Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study is intended to evaluate if 12 or 24 weeks of treatment with GSK3228836 followed by up to 24 weeks of pegylated interferon (PegIFN) can increase the rate of hepatitis B virus surface antigen (HBsAg) loss in participants on stable nucleos(t)ide analogue (NA) therapy, and whether virologic response can be sustained once PegIFN treatment is discontinued. Participants will be randomized to receive GSK3228836 for 12 or 24 weeks followed by up to 24 weeks of PegIFN.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GSK3228836 300 mg (24 weeks) + PegIFN 180 mcg (24 weeks) | Experimental | Participants on stable NA therapy received 300 milligrams per week (mg/week) GSK3228836 for 24 weeks (plus a loading dose on Day 4 and 11), followed by Pegylated Interferon (PegIFN) 180 microgram per week (mcg/week) up to 24 weeks. |
|
| GSK3228836 300 mg (12 weeks) + PegIFN 180 mcg (24 weeks) | Experimental | Participants on stable NA therapy received 300mg/week GSK3228836 for 12 weeks (plus a loading dose on Day 4 and 11), followed by PegIFN 180 mcg/week up to 24 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK3228836 | Drug | Participants will be administered GSK3228836. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Arm 1 - Percentage of Participants Achieving Sustained Virologic Response (SVR) for 24 Weeks After End of Treatment | 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. | Up to 24 weeks off treatment (Study Weeks 48 to 72) |
| Treatment Arm 2 - Percentage of Participants Achieving Sustained Virologic Response (SVR) for 24 Weeks After End of Treatment | 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. | Up to 24 weeks off treatment (Study Weeks 36 to 60) |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Arm 1: Percentage of Participants Achieving HBsAg and HBV DNA < Lower Limit of Quantitation (LLOQ) | Percentage of participants achieving HBsAg and HBV DNA \ | End of treatment (up to 48 weeks) and up to 24 weeks off treatment follow-up (Study Weeks 48 to 72) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Sacramento | California | 95817 | United States | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41042426 | Derived | Joshi S, Freudenberg JM, Singh JM, Jordan WT, Felton L, Dixon S, Paff M, Theodore D, Walker J. Immunomodulation by bepirovirsen may induce killing of infected hepatocytes (B-Together study). Hepatol Int. 2026 Feb;20(1):46-58. doi: 10.1007/s12072-025-10917-0. Epub 2025 Oct 3. | |
| 39214467 | Derived | Buti M, Heo J, Tanaka Y, Andreone P, Atsukawa M, Cabezas J, Chak E, Coffin CS, Fujiwara K, Gankina N, Gordon SC, Janczewska E, Komori A, Lampertico P, McPherson S, Morozov V, Plesniak R, Poulin S, Ryan P, Sagalova O, Sheng G, Voloshina N, Xie Q, Yim HJ, Dixon S, Paff M, Felton L, Lee M, Greene T, Lim J, Lakshminarayanan D, McGonagle G, Plein H, Youssef AS, Elston R, Kendrick S, Theodore D. Sequential Peg-IFN after bepirovirsen may reduce post-treatment relapse in chronic hepatitis B. J Hepatol. 2025 Feb;82(2):222-234. doi: 10.1016/j.jhep.2024.08.010. Epub 2024 Aug 29. |
Not provided
Not provided
IPD for this study will be made available via the Clinical Study Data Request site.
IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
Participants who were on stable nucleos(t)ide analogue (NA) therapy randomized (1:1) into one of 2 parallel treatment arms. Treatment arm 1: 300 mg/week GSK3228836 for 24 weeks + PegIFN 180 mcg/week for 24 weeks; on-treatment until Week 48 and off-treatment from Weeks 48 to 72. Treatment arm 2: 300 mg/week GSK3228836 for 12 weeks + 180 mcg/week PegIFN for 24 weeks, on-treatment until Week 36 and off-treatment follow-up from Weeks 36 to Week 60 and 72.
A total of 108 participants were enrolled in this study.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks) | Participants on stable NA therapy received 300 milligrams per week (mg/week) GSK3228836 for 24 weeks (plus a loading dose on Day 4 and 11), followed by Pegylated Interferon (PegIFN) 180 microgram per week (mcg/week) up to 24 weeks. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 24, 2021 | Feb 14, 2024 |
Not provided
Not provided
Participants will be randomised in a ratio of 1:1 to one of two treatment arms: 24 weeks GSK3228836 followed by up to 24 weeks PegIFN, or 12 weeks GSK3228836 followed by up to 24 weeks PegIFN.
