Italy: 33
    Country: Number of subjects enrolled
    United States: 336
    Country: Number of subjects enrolled
    Australia: 19
    Country: Number of subjects enrolled
    Russian Federation: 16
    Country: Number of subjects enrolled
    New Zealand: 2
    Worldwide total number of subjects
    461
    EEA total number of subjects
    50
    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)
    236
    Adolescents (12-17 years)
    225
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants were enrolled at study sites in Australia, Belgium, Germany, Italy, New Zealand, Poland, Russia, the United Kingdom, and the United States.

    Pre-assignment
    Screening details
    		 461 participants were enrolled in the registry.

    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 for 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 chronic hepatitis C infection 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 chronic hepatitis C infection study.

    Arm title
    		 LDV/SOF+/-RBV
    Arm description
    		 Participants who were previously treated with ledipasvir (LDV)/SOF with or without RBV were followed for 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 chronic hepatitis C infection 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 chronic hepatitis C infection study.

    Arm title
    		 SOF/VEL
    Arm description
    		 Participants who were previously treated with SOF/velpatasvir (VEL) were followed for 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 chronic hepatitis C infection study.

    Arm title
    		 SOF/VEL/VOX
    Arm description
    		 Participants who were previously treated with SOF/VEL/voxilaprevir (VOX) were followed for 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 in a previous Gilead-sponsored chronic hepatitis C infection study.

    Number of subjects in period 1 [1]
    		SOF+RBV LDV/SOF+/-RBV SOF/VEL SOF/VEL/VOX
    Started
    88
    178
    142
    18
    Completed
    58
    100
    15
    0
    Not completed
    30
    78
    127
    18
         Protocol violation
    1
    -
    -
    -
         Death
    -
    1
    -
    -
         Study terminated by sponsor
    2
    7
    69
    14
         Lost to follow-up
    14
    51
    42
    3
         Withdrew consent
    8
    18
    16
    1
         Investigator's discretion
    5
    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: Of the 461 participants who were enrolled, 426 participants who met eligibility criteria and had at least one post-Day 1 visit measurement available were included in the analysis.

    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 for up to 5 years.

    Reporting group title
    LDV/SOF+/-RBV
    Reporting group description
    		 Participants who were previously treated with ledipasvir (LDV)/SOF with or without RBV were followed for up to 5 years.

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

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

    Reporting group values
    		 SOF+RBV LDV/SOF+/-RBV SOF/VEL SOF/VEL/VOX Total
    Number of subjects
    		 88 178 142 18 426
    Age categorical
    Units: Subjects
        12 to < 18 years old
    		 42 75 70 18 205
        6 to < 12 years old
    		 36 77 51 0 164
        3 to < 6 years old
    		 10 26 21 0 57
    Gender categorical
    Units: Subjects
        Female
    		 52 100 84 11 247
        Male
    		 36 78 58 7 179
    Race
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 1 0 1
        Asian
    		 8 7 9 2 26
        Black or African American
    		 4 12 11 1 28
        Native Hawaiian or Pacific Islander
    		 1 1 1 0 3
        White
    		 69 152 108 13 342
        Other
    		 6 6 11 2 25
        Not Reported
    		 0 0 1 0 1
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 13 22 16 0 51
        Not Hispanic or Latino
    		 73 153 119 18 363
        Not Reported
    		 2 3 7 0 12

    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 for up to 5 years.

    Reporting group title
    LDV/SOF+/-RBV
    Reporting group description
    		 Participants who were previously treated with ledipasvir (LDV)/SOF with or without RBV were followed for up to 5 years.

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

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

    Subject analysis set title
    12 to < 18 years old
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants within the age group of 12 to < 18 years old who were previously treated with SOF along with RBV, or LDV/SOF with or without RBV, or SOF/VEL, or SOF/VEL/VOX were followed for up to 5 years.

    Subject analysis set title
    6 to < 12 years old
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants within the age group of 6 to < 12 years old who were previously treated with SOF along with RBV, or LDV/SOF with or without RBV, or SOF/VEL, or SOF/VEL/VOX were followed for up to 5 years.

