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
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EudraCT number |
2020-002000-39 |
Trial protocol |
NL GB |
Global end of trial date |
30 Nov 2023
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Results information
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Results version number |
v1(current) |
This version publication date |
15 Dec 2024
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First version publication date |
15 Dec 2024
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Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
212602
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT04544956 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
GlaxoSmithKline
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Sponsor organisation address |
Great West Road, Brentford, Middlesex, United Kingdom, TW8 9GS
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Public contact |
GSK Response Center, GlaxoSmithKline, 1 8664357343, GSKClinicalSupportHD@gsk.com
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Scientific contact |
GSK Response Center, GlaxoSmithKline, 1 8664357343, GSKClinicalSupportHD@gsk.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
05 Jan 2024
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
30 Nov 2023
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Was the trial ended prematurely? |
Yes
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General information about the trial
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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)
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Protection of trial subjects |
Not applicable
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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
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
Yes
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Canada: 4
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Country: Number of subjects enrolled |
Netherlands: 2
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Country: Number of subjects enrolled |
United Kingdom: 3
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Country: Number of subjects enrolled |
United States: 3
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Worldwide total number of subjects |
12
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EEA total number of subjects |
2
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
12
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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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
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Screening details |
A total of 12 participants were enrolled in this study. | ||||||||||
Period 1
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Period 1 title |
Overall Study (overall period)
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Is this the baseline period? |
Yes | ||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||
Arms
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Arm title
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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
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for injection
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Routes of administration |
Subcutaneous use
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Dosage and administration details |
Administered two subcutaneous injections for 300 milligrams dose.
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Baseline characteristics reporting groups
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Reporting group title |
GSK3228836 300 mg
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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). | ||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
GSK3228836 300 mg
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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). |
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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.
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End point type |
Primary
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End point timeframe |
Up to Week 12
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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. |
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Notes [2] - ITT Set |
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No statistical analyses for this end point |
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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.
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End point type |
Secondary
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End point timeframe |
Up to 24 weeks off treatment (Study Weeks 12 to 36)
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Notes [3] - ITT Set |
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No statistical analyses for this end point |
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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.
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End point type |
Secondary
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End point timeframe |
Up to 24 weeks off treatment (Study Weeks 12 to 36)
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Notes [4] - ITT Set |
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No statistical analyses for this end point |
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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).
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End point type |
Secondary
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End point timeframe |
Baseline (Week -1), treatment Day 78 and off treatment (OT) Day 162
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Notes [5] - ITT Set |
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No statistical analyses for this end point |
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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).
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End point type |
Secondary
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End point timeframe |
Baseline (Week -1), treatment Day 78 and off treatment Day 162
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Notes [6] - ITT Set |
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No statistical analyses for this end point |
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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).
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End point type |
Secondary
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End point timeframe |
Baseline (Week -1), treatment Day 78 and off treatment Day 162
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Notes [7] - ITT Set |
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No statistical analyses for this end point |
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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).
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End point type |
Secondary
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End point timeframe |
Baseline (Week -1), Treatment Week 12 and off treatment Week 24
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Notes [8] - ITT Set |
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No statistical analyses for this end point |
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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).
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End point type |
Secondary
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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
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Notes [9] - ITT Set |
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No statistical analyses for this end point |
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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).
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End point type |
Secondary
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End point timeframe |
Baseline (Week -1), treatment Days 29, 36, and 57; off treatment Days 1, 8, 22, 50, 78, 106, 134 and 162
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Notes [10] - ITT Set |
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No statistical analyses for this end point |
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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).
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End point type |
Secondary
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End point timeframe |
Baseline (Week -1), treatment Day 78 and off treatment Day 162
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Notes [11] - ITT Set |
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No statistical analyses for this end point |
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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.
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End point type |
Secondary
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End point timeframe |
Baseline (Week -1), treatment Day 78 and off treatment Day 162
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Notes [12] - ITT Set |
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No statistical analyses for this end point |
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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).
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End point type |
Secondary
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End point timeframe |
Baseline (Week -1), treatment Day 78 and off treatment Day 162
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Notes [13] - ITT Set |
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No statistical analyses for this end point |
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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.
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End point type |
Secondary
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End point timeframe |
Baseline (Week -1), treatment Day 78 and off treatment Day 162
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Notes [14] - ITT Set |
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No statistical analyses for this end point |
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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).
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End point type |
Secondary
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End point timeframe |
Baseline (Week -1) and off treatment Days 1 and 162
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Notes [15] - ITT Set |
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No statistical analyses for this end point |
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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).
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End point type |
Secondary
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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
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Notes [16] - ITT Set |
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No statistical analyses for this end point |
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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.
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End point type |
Secondary
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End point timeframe |
Up to Study Week 36
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Notes [17] - ITT Set |
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No statistical analyses for this end point |
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Adverse events information
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Timeframe for reporting adverse events |
Up to Week 36
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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.
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
26.1
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Reporting groups
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Reporting group title |
GSK3228836 300 mg
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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). | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 0% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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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). |
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Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |