18 and older, any sex, with Hepatitis B. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percentage of Participants Achieving Serum Hepatitis B Virus Surface Antigen (HBsAg) Level Less Than (<) Lower Limit of Quantitation (LLOQ)Primary· Up to Week 12
Percentage of participants achieving serum HBsAg level \<LLOQ were reported. Percentage values are rounded-off.
Group
Value
95% CI
GSK3228836 300 mg
25
Percentage of Participants With Sustained HBsAg Response (HBsAg <LLOQ) for 24 Weeks After the Planned and Actual End of GSK3228836 TreatmentSecondary· Up to 24 weeks off treatment (Study Weeks 12 to 36)
Sustained HBsAg response is defined as HBsAg \<LLOQ for 24 weeks from end of GSK3228836 treatment. Percentage values are rounded-off.
Sustained HBsAg Response for 24 Weeks after Planned End of GSK3228836 Treatment
Group
Value
95% CI
GSK3228836 300 mg
8
Sustained HBsAg Response for 24 Weeks after Actual End of GSK3228836 Treatment
Group
Value
95% CI
GSK3228836 300 mg
8
Percentage of Participants Achieving Sustained Virologic Response (HBsAg <LLOQ and HBV DNA <LLOQ) for 24 Weeks After the Planned and Actual End of GSK3228836 TreatmentSecondary· Up to 24 weeks off treatment (Study Weeks 12 to 36)
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.
Sustained Virologic Response for 24 Weeks after Planned End of GSK3228836 Treatment
Group
Value
95% CI
GSK3228836 300 mg
8
Sustained Virologic Response for 24 Weeks after Actual End of GSK3228836 Treatment
Group
Value
95% CI
GSK3228836 300 mg
8
Percentage of Participants Achieving HBsAg <LLOQ at Indicated Time PointsSecondary· Baseline (Week -1), treatment Day 78 and off treatment (OT) Day 162
Percentage of participants achieving HBsAg \<LLOQ were assessed at indicated time points. Percentage values are rounded-off.
Baseline (Week -1)
Group
Value
95% CI
GSK3228836 300 mg
0
Treatment Day 78
Group
Value
95% CI
GSK3228836 300 mg
30
Off Treatment Day 162
Group
Value
95% CI
GSK3228836 300 mg
18
Percentage of Participants Achieving HBV DNA <LLOQ at Indicated Time PointsSecondary· Baseline (Week -1), treatment Day 78 and off treatment Day 162
Percentage of participants achieving HBV DNA \<LLOQ were assessed at indicated time points. Percentage values are rounded-off.
Baseline (Week -1)
Group
Value
95% CI
GSK3228836 300 mg
92
Treatment Day 78
Group
Value
95% CI
GSK3228836 300 mg
78
Off Treatment Day 162
Group
Value
95% CI
GSK3228836 300 mg
100
Percentage of Participants Achieving HBsAg <LLOQ and HBV DNA <LLOQ at Indicated Time PointsSecondary· Baseline (Week -1), treatment Day 78 and off treatment Day 162
Percentage of participants achieving HBsAg \<LLOQ and HBV DNA \<LLOQ were assessed at indicated time points. Percentage values are rounded-off.
Baseline (Week -1)
Group
Value
95% CI
GSK3228836 300 mg
0
Treatment Day 78
Group
Value
95% CI
GSK3228836 300 mg
20
Off Treatment Day 162
Group
Value
95% CI
GSK3228836 300 mg
18
Percentage of Participants With Categorical Change From Baseline in HBsAg Values at Indicated Time PointsSecondary· Baseline (Week -1), Treatment Week 12 and off treatment Week 24
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.
Off Treatment Week 24, HBsAg decline <0.5 log10 IU/mL
Group
Value
95% CI
GSK3228836 300 mg
73
Number of Participants With Alanine Aminotransferase (ALT) Greater Than (>)3 Times Upper Limit of Normal (ULN) at Indicated Time PointsSecondary· 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
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.
Baseline (Week -1)
Group
Value
95% CI
GSK3228836 300 mg
0
Treatment Day 8
Group
Value
95% CI
GSK3228836 300 mg
0
Treatment Day 15
Group
Value
95% CI
GSK3228836 300 mg
0
Treatment Day 22
Group
Value
95% CI
GSK3228836 300 mg
0
Treatment Day 29
Group
Value
95% CI
GSK3228836 300 mg
0
Treatment Day 36
Group
Value
95% CI
GSK3228836 300 mg
1
Treatment Day 43
Group
Value
95% CI
GSK3228836 300 mg
1
Treatment Day 50
Group
Value
95% CI
GSK3228836 300 mg
1
Number of Participants With HBe Antibody (Anti-HBeAg) LevelsSecondary· Baseline (Week -1), treatment Days 29, 36, and 57; off treatment Days 1, 8, 22, 50, 78, 106, 134 and 162
Blood samples were collected to assess HBe antibody levels and results reported are for Baseline HBeAg positive participants.
