Hepatitis B
Conditions
Brief summary
The main purpose of this study is to evaluate efficacy of 24 weeks of study treatment, in terms of changes in hepatitis B surface antigen (HBsAg) levels.
Detailed description
The main study consists of 2-parts and each part will consist of 2 types of Chronic Hepatitis B-infected participant populations. Each part of the study will consist of screening phase (up to 8 weeks), treatment phase (24 weeks or 48 weeks, depending on treatment response), and post-treatment follow-up phase (24 weeks or 48 weeks, depending on treatment response). The duration of individual participation will be up to approximately 56 weeks (participants not eligible to continue treatment in extension phase), up to 80 weeks (participants continuing treatment in extension phase but not meeting treatment completion criteria), or up to 104 weeks (participants meeting treatment completion criteria). The safety and efficacy will be monitored throughout the study. In a separate substudy, at selected clinical sites, percutaneous core liver biopsy will be performed to evaluate changes of intrahepatic viral parameters.
Interventions
DRUGJNJ-56136379
Participants will receive JNJ-56136379 tablet orally.
DRUGPlacebo
Participants will receive matching placebo tablet orally.
DRUGNA (ETV or TDF)
Participants will receive NA (ETV or TDF) tablet orally as per approved label.
Sponsors
Janssen Sciences Ireland UC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Participants must have a body mass index (weight in kilogram (kg) divided by the square of height in meters) of 18.0 to 35.0 kilogram / square meter (kg/m\^2), extremes included * Participants must have chronic hepatitis B virus infection (CHB) infection documented by: Serum hepatitis B surface antigen (HBsAg)-positive at screening and serum HBsAg- or hepatitis B virus (HBV) deoxyribonucleic acid (DNA)-positive at least 6 months prior to screening; Serum immunoglobulin M (IgM) anti- hepatitis B core-related (HBc) antibody negative at screening * In participants currently not being treated (Treatment Arms 1-2-3 and 6-7-8): Participants must not be receiving any CHB treatment at screening, that is, Have never received treatment with HBV antiviral medicines, including NAs or interferon (IFN) products, OR Have not been on treatment with HBV antiviral medicines, including nucleos(t)ide analog (NA)s or IFN products within 6 months prior to baseline (first intake of study drugs), and participants must be HBeAg-positive and have HBV DNA greater than or equal to (\>=) 20,000 International Units Per Milliliter (IU/mL), OR be hepatitis B e antigen (HBeAg)-negative and have HBV DNA \>=2,000 IU /mL at screening, and participants must have HBsAg greater than (\>) 250 IU/mL at screening, and participants must have alanine aminotransferase (ALT) \> upper limit of normal (ULN) and less than or equal to (\<=) 5 \* ULN at screening, determined in the central laboratory * In virologically suppressed participants (Treatment Arms 4-5 and 9-10): Participants must be virologically suppressed by current NA treatment (entecavir (ETV) or tenofovir disoproxil fumarate (TDF)) as defined by HBV DNA less than (\<) 60 IU/mL at screening and at least 6 months prior to screening, and participants must be on the same NA treatment (ETV or TDF) and the same dose for \>=12 months prior to screening, and participants must have HBsAg \> 250 IU/mL at screening, and participants must have ALT \<=2\*ULN at screening * Participants must have: A liver biopsy result classified as Metavir F0-F2 within 1 year prior to screening or at the time of screening, OR FibroScan liver stiffness measurement \<8.0 kilopascal (kPa) within 6 months prior to screening or at the time of screening
Exclusion criteria
Main Study: * Participants who test positive for anti-hepatitis B surface (HBs) antibodies * Participants with current hepatitis A virus infection (confirmed by hepatitis A antibody immunoglobulin M \[IgM\]), hepatitis D virus (HDV) infection (confirmed by HDV antibody), hepatitis E virus infection (confirmed by hepatitis E antibody IgM), or human immunodeficiency virus (HIV)-1 or HIV-2 infection (confirmed by antibodies) at screening; participants with a history of or current HCV infection (confirmed by HCV antibody). Evidence of other active infection (bacterial, viral, fungal, including acute tuberculosis) deemed clinically relevant by the investigator that would interfere with study conduct or its interpretation will also lead to exclusion * Participants with any evidence of hepatic decompensation at any time point prior to or at the time of screening: Direct bilirubin \>1.2\* ULN, or International normalized ratio (INR) \>1.5\* ULN, or Serum albumin \< lower limit of normal (LLN), or documented history or current evidence of variceal bleeding, ascites, or hepatic encephalopathy * Participants with a history of cardiac arrhythmia (example, extrasystoli, tachycardia at rest), history of risk factors for Torsades de Pointes syndrome (example, hypokalemia, family history of long QT syndrome) or history or other clinical evidence of significant or unstable cardiac disease (example, angina, congestive heart failure, myocardial infarction, diastolic dysfunction, significant arrhythmia, coronary heart disease, and/or clinically significant 12 lead electrocardiograms (ECGs) abnormalities), moderate to severe valvular disease, or uncontrolled hypertension at screening * Participants with contraindications to the use of ETV or TDF per local prescribing information Substudy: * Presence of coagulopathy or hemoglobinopathy (including sickle cell disease, thalassemia) * Use of any anti-coagulant, anti-platelet, or non-steroidal anti-inflammatory drug medications from 10 days before until 5 days after each liver biopsy * Presence of ascites, focal liver lesions, and other findings that would be contraindications for liver biopsies
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Hepatitis B Surface Antigen (HBsAg) Levels in Currently Not Treated Population at Week 24 | Baseline and 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. |
| Change From Baseline in HBsAg Levels in Virologically Suppressed Population at Week 24 | Baseline and 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Clinically Significant Changes in Vital Signs, Physical Examinations, Electrocardiogram (ECG), and Clinical Laboratory Tests | Up to Week 80 | 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. |
| Change From Baseline in HBsAg Levels in Currently Not Treated Population Over Time | Weeks 24, 48 and Follow-up Week 24 | Change from baseline in HBsAg levels in currently not treated population based on HBeAg status was reported. |
| Change From Baseline in HBsAg Levels in Virologically Suppressed Population Over Time | Weeks 24, 48 and Follow-up Week 24 | 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. |
| Percentage of Participants With HBsAg Levels Less Than (<) 1,000 or <100 International Units Per Milliliter (IU/mL) in Currently Not Treated Population | Weeks 24, 48 and Follow-up Week 24 | Percentage of participants with HBsAg levels \<1,000 or \<100 IU/mL in currently not treated population based on their HBeAg status were reported. |
| Percentage of Participants With HBsAg Levels <1,000 or <100 IU/mL in Virologically Suppressed Population | Weeks 24, 48 and Follow-up Week 24 | 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. |
| 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 | Weeks 24, 48 and Follow-up Week 24 | 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. |
| Percentage of Participants With >0.5 log10 IU/mL or >1 log10 IU/mL Reduction in HBsAg From Baseline in Virologically Suppressed Population | Weeks 24, 48 and Follow-up Week 24 | 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. |
| Change From Baseline in Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels in Currently Not Treated Population | Baseline up to Weeks 24, 48 and Follow-up Week 24 | Change from baseline in HBV DNA levels in currently not treated population based on their HBeAg status was reported. |
| Change From Baseline in HBV DNA Levels in Virologically Suppressed Population | Baseline up to Weeks 24, 48 and Follow-up Week 24 | 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. |
| Percentage of Participants With Undetectable HBV DNA Levels in Currently Not Treated Population | Weeks 24, 48 and Follow-up Week 24 | Percentage of participants with undetectable HBV DNA levels in currently not treated population based on their HBeAg status was evaluated. |
| Percentage of Participants With Undetectable HBV DNA Levels in Virologically Suppressed Population | Weeks 24, 48 and Follow-up Week 24 | 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. |
| Change From Baseline in HBeAg Levels in Currently Not Treated Population | Baseline up to Weeks 24, 48 and Follow-up Week 24 | Change from baseline in HBeAg levels in HBeAg positive currently not treated population was reported. |
| Change From Baseline in HBeAg Levels in Virologically Suppressed Population | Baseline up to Weeks 24, 48 and Follow-up Week 24 | 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. |
| Percentage of Participants With >0.5 log10 IU/mL and >1 log10 IU/mL Reduction in HBeAg From Baseline in Currently Not Treated Population | Weeks 24, 48 and Follow-up Week 24 | 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. |
| Percentage of Participants With >0.5 log10 IU/mL and >1 log10 IU/mL Reduction in HBeAg From Baseline in Virologically Suppressed Population | Weeks 24, 48 and Follow-up Week 24 | 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. |
| Number of Participants With Treatment- Emergent Adverse Events (AEs) | Up to Week 48 | 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. |
| Percentage of Participants With HBsAg Seroclearance in Virologically Suppressed Population | Weeks 24 and 48 | 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 . |
| Percentage of Participants With HBsAg Seroconversion in Currently Not Treated Population | Weeks 24 and 48 | 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. |
| Percentage of Participants With HBsAg Seroconversion in Virologically Suppressed Population | Weeks 24 and 48 | 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. |
| Percentage of Participants With Normalized Alanine Aminotransferase (ALT) Levels in Currently Not Treated Population | Weeks 24, 48 and Follow-up Week 24 | 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. |
| Percentage of Participants With Normalized ALT Levels in Virologically Suppressed Population | Weeks 24, 48 and Follow-up Week 24 | 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. |
| Percentage of Participants With Virological Breakthrough in Currently Not Treated Population | Weeks 24 and 48 | 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. |
| Percentage of Participants With Virological Breakthrough in Virologically Suppressed Population | Weeks 24 and 48 | 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. |
| Plasma Concentrations of Entecavir [ETV] in Currently Not Treated Population | 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 | 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. |
| Plasma Concentrations of ETV in Virologically Suppressed Population | 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 | 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. |
| Plasma Concentrations of Tenofovir Disoproxil Fumarate (TDF) in Currently Not Treated Population | 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 | 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. |
| Plasma Concentrations of TDF in Virologically Suppressed Population | 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 | 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. |
| Plasma Concentrations of JNJ-56136379 in Currently Not Treated Population | 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 | 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. |
| Plasma Concentrations of JNJ-56136379 in Virologically Suppressed Population | 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 | 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. |
| Number of Participants With Treatment-Associated Mutations | From Week 0 to Week 24, From Week 25 to Week 48, Up to Follow-up Week 24 | 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. |
| Percentage of Participants With HBsAg Seroclearance in Currently Not Treated Population | Weeks 24 and 48 | 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. |
| Number of Participants With Serious Adverse Events (SAEs) | Up to Week 80 | 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. |
Countries
Belgium, Canada, China, France, Germany, Hong Kong, Italy, Japan, Malaysia, Poland, Russia, South Korea, Spain, Taiwan, Thailand, Turkey (Türkiye), Ukraine, United Kingdom, United States
Participant flow
Pre-assignment details
As per planned analysis, the data for Part A Placebo + Nucleos(t)ide analog (NA) and Part B Placebo + NA arm was pooled into a single Placebo + NA arm for data interpretation since there was considerable time overlap in randomization between the two parts, with almost half of the participants of Part B recruited while Part A was still ongoing.
Participants by arm
| Arm | Count |
|---|---|
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) Virologically suppressed (who were on entecavir \[ETV\] or tenofovir disoproxil fumarate \[TDF\] for at least 12 months prior to screening and had hepatitis B virus \[HBV\] deoxyribonucleic acid \[DNA\] less than (\<) 60 International units per milliliter \[IU/mL\]) or currently not treated (who didn't receive any HBV treatment 6 months prior to baseline) participants received placebo matching to JNJ-56136379 (75 milligrams \[mg\] or 250 mg) plus 1 tablet of NA (either 0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks. | 43 |
| Part A: JNJ-56136379 75 mg (Open Label) Currently not treated participants received JNJ-56136379 75 mg (3\*25 mg tablets) once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued treatment with JNJ-56136379 75 mg from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and received treatment with only NA (either ETV or TDF) for additional 24 weeks. | 28 |
| Part A: JNJ-56136379 75 mg + NA Virologically suppressed or currently not treated participants received JNJ-56136379 75 mg (3\*25 mg tablets) plus 1 tablet of NA either (0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 75 mg treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks. | 66 |
| Part B: JNJ-56136379 250 mg (Open-label) Currently not treated participants received JNJ-56136379 250 mg (2\*100 mg and 2\*25 mg tablets) once daily from Day 1 to Week 24 during the initial treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and received treatment with only NA (either ETV or TDF) for additional 24 weeks. | 32 |
| Part B: JNJ-56136379 250 mg + NA Virologically suppressed or currently not treated participants received JNJ-56136379 250 mg (2\*100 mg and 2\*25 mg tablets) plus 1 tablet of NA either (0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during treatment phase. Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who did not participate in the treatment extension phase after Week 24 and those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks. | 63 |
| Total | 232 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 | 1 | 1 | 0 |
| Overall Study | Disease Relapse | 0 | 0 | 1 | 0 | 0 |
| Overall Study | Lost to Follow-up | 0 | 0 | 1 | 1 | 2 |
| Overall Study | Other | 0 | 0 | 0 | 1 | 0 |
| Overall Study | Physician Decision | 0 | 2 | 0 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 2 | 2 | 0 | 3 |
Baseline characteristics
| Characteristic | Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Part B: JNJ-56136379 250 mg + NA | Part A: JNJ-56136379 75 mg (Open Label) | Part B: JNJ-56136379 250 mg (Open-label) | Part A: JNJ-56136379 75 mg + NA | Total |
|---|---|---|---|---|---|---|
| Age, Continuous | 41.6 years STANDARD_DEVIATION 9.53 | 40.5 years STANDARD_DEVIATION 10.99 | 39.2 years STANDARD_DEVIATION 12.06 | 37.7 years STANDARD_DEVIATION 10.92 | 40.3 years STANDARD_DEVIATION 11.12 | 40.1 years STANDARD_DEVIATION 10.87 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 42 Participants | 62 Participants | 28 Participants | 32 Participants | 66 Participants | 230 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 18 Participants | 30 Participants | 11 Participants | 16 Participants | 35 Participants | 110 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 3 Participants | 5 Participants | 1 Participants | 4 Participants | 14 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) White | 23 Participants | 30 Participants | 11 Participants | 15 Participants | 26 Participants | 105 Participants |
| Region of Enrollment BELGIUM | 3 Participants | 2 Participants | 2 Participants | 1 Participants | 3 Participants | 11 Participants |
| Region of Enrollment CANADA | 3 Participants | 6 Participants | 2 Participants | 0 Participants | 3 Participants | 14 Participants |
| Region of Enrollment CHINA | 1 Participants | 6 Participants | 2 Participants | 4 Participants | 5 Participants | 18 Participants |
| Region of Enrollment FRANCE | 3 Participants | 2 Participants | 3 Participants | 0 Participants | 3 Participants | 11 Participants |
| Region of Enrollment GERMANY | 3 Participants | 4 Participants | 0 Participants | 2 Participants | 0 Participants | 9 Participants |
| Region of Enrollment Hong Kong | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Region of Enrollment ITALY | 4 Participants | 1 Participants | 1 Participants | 1 Participants | 3 Participants | 10 Participants |
| Region of Enrollment JAPAN | 1 Participants | 3 Participants | 0 Participants | 2 Participants | 2 Participants | 8 Participants |
| Region of Enrollment MALAYSIA | 1 Participants | 3 Participants | 2 Participants | 1 Participants | 1 Participants | 8 Participants |
| Region of Enrollment POLAND | 4 Participants | 6 Participants | 1 Participants | 0 Participants | 7 Participants | 18 Participants |
| Region of Enrollment RUSSIAN FEDERATION | 4 Participants | 6 Participants | 1 Participants | 3 Participants | 4 Participants | 18 Participants |
| Region of Enrollment SOUTH KOREA | 1 Participants | 2 Participants | 1 Participants | 1 Participants | 2 Participants | 7 Participants |
| Region of Enrollment SPAIN | 2 Participants | 2 Participants | 1 Participants | 1 Participants | 6 Participants | 12 Participants |
| Region of Enrollment TAIWAN | 5 Participants | 4 Participants | 4 Participants | 1 Participants | 18 Participants | 32 Participants |
| Region of Enrollment THAILAND | 1 Participants | 3 Participants | 0 Participants | 3 Participants | 0 Participants | 7 Participants |
| Region of Enrollment TURKEY | 2 Participants | 5 Participants | 6 Participants | 4 Participants | 6 Participants | 23 Participants |
| Region of Enrollment UKRAINE | 1 Participants | 4 Participants | 0 Participants | 5 Participants | 0 Participants | 10 Participants |
| Region of Enrollment UNITED KINGDOM | 2 Participants | 2 Participants | 2 Participants | 2 Participants | 2 Participants | 10 Participants |
| Region of Enrollment UNITED STATES | 2 Participants | 2 Participants | 0 Participants | 0 Participants | 1 Participants | 5 Participants |
| Sex: Female, Male Female | 14 Participants | 13 Participants | 9 Participants | 14 Participants | 20 Participants | 70 Participants |
| Sex: Female, Male Male | 29 Participants | 50 Participants | 19 Participants | 18 Participants | 46 Participants | 162 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 43 | 0 / 28 | 0 / 66 | 0 / 32 | 0 / 63 | 0 / 33 | 0 / 3 | 0 / 43 | 0 / 20 | 0 / 48 |
| other Total, other adverse events | 9 / 43 | 18 / 28 | 19 / 66 | 12 / 32 | 11 / 63 | 25 / 33 | 2 / 3 | 38 / 43 | 15 / 20 | 42 / 48 |
| serious Total, serious adverse events | 1 / 43 | 1 / 28 | 0 / 66 | 0 / 32 | 1 / 63 | 0 / 33 | 0 / 3 | 4 / 43 | 0 / 20 | 3 / 48 |
Outcome results
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.
Time frame: Baseline and Week 24
Population: ITT population consisted of all participants who were randomized and received at least one dose of any study agent. If a participant received a study agent other than their randomly assigned study agent, participants were shown in the treatment arm as randomized. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure and 'n' (number analyzed) represents number of participants evaluable for the specified categories.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Change From Baseline in HBsAg Levels in Virologically Suppressed Population at Week 24 | HBeAg Positive | 0.008 log10 IU/mL | Standard Deviation 0.1224 |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Change From Baseline in HBsAg Levels in Virologically Suppressed Population at Week 24 | HBeAg Negative | 0.024 log10 IU/mL | Standard Deviation 0.0722 |
| Part A: JNJ-56136379 75 mg (Open Label) | Change From Baseline in HBsAg Levels in Virologically Suppressed Population at Week 24 | HBeAg Negative | -0.017 log10 IU/mL | Standard Deviation 0.0677 |
| Part A: JNJ-56136379 75 mg (Open Label) | Change From Baseline in HBsAg Levels in Virologically Suppressed Population at Week 24 | HBeAg Positive | -0.063 log10 IU/mL | Standard Deviation 0.2272 |
| Part A: JNJ-56136379 75 mg + NA | Change From Baseline in HBsAg Levels in Virologically Suppressed Population at Week 24 | HBeAg Positive | 0.105 log10 IU/mL | Standard Deviation 0.1809 |
| Part A: JNJ-56136379 75 mg + NA | Change From Baseline in HBsAg Levels in Virologically Suppressed Population at Week 24 | HBeAg Negative | 0.092 log10 IU/mL | Standard Deviation 0.0556 |
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.
Time frame: Baseline and Week 24
Population: Intent-to-Treat Population (ITT) consisted of all participants who were randomized and received at least one dose of any study agent. If a participant received a study agent other than their randomly assigned study agent, participants were shown in the treatment arm as randomized. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure and 'n'(number analyzed) represents number of participants evaluable for the specified categories.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Change From Baseline in Hepatitis B Surface Antigen (HBsAg) Levels in Currently Not Treated Population at Week 24 | HBeAg Negative | 0.015 log10 IU per milliliter (log10 IU/mL) | Standard Deviation 0.088 |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Change From Baseline in Hepatitis B Surface Antigen (HBsAg) Levels in Currently Not Treated Population at Week 24 | HBeAg Positive | -0.251 log10 IU per milliliter (log10 IU/mL) | Standard Deviation 0.3144 |
| Part A: JNJ-56136379 75 mg (Open Label) | Change From Baseline in Hepatitis B Surface Antigen (HBsAg) Levels in Currently Not Treated Population at Week 24 | HBeAg Negative | 0.053 log10 IU per milliliter (log10 IU/mL) | Standard Deviation 0.2066 |
| Part A: JNJ-56136379 75 mg (Open Label) | Change From Baseline in Hepatitis B Surface Antigen (HBsAg) Levels in Currently Not Treated Population at Week 24 | HBeAg Positive | -0.096 log10 IU per milliliter (log10 IU/mL) | Standard Deviation 0.3567 |
| Part A: JNJ-56136379 75 mg + NA | Change From Baseline in Hepatitis B Surface Antigen (HBsAg) Levels in Currently Not Treated Population at Week 24 | HBeAg Negative | 0.041 log10 IU per milliliter (log10 IU/mL) | Standard Deviation 0.0939 |
| Part A: JNJ-56136379 75 mg + NA | Change From Baseline in Hepatitis B Surface Antigen (HBsAg) Levels in Currently Not Treated Population at Week 24 | HBeAg Positive | -0.142 log10 IU per milliliter (log10 IU/mL) | Standard Deviation 0.3443 |
| Part B: JNJ-56136379 250 mg (Open Label) | Change From Baseline in Hepatitis B Surface Antigen (HBsAg) Levels in Currently Not Treated Population at Week 24 | HBeAg Negative | 0.064 log10 IU per milliliter (log10 IU/mL) | Standard Deviation 0.0913 |
| Part B: JNJ-56136379 250 mg (Open Label) | Change From Baseline in Hepatitis B Surface Antigen (HBsAg) Levels in Currently Not Treated Population at Week 24 | HBeAg Positive | -0.203 log10 IU per milliliter (log10 IU/mL) | Standard Deviation 0.4721 |
| Part B: JNJ-56136379 250 mg + NA | Change From Baseline in Hepatitis B Surface Antigen (HBsAg) Levels in Currently Not Treated Population at Week 24 | HBeAg Negative | 0.088 log10 IU per milliliter (log10 IU/mL) | Standard Deviation 0.1613 |
| Part B: JNJ-56136379 250 mg + NA | Change From Baseline in Hepatitis B Surface Antigen (HBsAg) Levels in Currently Not Treated Population at Week 24 | HBeAg Positive | -0.411 log10 IU per milliliter (log10 IU/mL) | Standard Deviation 0.4843 |
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.
