| Primary | Number of Participants With Serious Adverse Events (SAEs) and Non-Serious Adverse Events (Non-SAEs >=5%) | An adverse event is any unfavorable and unintended sign (including a clinically-significant abnormal laboratory finding, for example), symptom, or disease temporally associated with the study or use of investigational drug product, whether or not the AE is considered related to the investigational drug product. Any adverse event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any important medical event according to medical judgment were categorized as SAE. | Safety Population includes all randomized participants who received at least 1 dose of GSK3228836 or placebo. In Cohort 3 participants were administered GSK3228836 300 mg instead of 450 mg as per sponsor's decision, hence Cohort 2 and Cohort 3 have been combined. | Posted | | Count of Participants | | Participants | | Up to Day 211 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1 GSK3228836 150 mg | Treatment-naive participants were subcutaneously administered GSK3228836 150 mg on Days 1, 4, 8, 11, 15 and 22 by trained study center personnel in abdomen, upper arm or thigh. | | OG001 | Cohort 2 and Cohort 3 GSK3228836 300 mg | Treatment-naive participants were subcutaneously administered GSK3228836 300 mg on Days 1, 4, 8, 11, 15 and 22 by trained study center personnel in abdomen, upper arm or thigh. | | OG002 | Cohorts 1-3 Placebo | Treatment-naive participants were subcutaneously administered placebo on Days 1, 4, 8, 11, 15, and 22 by trained study center personnel in abdomen, upper arm or thigh. | | OG003 | Cohort 4 GSK3228836 300 mg | Participants on stable nucleos(t)ide treatment were subcutaneously administered GSK3228836 300 mg on Days 1, 4, 8, 11, 15 and 22 by trained study center personnel in abdomen, upper arm or thigh. | | OG004 | Cohort 4 Placebo | Participants on stable nucleos(t)ide treatment were subcutaneously administered placebo on Days 1, 4, 8, 11, 15 and 22 by trained study center personnel in abdomen, upper arm or thigh. |
| | | Title | Denominators | Categories |
|---|
| Non-SAE (>=5%) | | |
| |
| Primary | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Over Time | Blood samples were collected for the analysis of clinical parameters including ALT, ALP, CK, GGT, LDH and AST. Baseline value is defined as last non-missing measurement prior to the first dose of study drug. Change from Baseline is defined as post-dose visit value minus Baseline value. | Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). In Cohort 3 participants were administered GSK3228836 300 mg instead of 450 mg as per sponsor's decision, hence Cohort 2 and Cohort 3 have been combined. | Posted | | Mean | Standard Deviation | Units per liter (U/L) | | Baseline (Day 1 pre-dose) and Days 29, 57, 85, 211 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1 GSK3228836 150 mg | Treatment-naive participants were subcutaneously administered GSK3228836 150 mg on Days 1, 4, 8, 11, 15 and 22 by trained study center personnel in abdomen, upper arm or thigh. | | OG001 | Cohort 2 and Cohort 3 GSK3228836 300 mg | Treatment-naive participants were subcutaneously administered GSK3228836 300 mg on Days 1, 4, 8, 11, 15 and 22 by trained study center personnel in abdomen, upper arm or thigh. |
|
| Primary | Change From Baseline in Clinical Chemistry Parameters : Albumin and Total Protein Over Time | Blood samples were collected for the analysis of clinical chemistry parameter-albumin and total protein. Baseline value is defined as last non-missing measurement prior to the first dose of study drug. Change from Baseline is defined as post-dose visit value minus Baseline value. | Safety population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). In Cohort 3 participants were administered GSK3228836 300 mg instead of 450 mg as per sponsor's decision, hence Cohort 2 and Cohort 3 have been combined. | Posted | | Mean | Standard Deviation | Grams per liter | | Baseline (Day 1 pre-dose) and Days 29, 57, 85, 211 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1 GSK3228836 150 mg | Treatment-naive participants were subcutaneously administered GSK3228836 150 mg on Days 1, 4, 8, 11, 15 and 22 by trained study center personnel in abdomen, upper arm or thigh. | | OG001 | Cohort 2 and Cohort 3 GSK3228836 300 mg | Treatment-naive participants were subcutaneously administered GSK3228836 300 mg on Days 1, 4, 8, 11, 15 and 22 by trained study center personnel in abdomen, upper arm or thigh. | | OG002 | Cohorts 1-3 Placebo |
|
| Primary | Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Magnesium, Phosphate, Glucose, Blood Urea Nitrogen, Cholesterol and Urate | Blood samples were collected for the analysis of clinical parameters including sodium, potassium, chloride, bicarbonate, calcium, magnesium, phosphate, glucose, blood urea nitrogen (BUN), cholesterol and urate. Baseline value is defined as last non-missing measurement prior to the first dose of study drug. Change from Baseline is defined as post-dose visit value minus Baseline value. | Safety population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). In Cohort 3 participants were administered GSK3228836 300 mg instead of 450 mg as per sponsor's decision, hence Cohort 2 and Cohort 3 have been combined. | Posted | | Mean | Standard Deviation | Millimoles per liter | | Outcome Measure Timeframe: Baseline (Day 1 pre-dose) and Days 29, 57, 85, 211 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1 GSK3228836 150 mg | Treatment-naive participants were subcutaneously administered GSK3228836 150 mg on Days 1, 4, 8, 11, 15 and 22 by trained study center personnel in abdomen, upper arm or thigh. | | OG001 | Cohort 2 and Cohort 3 GSK3228836 300 mg | Treatment-naive participants were subcutaneously administered GSK3228836 300 mg on Days 1, 4, 8, 11, 15 and 22 by trained study center personnel in abdomen, upper arm or thigh. |
|