Baseline (Week -1)
Group
Value
95% CI
GSK3228836 300 mg
11
Treatment Day 29
Group
Value
95% CI
GSK3228836 300 mg
11
Treatment Day 36
Group
Value
95% CI
GSK3228836 300 mg
0
Treatment Day 57
Group
Value
95% CI
GSK3228836 300 mg
9
Off Treatment Day 1
Group
Value
95% CI
GSK3228836 300 mg
9
Off Treatment Day 8
Group
Value
95% CI
GSK3228836 300 mg
10
Off Treatment Day 22
Group
Value
95% CI
GSK3228836 300 mg
10
Off Treatment Day 50
Group
Value
95% CI
GSK3228836 300 mg
10
Actual Values of HBsAg at Indicated Time PointsSecondary· Baseline (Week -1), treatment Day 78 and off treatment Day 162
Blood samples were collected from participants at indicated time points to assess HBsAg levels.
Baseline (Week -1)
Group
Value
95% CI
GSK3228836 300 mg
3.29
± 0.590
Treatment Day 78
Group
Value
95% CI
GSK3228836 300 mg
0.33
± 1.432
Off Treatment Day 162
Group
Value
95% CI
GSK3228836 300 mg
2.08
± 1.933
Mean Change From Baseline in HBsAg at Indicated Time PointsSecondary· Baseline (Week -1), treatment Day 78 and off treatment Day 162
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.
Treatment Day 78
Group
Value
95% CI
GSK3228836 300 mg
-2.923
± 1.5803
Off Treatment Day 162
Group
Value
95% CI
GSK3228836 300 mg
-1.183
± 1.8343
Actual Values of HBV DNA at Indicated Time PointsSecondary· Baseline (Week -1), treatment Day 78 and off treatment Day 162
Blood samples were collected from participants at indicated time points to assess HBV DNA levels.
Baseline (Week -1)
Group
Value
95% CI
GSK3228836 300 mg
0.43
± 0.849
Treatment Day 78
Group
Value
95% CI
GSK3228836 300 mg
0.31
± 0.611
Off Treatment Day 162
Group
Value
95% CI
GSK3228836 300 mg
0.24
± 0.525
Adverse events — posted to ClinicalTrials.gov
Time frame: Up to Study Week 36.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Hepatitis B virus (HBV) infection, especially chronic, is a significant worldwide medical problem. This is an exploratory study of the therapeutic mechanism of GSK3228836 in participants with chronic hepatitis B (CHB) on stable nucleos(t)ide therapy (which is the first line therapy for CHB). This study is a Phase IIa, multi-center open label exploratory study of the therapeutic mechanism of GSK3228836 in participants with hepatitis B virus e-antigen (HBeAg)-negative CHB on stable nucleos(t)ide therapy using repeat fine needle aspirations of the liver for intrahepatic immunophenotyping. It will investigate the virologic and immunologic correlates of hepatitis B virus surface antigen (HBsAg) loss observed in participants when treated for 12 weeks with 300 milligrams (mg) GSK3228836. Repeat fine needle aspirates of the liver will be performed to enable analysis of liver-resident immune cells to investigate any immunomodulatory properties of GSK3228836 and to study the biology of underlying treatment-associated liver flares. The study will consist of a screening, treatment, and post-treatment follow-up phase. Approximately 20 participants will be enrolled in the study.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
NCT05276297 — A Study on the Safety, Efficacy and Immune Response Following Sequential Treatment With an Anti-sense Oligonucleotide Ag
· Phase 2
· completed
NCT04971928 — Phase 1 Study of GSK3228836 Pharmacokinetics in Participants With Hepatic Impairment
· Phase 1
· completed
NCT04676724 — Study of Sequential GSK3228836 and Peginterferon Treatment in Participants With Chronic Hepatitis B (CHB)
· Phase 2
· completed
NCT04449029 — A Study of GSK3228836 in Participants With Chronic Hepatitis B (CHB)
· Phase 2
· completed
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by GlaxoSmithKline
Last refreshed: 15 July 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04544956.