Time frame: Baseline up to Weeks 24, 48 and Follow-up Week 24
Population: ITT population consisted of all participants who were randomized and received at least one dose of any study agent. If a participant received a study agent other than their randomly assigned study agent, participants were shown in the treatment arm as randomized. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure and 'n' (number analyzed) represents number of participants evaluable for the specified categories.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Change From Baseline in HBeAg Levels in Currently Not Treated Population | Week 48 | -2.250 log10 IU/mL | Standard Deviation 0.401 |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Change From Baseline in HBeAg Levels in Currently Not Treated Population | Week 24 | -0.811 log10 IU/mL | Standard Deviation 0.7953 |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Change From Baseline in HBeAg Levels in Currently Not Treated Population | Follow-up Week 24 | -1.139 log10 IU/mL | Standard Deviation 1.2528 |
| Part A: JNJ-56136379 75 mg (Open Label) | Change From Baseline in HBeAg Levels in Currently Not Treated Population | Week 24 | -0.456 log10 IU/mL | Standard Deviation 0.2908 |
| Part A: JNJ-56136379 75 mg (Open Label) | Change From Baseline in HBeAg Levels in Currently Not Treated Population | Follow-up Week 24 | -1.597 log10 IU/mL | Standard Deviation 1.1587 |
| Part A: JNJ-56136379 75 mg + NA | Change From Baseline in HBeAg Levels in Currently Not Treated Population | Follow-up Week 24 | -0.876 log10 IU/mL | Standard Deviation 0.5178 |
| Part A: JNJ-56136379 75 mg + NA | Change From Baseline in HBeAg Levels in Currently Not Treated Population | Week 24 | -0.487 log10 IU/mL | Standard Deviation 2974 |
| Part A: JNJ-56136379 75 mg + NA | Change From Baseline in HBeAg Levels in Currently Not Treated Population | Week 48 | -0.235 log10 IU/mL | Standard Deviation 0.0908 |
| Part B: JNJ-56136379 250 mg (Open Label) | Change From Baseline in HBeAg Levels in Currently Not Treated Population | Follow-up Week 24 | -1.243 log10 IU/mL | Standard Deviation 0.9933 |
| Part B: JNJ-56136379 250 mg (Open Label) | Change From Baseline in HBeAg Levels in Currently Not Treated Population | Week 24 | -0.974 log10 IU/mL | Standard Deviation 0.84 |
| Part B: JNJ-56136379 250 mg (Open Label) | Change From Baseline in HBeAg Levels in Currently Not Treated Population | Week 48 | -1.779 log10 IU/mL | Standard Deviation 1.3525 |
| Part B: JNJ-56136379 250 mg + NA | Change From Baseline in HBeAg Levels in Currently Not Treated Population | Week 48 | -1.601 log10 IU/mL | Standard Deviation 1.2689 |
| Part B: JNJ-56136379 250 mg + NA | Change From Baseline in HBeAg Levels in Currently Not Treated Population | Week 24 | -0.701 log10 IU/mL | Standard Deviation 0.6645 |
| Part B: JNJ-56136379 250 mg + NA | Change From Baseline in HBeAg Levels in Currently Not Treated Population | Follow-up Week 24 | -1.215 log10 IU/mL | Standard Deviation 1.291 |
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.
Time frame: Baseline up to Weeks 24, 48 and Follow-up Week 24
Population: ITT population consisted of all participants who were randomized and received at least one dose of any study agent. If a participant received a study agent other than their randomly assigned study agent, participants were shown in the treatment arm as randomized. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure and 'n' (number analyzed) represents number of participants evaluable for the specified categories.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Change From Baseline in HBeAg Levels in Virologically Suppressed Population | Follow-up Week 24 | -0.772 log10 IU/mL | Standard Deviation 0.7059 |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Change From Baseline in HBeAg Levels in Virologically Suppressed Population | Week 48 | -0.589 log10 IU/mL | Standard Deviation 0.6616 |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Change From Baseline in HBeAg Levels in Virologically Suppressed Population | Week 24 | -0.313 log10 IU/mL | Standard Deviation 0.5281 |
| Part A: JNJ-56136379 75 mg (Open Label) | Change From Baseline in HBeAg Levels in Virologically Suppressed Population | Follow-up Week 24 | -0.387 log10 IU/mL | Standard Deviation 0.5218 |
| Part A: JNJ-56136379 75 mg (Open Label) | Change From Baseline in HBeAg Levels in Virologically Suppressed Population | Week 24 | -0.315 log10 IU/mL | Standard Deviation 0.4681 |
| Part A: JNJ-56136379 75 mg (Open Label) | Change From Baseline in HBeAg Levels in Virologically Suppressed Population | Week 48 | -0.393 log10 IU/mL | Standard Deviation 0.4866 |
| Part A: JNJ-56136379 75 mg + NA | Change From Baseline in HBeAg Levels in Virologically Suppressed Population | Week 48 | -0.291 log10 IU/mL | Standard Deviation 0.2376 |
| Part A: JNJ-56136379 75 mg + NA | Change From Baseline in HBeAg Levels in Virologically Suppressed Population | Week 24 | -0.162 log10 IU/mL | Standard Deviation 0.2037 |
| Part A: JNJ-56136379 75 mg + NA | Change From Baseline in HBeAg Levels in Virologically Suppressed Population | Follow-up Week 24 | -0.351 log10 IU/mL | Standard Deviation 0.2877 |
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.
Time frame: Weeks 24, 48 and Follow-up Week 24
Population: ITT population consisted of all participants who were randomized and received at least one dose of any study agent. If a participant received a study agent other than their randomly assigned study agent, participants were shown in the treatment arm as randomized. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure and 'n' (number analyzed) represents number of participants evaluable for the specified categories.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Change From Baseline in HBsAg Levels in Currently Not Treated Population Over Time | Follow-up Week 24: HBeAg Positive | -0.300 log10 IU/mL | Standard Deviation 0.3333 |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Change From Baseline in HBsAg Levels in Currently Not Treated Population Over Time | Week 24: HBeAg Negative | 0.015 log10 IU/mL | Standard Deviation 0.088 |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Change From Baseline in HBsAg Levels in Currently Not Treated Population Over Time | Week 48: HBeAg Negative | 0.027 log10 IU/mL | Standard Deviation 0.0969 |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Change From Baseline in HBsAg Levels in Currently Not Treated Population Over Time | Follow-up Week 24: HBeAg Negative | 0.006 log10 IU/mL | Standard Deviation 0.1191 |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Change From Baseline in HBsAg Levels in Currently Not Treated Population Over Time | Week 48: HBeAg Positive | -0.109 log10 IU/mL | Standard Deviation 0.2065 |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Change From Baseline in HBsAg Levels in Currently Not Treated Population Over Time | Week 24: HBeAg Positive | -0.251 log10 IU/mL | Standard Deviation 0.3144 |
| Part A: JNJ-56136379 75 mg (Open Label) | Change From Baseline in HBsAg Levels in Currently Not Treated Population Over Time | Follow-up Week 24: HBeAg Negative | 0.000 log10 IU/mL | Standard Deviation 0.1889 |
| Part A: JNJ-56136379 75 mg (Open Label) | Change From Baseline in HBsAg Levels in Currently Not Treated Population Over Time | Week 24: HBeAg Positive | -0.096 log10 IU/mL | Standard Deviation 0.3567 |
| Part A: JNJ-56136379 75 mg (Open Label) | Change From Baseline in HBsAg Levels in Currently Not Treated Population Over Time | Week 24: HBeAg Negative | 0.053 log10 IU/mL | Standard Deviation 0.2066 |
| Part A: JNJ-56136379 75 mg (Open Label) | Change From Baseline in HBsAg Levels in Currently Not Treated Population Over Time | Follow-up Week 24: HBeAg Positive | -0.786 log10 IU/mL | Standard Deviation 0.6879 |
| Part A: JNJ-56136379 75 mg + NA | Change From Baseline in HBsAg Levels in Currently Not Treated Population Over Time | Week 24: HBeAg Positive | -0.142 log10 IU/mL | Standard Deviation 0.3443 |
| Part A: JNJ-56136379 75 mg + NA | Change From Baseline in HBsAg Levels in Currently Not Treated Population Over Time | Week 24: HBeAg Negative | 0.041 log10 IU/mL | Standard Deviation 0.0939 |
| Part A: JNJ-56136379 75 mg + NA | Change From Baseline in HBsAg Levels in Currently Not Treated Population Over Time | Week 48: HBeAg Positive | 0.061 log10 IU/mL | Standard Deviation 0.6817 |
| Part A: JNJ-56136379 75 mg + NA | Change From Baseline in HBsAg Levels in Currently Not Treated Population Over Time | Week 48: HBeAg Negative | -0.024 log10 IU/mL | Standard Deviation 0.1016 |
| Part A: JNJ-56136379 75 mg + NA | Change From Baseline in HBsAg Levels in Currently Not Treated Population Over Time | Follow-up Week 24: HBeAg Positive | -0.404 log10 IU/mL | Standard Deviation 0.5852 |
| Part A: JNJ-56136379 75 mg + NA | Change From Baseline in HBsAg Levels in Currently Not Treated Population Over Time | Follow-up Week 24: HBeAg Negative | -0.068 log10 IU/mL | Standard Deviation 0.0999 |
| Part B: JNJ-56136379 250 mg (Open Label) | Change From Baseline in HBsAg Levels in Currently Not Treated Population Over Time | Week 48: HBeAg Positive | -0.035 log10 IU/mL | Standard Deviation 0.6065 |
| Part B: JNJ-56136379 250 mg (Open Label) | Change From Baseline in HBsAg Levels in Currently Not Treated Population Over Time | Follow-up Week 24: HBeAg Negative | -0.073 log10 IU/mL | Standard Deviation 0.1195 |
| Part B: JNJ-56136379 250 mg (Open Label) | Change From Baseline in HBsAg Levels in Currently Not Treated Population Over Time | Week 24: HBeAg Negative | 0.064 log10 IU/mL | Standard Deviation 0.0913 |
| Part B: JNJ-56136379 250 mg (Open Label) | Change From Baseline in HBsAg Levels in Currently Not Treated Population Over Time | Follow-up Week 24: HBeAg Positive | -0.230 log10 IU/mL | Standard Deviation 0.511 |
| Part B: JNJ-56136379 250 mg (Open Label) | Change From Baseline in HBsAg Levels in Currently Not Treated Population Over Time | Week 48: HBeAg Negative | 0.011 log10 IU/mL | Standard Deviation 0.1086 |
| Part B: JNJ-56136379 250 mg (Open Label) | Change From Baseline in HBsAg Levels in Currently Not Treated Population Over Time | Week 24: HBeAg Positive | -0.203 log10 IU/mL | Standard Deviation 0.4721 |
| Part B: JNJ-56136379 250 mg + NA | Change From Baseline in HBsAg Levels in Currently Not Treated Population Over Time | Follow-up Week 24: HBeAg Positive | -0.721 log10 IU/mL | Standard Deviation 0.5666 |
| Part B: JNJ-56136379 250 mg + NA | Change From Baseline in HBsAg Levels in Currently Not Treated Population Over Time | Week 48: HBeAg Positive | -0.811 log10 IU/mL | Standard Deviation 1.0053 |
| Part B: JNJ-56136379 250 mg + NA | Change From Baseline in HBsAg Levels in Currently Not Treated Population Over Time | Week 48: HBeAg Negative | 0.075 log10 IU/mL | Standard Deviation 0.1528 |
| Part B: JNJ-56136379 250 mg + NA | Change From Baseline in HBsAg Levels in Currently Not Treated Population Over Time | Week 24: HBeAg Positive | -0.411 log10 IU/mL | Standard Deviation 0.4843 |
| Part B: JNJ-56136379 250 mg + NA | Change From Baseline in HBsAg Levels in Currently Not Treated Population Over Time | Week 24: HBeAg Negative | 0.088 log10 IU/mL | Standard Deviation 0.1613 |
| Part B: JNJ-56136379 250 mg + NA | Change From Baseline in HBsAg Levels in Currently Not Treated Population Over Time | Follow-up Week 24: HBeAg Negative | -0.017 log10 IU/mL | Standard Deviation 0.1533 |
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.
Time frame: Weeks 24, 48 and Follow-up Week 24
Population: ITT population consisted of all participants who were randomized and received at least one dose of any study agent. If a participant received a study agent other than their randomly assigned study agent, participants were shown in the treatment arm as randomized. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure and 'n' (number analyzed) represents number of participants evaluable for the specified categories.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Change From Baseline in HBsAg Levels in Virologically Suppressed Population Over Time | Week 24: HBeAg Negative | 0.024 log10 IU/mL | Standard Deviation 0.0722 |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Change From Baseline in HBsAg Levels in Virologically Suppressed Population Over Time | Week 48: HBeAg Positive | 0.043 log10 IU/mL | Standard Deviation 0.1374 |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Change From Baseline in HBsAg Levels in Virologically Suppressed Population Over Time | Week 48: HBeAg Negative | 0.011 log10 IU/mL | Standard Deviation 0.0736 |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Change From Baseline in HBsAg Levels in Virologically Suppressed Population Over Time | Follow-up Week 24: HBeAg Positive | -0.088 log10 IU/mL | Standard Deviation 0.0492 |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Change From Baseline in HBsAg Levels in Virologically Suppressed Population Over Time | Follow-up Week 24: HBeAg Negative | -0.006 log10 IU/mL | Standard Deviation 0.0789 |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Change From Baseline in HBsAg Levels in Virologically Suppressed Population Over Time | Week 24: HBeAg Positive | 0.008 log10 IU/mL | Standard Deviation 0.1224 |
| Part A: JNJ-56136379 75 mg (Open Label) | Change From Baseline in HBsAg Levels in Virologically Suppressed Population Over Time | Week 24: HBeAg Positive | -0.063 log10 IU/mL | Standard Deviation 0.2272 |
| Part A: JNJ-56136379 75 mg (Open Label) | Change From Baseline in HBsAg Levels in Virologically Suppressed Population Over Time | Week 24: HBeAg Negative | -0.017 log10 IU/mL | Standard Deviation 0.0677 |
| Part A: JNJ-56136379 75 mg (Open Label) | Change From Baseline in HBsAg Levels in Virologically Suppressed Population Over Time | Follow-up Week 24: HBeAg Positive | -0.146 log10 IU/mL | Standard Deviation 0.2821 |
| Part A: JNJ-56136379 75 mg (Open Label) | Change From Baseline in HBsAg Levels in Virologically Suppressed Population Over Time | Follow-up Week 24: HBeAg Negative | -0.119 log10 IU/mL | Standard Deviation 0.1172 |
| Part A: JNJ-56136379 75 mg (Open Label) | Change From Baseline in HBsAg Levels in Virologically Suppressed Population Over Time | Week 48: HBeAg Positive | -0.078 log10 IU/mL | Standard Deviation 0.266 |
| Part A: JNJ-56136379 75 mg (Open Label) | Change From Baseline in HBsAg Levels in Virologically Suppressed Population Over Time | Week 48: HBeAg Negative | -0.038 log10 IU/mL | Standard Deviation 0.0747 |
| Part A: JNJ-56136379 75 mg + NA | Change From Baseline in HBsAg Levels in Virologically Suppressed Population Over Time | Week 48: HBeAg Positive | 0.046 log10 IU/mL | Standard Deviation 0.2223 |
| Part A: JNJ-56136379 75 mg + NA | Change From Baseline in HBsAg Levels in Virologically Suppressed Population Over Time | Week 48: HBeAg Negative | 0.029 log10 IU/mL | Standard Deviation 0.0752 |
| Part A: JNJ-56136379 75 mg + NA | Change From Baseline in HBsAg Levels in Virologically Suppressed Population Over Time | Week 24: HBeAg Positive | 0.105 log10 IU/mL | Standard Deviation 0.1809 |
| Part A: JNJ-56136379 75 mg + NA | Change From Baseline in HBsAg Levels in Virologically Suppressed Population Over Time | Follow-up Week 24: HBeAg Positive | -0.159 log10 IU/mL | Standard Deviation 0.2141 |
| Part A: JNJ-56136379 75 mg + NA | Change From Baseline in HBsAg Levels in Virologically Suppressed Population Over Time | Week 24: HBeAg Negative | 0.092 log10 IU/mL | Standard Deviation 0.0556 |
| Part A: JNJ-56136379 75 mg + NA | Change From Baseline in HBsAg Levels in Virologically Suppressed Population Over Time | Follow-up Week 24: HBeAg Negative | -0.028 log10 IU/mL | Standard Deviation 0.0655 |
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.
Time frame: Baseline up to Weeks 24, 48 and Follow-up Week 24
Population: ITT population consisted of all participants who are randomized and received at least one dose of any study agent. If a participant received a study agent other than their randomly assigned study agent, participants would be shown in the treatment arm as randomized. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure and 'n' (number analyzed) represents number of participants evaluable for the specified categories.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Change From Baseline in HBV DNA Levels in Virologically Suppressed Population | Week 24: HbeAg Negative | -0.032 log10 IU/mL | Standard Deviation 0.2184 |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Change From Baseline in HBV DNA Levels in Virologically Suppressed Population | Follow-up Week 24: HbeAg Positive | 0.175 log10 IU/mL | Standard Deviation 0.3644 |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Change From Baseline in HBV DNA Levels in Virologically Suppressed Population | Week 48: HbeAg Negative | 0.000 log10 IU/mL | Standard Deviation 0.3896 |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Change From Baseline in HBV DNA Levels in Virologically Suppressed Population | Week 24: HbeAg Positive | -0.051 log10 IU/mL | Standard Deviation 0.1142 |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Change From Baseline in HBV DNA Levels in Virologically Suppressed Population | Follow-up Week 24: HbeAg Negative | -0.032 log10 IU/mL | Standard Deviation 0.2832 |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Change From Baseline in HBV DNA Levels in Virologically Suppressed Population | Week 48: HbeAg Positive | 0.044 log10 IU/mL | Standard Deviation 0.266 |
| Part A: JNJ-56136379 75 mg (Open Label) | Change From Baseline in HBV DNA Levels in Virologically Suppressed Population | Week 48: HbeAg Negative | -0.010 log10 IU/mL | Standard Deviation 0.3403 |
| Part A: JNJ-56136379 75 mg (Open Label) | Change From Baseline in HBV DNA Levels in Virologically Suppressed Population | Week 24: HbeAg Negative | 0.016 log10 IU/mL | Standard Deviation 0.3626 |
| Part A: JNJ-56136379 75 mg (Open Label) | Change From Baseline in HBV DNA Levels in Virologically Suppressed Population | Week 48: HbeAg Positive | 0.000 log10 IU/mL | Standard Deviation 0.3607 |
| Part A: JNJ-56136379 75 mg (Open Label) | Change From Baseline in HBV DNA Levels in Virologically Suppressed Population | Week 24: HbeAg Positive | 0.000 log10 IU/mL | Standard Deviation 0.3374 |
| Part A: JNJ-56136379 75 mg (Open Label) | Change From Baseline in HBV DNA Levels in Virologically Suppressed Population | Follow-up Week 24: HbeAg Positive | 0.000 log10 IU/mL | Standard Deviation 0.3374 |
| Part A: JNJ-56136379 75 mg (Open Label) | Change From Baseline in HBV DNA Levels in Virologically Suppressed Population | Follow-up Week 24: HbeAg Negative | -0.069 log10 IU/mL | Standard Deviation 0.3767 |
| Part A: JNJ-56136379 75 mg + NA | Change From Baseline in HBV DNA Levels in Virologically Suppressed Population | Follow-up Week 24: HbeAg Negative | 0.070 log10 IU/mL | Standard Deviation 0.3124 |
| Part A: JNJ-56136379 75 mg + NA | Change From Baseline in HBV DNA Levels in Virologically Suppressed Population | Follow-up Week 24: HbeAg Positive | 0.105 log10 IU/mL | Standard Deviation 0.537 |
| Part A: JNJ-56136379 75 mg + NA | Change From Baseline in HBV DNA Levels in Virologically Suppressed Population | Week 24: HbeAg Negative | -0.024 log10 IU/mL | Standard Deviation 0.2472 |
| Part A: JNJ-56136379 75 mg + NA | Change From Baseline in HBV DNA Levels in Virologically Suppressed Population | Week 24: HbeAg Positive | 0.021 log10 IU/mL | Standard Deviation 0.2665 |
| Part A: JNJ-56136379 75 mg + NA | Change From Baseline in HBV DNA Levels in Virologically Suppressed Population | Week 48: HbeAg Negative | -0.093 log10 IU/mL | Standard Deviation 0.2645 |
| Part A: JNJ-56136379 75 mg + NA | Change From Baseline in HBV DNA Levels in Virologically Suppressed Population | Week 48: HbeAg Positive | -0.233 log10 IU/mL | Standard Deviation 0.2817 |
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.