    Subject analysis set title
    3 to < 6 years old
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants within the age group of 3 to < 6 years old who were previously treated with SOF along with RBV, or LDV/SOF with or without RBV, or SOF/VEL, or SOF/VEL/VOX were followed for up to 5 years.

    Subject analysis set title
    Male: Baseline Stage 1
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Male participants who were previously treated with SOF along with RBV, or LDV/SOF with or without RBV, or SOF/VEL, or SOF/VEL/VOX were followed for up to 5 years.

    Subject analysis set title
    Male: Baseline Stage 2
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Male participants who were previously treated with SOF along with RBV, or LDV/SOF with or without RBV, or SOF/VEL, or SOF/VEL/VOX were followed for up to 5 years.

    Subject analysis set title
    Male: Baseline Stage 3
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Male participants who were previously treated with SOF along with RBV, or LDV/SOF with or without RBV, or SOF/VEL, or SOF/VEL/VOX were followed for up to 5 years.

    Subject analysis set title
    Male: Baseline Stage 4
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Male participants who were previously treated with SOF along with RBV, or LDV/SOF with or without RBV, or SOF/VEL, or SOF/VEL/VOX were followed for up to 5 years.

    Subject analysis set title
    Male: Baseline Stage 5
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Male participants who were previously treated with SOF along with RBV, or LDV/SOF with or without RBV, or SOF/VEL, or SOF/VEL/VOX were followed for up to 5 years.

    Subject analysis set title
    Female: Baseline Stage 1
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Female participants who were previously treated with SOF along with RBV, or LDV/SOF with or without RBV, or SOF/VEL, or SOF/VEL/VOX were followed for up to 5 years.

    Subject analysis set title
    Female: Baseline Stage 2
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Female participants who were previously treated with SOF along with RBV, or LDV/SOF with or without RBV, or SOF/VEL, or SOF/VEL/VOX were followed for up to 5 years.

    Subject analysis set title
    Female: Baseline Stage 3
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Female participants who were previously treated with SOF along with RBV, or LDV/SOF with or without RBV, or SOF/VEL, or SOF/VEL/VOX were followed for up to 5 years.

    Subject analysis set title
    Female: Baseline Stage 4
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Female participants who were previously treated with SOF along with RBV, or LDV/SOF with or without RBV, or SOF/VEL, or SOF/VEL/VOX were followed for up to 5 years.

    Subject analysis set title
    Female: Baseline Stage 5
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Female participants who were previously treated with SOF along with RBV, or LDV/SOF with or without RBV, or SOF/VEL, or SOF/VEL/VOX were followed for up to 5 years.

    Subject analysis set title
    All participants
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants who were previously treated with SOF along with RBV, or LDV/SOF with or without RBV, or SOF/VEL, or SOF/VEL/VOX were followed for up to 5 years.

    Primary: Change From Baseline in Height Z-scores as a Measurement of Growth and Development

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    End point title
    		 Change From Baseline in Height Z-scores as a Measurement of Growth and Development [1]
    End point description
    An age- and sex-specific Z-score was derived for each weight, height and body mass index (BMI) measurement according to the downloadable SAS program available on the Centers for Disease Control (CDC) website using the year 2000 growth charts. The Full Analysis Set (all enrolled participants who met all the study entry eligibility criteria and with at least one post-Day 1 visit measurement available) with available data were analysed.
    End point type
    Primary
    End point timeframe
    Baseline (Day 1); Weeks 24, 48, 72, 96, 144, 192, and 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: No statistical comparison was planned or performed for the overall population between the age groups.
    End point values
    		 12 to < 18 years old 6 to < 12 years old 3 to < 6 years old
    Number of subjects analysed
    205
    164
    57
    Units: z-score
    median (inter-quartile range (Q1-Q3))
        Baseline
    -0.2 (-0.9 to 0.5)
    -0.2 (-0.9 to 0.6)
    0.0 (-0.9 to 0.4)
        Change at Week 24 (N = 190, 163, 54)
    0.0 (-0.1 to 0.1)
    0.0 (-0.1 to 0.1)
    -0.1 (-0.3 to 0.0)
        Change at Week 48 (N = 164, 136, 45)
    0.0 (-0.2 to 0.2)
    0.1 (-0.1 to 0.2)
    0.0 (-0.3 to 0.1)
        Change at Week 72 (N = 170, 135, 38)
    0.0 (-0.2 to 0.1)
    0.1 (-0.1 to 0.3)
    0.0 (-0.3 to 0.2)
        Change at Week 96 (N = 165, 123, 38)
    -0.1 (-0.2 to 0.1)
    0.1 (-0.1 to 0.4)
    -0.1 (-0.3 to 0.1)
        Change at Week 144 (N = 153, 110, 34)
    -0.1 (-0.2 to 0.1)
    0.1 (-0.1 to 0.5)
    0.1 (-0.3 to 0.2)
        Change at Week 192 (N = 117, 94, 24)
    0.0 (-0.2 to 0.1)
    0.1 (-0.2 to 0.6)
    0.1 (-0.2 to 0.5)
        Change at Week 240 (N = 86, 72, 16)
    0.0 (-0.2 to 0.1)
    0.0 (-0.5 to 0.6)
    0.2 (-0.3 to 0.6)
    No statistical analyses for this end point

