Trial · NCT04449029
A Study of GSK3228836 in Participants With Chronic Hepatitis B (CHB)
NCT04449029, Phase 2, Completed, GlaxoSmithKline; results first posted 2023-05-16
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of GSK3228836 in Participants With Chronic Hepatitis B (CHB). Trials, record NCT04449029. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04449029
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of GSK3228836 in Participants With Chronic Hepatitis B (CHB)
- NCT number
- NCT04449029
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 457 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Hepatitis B
- Interventions
- GSK3228836, Placebo, Nucleos(t)ide therapy
- First posted
- 2020-06-26
- Last updated
- 2023-05-16
- Results first posted
- 2023-05-16
Source ClinicalTrials.gov
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Achieving Sustained Virologic Response (SVR) | Up to Week 48 | The SVR was a composite endpoint defined as Hepatitis B surface antigen (HBsAg) and Hepatitis B virus (HBV) Deoxyribonucleic acid (DNA) levels were less than (\<) Lower limit of quantitation (LLOQ) at the planned end of GSK3228836 treatment which is sustained for 24 weeks post-GSK3228836 treatment in the absence of rescue medication. |
| Secondary | Number of Participants Achieving HBsAg and HBV DNA<LLOQ | Up to Week 26 | Participants achieving HBsAg and HBV DNA levels \<LLOQ at the end of treatment (EOT) were reported. |
| Secondary | Number of Participants With Categorical Changes From Baseline in HBsAg Values | At Baseline and 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). |
| Secondary | Number of Participants With Categorical Changes From Baseline in HBV DNA Values | At Baseline and Week 24 | Participants who achieved a decline in HBV DNA values from baseline were reported. Participants were categorized in the following categorical HBV DNA decline of \<1, \>=1, \>=2, and \>=3 log IU/mL. |
| Secondary | Number of Participants With Alanine Aminotransferase (ALT) Normalization | At Baseline and Week 24 | The ALT normalization (ALT≤ upper limit of normal \[ULN\]) over time in absence of rescue medication in participants with baseline ALT\>ULN. Participants who achieved ALT normalization were reported. |
| Secondary | Median Time to ALT Normalization | Baseline and up to Week 48 | Time to ALT normalization (ALT≤ULN) in the absence of rescue medication in participants with baseline ALT\>ULN. Numbers of participants analyzed at Week 24 include participants with baseline ALT \>ULN, and are as follows for NA therapy population: n=6 in GSK3228836 for 24 WK, n= 7 in GSK3228836 for 12 WK+12 WK, n=6 in GSK3228836 for 12 WK + Placebo for 12 WK, n=2 in Placebo for 12 WK + GSK3228836 for 12 WK, respectively. The numbers of participants analyzed are as follows for the not on NA therapy population: n=20 GSK3228836 for 24 WK, n=20 in GSK3228836 for 12 WK+12 WK, n=21 in GSK3228836 for 12 WK + Placebo for 12 WK, n=9 in Placebo for 12 WK + GSK3228836 for 12 WK arm, respectively. |
| Secondary | Number of Participants With Positive Hepatitis B Virus E-antibody (HBeAb) | Up to Week 48 | Blood samples were collected to assess HBeAb level and participants with positive HBeAb were reported. |
| Secondary | Mean HBsAg and HBV DNA Level | At Baseline, Week 12, and 24 | Blood samples were collected from participants to assess HBsAg and HBV DNA level at indicated time points. |
| Secondary | Mean Values of Hepatitis B Virus e Antigen (HBeAg) Level | At Baseline, Week 12, and 24 | Blood samples were collected from participants to assess HBeAg level at indicated time points. Participants with presence of HBeAg at baseline were analyzed at indicated timepoint. Note: The units are on the log10 scale so negative values are expected (e.g. 0.933 U/mL = -0.03 log10 U/mL). |
| Secondary | Mean Change From Baseline in HBsAg and HBV DNA Level | At Baseline, Week 12, and 24 | Blood samples were collected from participants to assess HBsAg and HBV DNA level at indicated time points. Note: The units are on the log10 scale so negative values are expected (e.g. 0.933 IU/mL = -0.03 log10 IU/mL). |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 registered outcomesOutcomes22