Not provided
Not provided
Not provided
Not provided
| PegIFN | Drug | Participants will be administered PegIFN. |
|
| NA therapy | Drug | Participants will continue to receive their NA therapy for the duration of the study. |
|
| Treatment Arm 2: Percentage of Participants Achieving HBsAg and HBV DNA < Lower Limit of Quantitation (LLOQ) |
Percentage of participants achieving HBsAg and HBV DNA \ |
| 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) |
| Treatment Arm 1: Percentage of Participants With Categorical Changes From Baseline in HBsAg Values | 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. | Baseline, End of treatment (up to 48 weeks), and up to 24 weeks off treatment follow-up (Study Weeks 48 to 72) |
| Treatment Arm 2: Percentage of Participants With Categorical Changes From Baseline in HBsAg Values | 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. | 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) |
| Treatment Arm 1: Number of Participants With Alanine Aminotransferase (ALT) Normalization | 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. | At baseline, end of treatment (up to 48 weeks) and up to 24 weeks off treatment follow-up (Study Weeks 48 to 72) |
| Treatment Arm 2: Number of Participants With Alanine Aminotransferase (ALT) Normalization | 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. | 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) |
| Treatment Arm 1: Number of Participants With HBe Antibody (Anti-HBeAg) Levels | Blood samples were collected to assess HBe antibody levels and results reported are for baseline HBeAg positive participants. | At baseline, end of treatment (up to 48 weeks), and up to 24 weeks off treatment follow-up (Study Weeks 48 to 72) |
| Treatment Arm 2: Number of Participants With HBe Antibody (Anti-HBeAg) Levels | Blood samples were collected to assess HBe antibody levels and results reported are for baseline HBeAg positive participants. | 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) |
| Treatment Arm 1: Mean Change From Baseline in HBe Antibody Levels | Blood samples were collected to assess HBe antibody levels and results reported are for baseline HBeAg positive participants. 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. | At baseline, end of treatment (up to 48 weeks), and up to 24 weeks off treatment follow-up (Study Weeks 48 to 72) |
| Treatment Arm 2: Mean Change From Baseline in HBe Antibody Levels | Blood samples were collected to assess HBe antibody levels and results reported are for baseline HBeAg positive participants. 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. | 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) |
| Treatment Arm 1: Actual Values of HBsAg Levels | Blood samples were collected from participants to assess HBsAg at indicated time points. | At baseline, end of treatment (up to 48 weeks), and up to 24 weeks off treatment follow-up (Study Weeks 48 to 72) |
| Treatment Arm 2: Actual Values of HBsAg Levels | Blood samples were collected from participants to assess HBsAg at indicated time points. | 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) |
| Treatment Arm 1: Mean Change From Baseline in HBsAg Levels | Blood samples were collected to assess HBsAg change from baselines 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. | At baseline, end of treatment (up to 48 weeks), and up to 24 weeks off treatment follow-up (Study Weeks 48 to 72) |
| Treatment Arm 2: Mean Change From Baseline in HBsAg Levels | Blood samples were collected to assess HBsAg change from baselines 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. | 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) |
| Treatment Arm 1: Actual Values of HBV DNA Levels | Blood samples were collected to assess HBV DNA levels. | At baseline, end of treatment (up to 48 weeks), and up to 24 weeks off treatment follow-up (Study Weeks 48 to 72) |
| Treatment Arm 2: Actual Values of HBV DNA Levels | Blood samples were collected to assess HBV DNA 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) |
| Treatment Arm 1: Mean Change From Baseline in HBV DNA Levels | Blood samples were collected 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. | At baseline, end of treatment (up to 48 weeks), and up to 24 weeks off treatment follow-up (Study Weeks 48 to 72) |
| Treatment Arm 2: Mean Change From Baseline in HBV DNA Levels | Blood samples were collected 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. | 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) |
| Treatment Arm 1: Actual Values of Hepatitis B Virus E-antigen (HBeAg) Levels | Blood samples were collected to assess 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) |
| Treatment Arm 2: Actual Values of Hepatitis B Virus E-antigen (HBeAg) Levels | Blood samples were collected to assess 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) |
| Treatment Arm 1: Mean Change From Baseline in HBeAg Levels | Blood samples were collected to assess HBeAg 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. | At baseline, end of treatment (up to 48 weeks), and up to 24 weeks off treatment follow-up (Study Weeks 48 to 72) |
| Treatment Arm 2: Mean Change From Baseline in HBeAg Levels | Blood samples were collected to assess HBeAg 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. | 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) |
| Treatment Arm 1: Actual Values of HBs Antibody Levels | Blood samples were collected to assess HBs antibody levels. | At baseline, end of treatment (up to 48 weeks), and up to 24 weeks off treatment follow-up (Study Weeks 48 to 72) |
