Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
Change From Baseline in Hepatitis B Surface Antigen (HBsAg) Levels in Currently Not Treated Population at Week 24 |
Change from baseline in HBsAg levels in currently not treated population at Week 24 based on Hepatitis B e Antigen (HBeAg) status was reported. Currently not treated population defined as participants who didn't receive any hepatitis B virus (HBV) treatment 6 months prior to baseline. |
Baseline and Week 24 |
|
| Primary |
Change From Baseline in HBsAg Levels in Virologically Suppressed Population at Week 24 |
Change from baseline in HBsAg levels in virologically suppressed population at Week 24 based on HBeAg status was reported. Virologically suppressed population defined as participants who were on entecavir (ETV) or tenofovir disoproxil fumarate (TDF) for at least 12 months prior to screening and had HBV deoxyribonucleic acid (DNA) <60 IU/mL. This outcome measure was planned to be analyzed for specified arms only. |
Baseline and Week 24 |
|
| Secondary |
Number of Participants With Treatment- Emergent Adverse Events (AEs) |
An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. Treatment-emergent AEs were AEs with onset during the treatment phase or that worsened since baseline. |
Up to Week 48 |
|
| Secondary |
Number of Participants With Serious Adverse Events (SAEs) |
A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. |
Up to Week 80 |
|
| Secondary |
Number of Participants With Clinically Significant Changes in Vital Signs, Physical Examinations, Electrocardiogram (ECG), and Clinical Laboratory Tests |
Number of participants with clinically significant changes in vital signs, physical examinations, ECG, and clinical laboratory tests (including hematology, blood biochemistry, blood coagulation, and urinalysis) were reported. |
Up to Week 80 |
|
| Secondary |
Change From Baseline in HBsAg Levels in Currently Not Treated Population Over Time |
Change from baseline in HBsAg levels in currently not treated population based on HBeAg status was reported. |
Weeks 24, 48 and Follow-up Week 24 |
|
| Secondary |
Change From Baseline in HBsAg Levels in Virologically Suppressed Population Over Time |
Change from baseline in HBsAg levels in virologically suppressed population based on HBeAg status was reported. This outcome measure was planned to be analyzed for specified arms only. |
Weeks 24, 48 and Follow-up Week 24 |
|
| Secondary |
Percentage of Participants With HBsAg Levels Less Than (<) 1,000 or <100 International Units Per Milliliter (IU/mL) in Currently Not Treated Population |
Percentage of participants with HBsAg levels <1,000 or <100 IU/mL in currently not treated population based on their HBeAg status were reported. |
Weeks 24, 48 and Follow-up Week 24 |
|
| Secondary |
Percentage of Participants With HBsAg Levels <1,000 or <100 IU/mL in Virologically Suppressed Population |
Percentage of participants with HBsAg levels <1,000 or <100 IU/mL in virologically suppressed population based on their HBeAg status were reported. This outcome measure was planned to be analyzed for specified arms only. |
Weeks 24, 48 and Follow-up Week 24 |
|
| Secondary |
Percentage of Participants With Greater Than (>) 0.5 log10 IU/mL or >1 log10 IU/mL Reduction in HBsAg From Baseline in Currently Not Treated Population |
Percentage of participants with >0.5 log10 IU/mL or >1 log10 IU/mL reduction in HBsAg from baseline in currently not treated population based on their HBeAg status were reported. |
Weeks 24, 48 and Follow-up Week 24 |
|
| Secondary |
Percentage of Participants With >0.5 log10 IU/mL or >1 log10 IU/mL Reduction in HBsAg From Baseline in Virologically Suppressed Population |
Percentage of participants with >0.5 log10 IU/mL or >1 log10 IU/mL reduction in HBsAg from baseline in virologically suppressed population based on their HBeAg status were reported. This outcome measure was planned to be analyzed for specified arms only. |
Weeks 24, 48 and Follow-up Week 24 |
|
| Secondary |
Change From Baseline in Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels in Currently Not Treated Population |
Change from baseline in HBV DNA levels in currently not treated population based on their HBeAg status was reported. |
Baseline up to Weeks 24, 48 and Follow-up Week 24 |
|
| Secondary |
Change From Baseline in HBV DNA Levels in Virologically Suppressed Population |
Change from baseline in HBV DNA levels in virologically supressed population based on their HBeAg status was reported. This outcome measure was planned to be analyzed for specified arms only. |
Baseline up to Weeks 24, 48 and Follow-up Week 24 |
|
| Secondary |
Percentage of Participants With Undetectable HBV DNA Levels in Currently Not Treated Population |