| Primary | Change From Baseline Values in Clinical Chemistry Parameters: Total Bilirubin, Direct Bilirubin, Indirect Bilirubin, and Creatinine | Blood samples were collected for the analysis of clinical chemistry parameters: direct bilirubin, total bilirubin, indirect bilirubin and creatinine. Baseline value is defined as last non-missing measurement prior to the first dose of study drug. Change from Baseline is defined as post-dose visit value minus Baseline value. | Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). In Cohort 3 participants were administered GSK3228836 300 mg instead of 450 mg as per sponsor's decision, hence Cohort 2 and Cohort 3 have been combined. | Posted | | Mean | Standard Deviation | Micromoles per liter | | Baseline (Day 1 pre-dose) and Days 29, 57, 85, 211 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1 GSK3228836 150 mg | Treatment-naive participants were subcutaneously administered GSK3228836 150 mg on Days 1, 4, 8, 11, 15 and 22 by trained study center personnel in abdomen, upper arm or thigh. | | OG001 | Cohort 2 and Cohort 3 GSK3228836 300 mg | Treatment-naive participants were subcutaneously administered GSK3228836 300 mg on Days 1, 4, 8, 11, 15 and 22 by trained study center personnel in abdomen, upper arm or thigh. | | OG002 |
|
| Primary | Change From Baseline for Hematology Parameters: Basophils, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes, and Platelets | Blood samples were collected for the analysis of hematology parameters including basophil, eosinophils, WBC, lymphocytes, neutrophils, monocytes, and platelets at indicated timepoints. Baseline value is defined as last non-missing measurement prior to the first dose of study drug. Change from Baseline is defined as post-dose visit value minus Baseline value. | Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). In Cohort 3 participants were administered GSK3228836 300 mg instead of 450 mg as per sponsor's decision, hence Cohort 2 and Cohort 3 have been combined. | Posted | | Mean | Standard Deviation | 10^9 cells per liters | | Baseline (Day 1 pre-dose) and Days 29, 57, 85, 211 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1 GSK3228836 150 mg | Treatment-naive participants were subcutaneously administered GSK3228836 150 mg on Days 1, 4, 8, 11, 15 and 22 by trained study center personnel in abdomen, upper arm or thigh. | | OG001 | Cohort 2 and Cohort 3 GSK3228836 300 mg | Treatment-naive participants were subcutaneously administered GSK3228836 300 mg on Days 1, 4, 8, 11, 15 and 22 by trained study center personnel in abdomen, upper arm or thigh. | |
|
| Primary | Change From Baseline for Hematology Parameters: Hemoglobin | Blood samples were collected for the analysis of hematology parameters including hemoglobin at indicated timepoints. Baseline value is defined as last non-missing measurement prior to the first dose of study drug. Change from Baseline is defined as post-dose visit value minus Baseline value. | Safety population. Only those participants with data available at the specified data points were analyzed. In Cohort 3 participants were administered GSK3228836 300 mg instead of 450 mg as per sponsor's decision, hence Cohort 2 and Cohort 3 have been combined. | Posted | | Mean | Standard Deviation | Grams per liter | | Baseline (Day 1 pre-dose) and Days 29, 57, 85, 211 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1 GSK3228836 150 mg | Treatment-naive participants were subcutaneously administered GSK3228836 150 mg on Days 1, 4, 8, 11, 15 and 22 by trained study center personnel in abdomen, upper arm or thigh. | | OG001 | Cohort 2 and Cohort 3 GSK3228836 300 mg | Treatment-naive participants were subcutaneously administered GSK3228836 300 mg on Days 1, 4, 8, 11, 15 and 22 by trained study center personnel in abdomen, upper arm or thigh. | | OG002 | Cohorts 1-3 Placebo | |
|
| Primary | Change From Baseline for Hematology Parameter: Hematocrit | Blood samples were collected for the analysis of hematology parameter including hematocrit at indicated timepoints. Baseline value is defined as last non-missing measurement prior to the first dose of study drug. Change from Baseline is defined as post-dose visit value minus Baseline value. | Safety population. Only those participants with data available at the specified data points were analyzed. In Cohort 3 participants were administered GSK3228836 300 mg instead of 450 mg as per sponsor's decision, hence Cohort 2 and Cohort 3 have been combined. | Posted | | Mean | Standard Deviation | Percentage of red blood cells in blood | | Baseline (Day 1 pre-dose) and Days 29, 57, 85, 211 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1 GSK3228836 150 mg | Treatment-naive participants were subcutaneously administered GSK3228836 150 mg on Days 1, 4, 8, 11, 15 and 22 by trained study center personnel in abdomen, upper arm or thigh. | | OG001 | Cohort 2 and Cohort 3 GSK3228836 300 mg | Treatment-naive participants were subcutaneously administered GSK3228836 300 mg on Days 1, 4, 8, 11, 15 and 22 by trained study center personnel in abdomen, upper arm or thigh. | | OG002 | Cohorts 1-3 Placebo | |
|
| Primary | Change From Baseline Values in Urine Specific Gravity | Urine samples were collected for the analysis of urine specific gravity. Baseline value is defined as last non-missing measurement prior to the first dose of study drug. Change from Baseline is defined as post-dose visit value minus Baseline value. Urine specific gravity is measured as the ratio of urine density compared with water density. | Safety population. Only those participants with data available at the specified data points were analyzed. In Cohort 3 participants were administered GSK3228836 300 mg instead of 450 mg as per sponsor's decision, hence Cohort 2 and Cohort 3 have been combined. | Posted | | Mean | Standard Deviation | Ratio of urine to water density | | Baseline (Day 1 pre-dose) and Days 29, 57, 85, 211 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1 GSK3228836 150 mg | Treatment-naive participants were subcutaneously administered GSK3228836 150 mg on Days 1, 4, 8, 11, 15 and 22 by trained study center personnel in abdomen, upper arm or thigh. | | OG001 | Cohort 2 and Cohort 3 GSK3228836 300 mg | Treatment-naive participants were subcutaneously administered GSK3228836 300 mg on Days 1, 4, 8, 11, 15 and 22 by trained study center personnel in abdomen, upper arm or thigh. | | OG002 | Cohorts 1-3 Placebo |
