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    Clinical Trial Results:
    A Long Term Follow-up Registry of Subjects Treated in A Gilead-Sponsored Trial in Subjects with Chronic Hepatitis B Infection

    Summary
    EudraCT number
    2015-001050-16
    Trial protocol
    IT  
    Global end of trial date
    14 Aug 2017

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

    Trial information

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    Trial identification
    Sponsor protocol code
    GS-US-330-1508
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02258581
    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
    14 Aug 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    14 Aug 2017
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primary objective of this study was to evaluate the long term effects of hepatitis B virus (HBV) treatment of the parental study on the HBV serologic changes through Week 144.
    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
    09 Dec 2014
    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: 147
    Country: Number of subjects enrolled
    Canada: 21
    Country: Number of subjects enrolled
    Korea, Democratic People's Republic of: 18
    Country: Number of subjects enrolled
    New Zealand: 11
    Country: Number of subjects enrolled
    Hong Kong: 5
    Country: Number of subjects enrolled
    India: 5
    Country: Number of subjects enrolled
    Australia: 1
    Country: Number of subjects enrolled
    Netherlands: 6
    Country: Number of subjects enrolled
    Italy: 26
    Worldwide total number of subjects
    240
    EEA total number of subjects
    32
    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)
    230
    From 65 to 84 years
    10
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Participants were enrolled at study sites in North America, Europe, and Asia-Pacific. The first participant was screened on 09 December 2014. The last study visit occurred on 14 August 2017.

    Pre-assignment
    Screening details
    245 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
    Arm title
    Registry Study
    Arm description
    Participants who had been treated in selected Gilead-sponsored studies (GS-US-330-0101, GS-US-330-1401, GS-US-283-1059, and GS-US-174-0149) for chronic hepatitis B.
    Arm type
    No Intervention

    Investigational medicinal product name
    HBV treatment in the parental study
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    No investigational treatment was administered in this study. Routes of administration and pharmaceutical forms are entered because these are required data elements in the system.

    Number of subjects in period 1
    Registry Study
    Started
    240
    Completed
    1
    Not completed
    239
         Withdrawal By Subject
    19
         Study Terminated By Sponsor
    218
         Lost to follow-up
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Registry Study
    Reporting group description
    Participants who had been treated in selected Gilead-sponsored studies (GS-US-330-0101, GS-US-330-1401, GS-US-283-1059, and GS-US-174-0149) for chronic hepatitis B.

    Reporting group values
    Registry Study Total
    Number of subjects
    240 240
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    49 ± 10.4 -
    Gender categorical
    Units: Subjects
        Female
    69 69
        Male
    171 171
    Race
    Units: Subjects
        Asian
    179 179
        Black or African American
    8 8
        Native Hawaiian or Pacific Islander
    5 5
        White
    47 47
        Other
    1 1
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    3 3
        Not Hispanic or Latino
    232 232
        Not Permitted
    5 5
    HBsAg Status
    Units: Subjects
        Negative
    11 11
        Positive
    229 229
    HBeAg Status
    Units: Subjects
        Negative
    190 190
        Positive
    49 49
        Missing
    1 1
    HBsAg
    Units: log10 IU/mL
        arithmetic mean (standard deviation)
    2.8 ± 1.16 -
    HBV DNA
    Units: log10 IU/mL
        arithmetic mean (standard deviation)
    1.4 ± 0.73 -

    End points

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    End points reporting groups
    Reporting group title
    Registry Study
    Reporting group description
    Participants who had been treated in selected Gilead-sponsored studies (GS-US-330-0101, GS-US-330-1401, GS-US-283-1059, and GS-US-174-0149) for chronic hepatitis B.