Percentage of participants with undetectable HBV DNA levels in currently not treated population based on their HBeAg status was evaluated. |
Weeks 24, 48 and Follow-up Week 24 |
|
| Secondary |
Percentage of Participants With Undetectable HBV DNA Levels in Virologically Suppressed Population |
Percentage of participants with undetectable HBV DNA levels in virologically suppressed population based on their HBeAg status were reported. This outcome measure was planned to be analyzed for specified arms only. |
Weeks 24, 48 and Follow-up Week 24 |
|
| Secondary |
Change From Baseline in HBeAg Levels in Currently Not Treated Population |
Change from baseline in HBeAg levels in HBeAg positive currently not treated population was reported. |
Baseline up to Weeks 24, 48 and Follow-up Week 24 |
|
| Secondary |
Change From Baseline in HBeAg Levels in Virologically Suppressed Population |
Change from baseline in HBeAg levels in HBeAg positive virologically suppressed population was reported. This outcome measure was planned to be analyzed for specified arms only. |
Baseline up to Weeks 24, 48 and Follow-up Week 24 |
|
| Secondary |
Percentage of Participants With >0.5 log10 IU/mL and >1 log10 IU/mL Reduction in HBeAg From Baseline in Currently Not Treated Population |
Percentage of participants with >0.5 log10 IU/mL and >1 log10 IU/mL reduction in HBeAg from baseline in HBeAg positive currently not treated population was reported. |
Weeks 24, 48 and Follow-up Week 24 |
|
| Secondary |
Percentage of Participants With >0.5 log10 IU/mL and >1 log10 IU/mL Reduction in HBeAg From Baseline in Virologically Suppressed Population |
Percentage of participants with >0.5 log10 IU/mL and >1 log10 IU/mL reduction in HBeAg from baseline in HBeAg positive virologically suppressed population was reported. This outcome measure was planned to be analyzed for specified arms only. |
Weeks 24, 48 and Follow-up Week 24 |
|
| Secondary |
Percentage of Participants With HBsAg Seroclearance in Currently Not Treated Population |
Percentage of participants with HBsAg seroclearance in currently not treated population based on their HBeAg status were reported. Seroclearance at Week 24/48 of the treatment defined as a confirmed loss of HBsAg at Week 24/48. Loss is defined as a baseline HBsAg with a repeat reactive, confirmed or positive result and a post-baseline assessment with a negative result. This outcome measure was planned to be analyzed at specified timepoints only. |
Weeks 24 and 48 |
|
| Secondary |
Percentage of Participants With HBsAg Seroclearance in Virologically Suppressed Population |
Percentage of participants with HBsAg seroclearance in virologically suppressed population based on their HBeAg status were reported. Seroclearance at Week 24/48 of the treatment defined as a confirmed loss of HBsAg at Week 24/48. Loss is defined as a baseline HBsAg with a repeat reactive, confirmed or positive result and a post-baseline assessment with a negative result. This outcome measure was planned to be analyzed for specified arms and specific timepoints only . |
Weeks 24 and 48 |
|
| Secondary |
Percentage of Participants With HBsAg Seroconversion in Currently Not Treated Population |
Percentage of participants with HBsAg seroconversion in currently not treated population based on their HBeAg status were reported. Seroconversion at Week 24/48 of the treatment defined as a confirmed loss of HBsAg at week 24/48 of the treatment and an appearance of Anti-HBs. This outcome measure was planned to be analyzed for specified timepoints only. |
Weeks 24 and 48 |
|
| Secondary |
Percentage of Participants With HBsAg Seroconversion in Virologically Suppressed Population |
Percentage of participants with HBsAg seroconversion in virologically suppressed population based on their HBeAg status were reported. Seroconversion at Week 24/48 of the treatment defined as a confirmed loss of HBsAg at week 24/48 of the treatment and an appearance of Anti-HBs. This outcome measure was planned to be analyzed for specified arms and specified timepoints only. |
Weeks 24 and 48 |
|
| Secondary |
Percentage of Participants With Normalized Alanine Aminotransferase (ALT) Levels in Currently Not Treated Population |
Percentage of participants with normalized ALT levels in currently not treated population, whose ALT levels were above upper limit of normal at baseline based on their HBeAg status were reported. |
Weeks 24, 48 and Follow-up Week 24 |
|
| Secondary |
Percentage of Participants With Normalized ALT Levels in Virologically Suppressed Population |
Percentage of participants with normalized ALT levels in virologically suppressed population, whose ALT levels were above upper limit of normal at baseline based on their HBeAg status were reported. This outcome measure was planned to be analyzed for specified arms only. |