|
| Primary | Change From Baseline Values in Urine Albumin/Creatinine Ratio and Urine Protein/Creatinine Ratio | Urine samples were collected for the analysis of urine albumin/creatinine ratio and urine protein/creatinine ratio. Baseline value is defined as last non-missing measurement prior to the first dose of study drug. Change from Baseline is defined as post-dose visit value minus Baseline value. | Safety population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). In Cohort 3 participants were administered GSK3228836 300 mg instead of 450 mg as per sponsor's decision, hence Cohort 2 and Cohort 3 have been combined. | Posted | | Mean | Standard Deviation | Milligrams per millimole Creatinine | | Baseline (Day 1 pre-dose) and Days 29, 57, 85, 211 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1 GSK3228836 150 mg | Treatment-naive participants were subcutaneously administered GSK3228836 150 mg on Days 1, 4, 8, 11, 15 and 22 by trained study center personnel in abdomen, upper arm or thigh. | | OG001 | Cohort 2 and Cohort 3 GSK3228836 300 mg | Treatment-naive participants were subcutaneously administered GSK3228836 300 mg on Days 1, 4, 8, 11, 15 and 22 by trained study center personnel in abdomen, upper arm or thigh. | | OG002 | Cohorts 1-3 Placebo |
|
| Primary | Change From Baseline Values in Urine Protein | Urine samples were collected for the analysis of urine protein. Baseline value is defined as last non-missing measurement prior to the first dose of study drug. Change from Baseline is defined as post-dose visit value minus Baseline value. | Safety population. Only those participants with data available at the specified data points were analyzed. In Cohort 3 participants were administered GSK3228836 300 mg instead of 450 mg as per sponsor's decision, hence Cohort 2 and Cohort 3 have been combined. | Posted | | Mean | Standard Deviation | Milligrams per deciliter | | Baseline (Day 1 pre-dose) and Days 29, 57, 85, 211 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1 GSK3228836 150 mg | Treatment-naive participants were subcutaneously administered GSK3228836 150 mg on Days 1, 4, 8, 11, 15 and 22 by trained study center personnel in abdomen, upper arm or thigh. | | OG001 | Cohort 2 and Cohort 3 GSK3228836 300 mg | Treatment-naive participants were subcutaneously administered GSK3228836 300 mg on Days 1, 4, 8, 11, 15 and 22 by trained study center personnel in abdomen, upper arm or thigh. | | OG002 | Cohorts 1-3 Placebo | Treatment-naive participants were subcutaneously administered placebo on Days 1, 4, 8, 11, 15, and 22 by trained study center personnel in abdomen, upper arm or thigh. |
|
| Primary | Change From Baseline Values in Blood Coagulation Factors: Activated Partial Thromboplastin Time and Prothrombin Time | Blood samples were collected for the analysis of blood coagulation factors:activated partial thromboplastin time (aPTT) and Prothrombin Time (PT). Baseline value is defined as last non-missing measurement prior to the first dose of study drug. Change from Baseline is defined as post-dose visit value minus Baseline value. | Safety population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). In Cohort 3 participants were administered GSK3228836 300 mg instead of 450 mg as per sponsor's decision, hence Cohort 2 and Cohort 3 have been combined. | Posted | | Mean | Standard Deviation | Seconds | | Baseline (Day 1 pre-dose) and Days 23, 57, 85, 211 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1 GSK3228836 150 mg | Treatment-naive participants were subcutaneously administered GSK3228836 150 mg on Days 1, 4, 8, 11, 15 and 22 by trained study center personnel in abdomen, upper arm or thigh. | | OG001 | Cohort 2 and Cohort 3 GSK3228836 300 mg | Treatment-naive participants were subcutaneously administered GSK3228836 300 mg on Days 1, 4, 8, 11, 15 and 22 by trained study center personnel in abdomen, upper arm or thigh. | | OG002 | Cohorts 1-3 Placebo |
|
| Primary | Change From Baseline Values in Blood Coagulation Factor: Prothrombin International Normalized Ratio | Blood samples were collected for the analysis of blood coagulation factor: Prothrombin International normalized ratio. Baseline value is defined as last non-missing measurement prior to the first dose of study drug. Change from Baseline is defined as post-dose visit value minus Baseline value. | Safety population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). In Cohort 3 participants were administered GSK3228836 300 mg instead of 450 mg as per sponsor's decision, hence Cohort 2 and Cohort 3 have been combined. | Posted | | Mean | Standard Deviation | Ratio | | Baseline (Day 1 pre-dose) and Days 23, 57, 85, 211 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1 GSK3228836 150 mg | Treatment-naive participants were subcutaneously administered GSK3228836 150 mg on Days 1, 4, 8, 11, 15 and 22 by trained study center personnel in abdomen, upper arm or thigh. | | OG001 | Cohort 2 and Cohort 3 GSK3228836 300 mg | Treatment-naive participants were subcutaneously administered GSK3228836 300 mg on Days 1, 4, 8, 11, 15 and 22 by trained study center personnel in abdomen, upper arm or thigh. | | OG002 | Cohorts 1-3 Placebo |
|
