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This is an open-label, randomized study to investigate subcutaneous (SC) bepirovirsen when delivered via SC injection from vial or Prefilled syringe fitted with a Safety syringe device (PFS SSD) in healthy adult participants. The aim of this study is to provide relative bioavailability data to support the transition from the vial presentation of bepirovirsen, to a ready-to-use liquid in a PFS SSD when both are given by a health care professional. The study will also assess self-administration using the PFS SDD, and the safety and tolerability of bepirovirsen.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bepirovirsen Vial by HCP | Experimental | Participants will receive Bepirovirsen vial administered by Healthcare Professionals (HCP). |
|
| Bepirovirsen PFS SSD by HCP | Experimental | Participants will receive Bepirovirsen PFS SSD administered by HCP. |
|
| Bepirovirsen PFS SSD self-administered post-training | Experimental | Participants will receive Bepirovirsen PFS SSD self- administered with training by HCP. |
|
| Bepirovirsen PFS SSD self-administered without training | Experimental | Participants will receive Bepirovirsen PFS SSD self- administered with no training by HCP. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bepirovirsen | Drug | Bepirovirsen will be administered. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) Following Administration of Bepirovirsen Using Vial and PFS by HCP | Blood samples were collected at indicated timepoints for pharmacokinetic analysis of Bepirovirsen. Cmax calculation for this outcome measure is based on changes in model specifications and inclusion of different arms for respective outcome measures. Model includes Randomized Groups (Groups compared), injection site (arm, thigh and abdomen) as categorical covariates and log transformed Baseline weight as continuous covariate. The treatment is a factor in the model and position of a treatment as either test or reference would affect the Cmax values for a particular outcome measure due to differences in how the model accounts for variability and compares group for mean calculation. Pharmacokinetic (PK) Parameter Population included all participants in the PK concentration Population for whom valid and evaluable plasma PK parameters were derived. | Pre-dose (Day 1) and Post-dose (1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 12 hours, 24 hours, 48 hours, 72 hours, 168 hours, 336 hours, 672 hours, 1008 hours and 1512 hours) |
| Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC [0-Inf]) Following Administration of Bepirovirsen Using Vial and PFS by HCP | Blood samples were collected at indicated timepoints for pharmacokinetic analysis of Bepirovirsen. Blood samples were collected at indicated timepoints for PK analysis of Bepirovirsen. AUC(0-inf) calculation for this outcome measure is based on changes in model specifications and inclusion of different arms for respective outcome measures. Model includes Randomized Groups (Groups compared), injection site (arm, thigh and abdomen) as categorical covariates and log transformed Baseline weight as continuous covariate. The treatment is a factor in the model and position of a treatment as either test or reference would affect the AUC(0-inf) values for a particular outcome measure due to differences in how the model accounts for variability and compares group for mean calculation. | Pre-dose (Day 1) and Post-dose (1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 12 hours, 24 hours, 48 hours, 72 hours, 168 hours, 336 hours, 672 hours, 1008 hours and 1512 hours) |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) Following Administration of Bepirovirsen Using PFS SSD by HCP and PFS SSD Self-administered Post-training | Blood samples were collected at indicated timepoints for pharmacokinetic analysis of Bepirovirsen. Cmax calculation for this outcome measure is based on changes in model specifications and inclusion of different arms for respective outcome measures. Model includes Randomized Groups (Groups compared), injection site (arm, thigh and abdomen) as categorical covariates and log transformed Baseline weight as continuous covariate. The treatment is a factor in the model and position of a treatment as either test or reference would affect the Cmax values for a particular outcome measure due to differences in how the model accounts for variability and compares group for mean calculation. |
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Inclusion Criteria:
Exclusion Criteria:
Prior use of immunosuppressive drugs within 3 months before dosing or interferon within 12 months before dosing.
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Las Vegas | Nevada | 89113 | United States | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41085094 | Derived | Youssef AS, Shah P, Hu M, Plein H, Roy A, Sharma R, Mole S, Blazejczyk M, Cross W, Spears B, Pak S, Kaur R, Elston R, Theodore D, Hezareh M, Nader A. A Phase 1, Randomized, Open-Label, Parallel Group Study to Evaluate the Relative Bioavailability and Safety of Subcutaneous Bepirovirsen when Delivered from a Vial or Prefilled Syringe Fitted with a Safety Syringe Device in Healthy Adult Participants. Clin Pharmacol Drug Dev. 2026 Feb;15(2):e1615. doi: 10.1002/cpdd.1615. Epub 2025 Oct 14. |
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Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/
Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
Anonymized IPD is shared with researchers whose proposals are approved by an 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 may be granted, when justified, for up to 6 months.