Time frame: Baseline up to Weeks 24, 48 and Follow-up Week 24
Population: ITT population consisted of all participants who are randomized and received at least one dose of any study agent. If a participant received a study agent other than their randomly assigned study agent, participants would be shown in the treatment arm as randomized. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure and 'n' (number analyzed) represents number of participants evaluable for the specified categories.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Change From Baseline in Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels in Currently Not Treated Population | Week 48: HbeAg Negative | -3.650 log10 IU/mL | Standard Deviation 1.3342 |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Change From Baseline in Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels in Currently Not Treated Population | Week 48: HbeAg Positive | -6.359 log10 IU/mL | Standard Deviation 0.1989 |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Change From Baseline in Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels in Currently Not Treated Population | Week 24: HbeAg Positive | -5.211 log10 IU/mL | Standard Deviation 1.1986 |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Change From Baseline in Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels in Currently Not Treated Population | Follow-up Week 24: HbeAg Positive | -5.956 log10 IU/mL | Standard Deviation 0.658 |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Change From Baseline in Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels in Currently Not Treated Population | Follow-up Week 24: HbeAg Negative | -3.727 log10 IU/mL | Standard Deviation 1.6598 |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Change From Baseline in Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels in Currently Not Treated Population | Week 24:HbeAg Negative | -3.622 log10 IU/mL | Standard Deviation 1.3003 |
| Part A: JNJ-56136379 75 mg (Open Label) | Change From Baseline in Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels in Currently Not Treated Population | Week 24: HbeAg Positive | -3.284 log10 IU/mL | Standard Deviation 2.1148 |
| Part A: JNJ-56136379 75 mg (Open Label) | Change From Baseline in Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels in Currently Not Treated Population | Follow-up Week 24: HbeAg Negative | -4.805 log10 IU/mL | Standard Deviation 1.0557 |
| Part A: JNJ-56136379 75 mg (Open Label) | Change From Baseline in Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels in Currently Not Treated Population | Follow-up Week 24: HbeAg Positive | -6.318 log10 IU/mL | Standard Deviation 1.0238 |
| Part A: JNJ-56136379 75 mg (Open Label) | Change From Baseline in Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels in Currently Not Treated Population | Week 24:HbeAg Negative | -3.469 log10 IU/mL | Standard Deviation 1.2901 |
| Part A: JNJ-56136379 75 mg + NA | Change From Baseline in Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels in Currently Not Treated Population | Week 48: HbeAg Positive | -5.009 log10 IU/mL | Standard Deviation 1.8289 |
| Part A: JNJ-56136379 75 mg + NA | Change From Baseline in Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels in Currently Not Treated Population | Follow-up Week 24: HbeAg Positive | -6.080 log10 IU/mL | Standard Deviation 0.8678 |
| Part A: JNJ-56136379 75 mg + NA | Change From Baseline in Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels in Currently Not Treated Population | Follow-up Week 24: HbeAg Negative | -4.165 log10 IU/mL | Standard Deviation 1.1102 |
| Part A: JNJ-56136379 75 mg + NA | Change From Baseline in Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels in Currently Not Treated Population | Week 24: HbeAg Positive | -5.531 log10 IU/mL | Standard Deviation 0.7915 |
| Part A: JNJ-56136379 75 mg + NA | Change From Baseline in Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels in Currently Not Treated Population | Week 48: HbeAg Negative | -3.707 log10 IU/mL | Standard Deviation 1.6444 |
| Part A: JNJ-56136379 75 mg + NA | Change From Baseline in Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels in Currently Not Treated Population | Week 24:HbeAg Negative | -4.077 log10 IU/mL | Standard Deviation 0.9435 |
| Part B: JNJ-56136379 250 mg (Open Label) | Change From Baseline in Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels in Currently Not Treated Population | Follow-up Week 24: HbeAg Positive | -6.262 log10 IU/mL | Standard Deviation 0.6278 |
| Part B: JNJ-56136379 250 mg (Open Label) | Change From Baseline in Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels in Currently Not Treated Population | Week 48: HbeAg Negative | -3.313 log10 IU/mL | Standard Deviation 1.0138 |
| Part B: JNJ-56136379 250 mg (Open Label) | Change From Baseline in Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels in Currently Not Treated Population | Week 24:HbeAg Negative | -3.545 log10 IU/mL | Standard Deviation 1.1482 |
| Part B: JNJ-56136379 250 mg (Open Label) | Change From Baseline in Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels in Currently Not Treated Population | Week 48: HbeAg Positive | -6.413 log10 IU/mL | Standard Deviation 0.9121 |
| Part B: JNJ-56136379 250 mg (Open Label) | Change From Baseline in Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels in Currently Not Treated Population | Follow-up Week 24: HbeAg Negative | -3.721 log10 IU/mL | Standard Deviation 1.1937 |
| Part B: JNJ-56136379 250 mg (Open Label) | Change From Baseline in Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels in Currently Not Treated Population | Week 24: HbeAg Positive | -5.719 log10 IU/mL | Standard Deviation 0.8395 |
| Part B: JNJ-56136379 250 mg + NA | Change From Baseline in Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels in Currently Not Treated Population | Follow-up Week 24: HbeAg Negative | -3.906 log10 IU/mL | Standard Deviation 1.6486 |
| Part B: JNJ-56136379 250 mg + NA | Change From Baseline in Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels in Currently Not Treated Population | Week 48: HbeAg Positive | -6.205 log10 IU/mL | Standard Deviation 1.3358 |
| Part B: JNJ-56136379 250 mg + NA | Change From Baseline in Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels in Currently Not Treated Population | Week 48: HbeAg Negative | -3.520 log10 IU/mL | Standard Deviation 1.2505 |
| Part B: JNJ-56136379 250 mg + NA | Change From Baseline in Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels in Currently Not Treated Population | Follow-up Week 24: HbeAg Positive | -6.013 log10 IU/mL | Standard Deviation 1.8359 |
| Part B: JNJ-56136379 250 mg + NA | Change From Baseline in Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels in Currently Not Treated Population | Week 24: HbeAg Positive | -5.883 log10 IU/mL | Standard Deviation 1.1396 |
| Part B: JNJ-56136379 250 mg + NA | Change From Baseline in Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels in Currently Not Treated Population | Week 24:HbeAg Negative | -3.690 log10 IU/mL | Standard Deviation 1.5289 |
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.
Time frame: Up to Week 80
Population: The safety population included all participants who received at least one dose of the study agent; all safety endpoints were analyzed by the treatment arm as treated.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Number of Participants With Clinically Significant Changes in Vital Signs, Physical Examinations, Electrocardiogram (ECG), and Clinical Laboratory Tests | Clinical Laboratory Tests: Blood biochemistry | 0 Participants |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Number of Participants With Clinically Significant Changes in Vital Signs, Physical Examinations, Electrocardiogram (ECG), and Clinical Laboratory Tests | Clinical Laboratory Tests: Blood coagulation | 0 Participants |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Number of Participants With Clinically Significant Changes in Vital Signs, Physical Examinations, Electrocardiogram (ECG), and Clinical Laboratory Tests | ECG | 0 Participants |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Number of Participants With Clinically Significant Changes in Vital Signs, Physical Examinations, Electrocardiogram (ECG), and Clinical Laboratory Tests | Clinical Laboratory Tests: Urinalysis | 0 Participants |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Number of Participants With Clinically Significant Changes in Vital Signs, Physical Examinations, Electrocardiogram (ECG), and Clinical Laboratory Tests | Clinical Laboratory Tests: Hematology | 0 Participants |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Number of Participants With Clinically Significant Changes in Vital Signs, Physical Examinations, Electrocardiogram (ECG), and Clinical Laboratory Tests | Vital Signs | 0 Participants |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Number of Participants With Clinically Significant Changes in Vital Signs, Physical Examinations, Electrocardiogram (ECG), and Clinical Laboratory Tests | Physical Examinations | 0 Participants |
| Part A: JNJ-56136379 75 mg (Open Label) | Number of Participants With Clinically Significant Changes in Vital Signs, Physical Examinations, Electrocardiogram (ECG), and Clinical Laboratory Tests | Clinical Laboratory Tests: Blood biochemistry | 0 Participants |
| Part A: JNJ-56136379 75 mg (Open Label) | Number of Participants With Clinically Significant Changes in Vital Signs, Physical Examinations, Electrocardiogram (ECG), and Clinical Laboratory Tests | Clinical Laboratory Tests: Hematology | 0 Participants |
| Part A: JNJ-56136379 75 mg (Open Label) | Number of Participants With Clinically Significant Changes in Vital Signs, Physical Examinations, Electrocardiogram (ECG), and Clinical Laboratory Tests | Clinical Laboratory Tests: Urinalysis | 0 Participants |
| Part A: JNJ-56136379 75 mg (Open Label) | Number of Participants With Clinically Significant Changes in Vital Signs, Physical Examinations, Electrocardiogram (ECG), and Clinical Laboratory Tests | Clinical Laboratory Tests: Blood coagulation | 0 Participants |
| Part A: JNJ-56136379 75 mg (Open Label) | Number of Participants With Clinically Significant Changes in Vital Signs, Physical Examinations, Electrocardiogram (ECG), and Clinical Laboratory Tests | Physical Examinations | 0 Participants |
| Part A: JNJ-56136379 75 mg (Open Label) | Number of Participants With Clinically Significant Changes in Vital Signs, Physical Examinations, Electrocardiogram (ECG), and Clinical Laboratory Tests | Vital Signs | 0 Participants |
| Part A: JNJ-56136379 75 mg (Open Label) | Number of Participants With Clinically Significant Changes in Vital Signs, Physical Examinations, Electrocardiogram (ECG), and Clinical Laboratory Tests | ECG | 0 Participants |
| Part A: JNJ-56136379 75 mg + NA | Number of Participants With Clinically Significant Changes in Vital Signs, Physical Examinations, Electrocardiogram (ECG), and Clinical Laboratory Tests | Clinical Laboratory Tests: Blood coagulation | 0 Participants |
| Part A: JNJ-56136379 75 mg + NA | Number of Participants With Clinically Significant Changes in Vital Signs, Physical Examinations, Electrocardiogram (ECG), and Clinical Laboratory Tests | Physical Examinations | 0 Participants |
| Part A: JNJ-56136379 75 mg + NA | Number of Participants With Clinically Significant Changes in Vital Signs, Physical Examinations, Electrocardiogram (ECG), and Clinical Laboratory Tests | Vital Signs | 0 Participants |
| Part A: JNJ-56136379 75 mg + NA | Number of Participants With Clinically Significant Changes in Vital Signs, Physical Examinations, Electrocardiogram (ECG), and Clinical Laboratory Tests | Clinical Laboratory Tests: Hematology | 0 Participants |
| Part A: JNJ-56136379 75 mg + NA | Number of Participants With Clinically Significant Changes in Vital Signs, Physical Examinations, Electrocardiogram (ECG), and Clinical Laboratory Tests | Clinical Laboratory Tests: Urinalysis | 0 Participants |
| Part A: JNJ-56136379 75 mg + NA | Number of Participants With Clinically Significant Changes in Vital Signs, Physical Examinations, Electrocardiogram (ECG), and Clinical Laboratory Tests | ECG | 0 Participants |
| Part A: JNJ-56136379 75 mg + NA | Number of Participants With Clinically Significant Changes in Vital Signs, Physical Examinations, Electrocardiogram (ECG), and Clinical Laboratory Tests | Clinical Laboratory Tests: Blood biochemistry | 0 Participants |
| Part B: JNJ-56136379 250 mg (Open Label) | Number of Participants With Clinically Significant Changes in Vital Signs, Physical Examinations, Electrocardiogram (ECG), and Clinical Laboratory Tests | Vital Signs | 0 Participants |
| Part B: JNJ-56136379 250 mg (Open Label) | Number of Participants With Clinically Significant Changes in Vital Signs, Physical Examinations, Electrocardiogram (ECG), and Clinical Laboratory Tests | Physical Examinations | 0 Participants |
| Part B: JNJ-56136379 250 mg (Open Label) | Number of Participants With Clinically Significant Changes in Vital Signs, Physical Examinations, Electrocardiogram (ECG), and Clinical Laboratory Tests | ECG | 0 Participants |
| Part B: JNJ-56136379 250 mg (Open Label) | Number of Participants With Clinically Significant Changes in Vital Signs, Physical Examinations, Electrocardiogram (ECG), and Clinical Laboratory Tests | Clinical Laboratory Tests: Hematology | 0 Participants |
| Part B: JNJ-56136379 250 mg (Open Label) | Number of Participants With Clinically Significant Changes in Vital Signs, Physical Examinations, Electrocardiogram (ECG), and Clinical Laboratory Tests | Clinical Laboratory Tests: Blood biochemistry | 0 Participants |
| Part B: JNJ-56136379 250 mg (Open Label) | Number of Participants With Clinically Significant Changes in Vital Signs, Physical Examinations, Electrocardiogram (ECG), and Clinical Laboratory Tests | Clinical Laboratory Tests: Blood coagulation | 0 Participants |
| Part B: JNJ-56136379 250 mg (Open Label) | Number of Participants With Clinically Significant Changes in Vital Signs, Physical Examinations, Electrocardiogram (ECG), and Clinical Laboratory Tests | Clinical Laboratory Tests: Urinalysis | 0 Participants |
| Part B: JNJ-56136379 250 mg + NA | Number of Participants With Clinically Significant Changes in Vital Signs, Physical Examinations, Electrocardiogram (ECG), and Clinical Laboratory Tests | Clinical Laboratory Tests: Urinalysis | 0 Participants |
| Part B: JNJ-56136379 250 mg + NA | Number of Participants With Clinically Significant Changes in Vital Signs, Physical Examinations, Electrocardiogram (ECG), and Clinical Laboratory Tests | Clinical Laboratory Tests: Blood coagulation | 0 Participants |
| Part B: JNJ-56136379 250 mg + NA | Number of Participants With Clinically Significant Changes in Vital Signs, Physical Examinations, Electrocardiogram (ECG), and Clinical Laboratory Tests | ECG | 0 Participants |
| Part B: JNJ-56136379 250 mg + NA | Number of Participants With Clinically Significant Changes in Vital Signs, Physical Examinations, Electrocardiogram (ECG), and Clinical Laboratory Tests | Physical Examinations | 0 Participants |
| Part B: JNJ-56136379 250 mg + NA | Number of Participants With Clinically Significant Changes in Vital Signs, Physical Examinations, Electrocardiogram (ECG), and Clinical Laboratory Tests | Vital Signs | 0 Participants |
| Part B: JNJ-56136379 250 mg + NA | Number of Participants With Clinically Significant Changes in Vital Signs, Physical Examinations, Electrocardiogram (ECG), and Clinical Laboratory Tests | Clinical Laboratory Tests: Blood biochemistry | 0 Participants |
| Part B: JNJ-56136379 250 mg + NA | Number of Participants With Clinically Significant Changes in Vital Signs, Physical Examinations, Electrocardiogram (ECG), and Clinical Laboratory Tests | Clinical Laboratory Tests: Hematology | 0 Participants |
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.
Time frame: Up to Week 80
Population: The safety population included all participants who received at least one dose of the study agent; all safety endpoints were analyzed by the treatment arm as treated.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Number of Participants With Serious Adverse Events (SAEs) | 1 Participants |
| Part A: JNJ-56136379 75 mg (Open Label) | Number of Participants With Serious Adverse Events (SAEs) | 1 Participants |
| Part A: JNJ-56136379 75 mg + NA | Number of Participants With Serious Adverse Events (SAEs) | 4 Participants |
| Part B: JNJ-56136379 250 mg (Open Label) | Number of Participants With Serious Adverse Events (SAEs) | 0 Participants |
| Part B: JNJ-56136379 250 mg + NA | Number of Participants With Serious Adverse Events (SAEs) | 4 Participants |
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.
Time frame: From Week 0 to Week 24, From Week 25 to Week 48, Up to Follow-up Week 24
Population: ITT population consisted of all participants who were randomized and received at least one dose of any study agent. If a participant received a study agent other than their randomly assigned study agent, participants were shown in the treatment arm as randomized. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure and 'n' (number analyzed) represents number of participants evaluable for the specified categories.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Number of Participants With Treatment-Associated Mutations | Emergence of mutations during 24 weeks (Week 0 to Week 24) | 8 Participants |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Number of Participants With Treatment-Associated Mutations | Emergence of mutations on NA treatment (Up to Follow-up Week 24) | 0 Participants |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Number of Participants With Treatment-Associated Mutations | Emergence of mutations between 25 and 48 weeks (Week 25 to Week 48) | 2 Participants |
| Part A: JNJ-56136379 75 mg (Open Label) | Number of Participants With Treatment-Associated Mutations | Emergence of mutations during 24 weeks (Week 0 to Week 24) | 0 Participants |
| Part A: JNJ-56136379 75 mg (Open Label) | Number of Participants With Treatment-Associated Mutations | Emergence of mutations on NA treatment (Up to Follow-up Week 24) | 0 Participants |
| Part A: JNJ-56136379 75 mg (Open Label) | Number of Participants With Treatment-Associated Mutations | Emergence of mutations between 25 and 48 weeks (Week 25 to Week 48) | 0 Participants |
| Part A: JNJ-56136379 75 mg + NA | Number of Participants With Treatment-Associated Mutations | Emergence of mutations between 25 and 48 weeks (Week 25 to Week 48) | 0 Participants |
| Part A: JNJ-56136379 75 mg + NA | Number of Participants With Treatment-Associated Mutations | Emergence of mutations during 24 weeks (Week 0 to Week 24) | 4 Participants |
| Part A: JNJ-56136379 75 mg + NA | Number of Participants With Treatment-Associated Mutations | Emergence of mutations on NA treatment (Up to Follow-up Week 24) | 0 Participants |
| Part B: JNJ-56136379 250 mg (Open Label) | Number of Participants With Treatment-Associated Mutations | Emergence of mutations during 24 weeks (Week 0 to Week 24) | 0 Participants |
| Part B: JNJ-56136379 250 mg (Open Label) | Number of Participants With Treatment-Associated Mutations | Emergence of mutations on NA treatment (Up to Follow-up Week 24) | 0 Participants |
| Part B: JNJ-56136379 250 mg (Open Label) | Number of Participants With Treatment-Associated Mutations | Emergence of mutations between 25 and 48 weeks (Week 25 to Week 48) | 0 Participants |
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.
Time frame: Up to Week 48
Population: The safety population included all participants who received at least one dose of the study agent; all safety endpoints were analyzed by the treatment arm as treated.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Number of Participants With Treatment- Emergent Adverse Events (AEs) | 34 Participants |
| Part A: JNJ-56136379 75 mg (Open Label) | Number of Participants With Treatment- Emergent Adverse Events (AEs) | 18 Participants |
| Part A: JNJ-56136379 75 mg + NA | Number of Participants With Treatment- Emergent Adverse Events (AEs) | 55 Participants |
| Part B: JNJ-56136379 250 mg (Open Label) | Number of Participants With Treatment- Emergent Adverse Events (AEs) | 25 Participants |
| Part B: JNJ-56136379 250 mg + NA | Number of Participants With Treatment- Emergent Adverse Events (AEs) | 54 Participants |
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.
Time frame: Weeks 24, 48 and Follow-up Week 24
Population: ITT population consisted of all participants who were randomized and received at least one dose of any study agent. If a participant received a study agent other than their randomly assigned study agent, participants were shown in the treatment arm as randomized. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure and 'n' (number analyzed) represents number of participants evaluable for the specified categories.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Percentage of Participants With >0.5 log10 IU/mL and >1 log10 IU/mL Reduction in HBeAg From Baseline in Currently Not Treated Population | Week 24: >0.5 log10 IU/mL | 62.5 Percentage of participants |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Percentage of Participants With >0.5 log10 IU/mL and >1 log10 IU/mL Reduction in HBeAg From Baseline in Currently Not Treated Population | Week 24: >1 log10 IU/mL | 37.5 Percentage of participants |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Percentage of Participants With >0.5 log10 IU/mL and >1 log10 IU/mL Reduction in HBeAg From Baseline in Currently Not Treated Population | Week 48: >0.5 log10 IU/mL | 100 Percentage of participants |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Percentage of Participants With >0.5 log10 IU/mL and >1 log10 IU/mL Reduction in HBeAg From Baseline in Currently Not Treated Population | Week 48: >1 log10 IU/mL | 100.0 Percentage of participants |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Percentage of Participants With >0.5 log10 IU/mL and >1 log10 IU/mL Reduction in HBeAg From Baseline in Currently Not Treated Population | Follow-up Week 24: >0.5 log10 IU/mL | 42.9 Percentage of participants |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Percentage of Participants With >0.5 log10 IU/mL and >1 log10 IU/mL Reduction in HBeAg From Baseline in Currently Not Treated Population | Follow-up Week 24: >1 log10 IU/mL | 28.6 Percentage of participants |
| Part A: JNJ-56136379 75 mg (Open Label) | Percentage of Participants With >0.5 log10 IU/mL and >1 log10 IU/mL Reduction in HBeAg From Baseline in Currently Not Treated Population | Week 24: >0.5 log10 IU/mL | 50 Percentage of participants |
| Part A: JNJ-56136379 75 mg (Open Label) | Percentage of Participants With >0.5 log10 IU/mL and >1 log10 IU/mL Reduction in HBeAg From Baseline in Currently Not Treated Population | Week 24: >1 log10 IU/mL | 0 Percentage of participants |
| Part A: JNJ-56136379 75 mg (Open Label) | Percentage of Participants With >0.5 log10 IU/mL and >1 log10 IU/mL Reduction in HBeAg From Baseline in Currently Not Treated Population | Follow-up Week 24: >1 log10 IU/mL | 70.0 Percentage of participants |
| Part A: JNJ-56136379 75 mg (Open Label) | Percentage of Participants With >0.5 log10 IU/mL and >1 log10 IU/mL Reduction in HBeAg From Baseline in Currently Not Treated Population | Follow-up Week 24: >0.5 log10 IU/mL | 80.0 Percentage of participants |
| Part A: JNJ-56136379 75 mg + NA | Percentage of Participants With >0.5 log10 IU/mL and >1 log10 IU/mL Reduction in HBeAg From Baseline in Currently Not Treated Population | Follow-up Week 24: >1 log10 IU/mL | 25.0 Percentage of participants |
| Part A: JNJ-56136379 75 mg + NA | Percentage of Participants With >0.5 log10 IU/mL and >1 log10 IU/mL Reduction in HBeAg From Baseline in Currently Not Treated Population | Week 24: >0.5 log10 IU/mL | 41.7 Percentage of participants |
| Part A: JNJ-56136379 75 mg + NA | Percentage of Participants With >0.5 log10 IU/mL and >1 log10 IU/mL Reduction in HBeAg From Baseline in Currently Not Treated Population | Week 48: >0.5 log10 IU/mL | 0 Percentage of participants |
| Part A: JNJ-56136379 75 mg + NA | Percentage of Participants With >0.5 log10 IU/mL and >1 log10 IU/mL Reduction in HBeAg From Baseline in Currently Not Treated Population | Week 48: >1 log10 IU/mL | 0 Percentage of participants |
| Part A: JNJ-56136379 75 mg + NA | Percentage of Participants With >0.5 log10 IU/mL and >1 log10 IU/mL Reduction in HBeAg From Baseline in Currently Not Treated Population | Week 24: >1 log10 IU/mL | 8.3 Percentage of participants |
| Part A: JNJ-56136379 75 mg + NA | Percentage of Participants With >0.5 log10 IU/mL and >1 log10 IU/mL Reduction in HBeAg From Baseline in Currently Not Treated Population | Follow-up Week 24: >0.5 log10 IU/mL | 91.7 Percentage of participants |
| Part B: JNJ-56136379 250 mg (Open Label) | Percentage of Participants With >0.5 log10 IU/mL and >1 log10 IU/mL Reduction in HBeAg From Baseline in Currently Not Treated Population | Week 48: >1 log10 IU/mL | 80.0 Percentage of participants |
| Part B: JNJ-56136379 250 mg (Open Label) | Percentage of Participants With >0.5 log10 IU/mL and >1 log10 IU/mL Reduction in HBeAg From Baseline in Currently Not Treated Population | Follow-up Week 24: >0.5 log10 IU/mL | 84.6 Percentage of participants |
| Part B: JNJ-56136379 250 mg (Open Label) | Percentage of Participants With >0.5 log10 IU/mL and >1 log10 IU/mL Reduction in HBeAg From Baseline in Currently Not Treated Population | Follow-up Week 24: >1 log10 IU/mL | 61.5 Percentage of participants |
| Part B: JNJ-56136379 250 mg (Open Label) | Percentage of Participants With >0.5 log10 IU/mL and >1 log10 IU/mL Reduction in HBeAg From Baseline in Currently Not Treated Population | Week 24: >1 log10 IU/mL | 42.9 Percentage of participants |
| Part B: JNJ-56136379 250 mg (Open Label) | Percentage of Participants With >0.5 log10 IU/mL and >1 log10 IU/mL Reduction in HBeAg From Baseline in Currently Not Treated Population | Week 48: >0.5 log10 IU/mL | 100.0 Percentage of participants |
| Part B: JNJ-56136379 250 mg (Open Label) | Percentage of Participants With >0.5 log10 IU/mL and >1 log10 IU/mL Reduction in HBeAg From Baseline in Currently Not Treated Population | Week 24: >0.5 log10 IU/mL | 78.6 Percentage of participants |
| Part B: JNJ-56136379 250 mg + NA | Percentage of Participants With >0.5 log10 IU/mL and >1 log10 IU/mL Reduction in HBeAg From Baseline in Currently Not Treated Population | Follow-up Week 24: >1 log10 IU/mL | 45.5 Percentage of participants |
| Part B: JNJ-56136379 250 mg + NA | Percentage of Participants With >0.5 log10 IU/mL and >1 log10 IU/mL Reduction in HBeAg From Baseline in Currently Not Treated Population | Week 24: >1 log10 IU/mL | 36.4 Percentage of participants |
| Part B: JNJ-56136379 250 mg + NA | Percentage of Participants With >0.5 log10 IU/mL and >1 log10 IU/mL Reduction in HBeAg From Baseline in Currently Not Treated Population | Week 48: >0.5 log10 IU/mL | 80.0 Percentage of participants |
| Part B: JNJ-56136379 250 mg + NA | Percentage of Participants With >0.5 log10 IU/mL and >1 log10 IU/mL Reduction in HBeAg From Baseline in Currently Not Treated Population | Week 48: >1 log10 IU/mL | 80.0 Percentage of participants |
| Part B: JNJ-56136379 250 mg + NA | Percentage of Participants With >0.5 log10 IU/mL and >1 log10 IU/mL Reduction in HBeAg From Baseline in Currently Not Treated Population | Follow-up Week 24: >0.5 log10 IU/mL | 72.7 Percentage of participants |
| Part B: JNJ-56136379 250 mg + NA | Percentage of Participants With >0.5 log10 IU/mL and >1 log10 IU/mL Reduction in HBeAg From Baseline in Currently Not Treated Population | Week 24: >0.5 log10 IU/mL | 63.6 Percentage of participants |
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.