| Treatment Arm 2: Actual Values of HBs Antibody Levels | Blood samples were collected to assess HBs antibody 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) |
| Treatment Arm 1: Mean Change From Baseline in HBs Antibody Levels | Blood samples were collected to assess HBs antibody levels over time. 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. | At baseline, end of treatment (up to 48 weeks), and up to 24 weeks off treatment follow-up (Study Weeks 48 to 72) |
| Treatment Arm 2: Mean Change From Baseline in HBs Antibody Levels | Blood samples were collected to assess HBs antibody levels over time. 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. | 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) |
| Treatment Arm 1: Actual Values of ALT | Blood samples were collected to assess ALT mean values. | At baseline, end of treatment (up to 48 weeks), and up to 24 weeks off treatment follow-up (Study Weeks 48 to 72) |
| Treatment Arm 2: Actual Values of ALT | Blood samples were collected to assess ALT mean values. | 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) |
| Treatment Arm 1: Change From Baseline in ALT | Blood samples were collected to assess ALT values. 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. | At baseline, end of treatment (up to 48 weeks), and up to 24 weeks off treatment follow-up (Study Weeks 48 to 72) |
| Treatment Arm 2: Change From Baseline in ALT | Blood samples were collected to assess ALT values. 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. | 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) |
| Treatment Arm 1 - Median Time to ALT Normalization in Absence of Rescue Medication for 24 Weeks After End of Treatment | Time to ALT normalization in absence of rescue medication were measured in participants having Baseline ALT>ULN. | Up to 24 weeks off treatment (Study Week 48 to72) |
| Treatment Arm 2 - Median Time to ALT Normalization in Absence of Rescue Medication for 24 Weeks After End of Treatment | Time to ALT normalization in absence of rescue medication were measured in participants having Baseline ALT>ULN. | Up to 24 weeks off treatment (Study Weeks 36 to 60) |
| Percentage of Participants Achieving Sustained Virologic Response (SVR) for 24 Weeks Off Treatment for Comparison of Efficacy Between Different Treatment Durations | Sustained virologic response is defined as undetectable levels of HBsAg and Hepatitis-B virus deoxy-ribonucleic acid (HBV DNA) on treatment. 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. The point estimate for the difference in SVR and its respective credible interval (CI) were evaluated at 24 weeks off of planned treatment for both arms. The comparison of efficacy is between treatment durations and timepoint corresponds to Week 72 in Arm 1 and Week 60 in Arm 2. 95% CI here refers as credible interval. Percentage values are rounded-off. | Up to 24 weeks off treatment (Treatment Arm 1: Study Weeks 48 to 72 and Treatment Arm 2: Study Weeks 36 to 60) |
| Iowa City |
| Iowa |
| 52242 |
| United States |
| GSK Investigational Site | Detroit | Michigan | 48202 | United States |
| GSK Investigational Site | New York | New York | 10016 | United States |
| GSK Investigational Site | Calgary | Alberta | T2N 4Z6 | Canada |
| GSK Investigational Site | Edmonton | Alberta | T6G 2X8 | Canada |
| GSK Investigational Site | Montreal | Quebec | H2L 4E9 | Canada |
| GSK Investigational Site | Changchun | Jilin | 130021 | China |
| GSK Investigational Site | Beijing | 100015 | China |
| GSK Investigational Site | Beijing | 100069 | China |
| GSK Investigational Site | Hangzhou | 310000 | China |
| GSK Investigational Site | Shanghai | 200025 | China |
| GSK Investigational Site | Baggiovara (MO) | Emilia-Romagna | 40126 | Italy |
| GSK Investigational Site | Milan | Lombardy | 20122 | Italy |
| GSK Investigational Site | Milan | Lombardy | 20157 | Italy |
| GSK Investigational Site | Monza (MB) | Lombardy | 20900 | Italy |
| GSK Investigational Site | Aichi | 467-8602 | Japan |
| GSK Investigational Site | Fukui | 918-8503 | Japan |
| GSK Investigational Site | Gifu | 500-8717 | Japan |
| GSK Investigational Site | Hiroshima | 737-0023 | Japan |
| GSK Investigational Site | Kumamoto | 860-8556 | Japan |
| GSK Investigational Site | Nagasaki | 856-8562 | Japan |
| GSK Investigational Site | Tokyo | 113-8603 | Japan |
| GSK Investigational Site | Lublin | 20-884 | Poland |
| GSK Investigational Site | Mysłowice | 41-400 | Poland |
| GSK Investigational Site | Łańcut | 37-100 | Poland |
| GSK Investigational Site | Barnaul | 656010 | Russia |
| GSK Investigational Site | Chelyabinsk | 454052 | Russia |
| GSK Investigational Site | Moscow | 121170 | Russia |
| GSK Investigational Site | Novosibirsk | 630099 | Russia |
| GSK Investigational Site | Saint Petersburg | 190103 | Russia |
| GSK Investigational Site | Samara | 443063 | Russia |
| GSK Investigational Site | Красноярск | 660049 | Russia |
| GSK Investigational Site | Ennerdale | Gauteng | 1830 | South Africa |
| GSK Investigational Site | Johannesburg | Gauteng | 1401 | South Africa |
| GSK Investigational Site | Busan | 49241 | South Korea |
| GSK Investigational Site | Daegu | 41944 | South Korea |
| GSK Investigational Site | Gyeonggi-do | 15355 | South Korea |
| GSK Investigational Site | Gyeonggi-do | 463-712 | South Korea |
| GSK Investigational Site | Ulsan | 44033 | South Korea |
| GSK Investigational Site | Barcelona | 08011 | Spain |
| GSK Investigational Site | Barcelona | 08035 | Spain |
| GSK Investigational Site | Madrid | 28031 | Spain |