| Primary | Change in Complement C3 Level at Worst Case Post Baseline Relative to Baseline | Blood samples were collected from participants to evaluate change in complement C3 level at worst case post Baseline relative to Baseline. Worst case post Baseline in Complement C3 was the minimum post-Baseline level. Baseline value is defined as last non-missing measurement prior to the first dose of study drug. Change from Baseline is defined as post-dose visit value minus Baseline value. | Safety Population. In Cohort 3 participants were administered GSK3228836 300 mg instead of 450 mg as per sponsor's decision, hence Cohort 2 and Cohort 3 have been combined. | Posted | | Mean | Standard Deviation | Milligram per deciliter | | Baseline (Day 1 pre-dose) and up to Day 211 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1 GSK3228836 150 mg | Treatment-naive participants were subcutaneously administered GSK3228836 150 mg on Days 1, 4, 8, 11, 15 and 22 by trained study center personnel in abdomen, upper arm or thigh. | | OG001 | Cohort 2 and Cohort 3 GSK3228836 300 mg | Treatment-naive participants were subcutaneously administered GSK3228836 300 mg on Days 1, 4, 8, 11, 15 and 22 by trained study center personnel in abdomen, upper arm or thigh. | | OG002 | Cohorts 1-3 Placebo | |
|
| Primary | Change in Complement C5a Level at Worst Case Post Baseline Relative to Baseline | Blood samples were collected from participants to evaluate change in complement C5a level at worst case post Baseline relative to Baseline. Worst case post Baseline in Complement C5a was the maximum post-Baseline level. Baseline value is defined as last non-missing measurement prior to the first dose of study drug. Change from Baseline is defined as post-dose visit value minus Baseline value. | Safety Population. In Cohort 3 participants were administered GSK3228836 300 mg instead of 450 mg as per sponsor's decision, hence Cohort 2 and Cohort 3 have been combined. | Posted | | Mean | Standard Deviation | Nanogram per milliliter | | Baseline (Day 1 pre-dose) and up to Day 211 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1 GSK3228836 150 mg | Treatment-naive participants were subcutaneously administered GSK3228836 150 mg on Days 1, 4, 8, 11, 15 and 22 by trained study center personnel in abdomen, upper arm or thigh. | | OG001 | Cohort 2 and Cohort 3 GSK3228836 300 mg | Treatment-naive participants were subcutaneously administered GSK3228836 300 mg on Days 1, 4, 8, 11, 15 and 22 by trained study center personnel in abdomen, upper arm or thigh. | | OG002 | Cohorts 1-3 Placebo | |
|
| Primary | Change in Complement Bb Level at Worst Case Post Baseline Relative to Baseline | Blood samples were collected from participants to evaluate change in complement Bb level at worst case post Baseline relative to Baseline. Worst case post Baseline in Complement Bb was the maximum post-Baseline level. Baseline value is defined as last non-missing measurement prior to the first dose of study drug. Change from Baseline is defined as post-dose visit value minus Baseline value. | Safety Population. In Cohort 3 participants were administered GSK3228836 300 mg instead of 450 mg as per sponsor's decision, hence Cohort 2 and Cohort 3 have been combined. | Posted | | Mean | Standard Deviation | Microgram per milliliter | | Baseline (Day 1 pre-dose) and up to Day 211 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1 GSK3228836 150 mg | Treatment-naive participants were subcutaneously administered GSK3228836 150 mg on Days 1, 4, 8, 11, 15 and 22 by trained study center personnel in abdomen, upper arm or thigh. | | OG001 | Cohort 2 and Cohort 3 GSK3228836 300 mg | Treatment-naive participants were subcutaneously administered GSK3228836 300 mg on Days 1, 4, 8, 11, 15 and 22 by trained study center personnel in abdomen, upper arm or thigh. | | OG002 | Cohorts 1-3 Placebo | |
|
| Primary | Number of Participants With Reported Pregnancy | Female participants who were not surgically sterile or post-menopausal, underwent urine beta Human chorionic gonadotropin (Beta-HCG) pregnancy test. | Safety Population. Only those participants with data available at the specified data points were analyzed. In Cohort 3 participants were administered GSK3228836 300 mg instead of 450 mg as per sponsor's decision, hence Cohort 2 and Cohort 3 have been combined. | Posted | | Count of Participants | | Participants | | Up to Day 211 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1 GSK3228836 150 mg | Treatment-naive participants were subcutaneously administered GSK3228836 150 mg on Days 1, 4, 8, 11, 15 and 22 by trained study center personnel in abdomen, upper arm or thigh. | | OG001 | Cohort 2 and Cohort 3 GSK3228836 300 mg | Treatment-naive participants were subcutaneously administered GSK3228836 300 mg on Days 1, 4, 8, 11, 15 and 22 by trained study center personnel in abdomen, upper arm or thigh. | | OG002 | Cohorts 1-3 Placebo | Treatment-naive participants were subcutaneously administered placebo on Days 1, 4, 8, 11, 15, and 22 by trained study center personnel in abdomen, upper arm or thigh. |
|
| Primary | Change From Baseline in Body Temperature | Body temperature was measured at indicated timepoints. Baseline value is defined as last non-missing measurement prior to the first dose of study drug. Change from Baseline is defined as post-dose visit value minus Baseline value. | Safety Population. Only those participants with data available at the specified data points were analyzed. In Cohort 3 participants were administered GSK3228836 300 mg instead of 450 mg as per sponsor's decision, hence Cohort 2 and Cohort 3 have been combined. | Posted | | Mean | Standard Deviation | Degrees Celsius | | Baseline (Day 1 pre-dose) and Days 29, 57, 85, 211 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1 GSK3228836 150 mg | Treatment-naive participants were subcutaneously administered GSK3228836 150 mg on Days 1, 4, 8, 11, 15 and 22 by trained study center personnel in abdomen, upper arm or thigh. | | OG001 | Cohort 2 and Cohort 3 GSK3228836 300 mg | Treatment-naive participants were subcutaneously administered GSK3228836 300 mg on Days 1, 4, 8, 11, 15 and 22 by trained study center personnel in abdomen, upper arm or thigh. | | OG002 | Cohorts 1-3 Placebo | Treatment-naive participants were subcutaneously administered placebo on Days 1, 4, 8, 11, 15, and 22 by trained study center personnel in abdomen, upper arm or thigh. |
|