Time frame: Weeks 24, 48 and Follow-up Week 24
Population: ITT population consisted of all participants who were randomized and received at least one dose of any study agent. If a participant received a study agent other than their randomly assigned study agent, participants were shown in the treatment arm as randomized. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure and 'n' (number analyzed) represents number of participants evaluable for the specified categories.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Percentage of Participants With >0.5 log10 IU/mL and >1 log10 IU/mL Reduction in HBeAg From Baseline in Virologically Suppressed Population | Week 24: >0.5 log10 IU/mL | 20 Percentage of participants |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Percentage of Participants With >0.5 log10 IU/mL and >1 log10 IU/mL Reduction in HBeAg From Baseline in Virologically Suppressed Population | Week 24: >1 log10 IU/mL | 20 Percentage of participants |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Percentage of Participants With >0.5 log10 IU/mL and >1 log10 IU/mL Reduction in HBeAg From Baseline in Virologically Suppressed Population | Week 48: >0.5 log10 IU/mL | 20.0 Percentage of participants |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Percentage of Participants With >0.5 log10 IU/mL and >1 log10 IU/mL Reduction in HBeAg From Baseline in Virologically Suppressed Population | Week 48: >1 log10 IU/mL | 20.0 Percentage of participants |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Percentage of Participants With >0.5 log10 IU/mL and >1 log10 IU/mL Reduction in HBeAg From Baseline in Virologically Suppressed Population | Follow-up Week 24: >0.5 log10 IU/mL | 50.0 Percentage of participants |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Percentage of Participants With >0.5 log10 IU/mL and >1 log10 IU/mL Reduction in HBeAg From Baseline in Virologically Suppressed Population | Follow-up Week 24: >1 log10 IU/mL | 25.0 Percentage of participants |
| Part A: JNJ-56136379 75 mg (Open Label) | Percentage of Participants With >0.5 log10 IU/mL and >1 log10 IU/mL Reduction in HBeAg From Baseline in Virologically Suppressed Population | Follow-up Week 24: >1 log10 IU/mL | 11.1 Percentage of participants |
| Part A: JNJ-56136379 75 mg (Open Label) | Percentage of Participants With >0.5 log10 IU/mL and >1 log10 IU/mL Reduction in HBeAg From Baseline in Virologically Suppressed Population | Week 24: >0.5 log10 IU/mL | 33.3 Percentage of participants |
| Part A: JNJ-56136379 75 mg (Open Label) | Percentage of Participants With >0.5 log10 IU/mL and >1 log10 IU/mL Reduction in HBeAg From Baseline in Virologically Suppressed Population | Week 48: >1 log10 IU/mL | 25.0 Percentage of participants |
| Part A: JNJ-56136379 75 mg (Open Label) | Percentage of Participants With >0.5 log10 IU/mL and >1 log10 IU/mL Reduction in HBeAg From Baseline in Virologically Suppressed Population | Follow-up Week 24: >0.5 log10 IU/mL | 22.2 Percentage of participants |
| Part A: JNJ-56136379 75 mg (Open Label) | Percentage of Participants With >0.5 log10 IU/mL and >1 log10 IU/mL Reduction in HBeAg From Baseline in Virologically Suppressed Population | Week 24: >1 log10 IU/mL | 11.1 Percentage of participants |
| Part A: JNJ-56136379 75 mg (Open Label) | Percentage of Participants With >0.5 log10 IU/mL and >1 log10 IU/mL Reduction in HBeAg From Baseline in Virologically Suppressed Population | Week 48: >0.5 log10 IU/mL | 25.0 Percentage of participants |
| Part A: JNJ-56136379 75 mg + NA | Percentage of Participants With >0.5 log10 IU/mL and >1 log10 IU/mL Reduction in HBeAg From Baseline in Virologically Suppressed Population | Week 24: >1 log10 IU/mL | 0 Percentage of participants |
| Part A: JNJ-56136379 75 mg + NA | Percentage of Participants With >0.5 log10 IU/mL and >1 log10 IU/mL Reduction in HBeAg From Baseline in Virologically Suppressed Population | Week 48: >0.5 log10 IU/mL | 22.2 Percentage of participants |
| Part A: JNJ-56136379 75 mg + NA | Percentage of Participants With >0.5 log10 IU/mL and >1 log10 IU/mL Reduction in HBeAg From Baseline in Virologically Suppressed Population | Follow-up Week 24: >1 log10 IU/mL | 0 Percentage of participants |
| Part A: JNJ-56136379 75 mg + NA | Percentage of Participants With >0.5 log10 IU/mL and >1 log10 IU/mL Reduction in HBeAg From Baseline in Virologically Suppressed Population | Week 48: >1 log10 IU/mL | 0 Percentage of participants |
| Part A: JNJ-56136379 75 mg + NA | Percentage of Participants With >0.5 log10 IU/mL and >1 log10 IU/mL Reduction in HBeAg From Baseline in Virologically Suppressed Population | Week 24: >0.5 log10 IU/mL | 10 Percentage of participants |
| Part A: JNJ-56136379 75 mg + NA | Percentage of Participants With >0.5 log10 IU/mL and >1 log10 IU/mL Reduction in HBeAg From Baseline in Virologically Suppressed Population | Follow-up Week 24: >0.5 log10 IU/mL | 22.2 Percentage of participants |
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.
Time frame: Weeks 24, 48 and Follow-up Week 24
Population: ITT population consisted of all participants who were randomized and received at least one dose of any study agent. If a participant received a study agent other than their randomly assigned study agent, participants were shown in the treatment arm as randomized. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure and 'n' (number analyzed) represents number of participants evaluable for the specified categories.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Percentage of Participants With >0.5 log10 IU/mL or >1 log10 IU/mL Reduction in HBsAg From Baseline in Virologically Suppressed Population | Week 24: >0.5 log10 IU/mL: HBeAg Positive | 0 Percentage of participants |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Percentage of Participants With >0.5 log10 IU/mL or >1 log10 IU/mL Reduction in HBsAg From Baseline in Virologically Suppressed Population | Week 24: >1 log10 IU/mL: HBeAg Positive | 0 Percentage of participants |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Percentage of Participants With >0.5 log10 IU/mL or >1 log10 IU/mL Reduction in HBsAg From Baseline in Virologically Suppressed Population | Week 48: >1 log10 IU/mL: HBeAg Positive | 0 Percentage of participants |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Percentage of Participants With >0.5 log10 IU/mL or >1 log10 IU/mL Reduction in HBsAg From Baseline in Virologically Suppressed Population | Week 48: >0.5 log10 IU/mL: HBeAg Negative | 0 Percentage of participants |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Percentage of Participants With >0.5 log10 IU/mL or >1 log10 IU/mL Reduction in HBsAg From Baseline in Virologically Suppressed Population | Follow-up Week 24: >1 log10 IU/mL: HBeAg Negative | 0 Percentage of participants |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Percentage of Participants With >0.5 log10 IU/mL or >1 log10 IU/mL Reduction in HBsAg From Baseline in Virologically Suppressed Population | Week 24: >0.5 log10 IU/mL: HBeAg Negative | 0 Percentage of participants |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Percentage of Participants With >0.5 log10 IU/mL or >1 log10 IU/mL Reduction in HBsAg From Baseline in Virologically Suppressed Population | Week 24: >1 log10 IU/mL: HBeAg Negative | 0 Percentage of participants |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Percentage of Participants With >0.5 log10 IU/mL or >1 log10 IU/mL Reduction in HBsAg From Baseline in Virologically Suppressed Population | Week 48: >0.5 log10 IU/mL: HBeAg Positive | 0 Percentage of participants |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Percentage of Participants With >0.5 log10 IU/mL or >1 log10 IU/mL Reduction in HBsAg From Baseline in Virologically Suppressed Population | Week 48: >1 log10 IU/mL: HBeAg Negative | 0 Percentage of participants |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Percentage of Participants With >0.5 log10 IU/mL or >1 log10 IU/mL Reduction in HBsAg From Baseline in Virologically Suppressed Population | Follow-up Week 24: >0.5 log10 IU/mL: HBeAg Positive | 0 Percentage of participants |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Percentage of Participants With >0.5 log10 IU/mL or >1 log10 IU/mL Reduction in HBsAg From Baseline in Virologically Suppressed Population | Follow-up Week 24: >1 log10 IU/mL: HBeAg Positive | 0 Percentage of participants |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Percentage of Participants With >0.5 log10 IU/mL or >1 log10 IU/mL Reduction in HBsAg From Baseline in Virologically Suppressed Population | Follow-up Week 24: >0.5 log10 IU/mL: HBeAg Negative | 0 Percentage of participants |
| Part A: JNJ-56136379 75 mg (Open Label) | Percentage of Participants With >0.5 log10 IU/mL or >1 log10 IU/mL Reduction in HBsAg From Baseline in Virologically Suppressed Population | Week 48: >1 log10 IU/mL: HBeAg Negative | 0 Percentage of participants |
| Part A: JNJ-56136379 75 mg (Open Label) | Percentage of Participants With >0.5 log10 IU/mL or >1 log10 IU/mL Reduction in HBsAg From Baseline in Virologically Suppressed Population | Follow-up Week 24: >1 log10 IU/mL: HBeAg Negative | 0 Percentage of participants |
| Part A: JNJ-56136379 75 mg (Open Label) | Percentage of Participants With >0.5 log10 IU/mL or >1 log10 IU/mL Reduction in HBsAg From Baseline in Virologically Suppressed Population | Follow-up Week 24: >0.5 log10 IU/mL: HBeAg Positive | 11.1 Percentage of participants |
| Part A: JNJ-56136379 75 mg (Open Label) | Percentage of Participants With >0.5 log10 IU/mL or >1 log10 IU/mL Reduction in HBsAg From Baseline in Virologically Suppressed Population | Week 24: >0.5 log10 IU/mL: HBeAg Negative | 0 Percentage of participants |
| Part A: JNJ-56136379 75 mg (Open Label) | Percentage of Participants With >0.5 log10 IU/mL or >1 log10 IU/mL Reduction in HBsAg From Baseline in Virologically Suppressed Population | Week 24: >1 log10 IU/mL: HBeAg Negative | 0 Percentage of participants |
| Part A: JNJ-56136379 75 mg (Open Label) | Percentage of Participants With >0.5 log10 IU/mL or >1 log10 IU/mL Reduction in HBsAg From Baseline in Virologically Suppressed Population | Follow-up Week 24: >0.5 log10 IU/mL: HBeAg Negative | 0 Percentage of participants |
| Part A: JNJ-56136379 75 mg (Open Label) | Percentage of Participants With >0.5 log10 IU/mL or >1 log10 IU/mL Reduction in HBsAg From Baseline in Virologically Suppressed Population | Week 24: >0.5 log10 IU/mL: HBeAg Positive | 0 Percentage of participants |
| Part A: JNJ-56136379 75 mg (Open Label) | Percentage of Participants With >0.5 log10 IU/mL or >1 log10 IU/mL Reduction in HBsAg From Baseline in Virologically Suppressed Population | Week 48: >0.5 log10 IU/mL: HBeAg Positive | 12.5 Percentage of participants |
| Part A: JNJ-56136379 75 mg (Open Label) | Percentage of Participants With >0.5 log10 IU/mL or >1 log10 IU/mL Reduction in HBsAg From Baseline in Virologically Suppressed Population | Week 24: >1 log10 IU/mL: HBeAg Positive | 0 Percentage of participants |
| Part A: JNJ-56136379 75 mg (Open Label) | Percentage of Participants With >0.5 log10 IU/mL or >1 log10 IU/mL Reduction in HBsAg From Baseline in Virologically Suppressed Population | Week 48: >1 log10 IU/mL: HBeAg Positive | 0 Percentage of participants |
| Part A: JNJ-56136379 75 mg (Open Label) | Percentage of Participants With >0.5 log10 IU/mL or >1 log10 IU/mL Reduction in HBsAg From Baseline in Virologically Suppressed Population | Follow-up Week 24: >1 log10 IU/mL: HBeAg Positive | 0 Percentage of participants |
| Part A: JNJ-56136379 75 mg (Open Label) | Percentage of Participants With >0.5 log10 IU/mL or >1 log10 IU/mL Reduction in HBsAg From Baseline in Virologically Suppressed Population | Week 48: >0.5 log10 IU/mL: HBeAg Negative | 0 Percentage of participants |
| Part A: JNJ-56136379 75 mg + NA | Percentage of Participants With >0.5 log10 IU/mL or >1 log10 IU/mL Reduction in HBsAg From Baseline in Virologically Suppressed Population | Week 48: >0.5 log10 IU/mL: HBeAg Positive | 0 Percentage of participants |
| Part A: JNJ-56136379 75 mg + NA | Percentage of Participants With >0.5 log10 IU/mL or >1 log10 IU/mL Reduction in HBsAg From Baseline in Virologically Suppressed Population | Follow-up Week 24: >0.5 log10 IU/mL: HBeAg Negative | 0 Percentage of participants |
| Part A: JNJ-56136379 75 mg + NA | Percentage of Participants With >0.5 log10 IU/mL or >1 log10 IU/mL Reduction in HBsAg From Baseline in Virologically Suppressed Population | Follow-up Week 24: >1 log10 IU/mL: HBeAg Positive | 0 Percentage of participants |
| Part A: JNJ-56136379 75 mg + NA | Percentage of Participants With >0.5 log10 IU/mL or >1 log10 IU/mL Reduction in HBsAg From Baseline in Virologically Suppressed Population | Week 48: >1 log10 IU/mL: HBeAg Negative | 0 Percentage of participants |
| Part A: JNJ-56136379 75 mg + NA | Percentage of Participants With >0.5 log10 IU/mL or >1 log10 IU/mL Reduction in HBsAg From Baseline in Virologically Suppressed Population | Follow-up Week 24: >1 log10 IU/mL: HBeAg Negative | 0 Percentage of participants |
| Part A: JNJ-56136379 75 mg + NA | Percentage of Participants With >0.5 log10 IU/mL or >1 log10 IU/mL Reduction in HBsAg From Baseline in Virologically Suppressed Population | Week 24: >0.5 log10 IU/mL: HBeAg Positive | 0 Percentage of participants |
| Part A: JNJ-56136379 75 mg + NA | Percentage of Participants With >0.5 log10 IU/mL or >1 log10 IU/mL Reduction in HBsAg From Baseline in Virologically Suppressed Population | Week 48: >1 log10 IU/mL: HBeAg Positive | 0 Percentage of participants |
| Part A: JNJ-56136379 75 mg + NA | Percentage of Participants With >0.5 log10 IU/mL or >1 log10 IU/mL Reduction in HBsAg From Baseline in Virologically Suppressed Population | Week 48: >0.5 log10 IU/mL: HBeAg Negative | 0 Percentage of participants |
| Part A: JNJ-56136379 75 mg + NA | Percentage of Participants With >0.5 log10 IU/mL or >1 log10 IU/mL Reduction in HBsAg From Baseline in Virologically Suppressed Population | Week 24: >0.5 log10 IU/mL: HBeAg Negative | 0 Percentage of participants |
| Part A: JNJ-56136379 75 mg + NA | Percentage of Participants With >0.5 log10 IU/mL or >1 log10 IU/mL Reduction in HBsAg From Baseline in Virologically Suppressed Population | Follow-up Week 24: >0.5 log10 IU/mL: HBeAg Positive | 11.1 Percentage of participants |
| Part A: JNJ-56136379 75 mg + NA | Percentage of Participants With >0.5 log10 IU/mL or >1 log10 IU/mL Reduction in HBsAg From Baseline in Virologically Suppressed Population | Week 24: >1 log10 IU/mL: HBeAg Positive | 0 Percentage of participants |
| Part A: JNJ-56136379 75 mg + NA | Percentage of Participants With >0.5 log10 IU/mL or >1 log10 IU/mL Reduction in HBsAg From Baseline in Virologically Suppressed Population | Week 24: >1 log10 IU/mL: HBeAg Negative | 0 Percentage of participants |
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.
