Trial · NCT04676724
Study of Sequential GSK3228836 and Peginterferon Treatment in Participants With Chronic Hepatitis B (CHB)
NCT04676724, Phase 2, Completed, GlaxoSmithKline; results first posted 2024-05-02
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Sequential GSK3228836 and Peginterferon Treatment in Participants With Chronic Hepatitis B (CHB). Trials, record NCT04676724. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04676724
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Sequential GSK3228836 and Peginterferon Treatment in Participants With Chronic Hepatitis B (CHB)
- NCT number
- NCT04676724
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 108 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Hepatitis B
- Interventions
- GSK3228836, PegIFN, NA therapy
- First posted
- 2020-12-21
- Last updated
- 2024-05-02
- Results first posted
- 2024-05-02
Source ClinicalTrials.gov
Registered outcomes35
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Treatment Arm 1 - Percentage of Participants Achieving Sustained Virologic Response (SVR) for 24 Weeks After End of Treatment | Up to 24 weeks off treatment (Study Weeks 48 to 72) | Sustained virologic response is defined as undetectable levels of Hepatitis B surface antigen (HBsAg) and Hepatitis-B virus deoxy-ribonucleic acid (HBV DNA) on treatment. The SVR was a composite endpoint defined as HBsAg and HBV DNA levels were less than (\<) Lower limit of quantitation (LLOQ) at the planned end of sequential treatment of GSK3228836 and PegIFN treatment which is sustained for 24 weeks post-GSK3228836 and PegIFN treatment in the absence of any rescue medication. Percentage values are rounded-off. |
| Primary | Treatment Arm 2 - Percentage of Participants Achieving Sustained Virologic Response (SVR) for 24 Weeks After End of Treatment | Up to 24 weeks off treatment (Study Weeks 36 to 60) | Sustained virologic response is defined as undetectable levels of Hepatitis B surface antigen (HBsAg) and Hepatitis-B virus deoxy-ribonucleic acid (HBV DNA) on treatment. The SVR was a composite endpoint defined as HBsAg and HBV DNA levels were less than (\<) Lower limit of quantitation (LLOQ) at the planned end of sequential treatment of GSK3228836 and PegIFN treatment which is sustained for 24 weeks post-GSK3228836 and PegIFN treatment in the absence of any rescue medication. Percentage values are rounded-off. |
| Secondary | Treatment Arm 1: Percentage of Participants Achieving HBsAg and HBV DNA < Lower Limit of Quantitation (LLOQ) | End of treatment (up to 48 weeks) and up to 24 weeks off treatment follow-up (Study Weeks 48 to 72) | Percentage of participants achieving HBsAg and HBV DNA \<LLOQ were reported. Percentage values are rounded-off. |
| Secondary | Treatment Arm 2: Percentage of Participants Achieving HBsAg and HBV DNA < Lower Limit of Quantitation (LLOQ) | End of treatment (up to 36 weeks), up to 24 weeks off treatment follow-up (Study Weeks 36 to 60) and up to 36 weeks off treatment follow-up (Study Weeks 36 to 72) | Percentage of participants achieving HBsAg and HBV DNA \<LLOQ were reported. Percentage values are rounded-off. |
| Secondary | Treatment Arm 1: Percentage of Participants With Categorical Changes From Baseline in HBsAg Values | Baseline, End of treatment (up to 48 weeks), and up to 24 weeks off treatment follow-up (Study Weeks 48 to 72) | 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. |
| Secondary | Treatment Arm 2: Percentage of Participants With Categorical Changes From Baseline in HBsAg Values | Baseline, End of treatment (up to 36 weeks), up to 24 weeks off treatment follow-up (Study Weeks 36 to 60) and up to 36 weeks off treatment follow-up (Study Weeks 36 to 72) | 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. |
| Secondary | Treatment Arm 1: Number of Participants With Alanine Aminotransferase (ALT) Normalization | At baseline, end of treatment (up to 48 weeks) and up to 24 weeks off treatment follow-up (Study Weeks 48 to 72) | 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. |
| Secondary | Treatment Arm 2: Number of Participants With Alanine Aminotransferase (ALT) Normalization | At baseline, End of treatment (up to 36 weeks), up to 24 weeks off treatment follow-up (Study Weeks 36 to 60), and up to 36 weeks off treatment follow-up (Study Weeks 36 to 72) | 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. |
| Secondary | Treatment Arm 1: Number of Participants With HBe Antibody (Anti-HBeAg) Levels | At baseline, end of treatment (up to 48 weeks), and up to 24 weeks off treatment follow-up (Study Weeks 48 to 72) | Blood samples were collected to assess HBe antibody levels and results reported are for baseline HBeAg positive participants. |
| Secondary | Treatment Arm 2: Number of Participants With HBe Antibody (Anti-HBeAg) Levels | At baseline, End of treatment (up to 36 weeks), up to 24 weeks off treatment follow-up (Study Weeks 36 to 60), and up to 36 weeks off treatment follow-up (Study Weeks 36 to 72) | Blood samples were collected to assess HBe antibody levels and results reported are for baseline HBeAg positive participants. |