    Primary: Change From Baseline in Weight Z-scores as a Measurement of Growth and Development

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    End point title
    		 Change From Baseline in Weight Z-scores as a Measurement of Growth and Development [2]
    End point description
    An age- and sex-specific Z-score was derived for each weight, height and BMI measurement according to the downloadable SAS program available on the CDC website using the year 2000 growth charts. Participants in the Full Analysis Set with available data were analysed.
    End point type
    Primary
    End point timeframe
    Baseline (Day 1); Weeks 24, 48, 72, 96, 144, 192, and 240
    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 for the overall population between the age groups.
    End point values
    		 12 to < 18 years old 6 to < 12 years old 3 to < 6 years old
    Number of subjects analysed
    205
    164
    57
    Units: z-score
    median (inter-quartile range (Q1-Q3))
        Baseline
    0.3 (-0.3 to 1.0)
    0.3 (-0.7 to 1.0)
    0.2 (-0.7 to 0.7)
        Change at Week 24 (N = 191, 163, 54)
    0.0 (-0.1 to 0.2)
    0.0 (-0.1 to 0.2)
    -0.1 (-0.2 to 0.1)
        Change at Week 48 (N = 165, 136, 45)
    0.0 (-0.2 to 0.2)
    0.1 (-0.1 to 0.3)
    -0.1 (-0.2 to 0.1)
        Change at Week 72 (N = 170, 135, 39)
    0.0 (-0.3 to 0.3)
    0.0 (-0.2 to 0.3)
    0.0 (-0.2 to 0.3)
        Change at Week 96 (N = 165, 123, 38)
    0.0 (-0.4 to 0.3)
    0.1 (-0.1 to 0.4)
    0.1 (-0.1 to 0.3)
        Change at Week 144 (N = 153, 111, 34)
    -0.1 (-0.4 to 0.3)
    0.2 (-0.1 to 0.6)
    0.0 (-0.3 to 0.3)
        Change at Week 192 (N = 117, 94, 24)
    -0.1 (-0.4 to 0.5)
    0.2 (-0.1 to 0.6)
    0.2 (-0.1 to 0.5)
        Change at Week 240 (N = 86, 72, 16)
    0.1 (-0.5 to 0.5)
    0.3 (-0.1 to 0.5)
    0.3 (-0.2 to 0.6)
    No statistical analyses for this end point

    Primary: Change From Baseline in Body Mass Index (BMI) Z-scores as a Measurement of Growth and Development