Time frame: Weeks 24, 48 and Follow-up Week 24
Population: ITT population consisted of all participants who were randomized and received at least one dose of any study agent. If a participant received a study agent other than their randomly assigned study agent, participants were shown in the treatment arm as randomized. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure and 'n' (number analyzed) represents number of participants evaluable for the specified categories.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | 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 | Week 48: >1 log10 IU/mL: HBeAg Negative | 0 Percentage of participants |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | 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 | Follow-up Week 24: >1 log10 IU/mL: HBeAg Negative | 0 Percentage of participants |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | 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 | Week 24: >0.5 log10 IU/mL: HBeAg Negative | 0 Percentage of participants |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | 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 | Week 48: >1 log10 IU/mL: HBeAg Positive | 0 Percentage of participants |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | 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 | Week 48: >0.5 log10 IU/mL: HBeAg Negative | 0 Percentage of participants |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | 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 | Week 24: >1 log10IU/mL: HBeAg Positive | 0 Percentage of participants |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | 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 | Week 24: >0.5 log10 IU/mL: HBeAg Positive | 12.5 Percentage of participants |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | 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 | Week 48: >0.5 log10 IU/mL: HBeAg Positive | 0 Percentage of participants |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | 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 | Week 24: >1 log10 IU/mL: Negative | 0 Percentage of participants |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | 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 | Follow-up Week 24: >1 log10 IU/mL: HBeAg Positive | 0 Percentage of participants |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | 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 | Follow-up Week 24: >0.5 log10 IU/mL: HBeAg Negative | 0 Percentage of participants |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | 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 | Follow-up Week 24: >0.5 log10 IU/mL: HBeAg Positive | 14.3 Percentage of participants |
| Part A: JNJ-56136379 75 mg (Open Label) | 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 | Week 24: >0.5 log10 IU/mL: HBeAg Positive | 12.5 Percentage of participants |
| Part A: JNJ-56136379 75 mg (Open Label) | 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 | Week 24: >0.5 log10 IU/mL: HBeAg Negative | 0 Percentage of participants |
| Part A: JNJ-56136379 75 mg (Open Label) | 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 | Week 24: >1 log10IU/mL: HBeAg Positive | 0 Percentage of participants |
| Part A: JNJ-56136379 75 mg (Open Label) | 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 | Follow-up Week 24: >1 log10 IU/mL: HBeAg Positive | 40.0 Percentage of participants |
| Part A: JNJ-56136379 75 mg (Open Label) | 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 | Follow-up Week 24: >0.5 log10 IU/mL: HBeAg Negative | 0 Percentage of participants |
| Part A: JNJ-56136379 75 mg (Open Label) | 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 | Follow-up Week 24: >0.5 log10 IU/mL: HBeAg Positive | 60.0 Percentage of participants |
| Part A: JNJ-56136379 75 mg (Open Label) | 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 | Follow-up Week 24: >1 log10 IU/mL: HBeAg Negative | 0 Percentage of participants |
| Part A: JNJ-56136379 75 mg (Open Label) | 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 | Week 24: >1 log10 IU/mL: Negative | 0 Percentage of participants |
| Part A: JNJ-56136379 75 mg + NA | 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 | Follow-up Week 24: >0.5 log10 IU/mL: HBeAg Negative | 0 Percentage of participants |
| Part A: JNJ-56136379 75 mg + NA | 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 | Week 48: >0.5 log10 IU/mL: HBeAg Positive | 0 Percentage of participants |
| Part A: JNJ-56136379 75 mg + NA | 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 | Week 48: >1 log10 IU/mL: HBeAg Positive | 0 Percentage of participants |
| Part A: JNJ-56136379 75 mg + NA | 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 | Follow-up Week 24: >1 log10 IU/mL: HBeAg Positive | 16.7 Percentage of participants |
| Part A: JNJ-56136379 75 mg + NA | 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 | Follow-up Week 24: >1 log10 IU/mL: HBeAg Negative | 0 Percentage of participants |
| Part A: JNJ-56136379 75 mg + NA | 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 | Week 24: >0.5 log10 IU/mL: HBeAg Positive | 8.3 Percentage of participants |
| Part A: JNJ-56136379 75 mg + NA | 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 | Week 24: >1 log10IU/mL: HBeAg Positive | 0 Percentage of participants |
| Part A: JNJ-56136379 75 mg + NA | 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 | Week 24: >0.5 log10 IU/mL: HBeAg Negative | 0 Percentage of participants |
| Part A: JNJ-56136379 75 mg + NA | 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 | Week 24: >1 log10 IU/mL: Negative | 0 Percentage of participants |
| Part A: JNJ-56136379 75 mg + NA | 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 | Week 48: >0.5 log10 IU/mL: HBeAg Negative | 0 Percentage of participants |
| Part A: JNJ-56136379 75 mg + NA | 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 | Week 48: >1 log10 IU/mL: HBeAg Negative | 0 Percentage of participants |
| Part A: JNJ-56136379 75 mg + NA | 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 | Follow-up Week 24: >0.5 log10 IU/mL: HBeAg Positive | 33.3 Percentage of participants |
| Part B: JNJ-56136379 250 mg (Open Label) | 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 | Week 24: >0.5 log10 IU/mL: HBeAg Negative | 0 Percentage of participants |
| Part B: JNJ-56136379 250 mg (Open Label) | 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 | Week 24: >0.5 log10 IU/mL: HBeAg Positive | 28.6 Percentage of participants |
| Part B: JNJ-56136379 250 mg (Open Label) | 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 | Week 24: >1 log10 IU/mL: Negative | 0 Percentage of participants |
| Part B: JNJ-56136379 250 mg (Open Label) | 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 | Follow-up Week 24: >1 log10 IU/mL: HBeAg Negative | 0 Percentage of participants |
| Part B: JNJ-56136379 250 mg (Open Label) | 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 | Week 48: >1 log10 IU/mL: HBeAg Positive | 0 Percentage of participants |
| Part B: JNJ-56136379 250 mg (Open Label) | 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 | Week 48: >0.5 log10 IU/mL: HBeAg Negative | 0 Percentage of participants |
| Part B: JNJ-56136379 250 mg (Open Label) | 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 | Week 48: >1 log10 IU/mL: HBeAg Negative | 0 Percentage of participants |
| Part B: JNJ-56136379 250 mg (Open Label) | 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 | Follow-up Week 24: >0.5 log10 IU/mL: HBeAg Negative | 0 Percentage of participants |
| Part B: JNJ-56136379 250 mg (Open Label) | 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 | Week 48: >0.5 log10 IU/mL: HBeAg Positive | 20.0 Percentage of participants |
| Part B: JNJ-56136379 250 mg (Open Label) | 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 | Follow-up Week 24: >0.5 log10 IU/mL: HBeAg Positive | 30.0 Percentage of participants |
| Part B: JNJ-56136379 250 mg (Open Label) | 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 | Week 24: >1 log10IU/mL: HBeAg Positive | 7.1 Percentage of participants |
| Part B: JNJ-56136379 250 mg (Open Label) | 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 | Follow-up Week 24: >1 log10 IU/mL: HBeAg Positive | 7.7 Percentage of participants |
| Part B: JNJ-56136379 250 mg + NA | 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 | Follow-up Week 24: >0.5 log10 IU/mL: HBeAg Positive | 54.5 Percentage of participants |
| Part B: JNJ-56136379 250 mg + NA | 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 | Week 48: >1 log10 IU/mL: HBeAg Negative | 0 Percentage of participants |
| Part B: JNJ-56136379 250 mg + NA | 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 | Follow-up Week 24: >1 log10 IU/mL: HBeAg Negative | 0 Percentage of participants |
| Part B: JNJ-56136379 250 mg + NA | 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 | Week 48: >1 log10 IU/mL: HBeAg Positive | 60.0 Percentage of participants |
| Part B: JNJ-56136379 250 mg + NA | 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 | Week 24: >1 log10IU/mL: HBeAg Positive | 18.2 Percentage of participants |
| Part B: JNJ-56136379 250 mg + NA | 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 | Week 24: >1 log10 IU/mL: Negative | 0 Percentage of participants |
| Part B: JNJ-56136379 250 mg + NA | 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 | Follow-up Week 24: >1 log10 IU/mL: HBeAg Positive | 27.3 Percentage of participants |
| Part B: JNJ-56136379 250 mg + NA | 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 | Week 24: >0.5 log10 IU/mL: HBeAg Negative | 0 Percentage of participants |
| Part B: JNJ-56136379 250 mg + NA | 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 | Week 24: >0.5 log10 IU/mL: HBeAg Positive | 36.4 Percentage of participants |
| Part B: JNJ-56136379 250 mg + NA | 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 | Week 48: >0.5 log10 IU/mL: HBeAg Negative | 0 Percentage of participants |
| Part B: JNJ-56136379 250 mg + NA | 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 | Follow-up Week 24: >0.5 log10 IU/mL: HBeAg Negative | 0 Percentage of participants |
| Part B: JNJ-56136379 250 mg + NA | 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 | Week 48: >0.5 log10 IU/mL: HBeAg Positive | 60.0 Percentage of participants |
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.
Time frame: Weeks 24, 48 and Follow-up Week 24
Population: ITT population consisted of all participants who were randomized and received at least one dose of any study agent. If a participant received a study agent other than their randomly assigned study agent, participants were shown in the treatment arm as randomized. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure and 'n' (number analyzed) represents number of participants evaluable for the specified categories.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Percentage of Participants With HBsAg Levels <1,000 or <100 IU/mL in Virologically Suppressed Population | Follow-up Week 24: HBsAg<1000 IU/mL: HBeAg negative | 13.3 Percentage of participants |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Percentage of Participants With HBsAg Levels <1,000 or <100 IU/mL in Virologically Suppressed Population | Week 48: HBsAg<1000 IU/mL: HBeAg positive | 20.0 Percentage of participants |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Percentage of Participants With HBsAg Levels <1,000 or <100 IU/mL in Virologically Suppressed Population | Week 24: HBsAg<1000 IU/mL: HBeAg negative | 0 Percentage of participants |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Percentage of Participants With HBsAg Levels <1,000 or <100 IU/mL in Virologically Suppressed Population | Follow-up Week 24: HBsAg<100 IU/mL: HBeAg negative | 0 Percentage of participants |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Percentage of Participants With HBsAg Levels <1,000 or <100 IU/mL in Virologically Suppressed Population | Week 24: HBsAg<100 IU/mL: HBeAg positive | 0 Percentage of participants |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Percentage of Participants With HBsAg Levels <1,000 or <100 IU/mL in Virologically Suppressed Population | Week 48: HBsAg<100 IU/mL: HBeAg positive | 0 Percentage of participants |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Percentage of Participants With HBsAg Levels <1,000 or <100 IU/mL in Virologically Suppressed Population | Week 48: HBsAg<100 IU/mL: HBeAg Negative | 0 Percentage of participants |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Percentage of Participants With HBsAg Levels <1,000 or <100 IU/mL in Virologically Suppressed Population | Follow-up Week 24: HBsAg<1000 IU/mL: HBeAg positive | 25.0 Percentage of participants |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Percentage of Participants With HBsAg Levels <1,000 or <100 IU/mL in Virologically Suppressed Population | Week 48: HBsAg<1000 IU/mL: HBeAg Negative | 7.7 Percentage of participants |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Percentage of Participants With HBsAg Levels <1,000 or <100 IU/mL in Virologically Suppressed Population | Week 24: HBsAg<1000 IU/mL: HBeAg positive | 20.0 Percentage of participants |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Percentage of Participants With HBsAg Levels <1,000 or <100 IU/mL in Virologically Suppressed Population | Follow-up Week 24: HBsAg<100 IU/mL: HBeAg positive | 0 Percentage of participants |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Percentage of Participants With HBsAg Levels <1,000 or <100 IU/mL in Virologically Suppressed Population | Week 24: HBsAg<100 IU/mL: HBeAg negative | 0 Percentage of participants |
| Part A: JNJ-56136379 75 mg (Open Label) | Percentage of Participants With HBsAg Levels <1,000 or <100 IU/mL in Virologically Suppressed Population | Week 48: HBsAg<100 IU/mL: HBeAg positive | 0 Percentage of participants |
| Part A: JNJ-56136379 75 mg (Open Label) | Percentage of Participants With HBsAg Levels <1,000 or <100 IU/mL in Virologically Suppressed Population | Week 24: HBsAg<100 IU/mL: HBeAg positive | 0 Percentage of participants |
| Part A: JNJ-56136379 75 mg (Open Label) | Percentage of Participants With HBsAg Levels <1,000 or <100 IU/mL in Virologically Suppressed Population | Week 48: HBsAg<1000 IU/mL: HBeAg positive | 12.5 Percentage of participants |
| Part A: JNJ-56136379 75 mg (Open Label) | Percentage of Participants With HBsAg Levels <1,000 or <100 IU/mL in Virologically Suppressed Population | Week 24: HBsAg<1000 IU/mL: HBeAg positive | 11.1 Percentage of participants |
| Part A: JNJ-56136379 75 mg (Open Label) | Percentage of Participants With HBsAg Levels <1,000 or <100 IU/mL in Virologically Suppressed Population | Week 24: HBsAg<100 IU/mL: HBeAg negative | 0 Percentage of participants |
| Part A: JNJ-56136379 75 mg (Open Label) | Percentage of Participants With HBsAg Levels <1,000 or <100 IU/mL in Virologically Suppressed Population | Week 24: HBsAg<1000 IU/mL: HBeAg negative | 29.2 Percentage of participants |
| Part A: JNJ-56136379 75 mg (Open Label) | Percentage of Participants With HBsAg Levels <1,000 or <100 IU/mL in Virologically Suppressed Population | Week 48: HBsAg<100 IU/mL: HBeAg Negative | 0 Percentage of participants |
| Part A: JNJ-56136379 75 mg (Open Label) | Percentage of Participants With HBsAg Levels <1,000 or <100 IU/mL in Virologically Suppressed Population | Week 48: HBsAg<1000 IU/mL: HBeAg Negative | 33.3 Percentage of participants |
| Part A: JNJ-56136379 75 mg (Open Label) | Percentage of Participants With HBsAg Levels <1,000 or <100 IU/mL in Virologically Suppressed Population | Follow-up Week 24: HBsAg<100 IU/mL: HBeAg positive | 11.1 Percentage of participants |
| Part A: JNJ-56136379 75 mg (Open Label) | Percentage of Participants With HBsAg Levels <1,000 or <100 IU/mL in Virologically Suppressed Population | Follow-up Week 24: HBsAg<1000 IU/mL: HBeAg positive | 11.1 Percentage of participants |
| Part A: JNJ-56136379 75 mg (Open Label) | Percentage of Participants With HBsAg Levels <1,000 or <100 IU/mL in Virologically Suppressed Population | Follow-up Week 24: HBsAg<100 IU/mL: HBeAg negative | 0 Percentage of participants |
| Part A: JNJ-56136379 75 mg (Open Label) | Percentage of Participants With HBsAg Levels <1,000 or <100 IU/mL in Virologically Suppressed Population | Follow-up Week 24: HBsAg<1000 IU/mL: HBeAg negative | 34.8 Percentage of participants |
| Part A: JNJ-56136379 75 mg + NA | Percentage of Participants With HBsAg Levels <1,000 or <100 IU/mL in Virologically Suppressed Population | Week 24: HBsAg<1000 IU/mL: HBeAg positive | 10.0 Percentage of participants |
| Part A: JNJ-56136379 75 mg + NA | Percentage of Participants With HBsAg Levels <1,000 or <100 IU/mL in Virologically Suppressed Population | Follow-up Week 24: HBsAg<100 IU/mL: HBeAg negative | 0 Percentage of participants |
| Part A: JNJ-56136379 75 mg + NA | Percentage of Participants With HBsAg Levels <1,000 or <100 IU/mL in Virologically Suppressed Population | Follow-up Week 24: HBsAg<100 IU/mL: HBeAg positive | 0 Percentage of participants |
| Part A: JNJ-56136379 75 mg + NA | Percentage of Participants With HBsAg Levels <1,000 or <100 IU/mL in Virologically Suppressed Population | Week 48: HBsAg<100 IU/mL: HBeAg Negative | 0 Percentage of participants |
| Part A: JNJ-56136379 75 mg + NA | Percentage of Participants With HBsAg Levels <1,000 or <100 IU/mL in Virologically Suppressed Population | Week 24: HBsAg<100 IU/mL: HBeAg positive | 0 Percentage of participants |
| Part A: JNJ-56136379 75 mg + NA | Percentage of Participants With HBsAg Levels <1,000 or <100 IU/mL in Virologically Suppressed Population | Follow-up Week 24: HBsAg<1000 IU/mL: HBeAg positive | 44.4 Percentage of participants |
| Part A: JNJ-56136379 75 mg + NA | Percentage of Participants With HBsAg Levels <1,000 or <100 IU/mL in Virologically Suppressed Population | Week 24: HBsAg<1000 IU/mL: HBeAg negative | 15.8 Percentage of participants |
| Part A: JNJ-56136379 75 mg + NA | Percentage of Participants With HBsAg Levels <1,000 or <100 IU/mL in Virologically Suppressed Population | Week 48: HBsAg<100 IU/mL: HBeAg positive | 0 Percentage of participants |
| Part A: JNJ-56136379 75 mg + NA | Percentage of Participants With HBsAg Levels <1,000 or <100 IU/mL in Virologically Suppressed Population | Week 24: HBsAg<100 IU/mL: HBeAg negative | 0 Percentage of participants |
| Part A: JNJ-56136379 75 mg + NA | Percentage of Participants With HBsAg Levels <1,000 or <100 IU/mL in Virologically Suppressed Population | Week 48: HBsAg<1000 IU/mL: HBeAg positive | 33.3 Percentage of participants |
| Part A: JNJ-56136379 75 mg + NA | Percentage of Participants With HBsAg Levels <1,000 or <100 IU/mL in Virologically Suppressed Population | Follow-up Week 24: HBsAg<1000 IU/mL: HBeAg negative | 7.1 Percentage of participants |
| Part A: JNJ-56136379 75 mg + NA | Percentage of Participants With HBsAg Levels <1,000 or <100 IU/mL in Virologically Suppressed Population | Week 48: HBsAg<1000 IU/mL: HBeAg Negative | 20.0 Percentage of participants |
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.
Time frame: Weeks 24, 48 and Follow-up Week 24
Population: ITT population consisted of all participants who were randomized and received at least one dose of any study agent. If a participant received a study agent other than their randomly assigned study agent, participants were shown in the treatment arm as randomized. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure and 'n' (number analyzed) represents number of participants evaluable for the specified categories.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Percentage of Participants With HBsAg Levels Less Than (<) 1,000 or <100 International Units Per Milliliter (IU/mL) in Currently Not Treated Population | Week 48: HBsAg<100 IU/mL: HBeAg Negative | 0 Percentage of participants |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Percentage of Participants With HBsAg Levels Less Than (<) 1,000 or <100 International Units Per Milliliter (IU/mL) in Currently Not Treated Population | Follow-up Week 24: HBsAg<1000 IU/mL: HBeAg Negative | 18.2 Percentage of participants |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Percentage of Participants With HBsAg Levels Less Than (<) 1,000 or <100 International Units Per Milliliter (IU/mL) in Currently Not Treated Population | Week 24: HBsAg<1000 IU/mL: HBeAg positive | 0 Percentage of participants |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Percentage of Participants With HBsAg Levels Less Than (<) 1,000 or <100 International Units Per Milliliter (IU/mL) in Currently Not Treated Population | Week 24: HBsAg<100 IU/mL: HBeAg positive | 0 Percentage of participants |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Percentage of Participants With HBsAg Levels Less Than (<) 1,000 or <100 International Units Per Milliliter (IU/mL) in Currently Not Treated Population | Follow-up Week 24:HBsAg<100 IU/mL: HBeAg Negative | 0 Percentage of participants |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Percentage of Participants With HBsAg Levels Less Than (<) 1,000 or <100 International Units Per Milliliter (IU/mL) in Currently Not Treated Population | Week 24: HBsAg<100 IU/mL: HBeAg negative | 0 Percentage of participants |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Percentage of Participants With HBsAg Levels Less Than (<) 1,000 or <100 International Units Per Milliliter (IU/mL) in Currently Not Treated Population | Follow-up Week 24:HBsAg<100 IU/mL: HBeAg Positive | 0 Percentage of participants |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Percentage of Participants With HBsAg Levels Less Than (<) 1,000 or <100 International Units Per Milliliter (IU/mL) in Currently Not Treated Population | Week 24: HBsAg<1000 IU/mL: HBeAg negative | 15.4 Percentage of participants |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Percentage of Participants With HBsAg Levels Less Than (<) 1,000 or <100 International Units Per Milliliter (IU/mL) in Currently Not Treated Population | Week 48: HBsAg<1000 IU/mL: HBeAg Negative | 18.2 Percentage of participants |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Percentage of Participants With HBsAg Levels Less Than (<) 1,000 or <100 International Units Per Milliliter (IU/mL) in Currently Not Treated Population | Week 48: HBsAg<100 IU/mL: HBeAg positive | 0 Percentage of participants |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Percentage of Participants With HBsAg Levels Less Than (<) 1,000 or <100 International Units Per Milliliter (IU/mL) in Currently Not Treated Population | Follow-up Week 24:HBsAg<1000 IU/mL: HBeAg positive | 0 Percentage of participants |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Percentage of Participants With HBsAg Levels Less Than (<) 1,000 or <100 International Units Per Milliliter (IU/mL) in Currently Not Treated Population | Week 48: HBsAg<1000 IU/mL: HBeAg positive | 0 Percentage of participants |
| Part A: JNJ-56136379 75 mg (Open Label) | Percentage of Participants With HBsAg Levels Less Than (<) 1,000 or <100 International Units Per Milliliter (IU/mL) in Currently Not Treated Population | Follow-up Week 24:HBsAg<1000 IU/mL: HBeAg positive | 10.0 Percentage of participants |
| Part A: JNJ-56136379 75 mg (Open Label) | Percentage of Participants With HBsAg Levels Less Than (<) 1,000 or <100 International Units Per Milliliter (IU/mL) in Currently Not Treated Population | Follow-up Week 24: HBsAg<1000 IU/mL: HBeAg Negative | 23.1 Percentage of participants |
| Part A: JNJ-56136379 75 mg (Open Label) | Percentage of Participants With HBsAg Levels Less Than (<) 1,000 or <100 International Units Per Milliliter (IU/mL) in Currently Not Treated Population | Week 24: HBsAg<100 IU/mL: HBeAg negative | 0 Percentage of participants |
| Part A: JNJ-56136379 75 mg (Open Label) | Percentage of Participants With HBsAg Levels Less Than (<) 1,000 or <100 International Units Per Milliliter (IU/mL) in Currently Not Treated Population | Week 24: HBsAg<100 IU/mL: HBeAg positive | 0 Percentage of participants |