A total of 160 participants were enrolled in the study which were randomized in 4 groups. (Enrolled Population: All participants who entered the study [who were randomized or received study intervention or underwent a post-screening procedure]).
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| ID | Title | Description |
|---|---|---|
| FG000 | Bepirovirsen 300 mg Vial by HCP | Participants received a single dose of Bepirovirsen (GSK3228836) 300 milligrams (mg) (2*150 mg) subcutaneous (SC) injection packaged in a vial, administered by Healthcare Professionals (HCP). |
| FG001 | Bepirovirsen 300 mg PFS SSD by HCP |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 26, 2023 | Jul 1, 2025 |
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| Pre-dose (Day 1) and Post-dose (1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 12 hours, 24 hours, 48 hours, 72 hours, 168 hours, 336 hours, 672 hours, 1008 hours and 1512 hours) |
| AUC(0-inf) Following Administration of Bepirovirsen Using PFS SSD by HCP and PFS SSD Self-administered Post-training | Blood samples were collected at indicated timepoints for pharmacokinetic analysis of Bepirovirsen. Blood samples were collected at indicated timepoints for PK analysis of Bepirovirsen. AUC(0-inf) calculation for this outcome measure is based on changes in model specifications and inclusion of different arms for respective outcome measures. Model includes Randomized Groups (Groups compared), injection site (arm, thigh and abdomen) as categorical covariates and log transformed Baseline weight as continuous covariate. The treatment is a factor in the model and position of a treatment as either test or reference would affect the AUC(0-inf) values for a particular outcome measure due to differences in how the model accounts for variability and compares group for mean calculation. | Pre-dose (Day 1) and Post-dose (1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 12 hours, 24 hours, 48 hours, 72 hours, 168 hours, 336 hours, 672 hours, 1008 hours and 1512 hours) |
| Maximum Observed Plasma Concentration (Cmax) Following Administration of Bepirovirsen Using PFS SSD by HCP and PFS SSD Self-administered Without Training | Blood samples were collected at indicated timepoints for pharmacokinetic analysis of Bepirovirsen. Cmax calculation for this outcome measure is based on changes in model specifications and inclusion of different arms for respective outcome measures. Model includes Randomized Groups (Groups compared), injection site (arm, thigh and abdomen) as categorical covariates and log transformed Baseline weight as continuous covariate. The treatment is a factor in the model and position of a treatment as either test or reference would affect the Cmax values for a particular outcome measure due to differences in how the model accounts for variability and compares group for mean calculation. | Pre-dose (Day 1) and Post-dose (1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 12 hours, 24 hours, 48 hours, 72 hours, 168 hours, 336 hours, 672 hours, 1008 hours and 1512 hours) |
| AUC(0-Inf) Following Administration of Bepirovirsen Using PFS SSD by HCP and PFS SSD Self-administered Without Training | Blood samples were collected at indicated timepoints for pharmacokinetic analysis of Bepirovirsen. Blood samples were collected at indicated timepoints for PK analysis of Bepirovirsen. AUC(0-inf) calculation for this outcome measure is based on changes in model specifications and inclusion of different arms for respective outcome measures. Model includes Randomized Groups (Groups compared), injection site (arm, thigh and abdomen) as categorical covariates and log transformed Baseline weight as continuous covariate. The treatment is a factor in the model and position of a treatment as either test or reference would affect the AUC(0-inf) values for a particular outcome measure due to differences in how the model accounts for variability and compares group for mean calculation. | Pre-dose (Day 1) and Post-dose (1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 12 hours, 24 hours, 48 hours, 72 hours, 168 hours, 336 hours, 672 hours, 1008 hours and 1512 hours) |
| Austin |
| Texas |
| 78744 |
| United States |
Participants received a single dose of Bepirovirsen 300 mg (2*150 mg) SC injection packaged in a prefilled syringe (PFS) fitted with a safety syringe device (SSD), administered by HCP. |
| FG002 | Bepirovirsen 300 mg PFS SSD Self-administered Post-training | Participants received a single dose of Bepirovirsen 300 mg (2*150 mg) SC injection packaged in a PFS fitted with a SSD, self-administered with training from HCP. Participants were monitored by HCP during self-administration. |
| FG003 | Bepirovirsen 300 mg PFS SSD Self-administered Without Training | Participants received a single dose of Bepirovirsen 300 mg (2*150 mg) SC injection packaged in a PFS fitted with a SSD, self-administered with no training from HCP. Participants were monitored by HCP during self-administration. |
|
| Safety Population |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Baseline characteristics were reported for the Safety Population which included participants who received study intervention.