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    End point title
    		 Change From Baseline in Body Mass Index (BMI) Z-scores as a Measurement of Growth and Development [3]
    End point description
    An age- and sex-specific Z-score was derived for each weight, height and BMI measurement according to the downloadable SAS program available on the CDC website using the year 2000 growth charts. Participants in the Full Analysis Set with available data were analysed.
    End point type
    Primary
    End point timeframe
    Baseline (Day 1); Weeks 24, 48, 72, 96, 144, 192, and 240
    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: No statistical comparison was planned or performed for the overall population between the age groups.
    End point values
    		 12 to < 18 years old 6 to < 12 years old 3 to < 6 years old
    Number of subjects analysed
    205
    164
    57
    Units: z-score
    median (inter-quartile range (Q1-Q3))
        Baseline
    0.4 (-0.3 to 1.2)
    0.4 (-0.4 to 1.3)
    0.4 (-0.3 to 1.0)
        Change at Week 24 (N = 190, 163, 54)
    0.0 (-0.1 to 0.2)
    0.0 (-0.2 to 0.2)
    0.0 (-0.3 to 0.2)
        Change at Week 48 (N = 164, 136, 45)
    0.0 (-0.2 to 0.2)
    0.0 (-0.2 to 0.2)
    0.0 (-0.3 to 0.2)
        Change at Week 72 (N = 170, 135, 38)
    0.0 (-0.3 to 0.3)
    0.0 (-0.3 to 0.2)
    0.1 (-0.2 to 0.3)
        Change at Week 96 (N = 165, 123, 38)
    -0.1 (-0.4 to 0.3)
    0.0 (-0.2 to 0.4)
    0.0 (-0.2 to 0.4)
        Change at Week 144 (N = 153, 110, 34)
    -0.1 (-0.4 to 0.3)
    0.0 (-0.2 to 0.3)
    0.0 (-0.5 to 0.6)
        Change at Week 192 (N = 117, 94, 24)
    0.0 (-0.4 to 0.5)
    0.1 (-0.2 to 0.5)
    -0.1 (-0.4 to 0.4)
        Change at Week 240 (N = 86, 72, 16)
    0.1 (-0.5 to 0.5)
    0.1 (-0.2 to 0.4)
    0.1 (-0.5 to 0.9)
    No statistical analyses for this end point

    Primary: Change From Baseline in Height Percentiles as a Measurement of Growth and Development

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    End point title
    		 Change From Baseline in Height Percentiles as a Measurement of Growth and Development [4]
    End point description
    An age- and sex-specific percentile was derived for each weight, height and BMI measurement according to the downloadable SAS program available on the Centers for Disease Control (CDC) website using the year 2000 growth charts. Participants in the Full Analysis Set with available data were analysed.
    End point type
    Primary
    End point timeframe
    Baseline (Day 1); Weeks 24, 48, 72, 96, 144, 192, and 240
    Notes
    [4] - 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 for the overall population between the age groups.
    End point values
    		 12 to < 18 years old 6 to < 12 years old 3 to < 6 years old
    Number of subjects analysed
    205
    164
    57
    Units: percentile
    median (inter-quartile range (Q1-Q3))
        Baseline
    43.5 (19.6 to 69.1)
    42.7 (17.5 to 73.5)
    49.6 (19.0 to 63.7)
        Change at Week 24 (N = 190, 163, 54)
    0.0 (-2.7 to 2.4)
    0.5 (-1.7 to 3.7)
    -1.5 (-8.3 to 1.0)
        Change at Week 48 (N = 164, 136, 45)
    -0.2 (-3.6 to 3.9)
    1.2 (-1.1 to 6.4)
    -0.2 (-6.7 to 3.1)
        Change at Week 72 (N = 170, 135, 38)
    -0.6 (-4.9 to 2.7)
    2.1 (-1.7 to 6.4)
    0.0 (-8.9 to 2.6)
        Change at Week 96 (N = 165, 123, 38)
    -1.2 (-5.7 to 2.3)
    2.2 (-2.3 to 7.9)
    -2.6 (-9.1 to 1.2)
        Change at Week 144 (N = 153, 110, 34)
    -1.0 (-6.4 to 2.4)
    2.6 (-4.0 to 13.2)
    0.9 (-4.8 to 3.4)
        Change at Week 192 (N = 117, 94, 24)
    -0.6 (-6.7 to 2.6)
    2.5 (-3.3 to 16.3)
    2.5 (-6.3 to 13.8)
        Change at Week 240 (N = 86, 72, 16)
    -1.0 (-5.8 to 3.2)
    0.5 (-13.2 to 15.2)
    2.4 (-4.7 to 11.8)
    No statistical analyses for this end point