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Achieving Sustained Virologic Response (SVR) | Up to Week 48 | The analysis was performed on the Intent to Treat (ITT) Set that includes all randomized participants who received a treatment randomization number. This population was based on the treatment the participant was randomized to. The analysis was conducted separately for the on NA treatment and not currently on NA treatment populations. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Achieving HBsAg and HBV DNA<LLOQ | Up to Week 26 | The analysis was performed on the ITT Set that includes all randomized participants who received a treatment randomization number. This population was based on the treatment the participant was randomized to. The analysis was conducted separately for the on NA treatment and not currently on NA treatment populations. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Categorical Changes From Baseline in HBsAg Values | At Baseline and Week 24 | The analysis was performed on the ITT set that includes all randomized participants who received a treatment randomization number. This population was based on the treatment the participant was randomized to. The analysis was conducted separately for the on NA treatment and not currently on NA treatment populations. One participant from 12+12 weeks on NA therapy arm was randomized in error and is in ITT population but did not contribute any lab data so is not part of the analysis. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Categorical Changes From Baseline in HBV DNA Values | At Baseline and Week 24 | The analysis was performed on ITT set that includes all randomized participants who received a treatment randomization number. This population was based on the treatment participant was randomized to. One participant from 12+12 weeks on NA therapy arm who was randomized in error is in ITT population but did not contribute any lab data so is not part of the analysis. One participant from 12+12 weeks not on NA therapy has no baseline data due to insufficient sample quantity at baseline. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Alanine Aminotransferase (ALT) Normalization | At Baseline and Week 24 | The analysis was performed on the ITT Set that includes all randomized participants who received a treatment randomization number. This population was based on the treatment the participant was randomized to. The analysis was conducted separately for the on NA treatment and not currently on NA treatment populations. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Median Time to ALT Normalization | Baseline and up to Week 48 | The analysis was performed on the ITT Set that includes all randomized participants who received a treatment randomization number. This population was based on the treatment the participant was randomized to. The analysis was conducted separately for the on NA treatment and not currently on NA treatment populations. Only those participants with baseline ALT\>ULN were analyzed. | Weeks | MEDIAN |
| SECONDARY | Number of Participants With Positive Hepatitis B Virus E-antibody (HBeAb) | Up to Week 48 | The analysis was performed on the ITT Set that includes all randomized participants who received a treatment randomization number. This population was based on the treatment the participant was randomized to. The analysis was conducted separately for the on NA treatment and not currently on NA treatment populations. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Mean HBsAg and HBV DNA Level | At Baseline, Week 12, and 24 | The analysis was performed on ITT set that includes all randomized participants who received a treatment randomization number. This population was based on the treatment participant was randomized to. One participant from 12+12 weeks on NA therapy arm who was randomized in error is in ITT population but did not contribute any lab data so is not part of the analysis. One participant from 12+12 weeks not on NA therapy has no baseline data due to insufficient sample quantity at baseline. | Log10 (IU/mL) | MEAN |
| SECONDARY | Mean Values of Hepatitis B Virus e Antigen (HBeAg) Level | At Baseline, Week 12, and 24 | The analysis was performed on the ITT set that includes all randomized participants who received a treatment randomization number. This population was based on the treatment the participant was randomized to. The analysis was conducted separately for the on NA treatment and not currently on NA treatment populations. | Log10 unit per milliliter (U/mL) | MEAN |
| SECONDARY | Mean Change From Baseline in HBsAg and HBV DNA Level | At Baseline, Week 12, and 24 | The analysis was performed on ITT set that includes all randomized participants who received a treatment randomization number. This population was based on the treatment participant was randomized to. One participant from 12+12 weeks on NA therapy arm who was randomized in error is in ITT population but did not contribute any lab data so is not part of the analysis. One participant from 12+12 weeks not on NA therapy has no baseline data due to insufficient sample quantity at baseline. | log IU/mL | MEAN |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 outcomesResults by group362
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Achieving Sustained Virologic Response (SVR) | GSK3228836 for 24 Weeks (WK) (on NA Therapy) | 6 | Participants | ||