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| ID | Title | Description |
|---|---|---|
| BG000 | Bepirovirsen 300 mg Vial by HCP | Participants received a single dose of Bepirovirsen (GSK3228836) 300 milligrams (mg) (2*150 mg) subcutaneous (SC) injection packaged in a vial, administered by Healthcare Professionals (HCP). |
| BG001 | Bepirovirsen 300 mg PFS SSD by HCP | Participants received a single dose of Bepirovirsen 300 mg (2*150 mg) SC injection packaged in a prefilled syringe (PFS) fitted with a safety syringe device (SSD), administered by HCP. |
| BG002 | Bepirovirsen 300 mg PFS SSD Self-administered Post-training | Participants received a single dose of Bepirovirsen 300 mg (2*150 mg) SC injection packaged in a PFS fitted with a SSD, self-administered with training from HCP. Participants were monitored by HCP during self-administration. |
| BG003 | Bepirovirsen 300 mg PFS SSD Self-administered Without Training | Participants received a single dose of Bepirovirsen 300 mg (2*150 mg) SC injection packaged in a PFS fitted with a SSD, self-administered with no training from HCP. Participants were monitored by HCP during self-administration. |
| BG004 | 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 | The "All Other Races" category (AMERICAN INDIAN OR ALASKA NATIVE, ASIAN, BLACK OR AFRICAN AMERICAN, MIXED RACE, NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER and where 0\ | 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 | Maximum Observed Plasma Concentration (Cmax) Following Administration of Bepirovirsen Using Vial and PFS by HCP | Blood samples were collected at indicated timepoints for pharmacokinetic analysis of Bepirovirsen. Cmax calculation for this outcome measure is based on changes in model specifications and inclusion of different arms for respective outcome measures. Model includes Randomized Groups (Groups compared), injection site (arm, thigh and abdomen) as categorical covariates and log transformed Baseline weight as continuous covariate. The treatment is a factor in the model and position of a treatment as either test or reference would affect the Cmax values for a particular outcome measure due to differences in how the model accounts for variability and compares group for mean calculation. Pharmacokinetic (PK) Parameter Population included all participants in the PK concentration Population for whom valid and evaluable plasma PK parameters were derived. | PK parameter population was the analysis set used. Test group in this outcome measure is Bepirovirsen 300 mg PFS SSD by HCP and reference group is Bepirovirsen 300 mg Vial by HCP for this outcome measure. Based on the test and reference, data was analyzed and Cmax values were modelled as described in measure description which vary across different outcome measures. | Posted | Geometric Mean | Standard Error | Nanograms per milliliters (ng/mL) | Pre-dose (Day 1) and Post-dose (1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 12 hours, 24 hours, 48 hours, 72 hours, 168 hours, 336 hours, 672 hours, 1008 hours and 1512 hours) |
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| Primary | Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC [0-Inf]) Following Administration of Bepirovirsen Using Vial and PFS by HCP | Blood samples were collected at indicated timepoints for pharmacokinetic analysis of Bepirovirsen. Blood samples were collected at indicated timepoints for PK analysis of Bepirovirsen. AUC(0-inf) calculation for this outcome measure is based on changes in model specifications and inclusion of different arms for respective outcome measures. Model includes Randomized Groups (Groups compared), injection site (arm, thigh and abdomen) as categorical covariates and log transformed Baseline weight as continuous covariate. The treatment is a factor in the model and position of a treatment as either test or reference would affect the AUC(0-inf) values for a particular outcome measure due to differences in how the model accounts for variability and compares group for mean calculation. | PK parameter population was the analysis set used. Test group in this outcome measure is Bepirovirsen 300 mg PFS SSD by HCP and reference group is Bepirovirsen 300 mg Vial by HCP for this outcome measure. Based on the test and reference, data was analyzed and AUC(0-inf) values were modelled as described in measure description which vary across different outcome measures. | Posted | Geometric Mean | Standard Error | Hours*nanogram per milliliter (h*ng/mL) | Pre-dose (Day 1) and Post-dose (1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 12 hours, 24 hours, 48 hours, 72 hours, 168 hours, 336 hours, 672 hours, 1008 hours and 1512 hours) |
