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    Clinical Trial Results:
    B-Fine: An open label, single arm study to mechanistically interrogate the therapeutic effect of GSK3228836 in patients with Chronic Hepatitis B via intrahepatic immunophenotyping

    Summary
    EudraCT number
    		 2020-002000-39
    Trial protocol
    		 NL   GB  
    Global end of trial date
    30 Nov 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    15 Dec 2024
    First version publication date
    15 Dec 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    212602
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04544956
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline
    Sponsor organisation address
    Great West Road, Brentford, Middlesex, United Kingdom, TW8 9GS
    Public contact
    GSK Response Center, GlaxoSmithKline, 1 8664357343, GSKClinicalSupportHD@gsk.com
    Scientific contact
    GSK Response Center, GlaxoSmithKline, 1 8664357343, GSKClinicalSupportHD@gsk.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
    05 Jan 2024
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Nov 2023
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To assess the effect of 12 weeks of GSK3228836 on serum hepatitis B virus surface antigen (HBsAg) levels in participants with chronic hepatitis B (CHB)
    Protection of trial subjects
    Not applicable
    Background therapy
    		 Protocol inclusion criterion 2 states: Participants who have documented chronic HBV infection >=6 months prior to screening AND currently receiving stable nucleos(t)ide analogue therapy, defined as no changes to their nucleos(t)ide regimen from at least 6 months prior to screening and with no planned changes to the stable regimen over the duration of the study.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    06 Oct 2020
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Canada: 4
    Country: Number of subjects enrolled
    Netherlands: 2
    Country: Number of subjects enrolled
    United Kingdom: 3
    Country: Number of subjects enrolled
    United States: 3
    Worldwide total number of subjects
    12
    EEA total number of subjects
    2
    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)
    12
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 This was an open label, single arm study to mechanistically interrogate the therapeutic effect of GSK3228836 in participants with Chronic Hepatitis B via intrahepatic immunophenotyping.

    Pre-assignment
    Screening details
    		 A total of 12 participants were enrolled in this study.

    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
    		 GSK3228836 300 mg
    Arm description
    		 Participants on stable nucleos(t)ide therapy received GSK3228836 300 milligrams (mg) subcutaneously (SC) weekly once for 12 weeks along with a loading dose of GSK3228836 300 mg in Week 1 (Day 4) and Week 2 (Day 11).
    Arm type
    		 Experimental

    Investigational medicinal product name
    GSK3228836
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Administered two subcutaneous injections for 300 milligrams dose.

    Number of subjects in period 1
    		GSK3228836 300 mg
    Started
    12
    Completed
    11
    Not completed
    1
         Consent withdrawn by subject
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    GSK3228836 300 mg
    Reporting group description
    		 Participants on stable nucleos(t)ide therapy received GSK3228836 300 milligrams (mg) subcutaneously (SC) weekly once for 12 weeks along with a loading dose of GSK3228836 300 mg in Week 1 (Day 4) and Week 2 (Day 11).

    Reporting group values
    		 GSK3228836 300 mg Total
    Number of subjects
    		 12 12
    Age categorical
    Units: Participants
        Adults (18-64 years)
    		 12 12
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 48.8 ( 8.48 ) -
    Sex: Female, Male
    Gender categories (with 0<n<11) are combined into one ‘De-identified’ category to maintain participant confidentiality and privacy, as they could lead to participant re-identification.
    Units: Participants
        De-identified
    		 12 12
    Race/Ethnicity, Customized
    Race categories (with 0<n<11) are combined into one ‘De-identified’ category to maintain participant confidentiality and privacy, as they could lead to participant re-identification.
    Units: Subjects
        De-identified
    		 12 12

    End points

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    End points reporting groups
    Reporting group title
    GSK3228836 300 mg
    Reporting group description
    		 Participants on stable nucleos(t)ide therapy received GSK3228836 300 milligrams (mg) subcutaneously (SC) weekly once for 12 weeks along with a loading dose of GSK3228836 300 mg in Week 1 (Day 4) and Week 2 (Day 11).