| GSK Investigational Site | Málaga | 29010 | Spain |
| GSK Investigational Site | Santander | 39008 | Spain |
| GSK Investigational Site | London | WC1E 6JB | United Kingdom |
| GSK Investigational Site | Newcastle upon Tyne | NE7 7DN | United Kingdom |
| GSK Investigational Site | Nottingham | NG7 2UH | United Kingdom |
| GSK Investigational Site | Plymouth | PL68DH | United Kingdom |
| GSK3228836 300 mg (12 Weeks) + PegIFN 180 mcg (24 Weeks) |
Participants on stable NA therapy received 300mg/week GSK3228836 for 12 weeks (plus a loading dose on Day 4 and 11), followed by PegIFN 180 mcg/week up to 24 weeks. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks) | Participants on stable NA therapy received 300mg/week GSK3228836 for 24 weeks (plus a loading dose on Day 4 and 11), followed by PegIFN 180 microgram per week (mcg/week) up to 24 weeks. |
| BG001 | GSK3228836 300 mg (12 Weeks) + PegIFN 180 mcg (24 Weeks) | Participants on stable NA therapy received 300mg/week GSK3228836 for 12 weeks (plus a loading dose on Day 4 and 11), followed by PegIFN 180 mcg/week up to 24 weeks. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | YEARS |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Treatment Arm 1 - Percentage of Participants Achieving Sustained Virologic Response (SVR) for 24 Weeks After End of Treatment | 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. | Intent to Treat (ITT) Set that included all randomized participants. | Posted | Number | Percentage of Participants | Up to 24 weeks off treatment (Study Weeks 48 to 72) |
|
|
| ||||||||||||||||||||||||||
| Primary | Treatment Arm 2 - Percentage of Participants Achieving Sustained Virologic Response (SVR) for 24 Weeks After End of Treatment | 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. | 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. | Posted | Number | Percentage of Participants | Up to 24 weeks off treatment (Study Weeks 36 to 60) |
|
| |||||||||||||||||||||||||||
| Secondary | Treatment Arm 1: Percentage of Participants Achieving HBsAg and HBV DNA < Lower Limit of Quantitation (LLOQ) | Percentage of participants achieving HBsAg and HBV DNA \ | 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. | Posted | Number | Percentage of Participants | End of treatment (up to 48 weeks) and up to 24 weeks off treatment follow-up (Study Weeks 48 to 72) |
|
| |||||||||||||||||||||||||||
| Secondary | Treatment Arm 2: Percentage of Participants Achieving HBsAg and HBV DNA < Lower Limit of Quantitation (LLOQ) | Percentage of participants achieving HBsAg and HBV DNA \ | 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. | Posted | Number | Percentage of Participants | 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) |
|
| |||||||||||||||||||||||||||
| Secondary | Treatment Arm 1: Percentage of Participants With Categorical Changes From Baseline in HBsAg Values | 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 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. | Posted | Number | Percentage of Participants | Baseline, End of treatment (up to 48 weeks), and up to 24 weeks off treatment follow-up (Study Weeks 48 to 72) |
|
| |||||||||||||||||||||||||||
| Secondary | Treatment Arm 2: Percentage of Participants With Categorical Changes From Baseline in HBsAg Values | 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 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. | Posted | Number | Percentage of Participants | 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) |
|
| |||||||||||||||||||||||||||
| Secondary | Treatment Arm 1: Number of Participants With Alanine Aminotransferase (ALT) Normalization | 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 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. | Posted | Count of Participants | Participants | At baseline, end of treatment (up to 48 weeks) and up to 24 weeks off treatment follow-up (Study Weeks 48 to 72) |
|
| |||||||||||||||||||||||||||
| Secondary | Treatment Arm 2: Number of Participants With Alanine Aminotransferase (ALT) Normalization | 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 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. | Posted | Count of Participants | Participants | 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) |
|
| |||||||||||||||||||||||||||
| Secondary | Treatment Arm 1: Number of Participants With HBe Antibody (Anti-HBeAg) Levels | 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 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. | Posted | Count of Participants | Participants | At baseline, end of treatment (up to 48 weeks), and up to 24 weeks off treatment follow-up (Study Weeks 48 to 72) |
|
| |||||||||||||||||||||||||||
| Secondary | Treatment Arm 2: Number of Participants With HBe Antibody (Anti-HBeAg) Levels | 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 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. | Posted | Count of Participants | Participants | 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) |
|
| |||||||||||||||||||||||||||
| Secondary | Treatment Arm 1: Mean Change From Baseline in HBe Antibody Levels | Blood samples were collected to assess HBe antibody levels and results reported are for baseline HBeAg positive participants. 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 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. | Posted | Mean | Standard Deviation | Log10 IU/mL | At baseline, end of treatment (up to 48 weeks), and up to 24 weeks off treatment follow-up (Study Weeks 48 to 72) |
|
| ||||||||||||||||||||||||||