    Primary: Change From Baseline in Weight Percentiles as a Measurement of Growth and Development

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    End point title
    		 Change From Baseline in Weight Percentiles as a Measurement of Growth and Development [5]
    End point description
    An age- and sex-specific percentile was derived for each weight, height and BMI measurement according to the downloadable SAS program available on the CDC website using the year 2000 growth charts. Participants in the Full Analysis Set with available data were analysed.
    End point type
    Primary
    End point timeframe
    Baseline (Day 1); Weeks 24, 48, 72, 96, 144, 192, and 240
    Notes
    [5] - 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 for the overall population between the age groups.
    End point values
    		 12 to < 18 years old 6 to < 12 years old 3 to < 6 years old
    Number of subjects analysed
    205
    164
    57
    Units: percentile
    median (inter-quartile range (Q1-Q3))
        Baseline
    62.7 (37.2 to 84.2)
    60.3 (25.6 to 84.5)
    57.6 (23.9 to 74.9)
        Change at Week 24 (N = 191, 163, 54)
    0.0 (-3.5 to 3.2)
    0.3 (-2.3 to 3.8)
    -0.6 (-5.9 to 1.7)
        Change at Week 48 (N = 165, 136, 45)
    0.3 (-5.3 to 5.0)
    0.6 (-2.7 to 7.0)
    -0.8 (-6.0 to 1.5)
        Change at Week 72 (N = 170, 135, 39)
    -0.3 (-8.0 to 4.0)
    0.5 (-2.6 to 7.7)
    -0.1 (-6.9 to 3.2)
        Change at Week 96 (N = 165, 123, 38)
    0.0 (-12.4 to 5.6)
    2.3 (-1.1 to 9.7)
    1.0 (-4.7 to 2.6)
        Change at Week 144 (N = 153, 111, 34)
    -0.8 (-11.6 to 4.1)
    3.5 (-1.6 to 12.2)
    0.0 (-7.0 to 4.6)
        Change at Week 192 (N = 117, 94, 24)
    -0.1 (-13.0 to 6.3)
    3.2 (-1.3 to 12.9)
    0.5 (-3.9 to 5.6)
        Change at Week 240 (N = 86, 72, 16)
    0.3 (-13.3 to 10.0)
    2.4 (-1.5 to 12.4)
    2.8 (-6.0 to 12.7)
    No statistical analyses for this end point

    Primary: Change From Baseline in BMI Percentiles as a Measurement of Growth and Development

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    End point title
    		 Change From Baseline in BMI Percentiles as a Measurement of Growth and Development [6]
    End point description
    An age- and sex-specific percentile was derived for each weight, height and BMI measurement according to the downloadable SAS program available on the CDC website using the year 2000 growth charts. Participants in the Full Analysis Set with available data were analysed.
    End point type
    Primary
    End point timeframe
    Baseline (Day 1); Weeks 24, 48, 72, 96, 144, 192, and 240
    Notes
    [6] - 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 for the overall population between the age groups.
    End point values
    		 12 to < 18 years old 6 to < 12 years old 3 to < 6 years old
    Number of subjects analysed
    205
    164
    57
    Units: Percentile
    median (inter-quartile range (Q1-Q3))
        Baseline
    64.2 (38.1 to 88.0)
    66.4 (35.1 to 89.8)
    66.6 (39.2 to 84.8)
        Change at Week 24 (N = 190, 163, 54)
    0.1 (-4.2 to 3.9)
    -0.2 (-4.1 to 3.9)
    -0.1 (-7.4 to 5.1)
        Change at Week 48 (N = 164, 136, 45)
    0.3 (-5.2 to 4.8)
    0.3 (-5.5 to 4.6)
    0.0 (-7.7 to 3.7)
        Change at Week 72 (N = 170, 135, 38)
    -0.4 (-8.3 to 5.4)
    0.4 (-4.8 to 5.5)
    0.3 (-5.6 to 7.2)
        Change at Week 96 (N = 165, 123, 38)
    -1.1 (-9.7 to 5.0)
    0.1 (-4.3 to 6.9)
    0.3 (-5.5 to 7.8)
        Change at Week 144 (N = 153, 110, 34)
    -1.1 (-9.6 to 5.7)
    0.5 (-5.0 to 8.3)
    -0.8 (-13.3 to 10.4)
        Change at Week 192 (N = 117, 94, 24)
    -0.2 (-11.9 to 7.1)
    1.0 (-2.1 to 9.9)
    -0.8 (-8.6 to 8.3)
        Change at Week 240 (N = 86, 72, 16)
    1.1 (-13.6 to 9.7)
    1.5 (-2.3 to 6.0)
    1.2 (-12.5 to 25.0)
    No statistical analyses for this end point