| Part A: JNJ-56136379 75 mg (Open Label) | Percentage of Participants With HBsAg Levels Less Than (<) 1,000 or <100 International Units Per Milliliter (IU/mL) in Currently Not Treated Population | Week 24: HBsAg<1000 IU/mL: HBeAg positive | 0 Percentage of participants |
| Part A: JNJ-56136379 75 mg (Open Label) | Percentage of Participants With HBsAg Levels Less Than (<) 1,000 or <100 International Units Per Milliliter (IU/mL) in Currently Not Treated Population | Follow-up Week 24:HBsAg<100 IU/mL: HBeAg Positive | 0 Percentage of participants |
| Part A: JNJ-56136379 75 mg (Open Label) | Percentage of Participants With HBsAg Levels Less Than (<) 1,000 or <100 International Units Per Milliliter (IU/mL) in Currently Not Treated Population | Follow-up Week 24:HBsAg<100 IU/mL: HBeAg Negative | 0 Percentage of participants |
| Part A: JNJ-56136379 75 mg (Open Label) | Percentage of Participants With HBsAg Levels Less Than (<) 1,000 or <100 International Units Per Milliliter (IU/mL) in Currently Not Treated Population | Week 24: HBsAg<1000 IU/mL: HBeAg negative | 23.1 Percentage of participants |
| Part A: JNJ-56136379 75 mg + NA | Percentage of Participants With HBsAg Levels Less Than (<) 1,000 or <100 International Units Per Milliliter (IU/mL) in Currently Not Treated Population | Week 24: HBsAg<1000 IU/mL: HBeAg positive | 8.3 Percentage of participants |
| Part A: JNJ-56136379 75 mg + NA | Percentage of Participants With HBsAg Levels Less Than (<) 1,000 or <100 International Units Per Milliliter (IU/mL) in Currently Not Treated Population | Week 24: HBsAg<100 IU/mL: HBeAg positive | 0 Percentage of participants |
| Part A: JNJ-56136379 75 mg + NA | Percentage of Participants With HBsAg Levels Less Than (<) 1,000 or <100 International Units Per Milliliter (IU/mL) in Currently Not Treated Population | Week 24: HBsAg<100 IU/mL: HBeAg negative | 0 Percentage of participants |
| Part A: JNJ-56136379 75 mg + NA | Percentage of Participants With HBsAg Levels Less Than (<) 1,000 or <100 International Units Per Milliliter (IU/mL) in Currently Not Treated Population | Week 24: HBsAg<1000 IU/mL: HBeAg negative | 4.8 Percentage of participants |
| Part A: JNJ-56136379 75 mg + NA | Percentage of Participants With HBsAg Levels Less Than (<) 1,000 or <100 International Units Per Milliliter (IU/mL) in Currently Not Treated Population | Week 48: HBsAg<100 IU/mL: HBeAg positive | 0 Percentage of participants |
| Part A: JNJ-56136379 75 mg + NA | Percentage of Participants With HBsAg Levels Less Than (<) 1,000 or <100 International Units Per Milliliter (IU/mL) in Currently Not Treated Population | Follow-up Week 24:HBsAg<100 IU/mL: HBeAg Positive | 0 Percentage of participants |
| Part A: JNJ-56136379 75 mg + NA | Percentage of Participants With HBsAg Levels Less Than (<) 1,000 or <100 International Units Per Milliliter (IU/mL) in Currently Not Treated Population | Week 48: HBsAg<1000 IU/mL: HBeAg positive | 50.0 Percentage of participants |
| Part A: JNJ-56136379 75 mg + NA | Percentage of Participants With HBsAg Levels Less Than (<) 1,000 or <100 International Units Per Milliliter (IU/mL) in Currently Not Treated Population | Week 48: HBsAg<100 IU/mL: HBeAg Negative | 0 Percentage of participants |
| Part A: JNJ-56136379 75 mg + NA | Percentage of Participants With HBsAg Levels Less Than (<) 1,000 or <100 International Units Per Milliliter (IU/mL) in Currently Not Treated Population | Week 48: HBsAg<1000 IU/mL: HBeAg Negative | 22.2 Percentage of participants |
| Part A: JNJ-56136379 75 mg + NA | Percentage of Participants With HBsAg Levels Less Than (<) 1,000 or <100 International Units Per Milliliter (IU/mL) in Currently Not Treated Population | Follow-up Week 24:HBsAg<1000 IU/mL: HBeAg positive | 8.3 Percentage of participants |
| Part A: JNJ-56136379 75 mg + NA | Percentage of Participants With HBsAg Levels Less Than (<) 1,000 or <100 International Units Per Milliliter (IU/mL) in Currently Not Treated Population | Follow-up Week 24:HBsAg<100 IU/mL: HBeAg Negative | 0 Percentage of participants |
| Part A: JNJ-56136379 75 mg + NA | Percentage of Participants With HBsAg Levels Less Than (<) 1,000 or <100 International Units Per Milliliter (IU/mL) in Currently Not Treated Population | Follow-up Week 24: HBsAg<1000 IU/mL: HBeAg Negative | 18.8 Percentage of participants |
| Part B: JNJ-56136379 250 mg (Open Label) | Percentage of Participants With HBsAg Levels Less Than (<) 1,000 or <100 International Units Per Milliliter (IU/mL) in Currently Not Treated Population | Week 48: HBsAg<100 IU/mL: HBeAg positive | 0 Percentage of participants |
| Part B: JNJ-56136379 250 mg (Open Label) | Percentage of Participants With HBsAg Levels Less Than (<) 1,000 or <100 International Units Per Milliliter (IU/mL) in Currently Not Treated Population | Week 48: HBsAg<100 IU/mL: HBeAg Negative | 0 Percentage of participants |
| Part B: JNJ-56136379 250 mg (Open Label) | Percentage of Participants With HBsAg Levels Less Than (<) 1,000 or <100 International Units Per Milliliter (IU/mL) in Currently Not Treated Population | Week 24: HBsAg<1000 IU/mL: HBeAg negative | 0 Percentage of participants |
| Part B: JNJ-56136379 250 mg (Open Label) | Percentage of Participants With HBsAg Levels Less Than (<) 1,000 or <100 International Units Per Milliliter (IU/mL) in Currently Not Treated Population | Week 24: HBsAg<100 IU/mL: HBeAg positive | 0 Percentage of participants |
| Part B: JNJ-56136379 250 mg (Open Label) | Percentage of Participants With HBsAg Levels Less Than (<) 1,000 or <100 International Units Per Milliliter (IU/mL) in Currently Not Treated Population | Week 48: HBsAg<1000 IU/mL: HBeAg Negative | 7.7 Percentage of participants |
| Part B: JNJ-56136379 250 mg (Open Label) | Percentage of Participants With HBsAg Levels Less Than (<) 1,000 or <100 International Units Per Milliliter (IU/mL) in Currently Not Treated Population | Week 24: HBsAg<100 IU/mL: HBeAg negative | 0 Percentage of participants |
| Part B: JNJ-56136379 250 mg (Open Label) | Percentage of Participants With HBsAg Levels Less Than (<) 1,000 or <100 International Units Per Milliliter (IU/mL) in Currently Not Treated Population | Follow-up Week 24:HBsAg<1000 IU/mL: HBeAg positive | 0 Percentage of participants |
| Part B: JNJ-56136379 250 mg (Open Label) | Percentage of Participants With HBsAg Levels Less Than (<) 1,000 or <100 International Units Per Milliliter (IU/mL) in Currently Not Treated Population | Week 24: HBsAg<1000 IU/mL: HBeAg positive | 0 Percentage of participants |
| Part B: JNJ-56136379 250 mg (Open Label) | Percentage of Participants With HBsAg Levels Less Than (<) 1,000 or <100 International Units Per Milliliter (IU/mL) in Currently Not Treated Population | Follow-up Week 24: HBsAg<1000 IU/mL: HBeAg Negative | 7.1 Percentage of participants |
| Part B: JNJ-56136379 250 mg (Open Label) | Percentage of Participants With HBsAg Levels Less Than (<) 1,000 or <100 International Units Per Milliliter (IU/mL) in Currently Not Treated Population | Week 48: HBsAg<1000 IU/mL: HBeAg positive | 0 Percentage of participants |
| Part B: JNJ-56136379 250 mg (Open Label) | Percentage of Participants With HBsAg Levels Less Than (<) 1,000 or <100 International Units Per Milliliter (IU/mL) in Currently Not Treated Population | Follow-up Week 24:HBsAg<100 IU/mL: HBeAg Negative | 0 Percentage of participants |
| Part B: JNJ-56136379 250 mg (Open Label) | Percentage of Participants With HBsAg Levels Less Than (<) 1,000 or <100 International Units Per Milliliter (IU/mL) in Currently Not Treated Population | Follow-up Week 24:HBsAg<100 IU/mL: HBeAg Positive | 0 Percentage of participants |
| Part B: JNJ-56136379 250 mg + NA | Percentage of Participants With HBsAg Levels Less Than (<) 1,000 or <100 International Units Per Milliliter (IU/mL) in Currently Not Treated Population | Week 48: HBsAg<1000 IU/mL: HBeAg positive | 20.0 Percentage of participants |
| Part B: JNJ-56136379 250 mg + NA | Percentage of Participants With HBsAg Levels Less Than (<) 1,000 or <100 International Units Per Milliliter (IU/mL) in Currently Not Treated Population | Week 24: HBsAg<1000 IU/mL: HBeAg negative | 10.5 Percentage of participants |
| Part B: JNJ-56136379 250 mg + NA | Percentage of Participants With HBsAg Levels Less Than (<) 1,000 or <100 International Units Per Milliliter (IU/mL) in Currently Not Treated Population | Week 24: HBsAg<100 IU/mL: HBeAg positive | 0 Percentage of participants |
| Part B: JNJ-56136379 250 mg + NA | Percentage of Participants With HBsAg Levels Less Than (<) 1,000 or <100 International Units Per Milliliter (IU/mL) in Currently Not Treated Population | Follow-up Week 24:HBsAg<1000 IU/mL: HBeAg positive | 9.1 Percentage of participants |
| Part B: JNJ-56136379 250 mg + NA | Percentage of Participants With HBsAg Levels Less Than (<) 1,000 or <100 International Units Per Milliliter (IU/mL) in Currently Not Treated Population | Week 48: HBsAg<100 IU/mL: HBeAg Negative | 0 Percentage of participants |
| Part B: JNJ-56136379 250 mg + NA | Percentage of Participants With HBsAg Levels Less Than (<) 1,000 or <100 International Units Per Milliliter (IU/mL) in Currently Not Treated Population | Week 24: HBsAg<1000 IU/mL: HBeAg positive | 0 Percentage of participants |
| Part B: JNJ-56136379 250 mg + NA | Percentage of Participants With HBsAg Levels Less Than (<) 1,000 or <100 International Units Per Milliliter (IU/mL) in Currently Not Treated Population | Week 48: HBsAg<100 IU/mL: HBeAg positive | 0 Percentage of participants |
| Part B: JNJ-56136379 250 mg + NA | Percentage of Participants With HBsAg Levels Less Than (<) 1,000 or <100 International Units Per Milliliter (IU/mL) in Currently Not Treated Population | Follow-up Week 24:HBsAg<100 IU/mL: HBeAg Negative | 0 Percentage of participants |
| Part B: JNJ-56136379 250 mg + NA | Percentage of Participants With HBsAg Levels Less Than (<) 1,000 or <100 International Units Per Milliliter (IU/mL) in Currently Not Treated Population | Week 48: HBsAg<1000 IU/mL: HBeAg Negative | 14.3 Percentage of participants |
| Part B: JNJ-56136379 250 mg + NA | Percentage of Participants With HBsAg Levels Less Than (<) 1,000 or <100 International Units Per Milliliter (IU/mL) in Currently Not Treated Population | Week 24: HBsAg<100 IU/mL: HBeAg negative | 0 Percentage of participants |
| Part B: JNJ-56136379 250 mg + NA | Percentage of Participants With HBsAg Levels Less Than (<) 1,000 or <100 International Units Per Milliliter (IU/mL) in Currently Not Treated Population | Follow-up Week 24:HBsAg<100 IU/mL: HBeAg Positive | 0 Percentage of participants |
| Part B: JNJ-56136379 250 mg + NA | Percentage of Participants With HBsAg Levels Less Than (<) 1,000 or <100 International Units Per Milliliter (IU/mL) in Currently Not Treated Population | Follow-up Week 24: HBsAg<1000 IU/mL: HBeAg Negative | 5.9 Percentage of participants |
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.
Time frame: Weeks 24 and 48
Population: ITT population consisted of all participants who were randomized and received at least one dose of any study agent. If a participant received a study agent other than their randomly assigned study agent, participants were shown in the treatment arm as randomized. Here, 'n' (number analyzed) represents number of participants evaluable for the specified categories.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Percentage of Participants With HBsAg Seroclearance in Currently Not Treated Population | Week 24: HbeAg Negative | 0 Percentage of participants |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Percentage of Participants With HBsAg Seroclearance in Currently Not Treated Population | Week 24: HbeAg Positive | 0 Percentage of participants |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Percentage of Participants With HBsAg Seroclearance in Currently Not Treated Population | Week 48: HbeAg Negative | 0 Percentage of participants |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Percentage of Participants With HBsAg Seroclearance in Currently Not Treated Population | Week 48: HbeAg Positive | 0 Percentage of participants |
| Part A: JNJ-56136379 75 mg (Open Label) | Percentage of Participants With HBsAg Seroclearance in Currently Not Treated Population | Week 24: HbeAg Negative | 0 Percentage of participants |
| Part A: JNJ-56136379 75 mg (Open Label) | Percentage of Participants With HBsAg Seroclearance in Currently Not Treated Population | Week 24: HbeAg Positive | 0 Percentage of participants |
| Part A: JNJ-56136379 75 mg + NA | Percentage of Participants With HBsAg Seroclearance in Currently Not Treated Population | Week 48: HbeAg Negative | 0 Percentage of participants |
| Part A: JNJ-56136379 75 mg + NA | Percentage of Participants With HBsAg Seroclearance in Currently Not Treated Population | Week 24: HbeAg Positive | 0 Percentage of participants |
| Part A: JNJ-56136379 75 mg + NA | Percentage of Participants With HBsAg Seroclearance in Currently Not Treated Population | Week 24: HbeAg Negative | 0 Percentage of participants |
| Part A: JNJ-56136379 75 mg + NA | Percentage of Participants With HBsAg Seroclearance in Currently Not Treated Population | Week 48: HbeAg Positive | 0 Percentage of participants |
| Part B: JNJ-56136379 250 mg (Open Label) | Percentage of Participants With HBsAg Seroclearance in Currently Not Treated Population | Week 48: HbeAg Negative | 0 Percentage of participants |
| Part B: JNJ-56136379 250 mg (Open Label) | Percentage of Participants With HBsAg Seroclearance in Currently Not Treated Population | Week 24: HbeAg Positive | 0 Percentage of participants |
| Part B: JNJ-56136379 250 mg (Open Label) | Percentage of Participants With HBsAg Seroclearance in Currently Not Treated Population | Week 48: HbeAg Positive | 20.0 Percentage of participants |
| Part B: JNJ-56136379 250 mg (Open Label) | Percentage of Participants With HBsAg Seroclearance in Currently Not Treated Population | Week 24: HbeAg Negative | 0 Percentage of participants |
| Part B: JNJ-56136379 250 mg + NA | Percentage of Participants With HBsAg Seroclearance in Currently Not Treated Population | Week 24: HbeAg Positive | 0 Percentage of participants |
| Part B: JNJ-56136379 250 mg + NA | Percentage of Participants With HBsAg Seroclearance in Currently Not Treated Population | Week 24: HbeAg Negative | 0 Percentage of participants |
| Part B: JNJ-56136379 250 mg + NA | Percentage of Participants With HBsAg Seroclearance in Currently Not Treated Population | Week 48: HbeAg Positive | 0 Percentage of participants |
| Part B: JNJ-56136379 250 mg + NA | Percentage of Participants With HBsAg Seroclearance in Currently Not Treated Population | Week 48: HbeAg Negative | 0 Percentage of participants |
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 .
Time frame: Weeks 24 and 48
Population: ITT population consisted of all participants who were randomized and received at least one dose of any study agent. If a participant received a study agent other than their randomly assigned study agent, participants were shown in the treatment arm as randomized. Here, 'n' (number analyzed) represents number of participants evaluable for the specified categories.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Percentage of Participants With HBsAg Seroclearance in Virologically Suppressed Population | Week 24: HbeAg Positive | 0 Percentage of participants |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Percentage of Participants With HBsAg Seroclearance in Virologically Suppressed Population | Week 24: HbeAg Negative | 0 Percentage of participants |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Percentage of Participants With HBsAg Seroclearance in Virologically Suppressed Population | Week 48: HbeAg Positive | 20.0 Percentage of participants |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Percentage of Participants With HBsAg Seroclearance in Virologically Suppressed Population | Week 48: HbeAg Negative | 0 Percentage of participants |
| Part A: JNJ-56136379 75 mg (Open Label) | Percentage of Participants With HBsAg Seroclearance in Virologically Suppressed Population | Week 48: HbeAg Negative | 0 Percentage of participants |
| Part A: JNJ-56136379 75 mg (Open Label) | Percentage of Participants With HBsAg Seroclearance in Virologically Suppressed Population | Week 24: HbeAg Positive | 0 Percentage of participants |
| Part A: JNJ-56136379 75 mg (Open Label) | Percentage of Participants With HBsAg Seroclearance in Virologically Suppressed Population | Week 48: HbeAg Positive | 0 Percentage of participants |
| Part A: JNJ-56136379 75 mg (Open Label) | Percentage of Participants With HBsAg Seroclearance in Virologically Suppressed Population | Week 24: HbeAg Negative | 0 Percentage of participants |
| Part A: JNJ-56136379 75 mg + NA | Percentage of Participants With HBsAg Seroclearance in Virologically Suppressed Population | Week 48: HbeAg Negative | 0 Percentage of participants |
| Part A: JNJ-56136379 75 mg + NA | Percentage of Participants With HBsAg Seroclearance in Virologically Suppressed Population | Week 24: HbeAg Negative | 0 Percentage of participants |
| Part A: JNJ-56136379 75 mg + NA | Percentage of Participants With HBsAg Seroclearance in Virologically Suppressed Population | Week 48: HbeAg Positive | 0 Percentage of participants |
| Part A: JNJ-56136379 75 mg + NA | Percentage of Participants With HBsAg Seroclearance in Virologically Suppressed Population | Week 24: HbeAg Positive | 0 Percentage of participants |
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.
Time frame: Weeks 24 and 48
Population: ITT population consisted of all participants who were randomized and received at least one dose of any study agent. If a participant received a study agent other than their randomly assigned study agent, participants were shown in the treatment arm as randomized. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure and 'n' (number analyzed) represents number of participants evaluable for the specified categories.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Percentage of Participants With HBsAg Seroconversion in Currently Not Treated Population | Week 48: HbeAg negative | 0 Percentage of participants |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Percentage of Participants With HBsAg Seroconversion in Currently Not Treated Population | Week 48: HbeAg Positive | 0 Percentage of participants |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Percentage of Participants With HBsAg Seroconversion in Currently Not Treated Population | Week 24: HbeAg Positive | 0 Percentage of participants |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Percentage of Participants With HBsAg Seroconversion in Currently Not Treated Population | Week 24: HbeAg negative | 0 Percentage of participants |
| Part A: JNJ-56136379 75 mg (Open Label) | Percentage of Participants With HBsAg Seroconversion in Currently Not Treated Population | Week 24: HbeAg negative | 0 Percentage of participants |
| Part A: JNJ-56136379 75 mg (Open Label) | Percentage of Participants With HBsAg Seroconversion in Currently Not Treated Population | Week 24: HbeAg Positive | 0 Percentage of participants |
| Part A: JNJ-56136379 75 mg + NA | Percentage of Participants With HBsAg Seroconversion in Currently Not Treated Population | Week 24: HbeAg negative | 0 Percentage of participants |
| Part A: JNJ-56136379 75 mg + NA | Percentage of Participants With HBsAg Seroconversion in Currently Not Treated Population | Week 48: HbeAg negative | 0 Percentage of participants |
| Part A: JNJ-56136379 75 mg + NA | Percentage of Participants With HBsAg Seroconversion in Currently Not Treated Population | Week 24: HbeAg Positive | 0 Percentage of participants |
| Part A: JNJ-56136379 75 mg + NA | Percentage of Participants With HBsAg Seroconversion in Currently Not Treated Population | Week 48: HbeAg Positive | 0 Percentage of participants |
| Part B: JNJ-56136379 250 mg (Open Label) | Percentage of Participants With HBsAg Seroconversion in Currently Not Treated Population | Week 48: HbeAg negative | 0 Percentage of participants |
| Part B: JNJ-56136379 250 mg (Open Label) | Percentage of Participants With HBsAg Seroconversion in Currently Not Treated Population | Week 24: HbeAg Positive | 0 Percentage of participants |
| Part B: JNJ-56136379 250 mg (Open Label) | Percentage of Participants With HBsAg Seroconversion in Currently Not Treated Population | Week 24: HbeAg negative | 0 Percentage of participants |
| Part B: JNJ-56136379 250 mg (Open Label) | Percentage of Participants With HBsAg Seroconversion in Currently Not Treated Population | Week 48: HbeAg Positive | 0 Percentage of participants |
| Part B: JNJ-56136379 250 mg + NA | Percentage of Participants With HBsAg Seroconversion in Currently Not Treated Population | Week 48: HbeAg negative | 0 Percentage of participants |
| Part B: JNJ-56136379 250 mg + NA | Percentage of Participants With HBsAg Seroconversion in Currently Not Treated Population | Week 24: HbeAg Positive | 0 Percentage of participants |
| Part B: JNJ-56136379 250 mg + NA | Percentage of Participants With HBsAg Seroconversion in Currently Not Treated Population | Week 24: HbeAg negative | 0 Percentage of participants |
| Part B: JNJ-56136379 250 mg + NA | Percentage of Participants With HBsAg Seroconversion in Currently Not Treated Population | Week 48: HbeAg Positive | 0 Percentage of participants |
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.
Time frame: Weeks 24 and 48
Population: ITT population consisted of all participants who were randomized and received at least one dose of any study agent. If a participant received a study agent other than their randomly assigned study agent, participants were shown in the treatment arm as randomized. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure and 'n' (number analyzed) represents number of participants evaluable for the specified categories.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Percentage of Participants With HBsAg Seroconversion in Virologically Suppressed Population | Week 24: HbeAg Positive | 0.0 Percentage of participants |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Percentage of Participants With HBsAg Seroconversion in Virologically Suppressed Population | Week 24: HbeAg negative | 0.0 Percentage of participants |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Percentage of Participants With HBsAg Seroconversion in Virologically Suppressed Population | Week 48: HbeAg Positive | 0.0 Percentage of participants |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Percentage of Participants With HBsAg Seroconversion in Virologically Suppressed Population | Week 48: HbeAg negative | 0.0 Percentage of participants |
| Part A: JNJ-56136379 75 mg (Open Label) | Percentage of Participants With HBsAg Seroconversion in Virologically Suppressed Population | Week 48: HbeAg negative | 0.0 Percentage of participants |
| Part A: JNJ-56136379 75 mg (Open Label) | Percentage of Participants With HBsAg Seroconversion in Virologically Suppressed Population | Week 24: HbeAg Positive | 0.0 Percentage of participants |
| Part A: JNJ-56136379 75 mg (Open Label) | Percentage of Participants With HBsAg Seroconversion in Virologically Suppressed Population | Week 48: HbeAg Positive | 0.0 Percentage of participants |
| Part A: JNJ-56136379 75 mg (Open Label) | Percentage of Participants With HBsAg Seroconversion in Virologically Suppressed Population | Week 24: HbeAg negative | 0.0 Percentage of participants |
| Part A: JNJ-56136379 75 mg + NA | Percentage of Participants With HBsAg Seroconversion in Virologically Suppressed Population | Week 48: HbeAg negative | 0.0 Percentage of participants |
| Part A: JNJ-56136379 75 mg + NA | Percentage of Participants With HBsAg Seroconversion in Virologically Suppressed Population | Week 24: HbeAg negative | 0.0 Percentage of participants |
| Part A: JNJ-56136379 75 mg + NA | Percentage of Participants With HBsAg Seroconversion in Virologically Suppressed Population | Week 48: HbeAg Positive | 0.0 Percentage of participants |
| Part A: JNJ-56136379 75 mg + NA | Percentage of Participants With HBsAg Seroconversion in Virologically Suppressed Population | Week 24: HbeAg Positive | 0.0 Percentage of participants |
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.