    Primary: Percentage of participants achieving serum hepatitis B virus surface antigen (HBsAg) level less than (<) lower limit of quantitation (LLOQ)

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    End point title
    		 Percentage of participants achieving serum hepatitis B virus surface antigen (HBsAg) level less than (<) lower limit of quantitation (LLOQ) [1]
    End point description
    Percentage of participants achieving serum HBsAg level <LLOQ were reported. Percentage values are rounded-off. Intent to Treat (ITT) Set that included all participants who received at least one dose of study treatment.
    End point type
    Primary
    End point timeframe
    Up to Week 12
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: There are no statistical data to report.
    End point values
    		 GSK3228836 300 mg
    Number of subjects analysed
    12 [2]
    Units: Percentage of participants
    25
    Notes
    [2] - ITT Set
    No statistical analyses for this end point

    Secondary: Percentage of participants with Sustained HBsAg Response (HBsAg <LLOQ) for 24 weeks after the planned and actual end of GSK3228836 treatment

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    End point title
    		 Percentage of participants with Sustained HBsAg Response (HBsAg <LLOQ) for 24 weeks after the planned and actual end of GSK3228836 treatment
    End point description
    Sustained HBsAg response is defined as HBsAg <LLOQ for 24 weeks from end of GSK3228836 treatment. Percentage values are rounded-off. Intent to Treat (ITT) Set that included all participants who received at least one dose of study treatment.
    End point type
    Secondary
    End point timeframe
    Up to 24 weeks off treatment (Study Weeks 12 to 36)
    End point values
    		 GSK3228836 300 mg
    Number of subjects analysed
    12 [3]
    Units: Percentage of participants
        24 Weeks after Planned End of GSK3228836 Treatment
    8
        24 Weeks after Actual End of GSK3228836 Treatment
    8
    Notes
    [3] - ITT Set
    No statistical analyses for this end point

    Secondary: Percentage of participants achieving Sustained Virologic Response (HBsAg < LLOQ and HBV DNA < LLOQ) for 24 weeks after the planned and actual end of GSK3228836 treatment

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    End point title
    		 Percentage of participants achieving Sustained Virologic Response (HBsAg < LLOQ and HBV DNA < LLOQ) for 24 weeks after the planned and actual end of GSK3228836 treatment
    End point description
    Sustained virologic response is defined as HBsAg <LLOQ and hepatitis B virus (HBV) deoxyribonucleic acid (DNA) <LLOQ for 24 weeks from end of GSK3228836 treatment. Percentage values are rounded-off. Intent to Treat (ITT) Set that included all participants who received at least one dose of study treatment.
    End point type
    Secondary
    End point timeframe
    Up to 24 weeks off treatment (Study Weeks 12 to 36)
    End point values
    		 GSK3228836 300 mg
    Number of subjects analysed
    12 [4]
    Units: Percentage of participants
        24 Weeks after Planned End of GSK3228836 Treatment
    8
        24 Weeks after Actual End of GSK3228836 Treatment
    8
    Notes
    [4] - ITT Set
    No statistical analyses for this end point

    Secondary: Percentage of participants achieving HBsAg <LLOQ at indicated time points

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    End point title
    		 Percentage of participants achieving HBsAg <LLOQ at indicated time points
    End point description
    Percentage of participants achieving HBsAg <LLOQ were assessed at indicated time points. Percentage values are rounded-off. Intent to Treat (ITT) Set that included all participants who received at least one dose of study treatment. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the ‘Overall Number of Participants Analyzed’ field. 'Number Analyzed' signifies participants evaluable for the specified time points (represented by n=X in the category titles).
    End point type
    Secondary
    End point timeframe
    Baseline (Week -1), treatment Day 78 and off treatment (OT) Day 162
    End point values
    		 GSK3228836 300 mg
    Number of subjects analysed
    12 [5]
    Units: Percentage of participants
        Baseline (Week -1), n=12
    0
        Treatment Day 78, n=10
    30
        Off Treatment Day 162, n=11
    18
    Notes
    [5] - ITT Set
    No statistical analyses for this end point

    Secondary: Percentage of participants achieving HBV DNA <LLOQ at indicated time points