    Primary: Percentage of participants with serum hepatitis B surface antigen (HBsAg) decline ≥ 0.5 log10 IU/ml from baseline at Week 48

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    End point title
    Percentage of participants with serum hepatitis B surface antigen (HBsAg) decline ≥ 0.5 log10 IU/ml from baseline at Week 48 [1]
    End point description
    Participants in the Full Analysis Set (who were HBsAg positive at baseline) with available data were analyzed.
    End point type
    Primary
    End point timeframe
    Week 48
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical comparison was planned or performed.
    End point values
    Registry Study
    Number of subjects analysed
    176
    Units: Percentage of participants
        number (not applicable)
    1.7
    No statistical analyses for this end point

    Primary: Percentage of participants who remain HBsAg negative at Week 48

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    End point title
    Percentage of participants who remain HBsAg negative at Week 48 [2]
    End point description
    Participants in the Full Analysis Set (who were HBsAg negative at baseline) with available data were analyzed.
    End point type
    Primary
    End point timeframe
    Week 48
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical comparison was planned or performed.
    End point values
    Registry Study
    Number of subjects analysed
    7
    Units: Percentage of participants
        number (not applicable)
    100.0
    No statistical analyses for this end point

    Secondary: Percentage of participants with serum HBsAg decline ≥ 0.5 log10 IU/ml from baseline at Week 144

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    End point title
    Percentage of participants with serum HBsAg decline ≥ 0.5 log10 IU/ml from baseline at Week 144
    End point description
    Participants in the Full Analysis Set (who were HBsAg positive at baseline) with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Week 144
    End point values
    Registry Study
    Number of subjects analysed
    11
    Units: Percentage of participants
        number (not applicable)
    9.1
    No statistical analyses for this end point

    Secondary: Percentage of participants who achieve HBsAg loss at Week 48

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    End point title
    Percentage of participants who achieve HBsAg loss at Week 48
    End point description
    Participants in the Full Analysis Set (who were HBsAg positive at baseline) with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Week 48
    End point values
    Registry Study
    Number of subjects analysed
    178
    Units: Percentage of Participants
        number (not applicable)
    0.6
    No statistical analyses for this end point

    Secondary: Percentage of participants who achieve HBsAg loss at Week 144

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    End point title
    Percentage of participants who achieve HBsAg loss at Week 144
    End point description
    Participants in the Full Analysis Set (who were HBsAg positive at baseline) with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Week 144
    End point values
    Registry Study
    Number of subjects analysed
    11
    Units: Percentage of participants
        number (not applicable)
    0
    No statistical analyses for this end point

    Secondary: Percentage of participants with hepatitis B e antigen (HBeAg) loss and seroconversion at Week 48

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    End point title
    Percentage of participants with hepatitis B e antigen (HBeAg) loss and seroconversion at Week 48
    End point description
    Participants in the Full Analysis Set (who were HBeAg positive at baseline) with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Week 48
    End point values
    Registry Study
    Number of subjects analysed
    37
    Units: Percentage of participants
        number (not applicable)
    2.7
    No statistical analyses for this end point

    Secondary: Percentage of participants with HBeAg loss and seroconversion at Week 144

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    End point title
    Percentage of participants with HBeAg loss and seroconversion at Week 144
    End point description
    Participants in the Full Analysis Set (who were HBeAg positive at baseline) with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Week 144
    End point values
    Registry Study
    Number of subjects analysed
    3
    Units: Percentage of participants
        number (not applicable)
    33.3
    No statistical analyses for this end point

    Secondary: Percentage of participants who remain HBeAg negative and HBeAb positive at Week 48

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    End point title
    Percentage of participants who remain HBeAg negative and HBeAb positive at Week 48
    End point description
    Participants in the Full Analysis Set who achieved HBeAg seroconversion during the parental study were analyzed.
    End point type
    Secondary
    End point timeframe
    Week 48
    End point values
    Registry Study
    Number of subjects analysed
    3
    Units: Percentage of participants
        number (not applicable)
    100.0
    No statistical analyses for this end point

    Secondary: Percentage of participants with HBV DNA < the lower limit of quantitation (LLOQ < 20 IU/mL) at Week 48