| Primary | Change From Baseline in Body Weight | Body weight was measured at indicated time points. Baseline value is defined as last non-missing measurement prior to the first dose of study drug. Change from Baseline is defined as post-dose visit value minus Baseline value. | Safety Population. Only those participants with data available at the specified data points were analyzed. In Cohort 3 participants were administered GSK3228836 300 mg instead of 450 mg as per sponsor's decision, hence Cohort 2 and Cohort 3 have been combined. | Posted | | Mean | Standard Deviation | Kilograms | | Baseline (Day 1 pre-dose) and Days 29, 57, 211 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1 GSK3228836 150 mg | Treatment-naive participants were subcutaneously administered GSK3228836 150 mg on Days 1, 4, 8, 11, 15 and 22 by trained study center personnel in abdomen, upper arm or thigh. | | OG001 | Cohort 2 and Cohort 3 GSK3228836 300 mg | Treatment-naive participants were subcutaneously administered GSK3228836 300 mg on Days 1, 4, 8, 11, 15 and 22 by trained study center personnel in abdomen, upper arm or thigh. | | OG002 | Cohorts 1-3 Placebo | Treatment-naive participants were subcutaneously administered placebo on Days 1, 4, 8, 11, 15, and 22 by trained study center personnel in abdomen, upper arm or thigh. |
|
| Primary | Change From Baseline in Diastolic Blood Pressure and Systolic Blood Pressure | Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) was measured at indicated timepoints. Baseline value is defined as last non-missing measurement prior to the first dose of study drug. Change from Baseline is defined as post-dose visit value minus Baseline value. | Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). In Cohort 3 participants were administered GSK3228836 300 mg instead of 450 mg as per sponsor's decision, hence Cohort 2 and Cohort 3 have been combined. | Posted | | Mean | Standard Deviation | Millimeters of Mercury (mmHg) | | Baseline (Day 1 pre-dose) and Days 29, 57, 85, 211 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1 GSK3228836 150 mg | Treatment-naive participants were subcutaneously administered GSK3228836 150 mg on Days 1, 4, 8, 11, 15 and 22 by trained study center personnel in abdomen, upper arm or thigh. | | OG001 | Cohort 2 and Cohort 3 GSK3228836 300 mg | Treatment-naive participants were subcutaneously administered GSK3228836 300 mg on Days 1, 4, 8, 11, 15 and 22 by trained study center personnel in abdomen, upper arm or thigh. | | OG002 | Cohorts 1-3 Placebo |
|
| Primary | Change From Baseline in Respiratory Rate | Respiratory Rate was measured at indicated timepoints. Baseline value is defined as last non-missing measurement prior to the first dose of study drug. Change from Baseline is defined as post-dose visit value minus Baseline value. | Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). In Cohort 3 participants were administered GSK3228836 300 mg instead of 450 mg as per sponsor's decision, hence Cohort 2 and Cohort 3 have been combined. | Posted | | Mean | Standard Deviation | Breaths/minute | | Baseline (Day 1 pre-dose) and Days 29, 57, 85, 211 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1 GSK3228836 150 mg | Treatment-naive participants were subcutaneously administered GSK3228836 150 mg on Days 1, 4, 8, 11, 15 and 22 by trained study center personnel in abdomen, upper arm or thigh. | | OG001 | Cohort 2 and Cohort 3 GSK3228836 300 mg | Treatment-naive participants were subcutaneously administered GSK3228836 300 mg on Days 1, 4, 8, 11, 15 and 22 by trained study center personnel in abdomen, upper arm or thigh. | | OG002 | Cohorts 1-3 Placebo | Treatment-naive participants were subcutaneously administered placebo on Days 1, 4, 8, 11, 15, and 22 by trained study center personnel in abdomen, upper arm or thigh. |
|
| Primary | Change From Baseline in Pulse Rate | Pulse Rate was measured at indicated timepoints. Baseline value is defined as last non-missing measurement prior to the first dose of study drug. Change from Baseline is defined as post-dose visit value minus Baseline value. | Safety Population. Only those participants with data available at the specified data points were analyzed. In Cohort 3 participants were administered GSK3228836 300 mg instead of 450 mg as per sponsor's decision, hence Cohort 2 and Cohort 3 have been combined. | Posted | | Mean | Standard Deviation | Beats/minute | | Baseline (Day 1 pre-dose) and Days 29, 57, 85, 211 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1 GSK3228836 150 mg | Treatment-naive participants were subcutaneously administered GSK3228836 150 mg on Days 1, 4, 8, 11, 15 and 22 by trained study center personnel in abdomen, upper arm or thigh. | | OG001 | Cohort 2 and Cohort 3 GSK3228836 300 mg | Treatment-naive participants were subcutaneously administered GSK3228836 300 mg on Days 1, 4, 8, 11, 15 and 22 by trained study center personnel in abdomen, upper arm or thigh. | | OG002 | Cohorts 1-3 Placebo | Treatment-naive participants were subcutaneously administered placebo on Days 1, 4, 8, 11, 15, and 22 by trained study center personnel in abdomen, upper arm or thigh. |
|
| Primary | Number of Participants With Abnormal Findings in Physical Examination | Physical examinations included assessment of the dermatologic, cardiovascular, respiratory, gastrointestinal, and neurological systems. | Safety Population. In Cohort 3 participants were administered GSK3228836 300 mg instead of 450 mg as per sponsor's decision, hence Cohort 2 and Cohort 3 have been combined. | Posted | | Count of Participants | | Participants | | Up to Day 211 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1 GSK3228836 150 mg | Treatment-naive participants were subcutaneously administered GSK3228836 150 mg on Days 1, 4, 8, 11, 15 and 22 by trained study center personnel in abdomen, upper arm or thigh. | | OG001 | Cohort 2 and Cohort 3 GSK3228836 300 mg | Treatment-naive participants were subcutaneously administered GSK3228836 300 mg on Days 1, 4, 8, 11, 15 and 22 by trained study center personnel in abdomen, upper arm or thigh. | | OG002 | Cohorts 1-3 Placebo | Treatment-naive participants were subcutaneously administered placebo on Days 1, 4, 8, 11, 15, and 22 by trained study center personnel in abdomen, upper arm or thigh. | | OG003 |