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    End point title
    		 Percentage of participants achieving HBV DNA <LLOQ at indicated time points
    End point description
    Percentage of participants achieving HBV DNA <LLOQ were assessed at indicated time points. Percentage values are rounded-off. Intent to Treat (ITT) Set that included all participants who received at least one dose of study treatment. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the ‘Overall Number of Participants Analyzed’ field. 'Number Analyzed' signifies participants evaluable for the specified time points (represented by n=X in the category titles).
    End point type
    Secondary
    End point timeframe
    Baseline (Week -1), treatment Day 78 and off treatment Day 162
    End point values
    		 GSK3228836 300 mg
    Number of subjects analysed
    12 [6]
    Units: Percentage of participants
        Baseline (Week -1), n=12
    92
        Treatment Day 78, n=9
    78
        Off Treatment Day 162, n=11
    100
    Notes
    [6] - ITT Set
    No statistical analyses for this end point

    Secondary: Percentage of participants achieving HBsAg <LLOQ and HBV DNA <LLOQ at indicated time points

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    End point title
    		 Percentage of participants achieving HBsAg <LLOQ and HBV DNA <LLOQ at indicated time points
    End point description
    Percentage of participants achieving HBsAg <LLOQ and HBV DNA <LLOQ were assessed at indicated time points. Percentage values are rounded-off. Intent to Treat (ITT) Set that included all participants who received at least one dose of study treatment. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the ‘Overall Number of Participants Analyzed’ field. 'Number Analyzed' signifies participants evaluable for the specified time points (represented by n=X in the category titles).
    End point type
    Secondary
    End point timeframe
    Baseline (Week -1), treatment Day 78 and off treatment Day 162
    End point values
    		 GSK3228836 300 mg
    Number of subjects analysed
    12 [7]
    Units: Percentage of participants
        Baseline (Week -1), n=12
    0
        Treatment Day 78, n=10
    20
        Off Treatment Day 162, n=11
    18
    Notes
    [7] - ITT Set
    No statistical analyses for this end point

    Secondary: Percentage of participants with categorical change from Baseline in HBsAg Values at indicated time points

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    End point title
    		 Percentage of participants with categorical change from Baseline in HBsAg Values at indicated time points
    End point description
    Participants who achieved a decline in HBsAg values from Baseline were reported. Participants were categorized in the following categorical HBsAg decline of <0.5, greater than or equal to (>=) 0.5, >=1, >=1.5, and >=3 log10 international units per milliliter (IU/mL). The 'HBsAg < LLOQ' category is derived based on Absolute/raw HBsAg result. The HBsAg decline categories are based on change from Baseline values. Percentage values are rounded-off. Intent to Treat (ITT) Set that included all participants who received at least one dose of study treatment. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the ‘Overall Number of Participants Analyzed’ field. 'Number Analyzed' signifies participants evaluable for the specified time points (represented by n=X in the category titles).
    End point type
    Secondary
    End point timeframe
    Baseline (Week -1), Treatment Week 12 and off treatment Week 24
    End point values
    		 GSK3228836 300 mg
    Number of subjects analysed
    11 [8]
    Units: Percentage of participants
        Treatment (Treat.) Week 12, HBsAg < LLOQ, n=10
    30
        Treat. Week12, HBsAg decline <0.5 log10 IU/mL,n=10
    10
        Treat.Week 12,HBsAg decline >=0.5 log10 IU/mL,n=10
    90
        Treat. Week 12,HBsAg decline >=1 log10 IU/mL, n=10
    80
        Treat.Week12,HBsAg decline >=1.5 log10 IU/mL, n=10
    80
        Treat. Week12,HBsAg decline >=3 log10 IU/mL, n=10
    50
        Off Treatment (OT) Week 24, HBsAg < LLOQ, n=11
    18
        OT Week 24, HBsAg decline <0.5 log10 IU/mL, n=11
    73
        OT Week 24, HBsAg decline >=0.5 log10 IU/mL, n=11
    27
        OT Week 24, HBsAg decline >=1 log10 IU/mL, n=11
    27
        OT Week 24, HBsAg decline >=1.5 log10 IU/mL, n=11
    27
        OT Week 24, HBsAg decline >=3 log10 IU/mL, n=11
    18
    Notes
    [8] - ITT Set
    No statistical analyses for this end point