Time frame: Weeks 24, 48 and Follow-up Week 24
Population: The safety population included all participants who received at least one dose of the study agent with ALT values higher than upper limit of normal (ULN) at baseline if time point is available; all safety endpoints were analyzed by the treatment arm as treated. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure and 'n' (number analyzed) represents number of participants evaluable for the specified categories.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Percentage of Participants With Normalized Alanine Aminotransferase (ALT) Levels in Currently Not Treated Population | Week 24: HBeAg positive | 62.5 Percentage of participants |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Percentage of Participants With Normalized Alanine Aminotransferase (ALT) Levels in Currently Not Treated Population | Week 24: HBeAg negative | 55.6 Percentage of participants |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Percentage of Participants With Normalized Alanine Aminotransferase (ALT) Levels in Currently Not Treated Population | Week 48: HBeAg positive | 100.0 Percentage of participants |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Percentage of Participants With Normalized Alanine Aminotransferase (ALT) Levels in Currently Not Treated Population | Week 48: HBeAg negative | 75.0 Percentage of participants |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Percentage of Participants With Normalized Alanine Aminotransferase (ALT) Levels in Currently Not Treated Population | Follow-up Week 24: HBeAg positive | 71.4 Percentage of participants |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Percentage of Participants With Normalized Alanine Aminotransferase (ALT) Levels in Currently Not Treated Population | Follow-up Week 24: HBeAg negative | 87.5 Percentage of participants |
| Part A: JNJ-56136379 75 mg (Open Label) | Percentage of Participants With Normalized Alanine Aminotransferase (ALT) Levels in Currently Not Treated Population | Week 24: HBeAg positive | 60.0 Percentage of participants |
| Part A: JNJ-56136379 75 mg (Open Label) | Percentage of Participants With Normalized Alanine Aminotransferase (ALT) Levels in Currently Not Treated Population | Week 24: HBeAg negative | 91.7 Percentage of participants |
| Part A: JNJ-56136379 75 mg (Open Label) | Percentage of Participants With Normalized Alanine Aminotransferase (ALT) Levels in Currently Not Treated Population | Follow-up Week 24: HBeAg negative | 100.0 Percentage of participants |
| Part A: JNJ-56136379 75 mg (Open Label) | Percentage of Participants With Normalized Alanine Aminotransferase (ALT) Levels in Currently Not Treated Population | Follow-up Week 24: HBeAg positive | 71.4 Percentage of participants |
| Part A: JNJ-56136379 75 mg + NA | Percentage of Participants With Normalized Alanine Aminotransferase (ALT) Levels in Currently Not Treated Population | Follow-up Week 24: HBeAg negative | 83.3 Percentage of participants |
| Part A: JNJ-56136379 75 mg + NA | Percentage of Participants With Normalized Alanine Aminotransferase (ALT) Levels in Currently Not Treated Population | Week 24: HBeAg positive | 54.5 Percentage of participants |
| Part A: JNJ-56136379 75 mg + NA | Percentage of Participants With Normalized Alanine Aminotransferase (ALT) Levels in Currently Not Treated Population | Week 48: HBeAg positive | 100.0 Percentage of participants |
| Part A: JNJ-56136379 75 mg + NA | Percentage of Participants With Normalized Alanine Aminotransferase (ALT) Levels in Currently Not Treated Population | Week 48: HBeAg negative | 100.0 Percentage of participants |
| Part A: JNJ-56136379 75 mg + NA | Percentage of Participants With Normalized Alanine Aminotransferase (ALT) Levels in Currently Not Treated Population | Week 24: HBeAg negative | 68.8 Percentage of participants |
| Part A: JNJ-56136379 75 mg + NA | Percentage of Participants With Normalized Alanine Aminotransferase (ALT) Levels in Currently Not Treated Population | Follow-up Week 24: HBeAg positive | 63.6 Percentage of participants |
| Part B: JNJ-56136379 250 mg (Open Label) | Percentage of Participants With Normalized Alanine Aminotransferase (ALT) Levels in Currently Not Treated Population | Week 48: HBeAg negative | 77.8 Percentage of participants |
| Part B: JNJ-56136379 250 mg (Open Label) | Percentage of Participants With Normalized Alanine Aminotransferase (ALT) Levels in Currently Not Treated Population | Follow-up Week 24: HBeAg positive | 61.5 Percentage of participants |
| Part B: JNJ-56136379 250 mg (Open Label) | Percentage of Participants With Normalized Alanine Aminotransferase (ALT) Levels in Currently Not Treated Population | Follow-up Week 24: HBeAg negative | 90.9 Percentage of participants |
| Part B: JNJ-56136379 250 mg (Open Label) | Percentage of Participants With Normalized Alanine Aminotransferase (ALT) Levels in Currently Not Treated Population | Week 24: HBeAg negative | 72.7 Percentage of participants |
| Part B: JNJ-56136379 250 mg (Open Label) | Percentage of Participants With Normalized Alanine Aminotransferase (ALT) Levels in Currently Not Treated Population | Week 48: HBeAg positive | 60.0 Percentage of participants |
| Part B: JNJ-56136379 250 mg (Open Label) | Percentage of Participants With Normalized Alanine Aminotransferase (ALT) Levels in Currently Not Treated Population | Week 24: HBeAg positive | 64.3 Percentage of participants |
| Part B: JNJ-56136379 250 mg + NA | Percentage of Participants With Normalized Alanine Aminotransferase (ALT) Levels in Currently Not Treated Population | Follow-up Week 24: HBeAg negative | 86.7 Percentage of participants |
| Part B: JNJ-56136379 250 mg + NA | Percentage of Participants With Normalized Alanine Aminotransferase (ALT) Levels in Currently Not Treated Population | Week 24: HBeAg negative | 80.0 Percentage of participants |
| Part B: JNJ-56136379 250 mg + NA | Percentage of Participants With Normalized Alanine Aminotransferase (ALT) Levels in Currently Not Treated Population | Week 48: HBeAg positive | 40.0 Percentage of participants |
| Part B: JNJ-56136379 250 mg + NA | Percentage of Participants With Normalized Alanine Aminotransferase (ALT) Levels in Currently Not Treated Population | Week 48: HBeAg negative | 63.6 Percentage of participants |
| Part B: JNJ-56136379 250 mg + NA | Percentage of Participants With Normalized Alanine Aminotransferase (ALT) Levels in Currently Not Treated Population | Follow-up Week 24: HBeAg positive | 77.8 Percentage of participants |
| Part B: JNJ-56136379 250 mg + NA | Percentage of Participants With Normalized Alanine Aminotransferase (ALT) Levels in Currently Not Treated Population | Week 24: HBeAg positive | 44.4 Percentage of participants |
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.
Time frame: Weeks 24, 48 and Follow-up Week 24
Population: The safety population included all participants who received at least one dose of the study agent with ALT values higher than ULN at baseline if time point is available; all safety endpoints were analyzed by the treatment arm as treated. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure and 'n' (number analyzed) represents number of participants evaluable for the specified categories.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Percentage of Participants With Normalized ALT Levels in Virologically Suppressed Population | Follow-up Week 24: HBeAg negative | 50.0 Percentage of participants |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Percentage of Participants With Normalized ALT Levels in Virologically Suppressed Population | Week 48: HBeAg negative | 50.0 Percentage of participants |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Percentage of Participants With Normalized ALT Levels in Virologically Suppressed Population | Week 24: HBeAg Negative | 50.0 Percentage of participants |
| Part A: JNJ-56136379 75 mg (Open Label) | Percentage of Participants With Normalized ALT Levels in Virologically Suppressed Population | Week 24: HBeAg Positive | 100.0 Percentage of participants |
| Part A: JNJ-56136379 75 mg (Open Label) | Percentage of Participants With Normalized ALT Levels in Virologically Suppressed Population | Week 24: HBeAg Negative | 100.0 Percentage of participants |
| Part A: JNJ-56136379 75 mg (Open Label) | Percentage of Participants With Normalized ALT Levels in Virologically Suppressed Population | Week 48: HBeAg positive | 100.0 Percentage of participants |
| Part A: JNJ-56136379 75 mg (Open Label) | Percentage of Participants With Normalized ALT Levels in Virologically Suppressed Population | Week 48: HBeAg negative | 0 Percentage of participants |
| Part A: JNJ-56136379 75 mg (Open Label) | Percentage of Participants With Normalized ALT Levels in Virologically Suppressed Population | Follow-up Week 24: HBeAg Positive | 100.0 Percentage of participants |
| Part A: JNJ-56136379 75 mg (Open Label) | Percentage of Participants With Normalized ALT Levels in Virologically Suppressed Population | Follow-up Week 24: HBeAg negative | 66.7 Percentage of participants |
| Part A: JNJ-56136379 75 mg + NA | Percentage of Participants With Normalized ALT Levels in Virologically Suppressed Population | Week 48: HBeAg negative | 50.0 Percentage of participants |
| Part A: JNJ-56136379 75 mg + NA | Percentage of Participants With Normalized ALT Levels in Virologically Suppressed Population | Follow-up Week 24: HBeAg negative | 100.0 Percentage of participants |
| Part A: JNJ-56136379 75 mg + NA | Percentage of Participants With Normalized ALT Levels in Virologically Suppressed Population | Follow-up Week 24: HBeAg Positive | 33.3 Percentage of participants |
| Part A: JNJ-56136379 75 mg + NA | Percentage of Participants With Normalized ALT Levels in Virologically Suppressed Population | Week 48: HBeAg positive | 33.3 Percentage of participants |
| Part A: JNJ-56136379 75 mg + NA | Percentage of Participants With Normalized ALT Levels in Virologically Suppressed Population | Week 24: HBeAg Negative | 0 Percentage of participants |
| Part A: JNJ-56136379 75 mg + NA | Percentage of Participants With Normalized ALT Levels in Virologically Suppressed Population | Week 24: HBeAg Positive | 33.3 Percentage of participants |
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.
Time frame: Weeks 24, 48 and Follow-up Week 24
Population: ITT population consisted of all participants who were randomized and received at least one dose of any study agent. If a participant received a study agent other than their randomly assigned study agent, participants were shown in the treatment arm as randomized. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure 'n' (number analyzed) represents number of participants evaluable for the specified categories.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Percentage of Participants With Undetectable HBV DNA Levels in Currently Not Treated Population | Week 24: HBeAg Negative | 23.1 Percentage of participants |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Percentage of Participants With Undetectable HBV DNA Levels in Currently Not Treated Population | Follow-up Week 24: HBeAg Negative | 36.4 Percentage of participants |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Percentage of Participants With Undetectable HBV DNA Levels in Currently Not Treated Population | Follow-up Week 24: HBeAg Positive | 0 Percentage of participants |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Percentage of Participants With Undetectable HBV DNA Levels in Currently Not Treated Population | Week 48: HBeAg Positive | 0 Percentage of participants |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Percentage of Participants With Undetectable HBV DNA Levels in Currently Not Treated Population | Week 24: HBeAg Positive | 0 Percentage of participants |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Percentage of Participants With Undetectable HBV DNA Levels in Currently Not Treated Population | Week 48: HBeAg Negative | 27.3 Percentage of participants |
| Part A: JNJ-56136379 75 mg (Open Label) | Percentage of Participants With Undetectable HBV DNA Levels in Currently Not Treated Population | Week 24: HBeAg Negative | 14.3 Percentage of participants |
| Part A: JNJ-56136379 75 mg (Open Label) | Percentage of Participants With Undetectable HBV DNA Levels in Currently Not Treated Population | Week 24: HBeAg Positive | 0 Percentage of participants |
| Part A: JNJ-56136379 75 mg (Open Label) | Percentage of Participants With Undetectable HBV DNA Levels in Currently Not Treated Population | Follow-up Week 24: HBeAg Positive | 0 Percentage of participants |
| Part A: JNJ-56136379 75 mg (Open Label) | Percentage of Participants With Undetectable HBV DNA Levels in Currently Not Treated Population | Follow-up Week 24: HBeAg Negative | 38.5 Percentage of participants |
| Part A: JNJ-56136379 75 mg + NA | Percentage of Participants With Undetectable HBV DNA Levels in Currently Not Treated Population | Week 24: HBeAg Positive | 0 Percentage of participants |
| Part A: JNJ-56136379 75 mg + NA | Percentage of Participants With Undetectable HBV DNA Levels in Currently Not Treated Population | Week 48: HBeAg Negative | 55.6 Percentage of participants |
| Part A: JNJ-56136379 75 mg + NA | Percentage of Participants With Undetectable HBV DNA Levels in Currently Not Treated Population | Week 24: HBeAg Negative | 14.3 Percentage of participants |
| Part A: JNJ-56136379 75 mg + NA | Percentage of Participants With Undetectable HBV DNA Levels in Currently Not Treated Population | Week 48: HBeAg Positive | 20.0 Percentage of participants |
| Part A: JNJ-56136379 75 mg + NA | Percentage of Participants With Undetectable HBV DNA Levels in Currently Not Treated Population | Follow-up Week 24: HBeAg Positive | 0 Percentage of participants |
| Part A: JNJ-56136379 75 mg + NA | Percentage of Participants With Undetectable HBV DNA Levels in Currently Not Treated Population | Follow-up Week 24: HBeAg Negative | 18.8 Percentage of participants |
| Part B: JNJ-56136379 250 mg (Open Label) | Percentage of Participants With Undetectable HBV DNA Levels in Currently Not Treated Population | Follow-up Week 24: HBeAg Negative | 35.7 Percentage of participants |
| Part B: JNJ-56136379 250 mg (Open Label) | Percentage of Participants With Undetectable HBV DNA Levels in Currently Not Treated Population | Week 24: HBeAg Positive | 0 Percentage of participants |
| Part B: JNJ-56136379 250 mg (Open Label) | Percentage of Participants With Undetectable HBV DNA Levels in Currently Not Treated Population | Week 48: HBeAg Negative | 15.4 Percentage of participants |
| Part B: JNJ-56136379 250 mg (Open Label) | Percentage of Participants With Undetectable HBV DNA Levels in Currently Not Treated Population | Week 24: HBeAg Negative | 18.8 Percentage of participants |
| Part B: JNJ-56136379 250 mg (Open Label) | Percentage of Participants With Undetectable HBV DNA Levels in Currently Not Treated Population | Follow-up Week 24: HBeAg Positive | 15.4 Percentage of participants |
| Part B: JNJ-56136379 250 mg (Open Label) | Percentage of Participants With Undetectable HBV DNA Levels in Currently Not Treated Population | Week 48: HBeAg Positive | 0 Percentage of participants |
| Part B: JNJ-56136379 250 mg + NA | Percentage of Participants With Undetectable HBV DNA Levels in Currently Not Treated Population | Follow-up Week 24: HBeAg Negative | 23.5 Percentage of participants |
| Part B: JNJ-56136379 250 mg + NA | Percentage of Participants With Undetectable HBV DNA Levels in Currently Not Treated Population | Week 24: HBeAg Negative | 0 Percentage of participants |
| Part B: JNJ-56136379 250 mg + NA | Percentage of Participants With Undetectable HBV DNA Levels in Currently Not Treated Population | Week 48: HBeAg Negative | 28.6 Percentage of participants |
| Part B: JNJ-56136379 250 mg + NA | Percentage of Participants With Undetectable HBV DNA Levels in Currently Not Treated Population | Follow-up Week 24: HBeAg Positive | 11.9 Percentage of participants |
| Part B: JNJ-56136379 250 mg + NA | Percentage of Participants With Undetectable HBV DNA Levels in Currently Not Treated Population | Week 24: HBeAg Positive | 9.1 Percentage of participants |
| Part B: JNJ-56136379 250 mg + NA | Percentage of Participants With Undetectable HBV DNA Levels in Currently Not Treated Population | Week 48: HBeAg Positive | 0 Percentage of participants |
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.
Time frame: Weeks 24, 48 and Follow-up Week 24
Population: ITT population consisted of all participants who were randomized and received at least one dose of any study agent. If a participant received a study agent other than their randomly assigned study agent, participants were shown in the treatment arm as randomized. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure and 'n' (number analyzed) represents number of participants evaluable for the specified categories.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Percentage of Participants With Undetectable HBV DNA Levels in Virologically Suppressed Population | Week 24: HBeAg positive | 40.0 Percentage of participants |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Percentage of Participants With Undetectable HBV DNA Levels in Virologically Suppressed Population | Week 24: HBeAg negative | 60.0 Percentage of participants |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Percentage of Participants With Undetectable HBV DNA Levels in Virologically Suppressed Population | Week 48: HBeAg positive | 40.0 Percentage of participants |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Percentage of Participants With Undetectable HBV DNA Levels in Virologically Suppressed Population | Week 48: HBeAg negative | 53.8 Percentage of participants |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Percentage of Participants With Undetectable HBV DNA Levels in Virologically Suppressed Population | Follow-up Week 24: HBeAg positive | 25.0 Percentage of participants |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Percentage of Participants With Undetectable HBV DNA Levels in Virologically Suppressed Population | Follow-up Week 24: HBeAg negative | 60.0 Percentage of participants |
| Part A: JNJ-56136379 75 mg (Open Label) | Percentage of Participants With Undetectable HBV DNA Levels in Virologically Suppressed Population | Follow-up Week 24: HBeAg negative | 73.9 Percentage of participants |
| Part A: JNJ-56136379 75 mg (Open Label) | Percentage of Participants With Undetectable HBV DNA Levels in Virologically Suppressed Population | Week 24: HBeAg positive | 22.2 Percentage of participants |
| Part A: JNJ-56136379 75 mg (Open Label) | Percentage of Participants With Undetectable HBV DNA Levels in Virologically Suppressed Population | Week 48: HBeAg negative | 66.7 Percentage of participants |
| Part A: JNJ-56136379 75 mg (Open Label) | Percentage of Participants With Undetectable HBV DNA Levels in Virologically Suppressed Population | Follow-up Week 24: HBeAg positive | 44.4 Percentage of participants |
| Part A: JNJ-56136379 75 mg (Open Label) | Percentage of Participants With Undetectable HBV DNA Levels in Virologically Suppressed Population | Week 24: HBeAg negative | 58.3 Percentage of participants |
| Part A: JNJ-56136379 75 mg (Open Label) | Percentage of Participants With Undetectable HBV DNA Levels in Virologically Suppressed Population | Week 48: HBeAg positive | 37.5 Percentage of participants |
| Part A: JNJ-56136379 75 mg + NA | Percentage of Participants With Undetectable HBV DNA Levels in Virologically Suppressed Population | Week 24: HBeAg negative | 63.2 Percentage of participants |
| Part A: JNJ-56136379 75 mg + NA | Percentage of Participants With Undetectable HBV DNA Levels in Virologically Suppressed Population | Week 48: HBeAg positive | 77.8 Percentage of participants |
| Part A: JNJ-56136379 75 mg + NA | Percentage of Participants With Undetectable HBV DNA Levels in Virologically Suppressed Population | Follow-up Week 24: HBeAg negative | 42.9 Percentage of participants |
| Part A: JNJ-56136379 75 mg + NA | Percentage of Participants With Undetectable HBV DNA Levels in Virologically Suppressed Population | Week 48: HBeAg negative | 66.7 Percentage of participants |
| Part A: JNJ-56136379 75 mg + NA | Percentage of Participants With Undetectable HBV DNA Levels in Virologically Suppressed Population | Week 24: HBeAg positive | 40.0 Percentage of participants |
| Part A: JNJ-56136379 75 mg + NA | Percentage of Participants With Undetectable HBV DNA Levels in Virologically Suppressed Population | Follow-up Week 24: HBeAg positive | 44.4 Percentage of participants |
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.
Time frame: Weeks 24 and 48
Population: ITT population consisted of all participants who were randomized and received at least one dose of any study agent. If a participant received a study agent other than their randomly assigned study agent, participants were shown in the treatment arm as randomized. Here, 'n' (number analyzed) represents number of participants evaluable for the specified categories.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Percentage of Participants With Virological Breakthrough in Currently Not Treated Population | Week 48: HbeAg Positive | 100.0 Percentage of participants |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Percentage of Participants With Virological Breakthrough in Currently Not Treated Population | Week 24: HbeAg Positive | 0 Percentage of participants |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Percentage of Participants With Virological Breakthrough in Currently Not Treated Population | Week 24: HbeAg Negative | 0 Percentage of participants |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Percentage of Participants With Virological Breakthrough in Currently Not Treated Population | Week 48: HbeAg Negative | 0 Percentage of participants |
| Part A: JNJ-56136379 75 mg (Open Label) | Percentage of Participants With Virological Breakthrough in Currently Not Treated Population | Week 24: HbeAg Negative | 18.8 Percentage of participants |
| Part A: JNJ-56136379 75 mg (Open Label) | Percentage of Participants With Virological Breakthrough in Currently Not Treated Population | Week 48: HbeAg Negative | 33.3 Percentage of participants |
| Part A: JNJ-56136379 75 mg (Open Label) | Percentage of Participants With Virological Breakthrough in Currently Not Treated Population | Week 24: HbeAg Positive | 16.7 Percentage of participants |
| Part A: JNJ-56136379 75 mg + NA | Percentage of Participants With Virological Breakthrough in Currently Not Treated Population | Week 24: HbeAg Negative | 0 Percentage of participants |
| Part A: JNJ-56136379 75 mg + NA | Percentage of Participants With Virological Breakthrough in Currently Not Treated Population | Week 48: HbeAg Positive | 100.0 Percentage of participants |
| Part A: JNJ-56136379 75 mg + NA | Percentage of Participants With Virological Breakthrough in Currently Not Treated Population | Week 48: HbeAg Negative | 10.0 Percentage of participants |
| Part A: JNJ-56136379 75 mg + NA | Percentage of Participants With Virological Breakthrough in Currently Not Treated Population | Week 24: HbeAg Positive | 0 Percentage of participants |
| Part B: JNJ-56136379 250 mg (Open Label) | Percentage of Participants With Virological Breakthrough in Currently Not Treated Population | Week 24: HbeAg Negative | 5.6 Percentage of participants |
| Part B: JNJ-56136379 250 mg (Open Label) | Percentage of Participants With Virological Breakthrough in Currently Not Treated Population | Week 24: HbeAg Positive | 0 Percentage of participants |
| Part B: JNJ-56136379 250 mg (Open Label) | Percentage of Participants With Virological Breakthrough in Currently Not Treated Population | Week 48: HbeAg Positive | 100.0 Percentage of participants |
| Part B: JNJ-56136379 250 mg (Open Label) | Percentage of Participants With Virological Breakthrough in Currently Not Treated Population | Week 48: HbeAg Negative | 0 Percentage of participants |
| Part B: JNJ-56136379 250 mg + NA | Percentage of Participants With Virological Breakthrough in Currently Not Treated Population | Week 24: HbeAg Negative | 0 Percentage of participants |
| Part B: JNJ-56136379 250 mg + NA | Percentage of Participants With Virological Breakthrough in Currently Not Treated Population | Week 24: HbeAg Positive | 0 Percentage of participants |
| Part B: JNJ-56136379 250 mg + NA | Percentage of Participants With Virological Breakthrough in Currently Not Treated Population | Week 48: HbeAg Negative | 0 Percentage of participants |
| Part B: JNJ-56136379 250 mg + NA | Percentage of Participants With Virological Breakthrough in Currently Not Treated Population | Week 48: HbeAg Positive | 100.0 Percentage of participants |
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.