|
| Primary | Number of Participants Who Received Atleast One Concomitant Medication | A concomitant medication is defined as any medication initiated after the first dose of study, or initiated prior to the first dose of study drug and continued after the first dose of study drug. | Safety Population. In Cohort 3 participants were administered GSK3228836 300 mg instead of 450 mg as per sponsor's decision, hence Cohort 2 and Cohort 3 have been combined. | Posted | | Count of Participants | | Participants | | Up to Day 211 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1 GSK3228836 150 mg | Treatment-naive participants were subcutaneously administered GSK3228836 150 mg on Days 1, 4, 8, 11, 15 and 22 by trained study center personnel in abdomen, upper arm or thigh. | | OG001 | Cohort 2 and Cohort 3 GSK3228836 300 mg | Treatment-naive participants were subcutaneously administered GSK3228836 300 mg on Days 1, 4, 8, 11, 15 and 22 by trained study center personnel in abdomen, upper arm or thigh. | | OG002 | Cohorts 1-3 Placebo | Treatment-naive participants were subcutaneously administered placebo on Days 1, 4, 8, 11, 15, and 22 by trained study center personnel in abdomen, upper arm or thigh. |
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| Primary | Change From Baseline in Electrocardiogram Mean Ventricular Rate | Triplicate 12-lead Electrocardiograms (ECGs) were recorded at indicated timepoints. At each time point, ECG machine automatically measured mean ventricular rate (VR). Baseline ECG was the average of the triplicate taken on Day 1 Pre-dose, if only 1 or 2 assessments were available, the single assessment or average of the 2 assessments was used. Change from Baseline is defined as post-dose visit value minus Baseline value. | Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). In Cohort 3 participants were administered GSK3228836 300 mg instead of 450 mg as per sponsor's decision, hence Cohort 2 and Cohort 3 have been combined. | Posted | | Mean | Standard Deviation | Beats per minute | | Baseline (Day 1 pre-dose); Day1: 3 hours post-dose, 5 hours post-dose; Day 2; Day 22:pre-dose, 3 hours postdose, 5 hours post-dose; Days 23, 29 and 113 | | | | ID | Title | Description |
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| OG000 | Cohort 1 GSK3228836 150 mg | Treatment-naive participants were subcutaneously administered GSK3228836 150 mg on Days 1, 4, 8, 11, 15 and 22 by trained study center personnel in abdomen, upper arm or thigh. | | OG001 | Cohort 2 and Cohort 3 GSK3228836 300 mg | Treatment-naive participants were subcutaneously administered GSK3228836 300 mg on Days 1, 4, 8, 11, 15 and 22 by trained study center personnel in abdomen, upper arm or thigh. |
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| Primary | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval and QTc Corrected by Bazett's Formula | Triplicate 12-lead Electrocardiograms (ECGs) were recorded at indicated timepoints. At each time point, ECG machine automatically measured QRS duration, uncorrected QT interval, QT corrected interval-Fredericia [QTcF] interval and QTc corrected by Bazett's formula (QTcB). Baseline ECG was the average of the triplicate taken on Day 1 Pre-dose, if only 1 or 2 assessments were available, the single assessment or average of the 2 assessments was used. Change from Baseline is defined as post-dose visit value minus Baseline value. | Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). In Cohort 3 participants were administered GSK3228836 300 mg instead of 450 mg as per sponsor's decision, hence Cohort 2 and Cohort 3 have been combined. | Posted | | Mean | Standard Deviation | Milliseconds | | Baseline (Day 1 pre-dose); Day1: 3 hours post-dose, 5 hours post-dose; Day 2; Day 22:pre-dose, 3 hours postdose, 5 hours post-dose; Days 23, 29 and 113 | | | | ID | Title | Description |
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| OG000 | Cohort 1 GSK3228836 150 mg | Treatment-naive participants were subcutaneously administered GSK3228836 150 mg on Days 1, 4, 8, 11, 15 and 22 by trained study center personnel in abdomen, upper arm or thigh. | | OG001 | Cohort 2 and Cohort 3 GSK3228836 300 mg | |
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| Secondary | Change From Baseline in Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Viral Load in Plasma at Day 29 | Blood samples were collected from participants to assess HBV DNA viral load. Baseline is the last non-missing measurement prior to the first dose of study drug. The concentrations were logarithmic transformed with base 10 in this analysis. Change from Baseline is defined as post-dose visit value minus Baseline value. The last observation carried forward (LOCF) method was used to impute missing values at Day 29 in this analysis. | Full Analysis Set Population comprised of practically-feasible Intent-to-treat population, including subset of the Safety Set with a Baseline and at least 1 post-Baseline plasma HBV DNA concentration. Only those participants with data available at the specified data points were analyzed. In Cohort 3 participants were administered GSK3228836 300 mg instead of 450 mg as per sponsor's decision,hence Cohort 2 and Cohort 3 have been combined. | Posted | | Mean | Standard Deviation | Log10 (International Units/milliliter) | | Baseline (Day 1 pre-dose) and Day 29 | | | | ID | Title | Description |
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| OG000 | Cohort 1 GSK3228836 150 mg | Treatment-naive participants were subcutaneously administered GSK3228836 150 mg on Days 1, 4, 8, 11, 15 and 22 by trained study center personnel in abdomen, upper arm or thigh. | | OG001 | Cohort 2 and Cohort 3 GSK3228836 300 mg | Treatment-naive participants were subcutaneously administered GSK3228836 300 mg on Days 1, 4, 8, 11, 15 and 22 by trained study center personnel in abdomen, upper arm or thigh. |