    Secondary: Number of participants with alanine aminotransferase (ALT) greater than (>)3 times upper limit of normal (ULN) at indicated time points

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    End point title
    		 Number of participants with alanine aminotransferase (ALT) greater than (>)3 times upper limit of normal (ULN) at indicated time points
    End point description
    Blood samples were collected at indicated time points to assess ALT levels. The ALT normalization (ALT <=upper limit of normal [ULN]) over time in absence of rescue medication in participants with Baseline ALT>ULN and ALT data at that visit. Participants who achieved ALT normalization were reported. Intent to Treat (ITT) Set that included all participants who received at least one dose of study treatment. The "n" represents the number of participants with Baseline ALT > ULN and ALT data at that visit. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the ‘Overall Number of Participants Analyzed’ field. 'Number Analyzed' signifies participants evaluable for the specified time points (represented by n=X in the category titles).
    End point type
    Secondary
    End point timeframe
    Baseline (Week -1), treatment Days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78; off treatment Days 1, 8, 22, 50, 78, 106, 134 and 162
    End point values
    		 GSK3228836 300 mg
    Number of subjects analysed
    12 [9]
    Units: Participants
        Baseline (Week -1), n=12
    0
        Treatment Day 8, n=12
    0
        Treatment Day 15, n=11
    0
        Treatment Day 22, n=12
    0
        Treatment Day 29, n=11
    0
        Treatment Day 36, n=11
    1
        Treatment Day 43, n=10
    1
        Treatment Day 50, n=10
    1
        Treatment Day 57, n=10
    1
        Treatment Day 64, n=11
    1
        Treatment Day 71, n=11
    1
        Treatment Day 78, n=11
    0
        Off Treatment Day 1, n=10
    0
        Off Treatment Day 8, n=11
    0
        Off Treatment Day 22, n=11
    0
        Off Treatment Day 50, n=11
    0
        Off Treatment Day 78, n=9
    0
        Off Treatment Day 106, n=11
    1
        Off Treatment Day 134, n=9
    0
        Off Treatment Day 162, n=11
    0
    Notes
    [9] - ITT Set
    No statistical analyses for this end point

    Secondary: Number of Participants With HBe Antibody (Anti-HBeAg) Levels

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    End point title
    		 Number of Participants With HBe Antibody (Anti-HBeAg) Levels
    End point description
    Blood samples were collected to assess HBe antibody levels and results reported are for Baseline HBeAg positive participants. Intent to Treat (ITT) Set that included all participants who received at least one dose of study treatment. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the ‘Overall Number of Participants Analyzed’ field. 'Number Analyzed' signifies participants evaluable for the specified time points (represented by n=X in the category titles).
    End point type
    Secondary
    End point timeframe
    Baseline (Week -1), treatment Days 29, 36, and 57; off treatment Days 1, 8, 22, 50, 78, 106, 134 and 162
    End point values
    		 GSK3228836 300 mg
    Number of subjects analysed
    12 [10]
    Units: Participants
        Baseline (Week -1), n=12
    11
        Treatment Day 29, n=11
    11
        Treatment Day 36, n=1
    0
        Treatment Day 57, n=10
    9
        Off Treatment Day 1, n=10
    9
        Off Treatment Day 8, n=11
    10
        Off Treatment Day 22, n=11
    10
        Off Treatment Day 50, n=11
    10
        Off Treatment Day 78, n=11
    10
        Off Treatment Day 106, n=11
    10
        Off Treatment Day 134, n=9
    8
        Off Treatment Day 162, n=11
    10
    Notes
    [10] - ITT Set
    No statistical analyses for this end point

    Secondary: Actual values of HBsAg at indicated time points

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    End point title
    		 Actual values of HBsAg at indicated time points
    End point description
    Blood samples were collected from participants at indicated time points to assess HBsAg levels. Intent to Treat (ITT) Set that included all participants who received at least one dose of study treatment. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the ‘Overall Number of Participants Analyzed’ field. 'Number Analyzed' signifies participants evaluable for the specified time points (represented by n=X in the category titles).
    End point type
    Secondary
    End point timeframe
    Baseline (Week -1), treatment Day 78 and off treatment Day 162
    End point values
    		 GSK3228836 300 mg
    Number of subjects analysed
    12 [11]
    Units: Log10 IU/mL
    arithmetic mean (standard deviation)
        Baseline (Week -1), n=12
    3.29 ( 0.590 )
        Treatment Day 78, n=10
    0.33 ( 1.432 )
        Off Treatment Day 162, n=11
    2.08 ( 1.933 )
    Notes
    [11] - ITT Set
    No statistical analyses for this end point