1 to 10 of 35Source ClinicalTrials.gov
See all 35 registered outcomesOutcomes35
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Treatment Arm 1 - Percentage of Participants Achieving Sustained Virologic Response (SVR) for 24 Weeks After End of Treatment | Up to 24 weeks off treatment (Study Weeks 48 to 72) | Intent to Treat (ITT) Set that included all randomized participants. | Percentage of Participants | NUMBER |
| PRIMARY | Treatment Arm 2 - Percentage of Participants Achieving Sustained Virologic Response (SVR) for 24 Weeks After End of Treatment | Up to 24 weeks off treatment (Study Weeks 36 to 60) | Intent to Treat (ITT) Set that included all randomized participants. 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. | Percentage of Participants | NUMBER |
| SECONDARY | Treatment Arm 1: Percentage of Participants Achieving HBsAg and HBV DNA < Lower Limit of Quantitation (LLOQ) | End of treatment (up to 48 weeks) and up to 24 weeks off treatment follow-up (Study Weeks 48 to 72) | Intent to Treat (ITT) Set that included all randomized participants. 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. | Percentage of Participants | NUMBER |
| SECONDARY | Treatment Arm 2: Percentage of Participants Achieving HBsAg and HBV DNA < Lower Limit of Quantitation (LLOQ) | End of treatment (up to 36 weeks), up to 24 weeks off treatment follow-up (Study Weeks 36 to 60) and up to 36 weeks off treatment follow-up (Study Weeks 36 to 72) | Intent to Treat (ITT) Set that included all randomized participants. 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. | Percentage of Participants | NUMBER |
| SECONDARY | Treatment Arm 1: Percentage of Participants With Categorical Changes From Baseline in HBsAg Values | Baseline, End of treatment (up to 48 weeks), and up to 24 weeks off treatment follow-up (Study Weeks 48 to 72) | Intent to Treat (ITT) Set that included all randomized participants. 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. | Percentage of Participants | NUMBER |
| SECONDARY | Treatment Arm 2: Percentage of Participants With Categorical Changes From Baseline in HBsAg Values | Baseline, End of treatment (up to 36 weeks), up to 24 weeks off treatment follow-up (Study Weeks 36 to 60) and up to 36 weeks off treatment follow-up (Study Weeks 36 to 72) | Intent to Treat (ITT) Set that included all randomized participants. 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. | Percentage of Participants | NUMBER |
| SECONDARY | Treatment Arm 1: Number of Participants With Alanine Aminotransferase (ALT) Normalization | At baseline, end of treatment (up to 48 weeks) and up to 24 weeks off treatment follow-up (Study Weeks 48 to 72) | Intent to Treat (ITT) Set that included all randomized participants. 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Treatment Arm 2: Number of Participants With Alanine Aminotransferase (ALT) Normalization | At baseline, End of treatment (up to 36 weeks), up to 24 weeks off treatment follow-up (Study Weeks 36 to 60), and up to 36 weeks off treatment follow-up (Study Weeks 36 to 72) | Intent to Treat (ITT) Set that included all randomized participants. 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Treatment Arm 1: Number of Participants With HBe Antibody (Anti-HBeAg) Levels | At baseline, end of treatment (up to 48 weeks), and up to 24 weeks off treatment follow-up (Study Weeks 48 to 72) | Intent to Treat (ITT) Set that included all randomized participants. 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Treatment Arm 2: Number of Participants With HBe Antibody (Anti-HBeAg) Levels | At baseline, End of treatment (up to 36 weeks), up to 24 weeks off treatment follow-up (Study Weeks 36 to 60), and up to 36 weeks off treatment follow-up (Study Weeks 36 to 72) | Intent to Treat (ITT) Set that included all randomized participants. 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. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 35Source ClinicalTrials.gov
See all 35 outcomesResults by group120
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Treatment Arm 1 - Percentage of Participants Achieving Sustained Virologic Response (SVR) for 24 Weeks After End of Treatment | GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks) | 9 | Percentage of Participants | ||
| Treatment Arm 2 - Percentage of Participants Achieving Sustained Virologic Response (SVR) for 24 Weeks After End of Treatment | GSK3228836 300 mg (12 Weeks) + PegIFN 180 mcg (24 Weeks) | 15 | Percentage of Participants | ||
| Treatment Arm 1: Percentage of Participants Achieving HBsAg and HBV DNA < Lower Limit of Quantitation (LLOQ) | GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks) | End of treatment (up to 48 weeks) | 15 | Percentage of Participants | |