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| Secondary | Maximum Observed Plasma Concentration (Cmax) Following Administration of Bepirovirsen Using PFS SSD by HCP and PFS SSD Self-administered Post-training | Blood samples were collected at indicated timepoints for pharmacokinetic analysis of Bepirovirsen. Cmax calculation for this outcome measure is based on changes in model specifications and inclusion of different arms for respective outcome measures. Model includes Randomized Groups (Groups compared), injection site (arm, thigh and abdomen) as categorical covariates and log transformed Baseline weight as continuous covariate. The treatment is a factor in the model and position of a treatment as either test or reference would affect the Cmax values for a particular outcome measure due to differences in how the model accounts for variability and compares group for mean calculation. | PK parameter population was the analysis set used. Test group in this outcome measure is Bepirovirsen 300 mg PFS SSD self-administered post-training and reference group is Bepirovirsen 300 mg PFS SSD by HCP for this outcome measure. Based on the test and reference, data was analyzed and Cmax values were modelled as described in measure description which vary across different outcome measures. | Posted | Geometric Mean | Standard Error | Nanograms per milliliters | Pre-dose (Day 1) and Post-dose (1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 12 hours, 24 hours, 48 hours, 72 hours, 168 hours, 336 hours, 672 hours, 1008 hours and 1512 hours) |
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| Secondary | AUC(0-inf) Following Administration of Bepirovirsen Using PFS SSD by HCP and PFS SSD Self-administered Post-training | Blood samples were collected at indicated timepoints for pharmacokinetic analysis of Bepirovirsen. Blood samples were collected at indicated timepoints for PK analysis of Bepirovirsen. AUC(0-inf) calculation for this outcome measure is based on changes in model specifications and inclusion of different arms for respective outcome measures. Model includes Randomized Groups (Groups compared), injection site (arm, thigh and abdomen) as categorical covariates and log transformed Baseline weight as continuous covariate. The treatment is a factor in the model and position of a treatment as either test or reference would affect the AUC(0-inf) values for a particular outcome measure due to differences in how the model accounts for variability and compares group for mean calculation. | PK parameter population was the analysis set used. Test group in this outcome measure is Bepirovirsen 300 mg PFS SSD self-administered post-training and reference group is Bepirovirsen 300 mg PFS SSD by HCP for this outcome measure. Based on the test and reference, data was analyzed and AUC(0-inf) values were modelled as described in measure description which vary across different outcome measures. | Posted | Geometric Mean | Standard Error | Hours*nanograms per milliliters | Pre-dose (Day 1) and Post-dose (1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 12 hours, 24 hours, 48 hours, 72 hours, 168 hours, 336 hours, 672 hours, 1008 hours and 1512 hours) |
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| Secondary | Maximum Observed Plasma Concentration (Cmax) Following Administration of Bepirovirsen Using PFS SSD by HCP and PFS SSD Self-administered Without Training | Blood samples were collected at indicated timepoints for pharmacokinetic analysis of Bepirovirsen. Cmax calculation for this outcome measure is based on changes in model specifications and inclusion of different arms for respective outcome measures. Model includes Randomized Groups (Groups compared), injection site (arm, thigh and abdomen) as categorical covariates and log transformed Baseline weight as continuous covariate. The treatment is a factor in the model and position of a treatment as either test or reference would affect the Cmax values for a particular outcome measure due to differences in how the model accounts for variability and compares group for mean calculation. | PK parameter population was the analysis set used. Test group in this outcome measure is Bepirovirsen 300 mg PFS SSD self-administered without training and reference group is Bepirovirsen 300 mg PFS SSD by HCP for this outcome measure. Based on the test and reference, data was analyzed and Cmax values were modelled as described in measure description which vary across different outcome measures. | Posted | Geometric Mean | Standard Error | Nanograms per milliliters | Pre-dose (Day 1) and Post-dose (1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 12 hours, 24 hours, 48 hours, 72 hours, 168 hours, 336 hours, 672 hours, 1008 hours and 1512 hours) |
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| Secondary | AUC(0-Inf) Following Administration of Bepirovirsen Using PFS SSD by HCP and PFS SSD Self-administered Without Training | Blood samples were collected at indicated timepoints for pharmacokinetic analysis of Bepirovirsen. Blood samples were collected at indicated timepoints for PK analysis of Bepirovirsen. AUC(0-inf) calculation for this outcome measure is based on changes in model specifications and inclusion of different arms for respective outcome measures. Model includes Randomized Groups (Groups compared), injection site (arm, thigh and abdomen) as categorical covariates and log transformed Baseline weight as continuous covariate. The treatment is a factor in the model and position of a treatment as either test or reference would affect the AUC(0-inf) values for a particular outcome measure due to differences in how the model accounts for variability and compares group for mean calculation. | PK parameter population was the analysis set used. Test group in this outcome measure is Bepirovirsen 300 mg PFS SSD self-administered without training and reference group is Bepirovirsen 300 mg PFS SSD by HCP for this outcome measure. Based on the test and reference, data was analyzed and AUC(0-inf) values were modelled as described in measure description which vary across different outcome measures. | Posted | Geometric Mean | Standard Error | Hours*nanograms per milliliters | Pre-dose (Day 1) and Post-dose (1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 12 hours, 24 hours, 48 hours, 72 hours, 168 hours, 336 hours, 672 hours, 1008 hours and 1512 hours) |