Weeks 24, 48 and Follow-up Week 24 |
|
| Secondary |
Percentage of Participants With Virological Breakthrough in Currently Not Treated Population |
Percentage of participants with virological breakthrough in currently not treated population based on their HBeAg status was reported. Virological breakthrough defined as confirmed on treatment HBV DNA increase by >1 log10 from nadir level or confirmed on treatment level >200 IU/mL in participants who had HBV DNA level below the lower limit of quantification (LLOQ) of the HBV DNA assay. |
Weeks 24 and 48 |
|
| Secondary |
Percentage of Participants With Virological Breakthrough in Virologically Suppressed Population |
Percentage of participants with virological breakthrough in virologically suppressed population based on their HBeAg status was reported. Virological breakthrough defined as confirmed on treatment HBV DNA increase by >1 log10 from nadir level or confirmed on treatment level >200 IU/mL in participants who had HBV DNA level below the lower limit of quantification (LLOQ) of the HBV DNA assay. This outcome measure was planned to be analyzed for specified arms only. |
Weeks 24 and 48 |
|
| Secondary |
Plasma Concentrations of Entecavir [ETV] in Currently Not Treated Population |
Plasma concentrations of ETV administered as monotherapy or co-administered with JNJ-56136379 in currently not treated population was determined. As planned, plasma concentration of ETV co-administered with placebo was analyzed separately for Part A and Part B. Samples were analyzed using POP PK modeling. |
Day 1: 0 hours, 2 hours; Weeks 1, 2, 4, 8, 12, 20, 24, 28, 32, 36, 44, 48: 0 hours; Follow-up: Weeks 2 and 4 |
|
| Secondary |
Plasma Concentrations of ETV in Virologically Suppressed Population |
Plasma concentrations of ETV administered as monotherapy or co-administered with JNJ-56136379 in virologically suppressed population was determined. As planned, plasma concentration of ETV co-administered with placebo was analyzed separately for Part A and Part B. Samples were analyzed using POP PK modeling. |
Day 1: 0 hours, 2 hours; Weeks 1, 2, 4, 8, 12, 20, 24, 28, 32, 36, 44, 48: 0 hours; Follow-up: Weeks 2 and 4 |
|
| Secondary |
Plasma Concentrations of Tenofovir Disoproxil Fumarate (TDF) in Currently Not Treated Population |
Plasma concentrations of TDF administered as monotherapy or co-administered with JNJ-56136379 was determined. As planned, plasma concentration of TDF co-administered with placebo was analyzed separately for Part A and Part B. Samples were analyzed using POP PK modeling. |
Day 1: 0 hours, 2 hours; Weeks 1, 2, 4, 8, 12, 20, 24, 28, 32, 36, 44, 48: 0 hours; Follow-up: Weeks 2 and 4 |
|
| Secondary |
Plasma Concentrations of TDF in Virologically Suppressed Population |
Plasma concentrations of TDF administered as monotherapy or co-administered with JNJ-56136379 was determined. As planned, plasma concentration of TDF co-administered with placebo was analyzed separately for Part A and Part B. Samples were analyzed using POP PK modeling. |
Day 1: 0 hours, 2 hours; Weeks 1, 2, 4, 8, 12, 20, 24, 28, 32, 36, 44, 48: 0 hours; Follow-up: Weeks 2 and 4 |
|
| Secondary |
Plasma Concentrations of JNJ-56136379 in Currently Not Treated Population |
Plasma concentrations of JNJ-56136379 in currently not treated population administered as monotherapy or when co-administered with NA (ETV or TDF) was determined. As planned, the plasma concentration of JNJ-56136379 when co-administered with NA was determined separately for each NA treatment (ETV and TDF). Samples were analyzed using POP PK modeling. |
Day 1: 0 hours, 2 hours; Weeks 1, 2, 4, 8, 12, 20, 24, 28, 32, 36, 44, 48: 0 hours; Follow-up: Weeks 2 and 4 |
|
| Secondary |
Plasma Concentrations of JNJ-56136379 in Virologically Suppressed Population |
Plasma concentrations of JNJ-56136379 in virologically suppressed population administered as monotherapy or when co-administered with NA (ETV or TDF) was determined. As planned, the plasma concentration of JNJ-56136379 when co-administered with NA was determined separately for each NA treatment (ETV and TDF). Samples were analyzed using POP PK modeling. |
Day 1: 0 hours, 2 hours; Weeks 1, 2, 4, 8, 12, 20, 24, 28, 32, 36, 44, 48: 0 hours; Follow-up: Weeks 2 and 4 |
|
| Secondary |
Number of Participants With Treatment-Associated Mutations |
Number of participants with treatment-associated mutations were reported. Viral genome sequence analysis was performed to evaluate emergence of mutations associated with JNJ-56136379 considering 15 HBV core protein positions of interest. This outcome measure was planned to be analyzed for specified arms only. |
From Week 0 to Week 24, From Week 25 to Week 48, Up to Follow-up Week 24 |
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