| Secondary | Treatment Arm 2: Mean Change From Baseline in HBe Antibody Levels | Blood samples were collected to assess HBe antibody levels and results reported are for baseline HBeAg positive participants. 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 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. | Posted | Mean | Standard Deviation | Log10 IU/mL | 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) |
|
| ||||||||||||||||||||||||||
| Secondary | Treatment Arm 1: Actual Values of HBsAg Levels | Blood samples were collected from participants to assess HBsAg at indicated time points. | 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. | Posted | Mean | Standard Deviation | Log10 IU/mL | At baseline, end of treatment (up to 48 weeks), and up to 24 weeks off treatment follow-up (Study Weeks 48 to 72) |
|
| ||||||||||||||||||||||||||
| Secondary | Treatment Arm 2: Actual Values of HBsAg Levels | Blood samples were collected from participants to assess HBsAg at indicated time points. | 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. | Posted | Mean | Standard Deviation | Log10 IU/mL | 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) |
|
| ||||||||||||||||||||||||||
| Secondary | Treatment Arm 1: Mean Change From Baseline in HBsAg Levels | Blood samples were collected to assess HBsAg change from baselines 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 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. | Posted | Mean | Standard Deviation | Log10 IU/mL | At baseline, end of treatment (up to 48 weeks), and up to 24 weeks off treatment follow-up (Study Weeks 48 to 72) |
|
| ||||||||||||||||||||||||||
| Secondary | Treatment Arm 2: Mean Change From Baseline in HBsAg Levels | Blood samples were collected to assess HBsAg change from baselines 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 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. | Posted | Mean | Standard Deviation | Log10 IU/mL | 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) |
|
| ||||||||||||||||||||||||||
| Secondary | Treatment Arm 1: Actual Values of HBV DNA Levels | Blood samples were collected to assess HBV DNA levels. | 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. | Posted | Mean | Standard Deviation | Log10 IU/mL | At baseline, end of treatment (up to 48 weeks), and up to 24 weeks off treatment follow-up (Study Weeks 48 to 72) |
|
| ||||||||||||||||||||||||||
| Secondary | Treatment Arm 2: Actual Values of HBV DNA Levels | Blood samples were collected to assess HBV DNA levels. | 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. | Posted | Mean | Standard Deviation | Log10 IU/mL | 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) |
|
| ||||||||||||||||||||||||||
| Secondary | Treatment Arm 1: Mean Change From Baseline in HBV DNA Levels | Blood samples were collected 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 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. | Posted | Mean | Standard Deviation | Log10 IU/mL | At baseline, end of treatment (up to 48 weeks), and up to 24 weeks off treatment follow-up (Study Weeks 48 to 72) |
|
| ||||||||||||||||||||||||||
| Secondary | Treatment Arm 2: Mean Change From Baseline in HBV DNA Levels | Blood samples were collected 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 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. | Posted | Mean | Standard Deviation | Log10 IU/mL | 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) |
|
| ||||||||||||||||||||||||||
| Secondary | Treatment Arm 1: Actual Values of Hepatitis B Virus E-antigen (HBeAg) Levels | Blood samples were collected to assess HBeAg levels. | 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. | Posted | Mean | Standard Deviation | Log10 IU/mL | At baseline, end of treatment (up to 48 weeks), and up to 24 weeks off treatment follow-up (Study Weeks 48 to 72) |
|
| ||||||||||||||||||||||||||
| Secondary | Treatment Arm 2: Actual Values of Hepatitis B Virus E-antigen (HBeAg) Levels | Blood samples were collected to assess HBeAg levels. | 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. | Posted | Mean | Standard Deviation | Log10 IU/mL | 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) |
|
| ||||||||||||||||||||||||||
| Secondary | Treatment Arm 1: Mean Change From Baseline in HBeAg Levels | Blood samples were collected to assess HBeAg 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 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. | Posted | Mean | Standard Deviation | Log10 IU/mL | At baseline, end of treatment (up to 48 weeks), and up to 24 weeks off treatment follow-up (Study Weeks 48 to 72) |
|
| ||||||||||||||||||||||||||
| Secondary | Treatment Arm 2: Mean Change From Baseline in HBeAg Levels | Blood samples were collected to assess HBeAg 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 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. | Posted | Mean | Standard Deviation | Log10 IU/mL | 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) |
|
| ||||||||||||||||||||||||||
| Secondary | Treatment Arm 1: Actual Values of HBs Antibody Levels | Blood samples were collected to assess HBs antibody levels. | 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. | Posted | Mean | Standard Deviation | Log10 IU/L | At baseline, end of treatment (up to 48 weeks), and up to 24 weeks off treatment follow-up (Study Weeks 48 to 72) |
|
| ||||||||||||||||||||||||||
| Secondary | Treatment Arm 2: Actual Values of HBs Antibody Levels | Blood samples were collected to assess HBs antibody levels. | 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. | Posted | Mean | Standard Deviation | Log10 IU/L | 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) |