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| Secondary | Change From Baseline in Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Viral Load in Plasma at Week 31 | Blood samples were collected from participants to assess HBV DNA viral load. Baseline is the last non-missing measurement prior to the first dose of study drug. The concentrations were logarithmic transformed with base 10 in this analysis. Change from Baseline is defined as post-dose visit value minus Baseline value. | Full Analysis Set Population. Only those participants with data available at the specified data points were analyzed. In Cohort 3 participants were administered GSK3228836 300 mg instead of 450 mg as per sponsor's decision, hence Cohort 2 and Cohort 3 have been combined. | Posted | | Mean | Standard Deviation | Log10 (International Units/milliliter) | | Baseline (Day 1 pre-dose) and Week 31 | | | | ID | Title | Description |
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| OG000 | Cohort 1 GSK3228836 150 mg | Treatment-naive participants were subcutaneously administered GSK3228836 150 mg on Days 1, 4, 8, 11, 15 and 22 by trained study center personnel in abdomen, upper arm or thigh. | | OG001 | Cohort 2 and Cohort 3 GSK3228836 300 mg | Treatment-naive participants were subcutaneously administered GSK3228836 300 mg on Days 1, 4, 8, 11, 15 and 22 by trained study center personnel in abdomen, upper arm or thigh. | | OG002 | Cohorts 1-3 Placebo |
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| Secondary | Change From Baseline in HBV Surface Antigen (HBsAg) Level in Serum at Day 29 | Blood samples were collected from participants to assess HBsAg level. Baseline is the last non-missing measurement prior to the first dose of study drug. The concentrations were logarithmic transformed with base 10 in this analysis. Change from Baseline is defined as post-dose visit value minus Baseline value. The LOCF method was used to impute missing values at Day 29 in this analysis. | Full Analysis Set Population. Only those participants with data available at the specified data points were analyzed. In Cohort 3 participants were administered GSK3228836 300 mg instead of 450 mg as per sponsor's decision, hence Cohort 2 and Cohort 3 have been combined. | Posted | | Mean | Standard Deviation | Log10 (International Units/milliliter) | | Baseline (Day 1 pre-dose) and Day 29 | | | | ID | Title | Description |
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| OG000 | Cohort 1 GSK3228836 150 mg | Treatment-naive participants were subcutaneously administered GSK3228836 150 mg on Days 1, 4, 8, 11, 15 and 22 by trained study center personnel in abdomen, upper arm or thigh. | | OG001 | Cohort 2 and Cohort 3 GSK3228836 300 mg | Treatment-naive participants were subcutaneously administered GSK3228836 300 mg on Days 1, 4, 8, 11, 15 and 22 by trained study center personnel in abdomen, upper arm or thigh. | | OG002 |
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| Secondary | Change From Baseline in HBsAg Level in Serum at Week 31 | Blood samples were collected from participants to assess HBsAg level. Baseline is the last non-missing measurement prior to the first dose of study drug. The concentrations were logarithmic transformed with base 10 in this analysis. Change from Baseline is defined as post-dose visit value minus Baseline value. | Full Analysis Set Population. Only those participants with data available at the specified data points were analyzed. In Cohort 3 participants were administered GSK3228836 300 mg instead of 450 mg as per sponsor's decision, hence Cohort 2 and Cohort 3 have been combined. | Posted | | Mean | Standard Deviation | Log10 (International Units/milliliter) | | Baseline (Day 1 pre-dose) and Week 31 | | | | ID | Title | Description |
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| OG000 | Cohort 1 GSK3228836 150 mg | Treatment-naive participants were subcutaneously administered GSK3228836 150 mg on Days 1, 4, 8, 11, 15 and 22 by trained study center personnel in abdomen, upper arm or thigh. | | OG001 | Cohort 2 and Cohort 3 GSK3228836 300 mg | Treatment-naive participants were subcutaneously administered GSK3228836 300 mg on Days 1, 4, 8, 11, 15 and 22 by trained study center personnel in abdomen, upper arm or thigh. | | OG002 | Cohorts 1-3 Placebo | |
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| Secondary | Percentage of Participants Who Achieved HBsAg Loss at Day 29 and Week 31 | Blood samples were collected to evaluate the percentage of participants with HBsAg loss at Day 29 and Week 31. A 'Loss' of HBsAg means antigen is negative. HBsAg Loss percentage is defined as number of participants with HBsAg loss divided by total number of participants assessed multiplied by 100. Baseline is the last non-missing measurement prior to the first dose of study drug. | Full Analysis Set Population. In Cohort 3 participants were administered GSK3228836 300 mg instead of 450 mg as per sponsor's decision, hence Cohort 2 and Cohort 3 have been combined. | Posted | | Number | | Percentage of Participants | | At Day 29 and Week 31 | | | | ID | Title | Description |
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| OG000 | Cohort 1 GSK3228836 150 mg | Treatment-naive participants were subcutaneously administered GSK3228836 150 mg on Days 1, 4, 8, 11, 15 and 22 by trained study center personnel in abdomen, upper arm or thigh. | | OG001 | Cohort 2 and Cohort 3 GSK3228836 300 mg | Treatment-naive participants were subcutaneously administered GSK3228836 300 mg on Days 1, 4, 8, 11, 15 and 22 by trained study center personnel in abdomen, upper arm or thigh. | | OG002 | Cohorts 1-3 Placebo | |