    Primary: Number of Male Participants With a Change in Tanner Stage Assessment for Pubic Hair

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    End point title
    		 Number of Male Participants With a Change in Tanner Stage Assessment for Pubic Hair [7]
    End point description
    Tanner Pubertal Staging was assessed for pubic hair growth and genitalia development in males from stages 1 to 5. Tanner stages were used to evaluate the progression of pubertal changes from stage 1 (pre-pubertal) to stage 5 (adult). If a participant had reached Tanner stage 5, no further Tanner pubertal stage assessments were to be completed. Pubic hair growth: Tanner stages (1: No hair, 2: Downy hair, 3: More coarse and curly hair, 4: Adult-like hair quality; 5: Hair extends to the medial surface of the thighs). Participants in the Full Analysis Set with available data were analysed.
    End point type
    Primary
    End point timeframe
    Baseline (Day 1); Week 240
    Notes
    [7] - 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 analyses have been specified for this primary end point.
    End point values
    		 Male: Baseline Stage 1 Male: Baseline Stage 2 Male: Baseline Stage 3 Male: Baseline Stage 4 Male: Baseline Stage 5
    Number of subjects analysed
    79
    19
    11
    24
    46
    Units: participants
    number (not applicable)
        Week 240; Stage 1 (N = 75)
    9
    0
    0
    0
    0
        Week 240; Stage 2 (N = 75)
    5
    0
    0
    0
    0
        Week 240; Stage 3 (N = 75)
    4
    1
    0
    0
    0
        Week 240; Stage 4 (N = 75)
    7
    2
    0
    0
    0
        Week 240; Stage 5 (N = 75)
    6
    6
    7
    9
    19
        Not done
    1
    0
    0
    0
    0
        Visit not reached
    47
    10
    4
    15
    27
    No statistical analyses for this end point

    Primary: Number of Male Participants With a Change in Tanner Stage Assessment for Genitalia

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    End point title
    		 Number of Male Participants With a Change in Tanner Stage Assessment for Genitalia [8]
    End point description
    Tanner Pubertal Staging was assessed for pubic hair growth and genitalia development in males from stages 1 to 5. Tanner stages were used to evaluate the progression of pubertal changes from stage 1 (pre-pubertal) to stage 5 (adult). If a participant had reached Tanner stage 5, no further Tanner pubertal stage assessments were to be completed. Genitalia development: Tanner stages (1: Testes, scrotum, and penis about same size, 2: Enlargement of scrotum, testes and penis, 3: Enlargement of penis, 4: Penis size enlargement, 5: Genitalia adult in size and shape). Participants in the Full Analysis Set with available data were analysed.
    End point type
    Primary
    End point timeframe
    Baseline (Day 1); Week 240
    Notes
    [8] - 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 analyses have been specified for this primary end point.
    End point values
    		 Male: Baseline Stage 1 Male: Baseline Stage 2 Male: Baseline Stage 3 Male: Baseline Stage 4 Male: Baseline Stage 5
    Number of subjects analysed
    77
    18
    16
    20
    48
    Units: participants
    number (not applicable)
        Week 240; Stage 1 (N = 75)
    7
    0
    0
    0
    0
        Week 240; Stage 2 (N = 75)
    6
    0
    0
    0
    0
        Week 240; Stage 3 (N = 75)
    5
    1
    0
    0
    0
        Week 240; Stage 4 (N = 75)
    7
    2
    0
    0
    0
        Week 240; Stage 5 (N = 75)
    6
    5
    9
    8
    19
        Not done
    1
    0
    0
    0
    0
        Visit not reached
    45
    10
    7
    12
    29
    No statistical analyses for this end point