|
| ||||||||||||||||||||||||||
| Secondary | Treatment Arm 1: Mean Change From Baseline in HBs Antibody Levels | Blood samples were collected to assess HBs antibody levels over time. 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 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. | Posted | Mean | Standard Deviation | Log10 IU/L | At baseline, end of treatment (up to 48 weeks), and up to 24 weeks off treatment follow-up (Study Weeks 48 to 72) |
|
| ||||||||||||||||||||||||||
| Secondary | Treatment Arm 2: Mean Change From Baseline in HBs Antibody Levels | Blood samples were collected to assess HBs antibody levels over time. 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 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. | Posted | Mean | Standard Deviation | Log10 IU/L | 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) |
|
| ||||||||||||||||||||||||||
| Secondary | Treatment Arm 1: Actual Values of ALT | Blood samples were collected to assess ALT mean values. | 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. | Posted | Mean | Standard Deviation | International Units Per Liter (IU/L) | At baseline, end of treatment (up to 48 weeks), and up to 24 weeks off treatment follow-up (Study Weeks 48 to 72) |
|
| ||||||||||||||||||||||||||
| Secondary | Treatment Arm 2: Actual Values of ALT | Blood samples were collected to assess ALT mean values. | 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. | Posted | Mean | Standard Deviation | IU/L | 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) |
|
| ||||||||||||||||||||||||||
| Secondary | Treatment Arm 1: Change From Baseline in ALT | Blood samples were collected to assess ALT values. 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 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. | Posted | Mean | Standard Deviation | IU/L | At baseline, end of treatment (up to 48 weeks), and up to 24 weeks off treatment follow-up (Study Weeks 48 to 72) |
|
| ||||||||||||||||||||||||||
| Secondary | Treatment Arm 2: Change From Baseline in ALT | Blood samples were collected to assess ALT values. 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 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. | Posted | Mean | Standard Deviation | IU/L | 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) |
|
| ||||||||||||||||||||||||||
| Secondary | Treatment Arm 1 - Median Time to ALT Normalization in Absence of Rescue Medication for 24 Weeks After End of Treatment | Time to ALT normalization in absence of rescue medication were measured in participants having Baseline ALT>ULN. | 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. | Posted | Median | 95% Confidence Interval | Weeks | Up to 24 weeks off treatment (Study Week 48 to72) |
|
| ||||||||||||||||||||||||||
| Secondary | Treatment Arm 2 - Median Time to ALT Normalization in Absence of Rescue Medication for 24 Weeks After End of Treatment | Time to ALT normalization in absence of rescue medication were measured in participants having Baseline ALT>ULN. | 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. | Posted | Median | 95% Confidence Interval | Weeks | Up to 24 weeks off treatment (Study Weeks 36 to 60) |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants Achieving Sustained Virologic Response (SVR) for 24 Weeks Off Treatment for Comparison of Efficacy Between Different Treatment Durations | Sustained virologic response is defined as undetectable levels of HBsAg and Hepatitis-B virus deoxy-ribonucleic acid (HBV DNA) on treatment. 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. The point estimate for the difference in SVR and its respective credible interval (CI) were evaluated at 24 weeks off of planned treatment for both arms. The comparison of efficacy is between treatment durations and timepoint corresponds to Week 72 in Arm 1 and Week 60 in Arm 2. 95% CI here refers as credible interval. Percentage values are rounded-off. | Intent to Treat (ITT) Set that included all randomized participants. | Posted | Number | Percentage of participants | Up to 24 weeks off treatment (Treatment Arm 1: Study Weeks 48 to 72 and Treatment Arm 2: Study Weeks 36 to 60) |
|
Up to Week 72
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | GSK3228836 300 mg (24 Weeks) + PegIFN 180 mcg (24 Weeks) | Participants on stable NA therapy received 300mg/week GSK3228836 for 24 weeks (plus a loading dose on Day 4 and 11), followed by PegIFN 180 microgram per week (mcg/week) up to 24 weeks. | 0 | 55 | 6 | 55 | 52 | 55 |
| EG001 | GSK3228836 300 mg (12 Weeks) + PegIFN 180 mcg (24 Weeks) | Participants on stable NA therapy received 300mg/week GSK3228836 for 12 weeks (plus a loading dose on Day 4 and 11), followed by PegIFN 180 mcg/week up to 24 weeks. | 0 | 53 | 2 | 53 | 50 | 53 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cholecystitis | Hepatobiliary disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Drug-induced liver injury | Hepatobiliary disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Peritonsillar abscess | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Chest injury | Injury, poisoning and procedural complications | MedDRA v26.0 | Systematic Assessment |
| |
| Spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Lung adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v26.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Agranulocytosis | Blood and lymphatic system disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Coagulopathy | Blood and lymphatic system disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Neutrophilia | Blood and lymphatic system disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Bundle branch block left | Cardiac disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Ventricular extrasystoles | Cardiac disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Ear pruritus | Ear and labyrinth disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Eye pain | Eye disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Iridocyclitis | Eye disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Meibomian gland dysfunction | Eye disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Visual impairment | Eye disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Vitreous floaters | Eye disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Xerophthalmia | Eye disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Abdominal tenderness | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Anal blister | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Aphthous ulcer | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Gingival bleeding | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Gingival pain | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Hypoaesthesia oral | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Malocclusion | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Oral mucosal blistering | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Proctalgia | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Discomfort | General disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Facial pain | General disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Vaccination site pain | General disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Acute sinusitis | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Chlamydial infection | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Folliculitis | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Gingivitis | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Gonorrhoea | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Herpes dermatitis | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Hordeolum | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Laryngitis | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Localised infection | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Pulmonary tuberculosis | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Respiratory tract infection viral | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA v26.0 | Systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA v26.0 | Systematic Assessment |
| |
| Joint injury | Injury, poisoning and procedural complications | MedDRA v26.0 | Systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA v26.0 | Systematic Assessment |
| |
| Lip injury | Injury, poisoning and procedural complications | MedDRA v26.0 | Systematic Assessment |
| |
| Muscle strain | Injury, poisoning and procedural complications | MedDRA v26.0 | Systematic Assessment |
| |
| Wound complication | Injury, poisoning and procedural complications | MedDRA v26.0 | Systematic Assessment |
| |
| Activated partial thromboplastin time prolonged | Investigations | MedDRA v26.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA v26.0 | Systematic Assessment |
| |
| Antineutrophil cytoplasmic antibody increased | Investigations | MedDRA v26.0 | Systematic Assessment |
| |
| Antineutrophil cytoplasmic antibody positive | Investigations | MedDRA v26.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA v26.0 | Systematic Assessment |
| |
| Bilirubin conjugated increased | Investigations | MedDRA v26.0 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA v26.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA v26.0 | Systematic Assessment |
| |
| Blood phosphorus decreased | Investigations | MedDRA v26.0 | Systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA v26.0 | Systematic Assessment |
| |
| Blood thyroid stimulating hormone decreased | Investigations | MedDRA v26.0 | Systematic Assessment |
| |
| Blood thyroid stimulating hormone increased | Investigations | MedDRA v26.0 | Systematic Assessment |
| |
| Body temperature increased | Investigations | MedDRA v26.0 | Systematic Assessment |
| |
| C-reactive protein increased | Investigations | MedDRA v26.0 | Systematic Assessment |
| |
| Complement factor C3 decreased | Investigations | MedDRA v26.0 | Systematic Assessment |
| |
| Complement factor C4 decreased | Investigations | MedDRA v26.0 | Systematic Assessment |
| |
| Complement fragment Bb increased | Investigations | MedDRA v26.0 | Systematic Assessment |
| |
| Creatinine renal clearance decreased | Investigations | MedDRA v26.0 | Systematic Assessment |
| |
| Creatinine renal clearance increased | Investigations | MedDRA v26.0 | Systematic Assessment |
| |
| Glomerular filtration rate decreased | Investigations | MedDRA v26.0 | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA v26.0 | Systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA v26.0 | Systematic Assessment |
| |
| Hepatitis B DNA increased | Investigations | MedDRA v26.0 | Systematic Assessment |
| |
| Monocyte chemotactic protein-1 increased | Investigations | MedDRA v26.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA v26.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA v26.0 | Systematic Assessment |
| |
| Red blood cell count decreased | Investigations | MedDRA v26.0 | Systematic Assessment |
| |
| Thyroxine increased | Investigations | MedDRA v26.0 | Systematic Assessment |
| |