| Number of Participants Achieving Sustained Virologic Response (SVR) | GSK3228836 for 12+12 WK (on NA Therapy) | 6 | Participants | ||
| Number of Participants Achieving Sustained Virologic Response (SVR) | GSK3228836 for 12 WK + Placebo for 12 WK (on NA Therapy) | 2 | Participants | ||
| Number of Participants Achieving Sustained Virologic Response (SVR) | Placebo for 12 WK + GSK3228836 for 12 WK (on NA Therapy) | 0 | Participants | ||
| Number of Participants Achieving Sustained Virologic Response (SVR) | GSK3228836 for 24 WK (Not on NA Therapy) | 7 | Participants | ||
| Number of Participants Achieving Sustained Virologic Response (SVR) | GSK3228836 for 12+12 WK (Not on NA Therapy) | 4 | Participants | ||
| Number of Participants Achieving Sustained Virologic Response (SVR) | GSK3228836 for 12 WK + Placebo for 12 WK (Not on NA Therapy) | 1 | Participants | ||
| Number of Participants Achieving Sustained Virologic Response (SVR) | Placebo for 12 WK + GSK3228836 for 12 WK (Not on NA Therapy) | 0 | Participants | ||
| Number of Participants Achieving HBsAg and HBV DNA<LLOQ | GSK3228836 for 24 Weeks (WK) (on NA Therapy) | 16 | Participants | ||
| Number of Participants Achieving HBsAg and HBV DNA<LLOQ | GSK3228836 for 12+12 WK (on NA Therapy) | 9 | Participants |
1 to 10 of 362Source ClinicalTrials.gov
See all 362 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | GSK3228836 for 24 Weeks (WK) (on NA Therapy) | 68 | |
| Overall Study | STARTED | GSK3228836 for 12+12 WK (on NA Therapy) | 68 | |
| Overall Study | STARTED | GSK3228836 for 12 WK + Placebo for 12 WK (on NA Therapy) | 68 | |
| Overall Study | STARTED | Placebo for 12 WK + GSK3228836 for 12 WK (on NA Therapy) | 23 | |
| Overall Study | STARTED | GSK3228836 for 24 WK (Not on NA Therapy) | 70 | |
| Overall Study | STARTED | GSK3228836 for 12+12 WK (Not on NA Therapy) | 68 | |
| Overall Study | STARTED | GSK3228836 for 12 WK + Placebo for 12 WK (Not on NA Therapy) | 68 | |
| Overall Study | STARTED | Placebo for 12 WK + GSK3228836 for 12 WK (Not on NA Therapy) | 24 | |
| Overall Study | COMPLETED | GSK3228836 for 24 Weeks (WK) (on NA Therapy) | 65 | |
| Overall Study | COMPLETED | GSK3228836 for 12+12 WK (on NA Therapy) | 65 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events3,312
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abnormal clotting factor | Blood and lymphatic system disorders | GSK3228836 for 24 Weeks (WK) (on NA Therapy) | 0 | 68 | 0 |
| other | Abnormal clotting factor | Blood and lymphatic system disorders | GSK3228836 for 12+12 WK (on NA Therapy) | 0 | 67 | 0 |
| other | Abnormal clotting factor | Blood and lymphatic system disorders | GSK3228836 for 12 WK + Placebo for 12 WK (on NA Therapy) | 0 | 68 | 0 |
| other | Abnormal clotting factor | Blood and lymphatic system disorders | Placebo for 12 WK + GSK3228836 for 12 WK (on NA Therapy) | 0 | 23 | 0 |
| other | Abnormal clotting factor | Blood and lymphatic system disorders | GSK3228836 for 24 WK (Not on NA Therapy) | 0 | 70 | 0 |
| other | Abnormal clotting factor | Blood and lymphatic system disorders | GSK3228836 for 12+12 WK (Not on NA Therapy) | 0 | 67 | 0 |
| other | Abnormal clotting factor | Blood and lymphatic system disorders | GSK3228836 for 12 WK + Placebo for 12 WK (Not on NA Therapy) | 1 | 68 | 1 |
| other | Abnormal clotting factor | Blood and lymphatic system disorders | Placebo for 12 WK + GSK3228836 for 12 WK (Not on NA Therapy) | 0 | 24 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | GSK3228836 for 24 Weeks (WK) (on NA Therapy) | 0 | 68 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | GSK3228836 for 12+12 WK (on NA Therapy) | 3 | 67 | 4 |
1 to 10 of 3,312Source ClinicalTrials.gov
See all 3,312 adverse eventsAdverse event totals24
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | GSK3228836 for 24 Weeks (WK) (on NA Therapy) | 0 | 68 |
| Total, all-cause mortality | GSK3228836 for 12+12 WK (on NA Therapy) | 0 | 67 |
| Total, all-cause mortality | GSK3228836 for 12 WK + Placebo for 12 WK (on NA Therapy) | 0 | 68 |
| Total, all-cause mortality | Placebo for 12 WK + GSK3228836 for 12 WK (on NA Therapy) | 0 | 23 |
| Total, all-cause mortality | GSK3228836 for 24 WK (Not on NA Therapy) | 0 | 70 |
| Total, all-cause mortality | GSK3228836 for 12+12 WK (Not on NA Therapy) | 0 | 67 |
| Total, all-cause mortality | GSK3228836 for 12 WK + Placebo for 12 WK (Not on NA Therapy) | 0 | 68 |
| Total, all-cause mortality | Placebo for 12 WK + GSK3228836 for 12 WK (Not on NA Therapy) | 0 | 24 |
| Total, other adverse events | GSK3228836 for 24 Weeks (WK) (on NA Therapy) | 56 | 68 |
| Total, other adverse events | GSK3228836 for 12+12 WK (on NA Therapy) | 59 | 67 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse event totalsPapers4
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04449029
GET https://conductscience.org/api/trials/v1/NCT04449029/registered?page=2