    Primary: Number of Female Participants With a Change in Tanner Stage Assessment for Pubic Hair

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    End point title
    		 Number of Female Participants With a Change in Tanner Stage Assessment for Pubic Hair [9]
    End point description
    Tanner Pubertal Staging was assessed for pubic hair growth and breast development in females from stages 1 to 5. Tanner stages were used to evaluate the progression of pubertal changes from stage 1 (pre-pubertal) to stage 5 (adult). If a participant had reached Tanner stage 5, no further Tanner pubertal stage assessments were to be completed. Pubic hair growth: Tanner stages (1: No hair, 2: Downy hair, 3: More coarse and curly hair, 4: Adult-like hair quality; 5: Hair extends to the medial surface of the thighs). Participants in the Full Analysis Set with available data were analysed.
    End point type
    Primary
    End point timeframe
    Baseline (Day 1); Week 240
    Notes
    [9] - 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 analyses have been specified for this primary end point.
    End point values
    		 Female: Baseline Stage 1 Female: Baseline Stage 2 Female: Baseline Stage 3 Female: Baseline Stage 4 Female: Baseline Stage 5
    Number of subjects analysed
    101
    23
    29
    36
    58
    Units: participants
    number (not applicable)
        Week 240; Stage 1 (N = 97)
    7
    0
    0
    0
    0
        Week 240; Stage 2 (N = 97)
    5
    0
    0
    0
    0
        Week 240; Stage 3 (N = 97)
    7
    2
    0
    0
    0
        Week 240; Stage 4 (N = 97)
    7
    0
    2
    0
    0
        Week 240; Stage 5 (N = 97)
    9
    6
    10
    15
    27
        Not done
    1
    2
    0
    0
    0
        Visit not reached
    65
    13
    17
    21
    31
    No statistical analyses for this end point

    Primary: Number of Female Participants With a Change in Tanner Stage Assessment for Breast Development

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    End point title
    		 Number of Female Participants With a Change in Tanner Stage Assessment for Breast Development [10]
    End point description
    Tanner Pubertal Staging was assessed for pubic hair growth and breast development in females from stages 1 to 5. Tanner stages were used to evaluate the progression of pubertal changes from stage 1 (pre-pubertal) to stage 5 (adult). If a participant had reached Tanner stage 5, no further Tanner pubertal stage assessments were to be completed. Breast development: Tanner stages (1: No glandular tissue, 2: Breast bud forms,3: More elevated, outside areola, 4: Increased breast size,5: Final adult-size breasts). Participants in the Full Analysis Set with available data were analysed.
    End point type
    Primary
    End point timeframe
    Baseline (Day 1); Week 240
    Notes
    [10] - 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 analyses have been specified for this primary end point.
    End point values
    		 Female: Baseline Stage 1 Female: Baseline Stage 2 Female: Baseline Stage 3 Female: Baseline Stage 4 Female: Baseline Stage 5
    Number of subjects analysed
    86
    33
    31
    40
    57
    Units: participants
    number (not applicable)
        Week 240; Stage 1 (N = 97)
    8
    0
    0
    0
    0
        Week 240; Stage 2 (N = 97)
    2
    0
    0
    0
    0
        Week 240; Stage 3 (N = 97)
    8
    4
    1
    0
    0
        Week 240; Stage 4 (N = 97)
    4
    1
    2
    0
    0
        Week 240; Stage 5 (N = 97)
    8
    5
    12
    14
    28
        Not done
    1
    2
    0
    0
    0
        Visit not reached
    55
    21
    16
    26
    29
    No statistical analyses for this end point

    Secondary: Percentage of Participants Who Maintained Sustained Virologic Response (SVR) During the Study