    Secondary: Mean change from Baseline in HBsAg at indicated time points

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    End point title
    		 Mean change from Baseline in HBsAg at indicated time points
    End point description
    Blood samples were collected from participants at indicated time points to assess HBsAg levels. Change from Baseline was defined as value at the indicated time point minus Baseline value. Baseline was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Intent to Treat (ITT) Set that included all participants who received at least one dose of study treatment. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the ‘Overall Number of Participants Analyzed’ field. 'Number Analyzed' signifies participants evaluable for the specified time points (represented by n=X in the category titles). Participants who had Baseline and at least 1 post-Baseline visit values were included in analysis.
    End point type
    Secondary
    End point timeframe
    Baseline (Week -1), treatment Day 78 and off treatment Day 162
    End point values
    		 GSK3228836 300 mg
    Number of subjects analysed
    11 [12]
    Units: Log10 IU/mL
    arithmetic mean (standard deviation)
        Treatment Day 78, n=10
    -2.923 ( 1.5803 )
        Off Treatment Day 162, n=11
    -1.183 ( 1.8343 )
    Notes
    [12] - ITT Set
    No statistical analyses for this end point

    Secondary: Actual values of HBV DNA at indicated time points

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    End point title
    		 Actual values of HBV DNA at indicated time points
    End point description
    Blood samples were collected from participants at indicated time points to assess HBV DNA levels. Intent to Treat (ITT) Set that included all participants who received at least one dose of study treatment. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the ‘Overall Number of Participants Analyzed’ field. 'Number Analyzed' signifies participants evaluable for the specified time points (represented by n=X in the category titles).
    End point type
    Secondary
    End point timeframe
    Baseline (Week -1), treatment Day 78 and off treatment Day 162
    End point values
    		 GSK3228836 300 mg
    Number of subjects analysed
    12 [13]
    Units: Log10 IU/mL
    arithmetic mean (standard deviation)
        Baseline (Week -1), n=12
    0.43 ( 0.849 )
        Treatment Day 78, n=9
    0.31 ( 0.611 )
        Off Treatment Day 162, n=11
    0.24 ( 0.525 )
    Notes
    [13] - ITT Set
    No statistical analyses for this end point

    Secondary: Mean change from Baseline in HBV DNA at indicated time points

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    End point title
    		 Mean change from Baseline in HBV DNA at indicated time points
    End point description
    Blood samples were collected from participants at indicated time points to assess HBV DNA levels. Change from Baseline was defined as value at the indicated time point minus Baseline value. Baseline was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Intent to Treat (ITT) Set that included all participants who received at least one dose of study treatment. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the ‘Overall Number of Participants Analyzed’ field. 'Number Analyzed' signifies participants evaluable for the specified time points (represented by n=X in the category titles). Participants who had Baseline and at least 1 post-Baseline visit values were included in analysis.
    End point type
    Secondary
    End point timeframe
    Baseline (Week -1), treatment Day 78 and off treatment Day 162
    End point values
    		 GSK3228836 300 mg
    Number of subjects analysed
    11 [14]
    Units: Log10 IU/mL
    arithmetic mean (standard deviation)
        Treatment Day 78, n=9
    -0.271 ( 1.1145 )
        Off Treatment Day 162, n=11
    -0.237 ( 0.7871 )
    Notes
    [14] - ITT Set
    No statistical analyses for this end point

    Secondary: Actual values of HB surface antibody (anti-HBsAg) levels at indicated time points