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    End point title
    Percentage of participants with HBV DNA < the lower limit of quantitation (LLOQ < 20 IU/mL) at Week 48
    End point description
    Participants in the Full Analysis Set (who were on treatment with oral antiviral (OAV) for HBV) with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Week 48
    End point values
    Registry Study
    Number of subjects analysed
    161
    Units: Percentage of participants
        number (not applicable)
    93.2
    No statistical analyses for this end point

    Secondary: Percentage of participants with HBV DNA < LLOQ at Week 96

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    End point title
    Percentage of participants with HBV DNA < LLOQ at Week 96
    End point description
    Participants in the Full Analysis Set (who were on treatment with OAV for HBV) with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Week 96
    End point values
    Registry Study
    Number of subjects analysed
    104
    Units: Percentage of participants
        number (not applicable)
    96.2
    No statistical analyses for this end point

    Secondary: Percentage of participants with HBV DNA < LLOQ at Week 144

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    End point title
    Percentage of participants with HBV DNA < LLOQ at Week 144
    End point description
    Participants (who were on treatment with OAV for HBV) with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Week 144
    End point values
    Registry Study
    Number of subjects analysed
    11
    Units: Percentage of participants
        number (not applicable)
    90.9
    No statistical analyses for this end point

    Secondary: Change from Baseline in HBV DNA at Week 48

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    End point title
    Change from Baseline in HBV DNA at Week 48
    End point description
    Participants in the Full Analysis Set (all enrolled participants with at least one dose if one of the parental protocol defined treatment regimens and one visit during the registry) with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Week 48
    End point values
    Registry Study
    Number of subjects analysed
    184
    Units: log10 IU/mL
        arithmetic mean (standard deviation)
    -0.01 ± 0.403
    No statistical analyses for this end point

    Secondary: Change from Baseline in HBV DNA at Week 96

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    End point title
    Change from Baseline in HBV DNA at Week 96
    End point description
    Participants in the Full Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Week 96
    End point values
    Registry Study
    Number of subjects analysed
    108
    Units: log10 IU/mL
        arithmetic mean (standard deviation)
    0.01 ± 0.202
    No statistical analyses for this end point

    Secondary: Change from Baseline in HBV DNA at Week 144

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    End point title
    Change from Baseline in HBV DNA at Week 144
    End point description
    Participants in the Full Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Week 144
    End point values
    Registry Study
    Number of subjects analysed
    11
    Units: log10 IU/mL
        arithmetic mean (standard deviation)
    0.09 ± 0.310
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Up to Week 144
    Adverse event reporting additional description
    Safety Analysis Set: participants with at least one dose of one of the parental protocol defined treatment regimens
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    None
    Dictionary version
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    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: No participants experienced any adverse events during this registry.

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    11 Mar 2015
    1. Added language specifying study inclusion criteria for subjects who participated in Gilead-sponsored study number GS-US-174-0149 2. Revised study design and inclusion criteria so that Baseline visit may occur up to 120 days since the last study visit of Gilead-sponsored study for CHB 3. Updated analysis objectives and endpoints 4. Added language to specify distinction between symptom-directed physical exam and vital signs collection 5. Addition of quality of life assessments 6. Added language to clarify collection of adverse events deemed by investigator to be related to treatment from previous Gilead-sponsored CHB treatment protocol
    05 Oct 2016
    1. Added language to clarify how Adverse Events, Serious Adverse Events, and Special Situations are collected and reported based on association with registry protocol mandated procedures, initial Gilead-sponsored study, or commercially approved Gilead product as part of CHB standard of care treatment 2. Removed references throughout to the observational nature of the study 3. Clarified that no formal sample size statistical analysis will be performed

    Interruptions (globally)

    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    14 Aug 2017
    The registry was meant to evaluate the long-term effects of anti-HBV compounds. These compounds are either no longer in development or have not, to date, met the primary efficacy endpoint, and therefore the registry was terminated early. Consequently, although up to 500 participants were planned for the registry only 240 subjects were enrolled.
    -

    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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