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    End point title
    		 Percentage of Participants Who Maintained Sustained Virologic Response (SVR) During the Study
    End point description
    A participant was considered to have achieved SVR if the hepatitis C virus (HCV) levels were less than the lower limit of quantification (LLOQ) [i.e 15 international units (IU)/millilitre (mL)] during the parent study. Virologic failure is defined as having 2 consecutive blood samples (at least one week apart) with HCV ribonucleic acid (RNA) > LLOQ, or last available HCV RNA> LLOQ with no subsequent follow-up values. Participants in the Full Analysis Set who achieved SVR in the parent study were analyzed.
    End point type
    Secondary
    End point timeframe
    From enrollment up to maximum duration of 6.3 years
    End point values
    		 All participants
    Number of subjects analysed
    424
    Units: percentage
        number (not applicable)
    100
    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 (AEs): From enrollment up to maximum duration of 6.3 years
    Adverse event reporting additional description
    All-Cause Mortality: Included participants who signed informed consent and enrolled into study. AEs: Included all enrolled participants who met all inclusion criteria , and with at least one post-Day 1 visit measurement available.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.1
    Reporting groups
    Reporting group title
    SOF+RBV
    Reporting group description
    		 Participants who were previously treated with sofosbuvir (SOF) along with ribavirin (RBV) were followed for up to 5 years.

    Reporting group title
    LDV/SOF+/-RBV
    Reporting group description
    		 Participants who were previously treated with ledipasvir (LDV)/SOF with or without RBV were followed for up to 5 years.

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

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

    Serious adverse events
    		 SOF+RBV LDV/SOF+/-RBV SOF/VEL SOF/VEL/VOX
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 178 (0.00%)
    0 / 142 (0.00%)
    0 / 18 (0.00%)
         number of deaths (all causes)
    0
    1
    0
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 SOF+RBV LDV/SOF+/-RBV SOF/VEL SOF/VEL/VOX
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 178 (0.00%)
    0 / 142 (0.00%)
    0 / 18 (0.00%)
    Nervous system disorders
    Presyncope
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 178 (0.00%)
    0 / 142 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    07 May 2014
    - Quality of Life assessment was moved from a secondary objective/endpoint to an exploratory objective/endpoint. - Added exclusion criteria for subjects with history of clinically significant illness or any other major medical disorder that may interfere with the study - Modified discontinuation criteria to include subjects initiating any new course of hepatitis C therapy rather than only antiviral therapy. - Added Tanner Pubertal Stage Assessment as a baseline assessment - Modified the physical examination procedure performed at each study visit to a symptom-directed physical examination. - Modified inform consent procedures to align with parent pediatric procedures. - Added Tanner Pubertal Stage Assessment procedures and specifications. - Added Body Height & Weight Measurement procedures and specifications. - Added Quality of Life Surveys procedure and specifications. - Updated the SAE reporting procedure and requirements to align with Gilead Sciences Inc. (GSI) standard operating procedures.
    22 May 2015
    - Laboratory tests assessing liver function has been removed as a primary end point based on local standard of care and that the goal of the registry is to evaluate growth and development after therapy. - Each subject will not be required to complete the Day 1 assessments. These assessments will be documented as the last visit of the previous Gileadsponsored treatment protocol. - Study visits were reduced by fulfilling the minimum regulatory requirements. - Informed consent language was added to align with the Gilead-sponsored treatment protocols. - Since each subject’s Day 1 assessments will be documented from the last visit of the previous Gilead-sponsored treatment protocol, the informed consent must be signed prior to conduct of any study assessment at the Week 24 visit and within 120 days from the subject’s last visit in the Gileadsponsored treatment protocol. - The PedsQL™ Young Adult survey was added to the protocol for subjects who are >18 years old.
    09 Feb 2016
    - Additional language has been added for clarification on retesting procedures in the event of a positive HCV RNA result as requested by country-specific ethics committees. - Additional flexibility in the duration of time each subject and their parent/legal guardian has to sign the initial consent form(s) has been included within the Registry protocol. - Additional language was added to provide clarification on how SAEs related to the previous Gilead-sponsored study will be reported once the treatment protocols’ database has been locked. - Reminder phone calls to the subject by the study site have been added to the study procedures in order to increase subject retention. - Language for consent requirements has been modified to be more generic due to the varying country-specific regulations on the age of an adult subject. - Date of first menses is not a required data point in order to conduct the Tanner Pubertal Stage Assessment and therefore has been removed. - Adverse events had been added to the primary safety endpoints in error and therefore have been removed

    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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    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
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