| Transaminases increased | Investigations | MedDRA v26.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA v26.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA v26.0 | Systematic Assessment |
| |
| Cell death | Metabolism and nutrition disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Gout | Metabolism and nutrition disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Hip deformity | Musculoskeletal and connective tissue disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Limb discomfort | Musculoskeletal and connective tissue disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Osteoporosis | Musculoskeletal and connective tissue disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Spinal pain | Musculoskeletal and connective tissue disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Temporomandibular joint syndrome | Musculoskeletal and connective tissue disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Melanocytic naevus | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v26.0 | Systematic Assessment |
| |
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v26.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Muscle contractions involuntary | Nervous system disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Sensory disturbance | Nervous system disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Tension headache | Nervous system disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Depressed mood | Psychiatric disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Hyposomnia | Psychiatric disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Irritability | Psychiatric disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Libido decreased | Psychiatric disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Mood altered | Psychiatric disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Nervousness | Psychiatric disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Sleep disorder | Psychiatric disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Chronic kidney disease | Renal and urinary disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Diabetic nephropathy | Renal and urinary disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Breast swelling | Reproductive system and breast disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Erectile dysfunction | Reproductive system and breast disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Heavy menstrual bleeding | Reproductive system and breast disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Pelvic pain | Reproductive system and breast disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Prostatitis | Reproductive system and breast disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Pruritus genital | Reproductive system and breast disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Dry throat | Respiratory, thoracic and mediastinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Laryngeal discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Nasal obstruction | Respiratory, thoracic and mediastinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Angioedema | Skin and subcutaneous tissue disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Erythema multiforme | Skin and subcutaneous tissue disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Nail ridging | Skin and subcutaneous tissue disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Petechiae | Skin and subcutaneous tissue disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Purpura | Skin and subcutaneous tissue disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Rash macular | Skin and subcutaneous tissue disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Rash papular | Skin and subcutaneous tissue disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Skin discolouration | Skin and subcutaneous tissue disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Varicose vein | Vascular disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Injection site anaesthesia | General disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Injection site bruising | General disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Injection site discolouration | General disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Injection site discomfort | General disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Injection site haematoma | General disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Injection site haemorrhage | General disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Injection site induration | General disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Injection site nodule | General disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Injection site pruritus | General disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Injection site swelling | General disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Injection site warmth | General disorders | MedDRA v26.0 | Systematic Assessment |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 | GSKClinicalSupportHD@gsk.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 22, 2023 | Feb 14, 2024 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D019694 | Hepatitis B, Chronic |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D006521 | Hepatitis, Chronic |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| Male |
|
| BLACK OR AFRICAN AMERICAN |
|
| WHITE |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Participants on stable NA therapy received 300mg/week GSK3228836 for 12 weeks (plus a loading dose on Day 4 and 11), followed by PegIFN 180 mcg/week up to 24 weeks. |
|
|
|