| Treatment Arm 1: Percentage of Participants Achieving HBsAg and HBV DNA < Lower Limit of Quantitation (LLOQ) | GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks) | Up to 24 weeks off treatment follow-up (Study Weeks 48 to 72) | 13 | Percentage of Participants | |
| Treatment Arm 2: Percentage of Participants Achieving HBsAg and HBV DNA < Lower Limit of Quantitation (LLOQ) | GSK3228836 300 mg (12 Weeks) + PegIFN 180 mcg (24 Weeks) | End of treatment (up to 36 weeks) | 15 | Percentage of Participants | |
| Treatment Arm 2: Percentage of Participants Achieving HBsAg and HBV DNA < Lower Limit of Quantitation (LLOQ) | GSK3228836 300 mg (12 Weeks) + PegIFN 180 mcg (24 Weeks) | Up to 24 weeks off treatment follow-up (Study Weeks 36 to 60) | 17 | Percentage of Participants | |
| Treatment Arm 2: Percentage of Participants Achieving HBsAg and HBV DNA < Lower Limit of Quantitation (LLOQ) | GSK3228836 300 mg (12 Weeks) + PegIFN 180 mcg (24 Weeks) | Up to 36 weeks off treatment follow-up (Study Weeks 36 to 72) | 15 | Percentage of Participants | |
| Treatment Arm 1: Percentage of Participants With Categorical Changes From Baseline in HBsAg Values | GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks) | HBsAg <LLOQ - End of Treatment (up to 48 weeks) | 18 | Percentage of Participants | |
| Treatment Arm 1: Percentage of Participants With Categorical Changes From Baseline in HBsAg Values | GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks) | HBsAg<LLOQ - Up to 24 weeks off treatment follow-up (Study Weeks 48 to 72) | 13 | Percentage of Participants | |
| Treatment Arm 1: Percentage of Participants With Categorical Changes From Baseline in HBsAg Values | GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks) | HBsAg decline <0.5 - End of Treatment (up to 48 weeks) | 24 | Percentage of Participants |
1 to 10 of 120Source ClinicalTrials.gov
See all 120 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks) | 55 | |
| Overall Study | STARTED | GSK3228836 300 mg (12 Weeks) + PegIFN 180 mcg (24 Weeks) | 53 | |
| Overall Study | COMPLETED | GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks) | 49 | |
| Overall Study | COMPLETED | GSK3228836 300 mg (12 Weeks) + PegIFN 180 mcg (24 Weeks) | 50 | |
| Overall Study | NOT COMPLETED | GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks) | 6 | |
| Overall Study | NOT COMPLETED | GSK3228836 300 mg (12 Weeks) + PegIFN 180 mcg (24 Weeks) | 3 |
Source ClinicalTrials.gov
Adverse events474
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 | Agranulocytosis | Blood and lymphatic system disorders | GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks) | 0 | 55 | 0 |
| other | Agranulocytosis | Blood and lymphatic system disorders | GSK3228836 300 mg (12 Weeks) + PegIFN 180 mcg (24 Weeks) | 1 | 53 | 1 |
| other | Anaemia | Blood and lymphatic system disorders | GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks) | 3 | 55 | 3 |
| other | Anaemia | Blood and lymphatic system disorders | GSK3228836 300 mg (12 Weeks) + PegIFN 180 mcg (24 Weeks) | 1 | 53 | 3 |
| other | Coagulopathy | Blood and lymphatic system disorders | GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks) | 0 | 55 | 0 |
| other | Coagulopathy | Blood and lymphatic system disorders | GSK3228836 300 mg (12 Weeks) + PegIFN 180 mcg (24 Weeks) | 1 | 53 | 1 |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks) | 1 | 55 | 1 |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | GSK3228836 300 mg (12 Weeks) + PegIFN 180 mcg (24 Weeks) | 0 | 53 | 0 |
| other | Leukopenia | Blood and lymphatic system disorders | GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks) | 10 | 55 | 18 |
| other | Leukopenia | Blood and lymphatic system disorders | GSK3228836 300 mg (12 Weeks) + PegIFN 180 mcg (24 Weeks) | 7 | 53 | 10 |
1 to 10 of 474Source ClinicalTrials.gov
See all 474 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks) | 0 | 55 |
| Total, all-cause mortality | GSK3228836 300 mg (12 Weeks) + PegIFN 180 mcg (24 Weeks) | 0 | 53 |
| Total, other adverse events | GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks) | 52 | 55 |
| Total, other adverse events | GSK3228836 300 mg (12 Weeks) + PegIFN 180 mcg (24 Weeks) | 50 | 53 |
| Total, serious adverse events | GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks) | 6 | 55 |
| Total, serious adverse events | GSK3228836 300 mg (12 Weeks) + PegIFN 180 mcg (24 Weeks) | 2 | 53 |
Source ClinicalTrials.gov
Papers2
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks) vs GSK3228836 300 mg (12 Weeks) + PegIFN 180 mcg (24 Weeks): deaths from any cause | Trial comparisons |
| GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks) vs GSK3228836 300 mg (12 Weeks) + PegIFN 180 mcg (24 Weeks): serious adverse events | Trial comparisons |
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/NCT04676724
GET https://conductscience.org/api/trials/v1/NCT04676724/registered?page=2