|
All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to Day 64
All-cause mortality, SAEs and non-SAEs were reported for Safety Population which included participants who received study intervention. One participant from Enrolled Population (N=160) did not receive study intervention, hence was not included in Safety Population (N=159).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Bepirovirsen 300 mg Vial by HCP | Participants received a single dose of Bepirovirsen (GSK3228836) 300 milligrams (mg) (2*150 mg) subcutaneous (SC) injection packaged in a vial, administered by Healthcare Professionals (HCP). | 0 | 46 | 0 | 46 | 45 | 46 |
| EG001 | Bepirovirsen 300 mg PFS SSD by HCP | Participants received a single dose of Bepirovirsen 300 mg (2*150 mg) SC injection packaged in a prefilled syringe (PFS) fitted with a safety syringe device (SSD), administered by HCP. | 0 | 49 | 0 | 49 | 43 | 49 |
| EG002 | Bepirovirsen 300 mg PFS SSD Self-administered Post-training | Participants received a single dose of Bepirovirsen 300 mg (2*150 mg) SC injection packaged in a PFS fitted with a SSD, self-administered with training from HCP. Participants were monitored by HCP during self-administration. | 0 | 32 | 0 | 32 | 32 | 32 |
| EG003 | Bepirovirsen 300 mg PFS SSD Self-administered Without Training | Participants received a single dose of Bepirovirsen 300 mg (2*150 mg) SC injection packaged in a PFS fitted with a SSD, self-administered with no training from HCP. Participants were monitored by HCP during self-administration. | 0 | 32 | 0 | 32 | 30 | 32 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site erythema | General disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Injection site swelling | General disorders | MedDRA v27.0 | Systematic Assessment |
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| Injection site pain | General disorders | MedDRA v27.0 | Systematic Assessment |
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| Injection site pruritus | General disorders | MedDRA v27.0 | Systematic Assessment |
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| Injection site discolouration | General disorders | MedDRA v27.0 | Systematic Assessment |
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| Injection site pallor | General disorders | MedDRA v27.0 | Systematic Assessment |
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| Injection site haemorrhage | General disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Injection site bruising | General disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Injection site warmth | General disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Injection site inflammation | General disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Injection site nodule | General disorders | MedDRA v27.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Medical device site dermatitis | General disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Feeling of body temperature change | General disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Injection site dermatitis | General disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Injection site discomfort | General disorders | MedDRA v27.0 | Systematic Assessment |
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| Injection site exfoliation | General disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Injection site paraesthesia | General disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Injection site scab | General disorders | MedDRA v27.0 | Systematic Assessment |
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| Malaise | General disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Vessel puncture site reaction | General disorders | MedDRA v27.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA v27.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA v27.0 | Systematic Assessment |
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| Presyncope | Nervous system disorders | MedDRA v27.0 | Systematic Assessment |
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| Dysgeusia | Nervous system disorders | MedDRA v27.0 | Systematic Assessment |
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| Syncope | Nervous system disorders | MedDRA v27.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA v27.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA v27.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA v27.0 | Systematic Assessment |
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| Abdominal discomfort | Gastrointestinal disorders | MedDRA v27.0 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA v27.0 | Systematic Assessment |
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| Aphthous ulcer | Gastrointestinal disorders | MedDRA v27.0 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA v27.0 | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA v27.0 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA v27.0 | Systematic Assessment |
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| Viral infection | Infections and infestations | MedDRA v27.0 | Systematic Assessment |
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| Bacterial vaginosis | Infections and infestations | MedDRA v27.0 | Systematic Assessment |