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    End point title
    		 Actual values of HB surface antibody (anti-HBsAg) levels at indicated time points
    End point description
    Blood samples were collected from participants at indicated time points to assess anti-HBsAg levels. Intent to Treat (ITT) Set that included all participants who received at least one dose of study treatment. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the ‘Overall Number of Participants Analyzed’ field. 'Number Analyzed' signifies participants evaluable for the specified time points (represented by n=X in the category titles).
    End point type
    Secondary
    End point timeframe
    Baseline (Week -1) and off treatment Days 1 and 162
    End point values
    		 GSK3228836 300 mg
    Number of subjects analysed
    12 [15]
    Units: Log10 IU/mL
    arithmetic mean (standard deviation)
        Baseline (Week -1), n=12
    0.60 ( 0.000 )
        Off Treatment Day 1, n=10
    0.71 ( 0.238 )
        Off Treatment Day 162, n=11
    0.70 ( 0.260 )
    Notes
    [15] - ITT Set
    No statistical analyses for this end point

    Secondary: Area under the concentration-time curve (AUC) for ALT at indicated time points

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    End point title
    		 Area under the concentration-time curve (AUC) for ALT at indicated time points
    End point description
    Blood samples were collected from participants to assess AUC for ALT. On-treatment blood samples were collected from Weeks 1 to 12 and follow-up blood samples were collected from Weeks 12 to 36. AUC was calculated and presented for on-treatment (12 Weeks), follow-up (24 weeks), and On-treatment + follow-up (Weeks 1 to 36). Intent to Treat (ITT) Set that included all participants who received at least one dose of study treatment. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the ‘Overall Number of Participants Analyzed’ field. 'Number Analyzed' signifies participants evaluable for the specified time points (represented by n=X in the category titles).
    End point type
    Secondary
    End point timeframe
    Study Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 16, 20, 24, 28, 32 and 36
    End point values
    		 GSK3228836 300 mg
    Number of subjects analysed
    12 [16]
    Units: Weeks*International Units Per Liter
    arithmetic mean (standard deviation)
        On-Treatment (12 Weeks), n=12
    494.75 ( 562.593 )
        Follow-up (24 weeks), n=11
    650.58 ( 462.762 )
        On-Treatment + Follow-Up (Weeks 1 to 36), n=11
    1173.72 ( 836.768 )
    Notes
    [16] - ITT Set
    No statistical analyses for this end point

    Secondary: Time to Maximum ALT

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    End point title
    		 Time to Maximum ALT
    End point description
    Time to maximum ALT (maximum peak in ALT) during 36 week (treatment + follow-up) is defined as time from Baseline to the time of first peak in ALT. Intent to Treat (ITT) Set that included all participants who received at least one dose of study treatment. 99999 indicates median and 95% CI (upper limit) could not be derived, as <50% of participants experienced the event within the treatment arm.
    End point type
    Secondary
    End point timeframe
    Up to Study Week 36
    End point values
    		 GSK3228836 300 mg
    Number of subjects analysed
    12 [17]
    Units: Weeks
        median (confidence interval 95%)
    99999 (27.1 to 99999)
    Notes
    [17] - ITT Set
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to Week 36
    Adverse event reporting additional description
    All-cause mortality, serious adverse events and non-serious adverse events were reported for the Safety Population which consisted of all participants who received at least one dose of study treatment.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26.1
    Reporting groups
    Reporting group title
    GSK3228836 300 mg
    Reporting group description
    		 Participants on stable nucleos(t)ide therapy received GSK3228836 300 milligrams (mg) subcutaneously (SC) weekly once for 12 weeks along with a loading dose of GSK3228836 300 mg in Week 1 (Day 4) and Week 2 (Day 11).