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| Secondary | Percentage of Participants Who Achieved HBV e Antigen (HBeAg) Loss at Day 29 and Week 31 Who Were HBeAg Positive at Baseline | Blood samples were collected to evaluate the percentage of participants with HBeAg loss at Day 29 and Week 31. A 'Loss' of HBeAg means antigen is negative. HBeAg Loss percentage is defined as number of participants with HBeAg loss divided by number of participants with positive HBeAg at Baseline multiplied by 100. Baseline is the last non-missing measurement prior to the first dose of study drug. Participants was considered HBeAg positive at Baseline if the Baseline value> 0.09 U/mL. | Full Analysis Set Population. Only those participants with data available at the specified data points were analyzed. None of the participants were HBeAg positive at Baseline in Cohort 4, hence no data to report (N=0) for Cohort 4 arms. In Cohort 3 participants were administered GSK3228836 300 mg instead of 450 mg as per sponsor's decision, hence Cohort 2 and Cohort 3 have been combined. | Posted | | Number | | Percentage of Participants | | Baseline (Day 1, Pre dose) and at Day 29 and Week 31 | | | | ID | Title | Description |
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| OG000 | Cohort 1 GSK3228836 150 mg | Treatment-naive participants were subcutaneously administered GSK3228836 150 mg on Days 1, 4, 8, 11, 15 and 22 by trained study center personnel in abdomen, upper arm or thigh. | | OG001 | Cohort 2 and Cohort 3 GSK3228836 300 mg | Treatment-naive participants were subcutaneously administered GSK3228836 300 mg on Days 1, 4, 8, 11, 15 and 22 by trained study center personnel in abdomen, upper arm or thigh. |
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| Secondary | Change From Baseline in Serum HBeAg Concentration at Day 29 in Participants Who Were HBeAg Positive at Baseline | Blood samples were collected from participants to assess HBeAg level. Baseline is the last non-missing measurement prior to the first dose of study drug. The concentrations were logarithmic transformed with base 10 in this analysis. Change from Baseline is defined as post-dose visit value minus Baseline value. Participant was considered HBeAg positive at Baseline if the Baseline value> 0.09 International Units/milliliter (IU/mL). | Full Analysis Set Population. Only those participants with data available at the specified data points were analyzed. None of the participants were HBeAg positive at Baseline in Cohort 4, hence no data to report (N=0) for Cohort 4 arms. In Cohort 3 participants were administered GSK3228836 300 mg instead of 450 mg as per sponsor's decision, hence Cohort 2 and Cohort 3 have been combined. | Posted | | Mean | Standard Deviation | Log10 (IU/mL) | | Baseline (Day 1, Pre dose) and at Day 29 | | | | ID | Title | Description |
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| OG000 | Cohort 1 GSK3228836 150 mg | Treatment-naive participants were subcutaneously administered GSK3228836 150 mg on Days 1, 4, 8, 11, 15 and 22 by trained study center personnel in abdomen, upper arm or thigh. | | OG001 | Cohort 2 and Cohort 3 GSK3228836 300 mg | Treatment-naive participants were subcutaneously administered GSK3228836 300 mg on Days 1, 4, 8, 11, 15 and 22 by trained study center personnel in abdomen, upper arm or thigh. |
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| Secondary | Change From Baseline in Serum HBeAg Concentration at Week 31 in Participants Who Were HBeAg Positive at Baseline | Blood samples were collected from participants to assess HBeAg level. Baseline is the last non-missing measurement prior to the first dose of study drug. The concentrations were logarithmic transformed with base 10 in this analysis. Change from Baseline is defined as post-dose visit value minus Baseline value. Participant was considered HBeAg positive at Baseline if the Baseline value> 0.09 U/mL. | Full Analysis Set Population. Only those participants with data available at the specified data points were analyzed. None of the participants were HBeAg positive at Baseline in Cohort 4, hence no data to report (N=0) for Cohort 4 arms. In Cohort 3 participants were administered GSK3228836 300 mg instead of 450 mg as per sponsor's decision, hence Cohort 2 and Cohort 3 have been combined. | Posted | | Mean | Standard Deviation | Log10 IU/mL | | Baseline (Day 1, Pre dose) and Week 31 | | | | ID | Title | Description |
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| OG000 | Cohort 1 GSK3228836 150 mg | Treatment-naive participants were subcutaneously administered GSK3228836 150 mg on Days 1, 4, 8, 11, 15 and 22 by trained study center personnel in abdomen, upper arm or thigh. | | OG001 | Cohort 2 and Cohort 3 GSK3228836 300 mg | Treatment-naive participants were subcutaneously administered GSK3228836 300 mg on Days 1, 4, 8, 11, 15 and 22 by trained study center personnel in abdomen, upper arm or thigh. |
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| Secondary | Plasma Concentrations of GSK3228836 in Participants With Chronic HBV Infection | Plasma samples were collected from participants with chronic HBV infection at indicated time points for pharmacokinetic analysis of GSK3228836. | Pharmacokinetic Population consisted of participants who were randomized, received at least 1 dose of study drug, and had at least 1 valid pharmacokinetic metric. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). In Cohort 3 participants were administered GSK3228836 300 mg instead of 450 mg as per sponsor's decision, hence Cohort 2 and Cohort 3 have been combined. | Posted | | Mean | Standard Deviation | Nanogram per milliliter | | Day 1:pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, and 6 hours post-dose, Days 2 and 23: 24 hours post-dose, Day 4: 72 hours post-dose, Days 8 and 15: pre-dose, Day 22: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, and 6 hours post-dose, and Days 29, 36, 57, 85, 113, and 211 | | | | ID | Title | Description |
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| OG000 | Cohort 1 GSK3228836 150 mg | Treatment-naive participants were subcutaneously administered GSK3228836 150 mg on Days 1, 4, 8, 11, 15 and 22 by trained study center personnel in abdomen, upper arm or thigh. | | OG001 | Cohort 2 and Cohort 3 GSK3228836 300 mg | Treatment-naive participants were subcutaneously administered GSK3228836 300 mg on Days 1, 4, 8, 11, 15 and 22 by trained study center personnel in abdomen, upper arm or thigh. |
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