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| Folliculitis | Infections and infestations | MedDRA v27.0 | Systematic Assessment |
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| Impetigo | Infections and infestations | MedDRA v27.0 | Systematic Assessment |
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| Influenza | Infections and infestations | MedDRA v27.0 | Systematic Assessment |
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| Paronychia | Infections and infestations | MedDRA v27.0 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA v27.0 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA v27.0 | Systematic Assessment |
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| Viral upper respiratory tract infection | Infections and infestations | MedDRA v27.0 | Systematic Assessment |
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| Vulvovaginal mycotic infection | Infections and infestations | MedDRA v27.0 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA v27.0 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v27.0 | Systematic Assessment |
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| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA v27.0 | Systematic Assessment |
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| Musculoskeletal discomfort | Musculoskeletal and connective tissue disorders | MedDRA v27.0 | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA v27.0 | Systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | MedDRA v27.0 | Systematic Assessment |
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| Injection related reaction | Injury, poisoning and procedural complications | MedDRA v27.0 | Systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA v27.0 | Systematic Assessment |
| |
| Muscle strain | Injury, poisoning and procedural complications | MedDRA v27.0 | Systematic Assessment |
| |
| Skin abrasion | Injury, poisoning and procedural complications | MedDRA v27.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Sneezing | Respiratory, thoracic and mediastinal disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Throat tightness | Respiratory, thoracic and mediastinal disorders | MedDRA v27.0 | Systematic Assessment |
| |
| C-reactive protein increased | Investigations | MedDRA v27.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA v27.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA v27.0 | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA v27.0 | Systematic Assessment |
| |
| Neutrophil percentage increased | Investigations | MedDRA v27.0 | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA v27.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Papule | Skin and subcutaneous tissue disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Photosensitivity reaction | Skin and subcutaneous tissue disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Allergy to arthropod sting | Immune system disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Increased appetite | Metabolism and nutrition disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Urinary tract discomfort | Renal and urinary disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Menstruation delayed | Reproductive system and breast disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Conjunctival hyperaemia | Eye disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA v27.0 | Systematic Assessment |
| |
| Seasonal allergy | Immune system disorders | MedDRA v27.0 | 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 | Aug 28, 2023 | Jul 1, 2025 | SAP_001.pdf |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D006505 | Hepatitis |
| D014777 | Virus Diseases |
| D008107 | Liver Diseases |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D006525 | Hepatitis, Viral, Human |
| D004066 | Digestive System Diseases |
Not provided
Not provided
| Male |
|
| All Other Races |
|
| OG001 | Bepirovirsen 300 mg PFS SSD by HCP | Participants received a single dose of Bepirovirsen 300 mg (2*150 mg) SC injection packaged in a prefilled syringe (PFS) fitted with a safety syringe device (SSD), administered by HCP. |
|
|
|
| OG001 | Bepirovirsen 300 mg PFS SSD Self-administered Post-training | Participants received a single dose of Bepirovirsen 300 mg (2*150 mg) SC injection packaged in a PFS fitted with a SSD, self-administered with training from HCP. Participants were monitored by HCP during self-administration. |
|
|
|
| OG001 | Bepirovirsen 300 mg PFS SSD Self-administered Post-training | Participants received a single dose of Bepirovirsen 300 mg (2*150 mg) SC injection packaged in a PFS fitted with a SSD, self-administered with training from HCP. Participants were monitored by HCP during self-administration. |
|
|
|
| OG001 | Bepirovirsen 300 mg PFS SSD Self-administered Without Training | Participants received a single dose of Bepirovirsen 300 mg (2*150 mg) SC injection packaged in a PFS fitted with a SSD, self-administered with no training from HCP. Participants were monitored by HCP during self-administration. |
|
|
|
| OG001 | Bepirovirsen 300 mg PFS SSD Self-administered Without Training | Participants received a single dose of Bepirovirsen 300 mg (2*150 mg) SC injection packaged in a PFS fitted with a SSD, self-administered with no training from HCP. Participants were monitored by HCP during self-administration. |
|
|
|