    Serious adverse events
    		 GSK3228836 300 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 12 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 GSK3228836 300 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    11 / 12 (91.67%)
    General disorders and administration site conditions
    Pyrexia
    alternative dictionary used: 26.1 26.1
         subjects affected / exposed
    2 / 12 (16.67%)
         occurrences all number
    2
    Injection site pain
    alternative dictionary used: 26.1 26.1
         subjects affected / exposed
    2 / 12 (16.67%)
         occurrences all number
    40
    Injection site bruising
    alternative dictionary used: 26.1 26.1
         subjects affected / exposed
    2 / 12 (16.67%)
         occurrences all number
    10
    Fatigue
    alternative dictionary used: 26.1 26.1
         subjects affected / exposed
    2 / 12 (16.67%)
         occurrences all number
    2
    Injection site pruritus
    alternative dictionary used: 26.1 26.1
         subjects affected / exposed
    4 / 12 (33.33%)
         occurrences all number
    18
    Injection site erythema
    alternative dictionary used: 26.1 26.1
         subjects affected / exposed
    7 / 12 (58.33%)
         occurrences all number
    30
    Chest discomfort
    alternative dictionary used: 26.1 26.1
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Injection site discomfort
    alternative dictionary used: 26.1 26.1
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Injection site swelling
    alternative dictionary used: 26.1 26.1
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Immune system disorders
    Seasonal allergy
    alternative dictionary used: 26.1 26.1
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Reproductive system and breast disorders
    Prostatomegaly
    alternative dictionary used: 26.1 26.1
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Investigations
    SARS-CoV-2 test positive
    alternative dictionary used: 26.1 26.1
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Platelet count decreased
    alternative dictionary used: 26.1 26.1
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Creatinine renal clearance decreased
    alternative dictionary used: 26.1 26.1
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Alanine aminotransferase increased
    alternative dictionary used: 26.1 26.1
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Injury, poisoning and procedural complications
    Procedural pain
    alternative dictionary used: 26.1 26.1
         subjects affected / exposed
    3 / 12 (25.00%)
         occurrences all number
    3
    Contusion
    alternative dictionary used: 26.1 26.1
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Post procedural discomfort
    alternative dictionary used: 26.1 26.1
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Nervous system disorders
    Sensory disturbance
    alternative dictionary used: 26.1 26.1
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Headache
    alternative dictionary used: 26.1 26.1
         subjects affected / exposed
    2 / 12 (16.67%)
         occurrences all number
    2
    Dizziness
    alternative dictionary used: 26.1 26.1
         subjects affected / exposed
    2 / 12 (16.67%)
         occurrences all number
    2
    Eye disorders
    Diplopia
    alternative dictionary used: 26.1 26.1
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Gastrointestinal disorders
    Diarrhoea
    alternative dictionary used: 26.1 26.1
         subjects affected / exposed
    2 / 12 (16.67%)
         occurrences all number
    2
    Abdominal discomfort
    alternative dictionary used: 26.1 26.1
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Nausea
    alternative dictionary used: 26.1 26.1
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Dyspepsia
    alternative dictionary used: 26.1 26.1
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Hepatobiliary disorders
    Hypertransaminasaemia
    alternative dictionary used: 26.1 26.1
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Pruritus
    alternative dictionary used: 26.1 26.1
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    2
    Hyperhidrosis
    alternative dictionary used: 26.1 26.1
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Acne
    alternative dictionary used: 26.1 26.1
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Renal and urinary disorders
    Dysuria
    alternative dictionary used: 26.1 26.1
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Muscle tightness
    alternative dictionary used: 26.1 26.1
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Back pain
    alternative dictionary used: 26.1 26.1
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Arthralgia
    alternative dictionary used: 26.1 26.1
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    2
    Pain in extremity
    alternative dictionary used: 26.1 26.1
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Neck pain
    alternative dictionary used: 26.1 26.1
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Myalgia
    alternative dictionary used: 26.1 26.1
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Muscle twitching
    alternative dictionary used: 26.1 26.1
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Infections and infestations
    Rhinitis
    alternative dictionary used: 26.1 26.1
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    COVID-19
    alternative dictionary used: 26.1 26.1
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Respiratory tract infection viral
    alternative dictionary used: 26.1 26.1
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    15 Mar 2021
    Protocol amendment 1: The primary driver for this protocol amendment was to reduce the number of sampling timepoints for peripheral blood mononuclear cells (PBMC) analysis, due to the increased blood volume required for this analysis. Other key changes include: a description of the risk of Coronavirus disease-2019 (Covid-19) infection in the hepatis B population, added at the request of the Medicines & Healthcare products Regulatory Agency (MHRA); an update to the time to maximum alanine aminotransferase (ALT) analysis method; additional guidance and clarity for Investigators has been added; corrections to visit windows and visit numbering in the schedule of activities (SoA).

    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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