Time frame: Weeks 24 and 48
Population: ITT population consisted of all participants who were randomized and received at least one dose of any study agent. If a participant received a study agent other than their randomly assigned study agent, participants were shown in the treatment arm as randomized. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure and 'n' (number analyzed) represents number of participants evaluable for the specified categories.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Percentage of Participants With Virological Breakthrough in Virologically Suppressed Population | Week 24: HbeAg Negative | 0 Percentage of participants |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Percentage of Participants With Virological Breakthrough in Virologically Suppressed Population | Week 24: HbeAg Positive | 0 Percentage of participants |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Percentage of Participants With Virological Breakthrough in Virologically Suppressed Population | Week 48: HbeAg Positive | 0 Percentage of participants |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Percentage of Participants With Virological Breakthrough in Virologically Suppressed Population | Week 48: HbeAg Negative | 0 Percentage of participants |
| Part A: JNJ-56136379 75 mg (Open Label) | Percentage of Participants With Virological Breakthrough in Virologically Suppressed Population | Week 48: HbeAg Negative | 0 Percentage of participants |
| Part A: JNJ-56136379 75 mg (Open Label) | Percentage of Participants With Virological Breakthrough in Virologically Suppressed Population | Week 24: HbeAg Positive | 0 Percentage of participants |
| Part A: JNJ-56136379 75 mg (Open Label) | Percentage of Participants With Virological Breakthrough in Virologically Suppressed Population | Week 24: HbeAg Negative | 0 Percentage of participants |
| Part A: JNJ-56136379 75 mg (Open Label) | Percentage of Participants With Virological Breakthrough in Virologically Suppressed Population | Week 48: HbeAg Positive | 0 Percentage of participants |
| Part A: JNJ-56136379 75 mg + NA | Percentage of Participants With Virological Breakthrough in Virologically Suppressed Population | Week 48: HbeAg Negative | 0 Percentage of participants |
| Part A: JNJ-56136379 75 mg + NA | Percentage of Participants With Virological Breakthrough in Virologically Suppressed Population | Week 48: HbeAg Positive | 0 Percentage of participants |
| Part A: JNJ-56136379 75 mg + NA | Percentage of Participants With Virological Breakthrough in Virologically Suppressed Population | Week 24: HbeAg Positive | 0 Percentage of participants |
| Part A: JNJ-56136379 75 mg + NA | Percentage of Participants With Virological Breakthrough in Virologically Suppressed Population | Week 24: HbeAg Negative | 0 Percentage of participants |
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.
Time frame: 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
Population: The pharmacokinetic (PK) analysis set included data for all participants with available plasma concentrations. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure and 'n' (number analyzed) represents number of participants evaluable for the specified timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Plasma Concentrations of Entecavir [ETV] in Currently Not Treated Population | Week 24: 0 hours | NA nanograms per milliliter (ng/mL) | — |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Plasma Concentrations of Entecavir [ETV] in Currently Not Treated Population | Week 1: 0 hours | NA nanograms per milliliter (ng/mL) | — |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Plasma Concentrations of Entecavir [ETV] in Currently Not Treated Population | Week 4: 0 hours | NA nanograms per milliliter (ng/mL) | — |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Plasma Concentrations of Entecavir [ETV] in Currently Not Treated Population | Week 28: 0 hours | NA nanograms per milliliter (ng/mL) | — |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Plasma Concentrations of Entecavir [ETV] in Currently Not Treated Population | Week 12: 0 hours | NA nanograms per milliliter (ng/mL) | — |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Plasma Concentrations of Entecavir [ETV] in Currently Not Treated Population | Week 8: 0 hours | NA nanograms per milliliter (ng/mL) | — |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Plasma Concentrations of Entecavir [ETV] in Currently Not Treated Population | Week 48: 0 hours | NA nanograms per milliliter (ng/mL) | — |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Plasma Concentrations of Entecavir [ETV] in Currently Not Treated Population | Week 20: 0 hours | NA nanograms per milliliter (ng/mL) | — |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Plasma Concentrations of Entecavir [ETV] in Currently Not Treated Population | Week 36: 0 hours | NA nanograms per milliliter (ng/mL) | — |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Plasma Concentrations of Entecavir [ETV] in Currently Not Treated Population | Week 32: 0 hours | NA nanograms per milliliter (ng/mL) | — |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Plasma Concentrations of Entecavir [ETV] in Currently Not Treated Population | Week 44: 0 hours | NA nanograms per milliliter (ng/mL) | — |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Plasma Concentrations of Entecavir [ETV] in Currently Not Treated Population | Follow-up: Week 2 | NA nanograms per milliliter (ng/mL) | — |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Plasma Concentrations of Entecavir [ETV] in Currently Not Treated Population | Day 1: 2 hours | NA nanograms per milliliter (ng/mL) | — |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Plasma Concentrations of Entecavir [ETV] in Currently Not Treated Population | Week 2: 0 hours | NA nanograms per milliliter (ng/mL) | — |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Plasma Concentrations of Entecavir [ETV] in Currently Not Treated Population | Follow-up: Week 4 | NA nanograms per milliliter (ng/mL) | — |
| Part A: JNJ-56136379 75 mg (Open Label) | Plasma Concentrations of Entecavir [ETV] in Currently Not Treated Population | Week 1: 0 hours | NA nanograms per milliliter (ng/mL) | — |
| Part A: JNJ-56136379 75 mg (Open Label) | Plasma Concentrations of Entecavir [ETV] in Currently Not Treated Population | Follow-up: Week 4 | NA nanograms per milliliter (ng/mL) | — |
| Part A: JNJ-56136379 75 mg (Open Label) | Plasma Concentrations of Entecavir [ETV] in Currently Not Treated Population | Week 12: 0 hours | NA nanograms per milliliter (ng/mL) | — |
| Part A: JNJ-56136379 75 mg (Open Label) | Plasma Concentrations of Entecavir [ETV] in Currently Not Treated Population | Day 1: 2 hours | NA nanograms per milliliter (ng/mL) | — |
| Part A: JNJ-56136379 75 mg (Open Label) | Plasma Concentrations of Entecavir [ETV] in Currently Not Treated Population | Week 2: 0 hours | NA nanograms per milliliter (ng/mL) | — |
| Part A: JNJ-56136379 75 mg (Open Label) | Plasma Concentrations of Entecavir [ETV] in Currently Not Treated Population | Follow-up: Week 2 | NA nanograms per milliliter (ng/mL) | — |
| Part A: JNJ-56136379 75 mg (Open Label) | Plasma Concentrations of Entecavir [ETV] in Currently Not Treated Population | Week 4: 0 hours | NA nanograms per milliliter (ng/mL) | — |
| Part A: JNJ-56136379 75 mg (Open Label) | Plasma Concentrations of Entecavir [ETV] in Currently Not Treated Population | Week 8: 0 hours | NA nanograms per milliliter (ng/mL) | — |
| Part A: JNJ-56136379 75 mg (Open Label) | Plasma Concentrations of Entecavir [ETV] in Currently Not Treated Population | Week 20: 0 hours | NA nanograms per milliliter (ng/mL) | — |
| Part A: JNJ-56136379 75 mg (Open Label) | Plasma Concentrations of Entecavir [ETV] in Currently Not Treated Population | Week 28: 0 hours | NA nanograms per milliliter (ng/mL) | — |
| Part A: JNJ-56136379 75 mg (Open Label) | Plasma Concentrations of Entecavir [ETV] in Currently Not Treated Population | Week 24: 0 hours | NA nanograms per milliliter (ng/mL) | — |
| Part A: JNJ-56136379 75 mg + NA | Plasma Concentrations of Entecavir [ETV] in Currently Not Treated Population | Week 48: 0 hours | 0.434 nanograms per milliliter (ng/mL) | Standard Deviation 0.0968 |
| Part A: JNJ-56136379 75 mg + NA | Plasma Concentrations of Entecavir [ETV] in Currently Not Treated Population | Week 4: 0 hours | 0.417 nanograms per milliliter (ng/mL) | Standard Deviation 0.143 |
| Part A: JNJ-56136379 75 mg + NA | Plasma Concentrations of Entecavir [ETV] in Currently Not Treated Population | Week 20: 0 hours | 0.441 nanograms per milliliter (ng/mL) | Standard Deviation 0.147 |
| Part A: JNJ-56136379 75 mg + NA | Plasma Concentrations of Entecavir [ETV] in Currently Not Treated Population | Week 24: 0 hours | 0.395 nanograms per milliliter (ng/mL) | Standard Deviation 0.309 |
| Part A: JNJ-56136379 75 mg + NA | Plasma Concentrations of Entecavir [ETV] in Currently Not Treated Population | Week 28: 0 hours | NA nanograms per milliliter (ng/mL) | — |
| Part A: JNJ-56136379 75 mg + NA | Plasma Concentrations of Entecavir [ETV] in Currently Not Treated Population | Week 32: 0 hours | NA nanograms per milliliter (ng/mL) | — |
| Part A: JNJ-56136379 75 mg + NA | Plasma Concentrations of Entecavir [ETV] in Currently Not Treated Population | Week 36: 0 hours | NA nanograms per milliliter (ng/mL) | — |
| Part A: JNJ-56136379 75 mg + NA | Plasma Concentrations of Entecavir [ETV] in Currently Not Treated Population | Day 1: 0 hours | NA nanograms per milliliter (ng/mL) | — |
| Part A: JNJ-56136379 75 mg + NA | Plasma Concentrations of Entecavir [ETV] in Currently Not Treated Population | Day 1: 2 hours | 1.39 nanograms per milliliter (ng/mL) | Standard Deviation 0.709 |
| Part A: JNJ-56136379 75 mg + NA | Plasma Concentrations of Entecavir [ETV] in Currently Not Treated Population | Week 1: 0 hours | 0.321 nanograms per milliliter (ng/mL) | Standard Deviation 0.0961 |
| Part A: JNJ-56136379 75 mg + NA | Plasma Concentrations of Entecavir [ETV] in Currently Not Treated Population | Week 2: 0 hours | 0.285 nanograms per milliliter (ng/mL) | Standard Deviation 0.166 |
| Part A: JNJ-56136379 75 mg + NA | Plasma Concentrations of Entecavir [ETV] in Currently Not Treated Population | Week 8: 0 hours | 0.353 nanograms per milliliter (ng/mL) | Standard Deviation 0.226 |
| Part A: JNJ-56136379 75 mg + NA | Plasma Concentrations of Entecavir [ETV] in Currently Not Treated Population | Week 12: 0 hours | 0.467 nanograms per milliliter (ng/mL) | Standard Deviation 0.188 |
| Part A: JNJ-56136379 75 mg + NA | Plasma Concentrations of Entecavir [ETV] in Currently Not Treated Population | Week 44: 0 hours | NA nanograms per milliliter (ng/mL) | — |
| Part A: JNJ-56136379 75 mg + NA | Plasma Concentrations of Entecavir [ETV] in Currently Not Treated Population | Follow-up: Week 2 | 0.542 nanograms per milliliter (ng/mL) | Standard Deviation 0.311 |
| Part A: JNJ-56136379 75 mg + NA | Plasma Concentrations of Entecavir [ETV] in Currently Not Treated Population | Follow-up: Week 4 | 0.354 nanograms per milliliter (ng/mL) | Standard Deviation 0.26 |
| Part B: JNJ-56136379 250 mg (Open Label) | Plasma Concentrations of Entecavir [ETV] in Currently Not Treated Population | Week 20: 0 hours | 0.481 nanograms per milliliter (ng/mL) | Standard Deviation 0.0625 |
| Part B: JNJ-56136379 250 mg (Open Label) | Plasma Concentrations of Entecavir [ETV] in Currently Not Treated Population | Day 1: 2 hours | 1.18 nanograms per milliliter (ng/mL) | Standard Deviation 0.197 |
| Part B: JNJ-56136379 250 mg (Open Label) | Plasma Concentrations of Entecavir [ETV] in Currently Not Treated Population | Day 1: 0 hours | NA nanograms per milliliter (ng/mL) | — |
| Part B: JNJ-56136379 250 mg (Open Label) | Plasma Concentrations of Entecavir [ETV] in Currently Not Treated Population | Week 36: 0 hours | 0.442 nanograms per milliliter (ng/mL) | Standard Deviation 0.0517 |
| Part B: JNJ-56136379 250 mg (Open Label) | Plasma Concentrations of Entecavir [ETV] in Currently Not Treated Population | Week 32: 0 hours | 0.462 nanograms per milliliter (ng/mL) | Standard Deviation 0.041 |
| Part B: JNJ-56136379 250 mg (Open Label) | Plasma Concentrations of Entecavir [ETV] in Currently Not Treated Population | Week 4: 0 hours | 0.414 nanograms per milliliter (ng/mL) | Standard Deviation 0.0742 |
| Part B: JNJ-56136379 250 mg (Open Label) | Plasma Concentrations of Entecavir [ETV] in Currently Not Treated Population | Week 44: 0 hours | 0.438 nanograms per milliliter (ng/mL) | Standard Deviation 0.0352 |
| Part B: JNJ-56136379 250 mg (Open Label) | Plasma Concentrations of Entecavir [ETV] in Currently Not Treated Population | Week 28: 0 hours | 0.527 nanograms per milliliter (ng/mL) | Standard Deviation 0.0302 |
| Part B: JNJ-56136379 250 mg (Open Label) | Plasma Concentrations of Entecavir [ETV] in Currently Not Treated Population | Week 2: 0 hours | 0.377 nanograms per milliliter (ng/mL) | Standard Deviation 0.0531 |
| Part B: JNJ-56136379 250 mg (Open Label) | Plasma Concentrations of Entecavir [ETV] in Currently Not Treated Population | Week 48: 0 hours | 0.539 nanograms per milliliter (ng/mL) | Standard Deviation 0.0414 |
| Part B: JNJ-56136379 250 mg (Open Label) | Plasma Concentrations of Entecavir [ETV] in Currently Not Treated Population | Follow-up: Week 4 | 0.309 nanograms per milliliter (ng/mL) | Standard Deviation 0.161 |
| Part B: JNJ-56136379 250 mg (Open Label) | Plasma Concentrations of Entecavir [ETV] in Currently Not Treated Population | Follow-up: Week 2 | 0.307 nanograms per milliliter (ng/mL) | Standard Deviation 0.176 |
| Part B: JNJ-56136379 250 mg (Open Label) | Plasma Concentrations of Entecavir [ETV] in Currently Not Treated Population | Week 8: 0 hours | 0.466 nanograms per milliliter (ng/mL) | Standard Deviation 0.0913 |
| Part B: JNJ-56136379 250 mg (Open Label) | Plasma Concentrations of Entecavir [ETV] in Currently Not Treated Population | Week 1: 0 hours | 0.289 nanograms per milliliter (ng/mL) | Standard Deviation 0.0351 |
| Part B: JNJ-56136379 250 mg (Open Label) | Plasma Concentrations of Entecavir [ETV] in Currently Not Treated Population | Week 24: 0 hours | 0.385 nanograms per milliliter (ng/mL) | Standard Deviation 0.0415 |
| Part B: JNJ-56136379 250 mg (Open Label) | Plasma Concentrations of Entecavir [ETV] in Currently Not Treated Population | Week 12: 0 hours | 0.479 nanograms per milliliter (ng/mL) | Standard Deviation 0.065 |
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.
Time frame: 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
Population: The PK analysis set included data for all participants with available plasma concentrations. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure and 'n' (number analyzed) represents number of participants evaluable for the specified timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Plasma Concentrations of ETV in Virologically Suppressed Population | Follow-up: Week 4 | 1.00 ng/mL | Standard Deviation 1.13 |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Plasma Concentrations of ETV in Virologically Suppressed Population | Week 2: 0 hours | 0.871 ng/mL | Standard Deviation 0.909 |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Plasma Concentrations of ETV in Virologically Suppressed Population | Week 44: 0 hours | NA ng/mL | — |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Plasma Concentrations of ETV in Virologically Suppressed Population | Day 1: 2 hours | NA ng/mL | — |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Plasma Concentrations of ETV in Virologically Suppressed Population | Week 1: 0 hours | 1.94 ng/mL | Standard Deviation 2.43 |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Plasma Concentrations of ETV in Virologically Suppressed Population | Week 4: 0 hours | 0.647 ng/mL | Standard Deviation 0.628 |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Plasma Concentrations of ETV in Virologically Suppressed Population | Week 8: 0 hours | NA ng/mL | — |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Plasma Concentrations of ETV in Virologically Suppressed Population | Week 12: 0 hours | 0.277 ng/mL | Standard Deviation 0.0733 |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Plasma Concentrations of ETV in Virologically Suppressed Population | Week 20: 0 hours | NA ng/mL | — |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Plasma Concentrations of ETV in Virologically Suppressed Population | Week 24: 0 hours | NA ng/mL | — |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Plasma Concentrations of ETV in Virologically Suppressed Population | Day 1: 0 hours | NA ng/mL | — |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Plasma Concentrations of ETV in Virologically Suppressed Population | Week 28: 0 hours | NA ng/mL | — |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Plasma Concentrations of ETV in Virologically Suppressed Population | Week 32: 0 hours | NA ng/mL | — |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Plasma Concentrations of ETV in Virologically Suppressed Population | Week 36: 0 hours | 0.962 ng/mL | Standard Deviation 1.07 |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Plasma Concentrations of ETV in Virologically Suppressed Population | Week 48: 0 hours | 0.766 ng/mL | Standard Deviation 0.594 |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Plasma Concentrations of ETV in Virologically Suppressed Population | Follow-up: Week 2 | NA ng/mL | — |
| Part A: JNJ-56136379 75 mg (Open Label) | Plasma Concentrations of ETV in Virologically Suppressed Population | Week 20: 0 hours | NA ng/mL | — |
| Part A: JNJ-56136379 75 mg (Open Label) | Plasma Concentrations of ETV in Virologically Suppressed Population | Week 8: 0 hours | NA ng/mL | — |
| Part A: JNJ-56136379 75 mg (Open Label) | Plasma Concentrations of ETV in Virologically Suppressed Population | Week 4: 0 hours | NA ng/mL | — |
| Part A: JNJ-56136379 75 mg (Open Label) | Plasma Concentrations of ETV in Virologically Suppressed Population | Week 2: 0 hours | NA ng/mL | — |
| Part A: JNJ-56136379 75 mg (Open Label) | Plasma Concentrations of ETV in Virologically Suppressed Population | Follow-up: Week 2 | NA ng/mL | — |
| Part A: JNJ-56136379 75 mg (Open Label) | Plasma Concentrations of ETV in Virologically Suppressed Population | Week 24: 0 hours | NA ng/mL | — |
| Part A: JNJ-56136379 75 mg (Open Label) | Plasma Concentrations of ETV in Virologically Suppressed Population | Follow-up: Week 4 | NA ng/mL | — |
| Part A: JNJ-56136379 75 mg (Open Label) | Plasma Concentrations of ETV in Virologically Suppressed Population | Week 12: 0 hours | NA ng/mL | — |
| Part A: JNJ-56136379 75 mg (Open Label) | Plasma Concentrations of ETV in Virologically Suppressed Population | Week 1: 0 hours | NA ng/mL | — |
| Part A: JNJ-56136379 75 mg + NA | Plasma Concentrations of ETV in Virologically Suppressed Population | Day 1: 2 hours | 1.86 ng/mL | Standard Deviation 0.639 |
| Part A: JNJ-56136379 75 mg + NA | Plasma Concentrations of ETV in Virologically Suppressed Population | Week 20: 0 hours | 0.617 ng/mL | Standard Deviation 0.408 |
| Part A: JNJ-56136379 75 mg + NA | Plasma Concentrations of ETV in Virologically Suppressed Population | Week 48: 0 hours | 0.554 ng/mL | Standard Deviation 0.287 |
| Part A: JNJ-56136379 75 mg + NA | Plasma Concentrations of ETV in Virologically Suppressed Population | Week 4: 0 hours | 0.529 ng/mL | Standard Deviation 0.198 |
| Part A: JNJ-56136379 75 mg + NA | Plasma Concentrations of ETV in Virologically Suppressed Population | Week 24: 0 hours | 0.491 ng/mL | Standard Deviation 0.144 |
| Part A: JNJ-56136379 75 mg + NA | Plasma Concentrations of ETV in Virologically Suppressed Population | Week 2: 0 hours | 0.469 ng/mL | Standard Deviation 0.153 |
| Part A: JNJ-56136379 75 mg + NA | Plasma Concentrations of ETV in Virologically Suppressed Population | Follow-up: Week 2 | 0.635 ng/mL | Standard Deviation 0.449 |
| Part A: JNJ-56136379 75 mg + NA | Plasma Concentrations of ETV in Virologically Suppressed Population | Day 1: 0 hours | 0.683 ng/mL | Standard Deviation 0.414 |
| Part A: JNJ-56136379 75 mg + NA | Plasma Concentrations of ETV in Virologically Suppressed Population | Week 28: 0 hours | 0.446 ng/mL | Standard Deviation 0.148 |
| Part A: JNJ-56136379 75 mg + NA | Plasma Concentrations of ETV in Virologically Suppressed Population | Week 8: 0 hours | 0.496 ng/mL | Standard Deviation 0.179 |
| Part A: JNJ-56136379 75 mg + NA | Plasma Concentrations of ETV in Virologically Suppressed Population | Week 36: 0 hours | 0.487 ng/mL | Standard Deviation 0.185 |
| Part A: JNJ-56136379 75 mg + NA | Plasma Concentrations of ETV in Virologically Suppressed Population | Week 44: 0 hours | 0.525 ng/mL | Standard Deviation 0.177 |
| Part A: JNJ-56136379 75 mg + NA | Plasma Concentrations of ETV in Virologically Suppressed Population | Week 12: 0 hours | 0.454 ng/mL | Standard Deviation 0.135 |
| Part A: JNJ-56136379 75 mg + NA | Plasma Concentrations of ETV in Virologically Suppressed Population | Follow-up: Week 4 | 0.445 ng/mL | Standard Deviation 0.164 |
| Part A: JNJ-56136379 75 mg + NA | Plasma Concentrations of ETV in Virologically Suppressed Population | Week 32: 0 hours | 0.467 ng/mL | Standard Deviation 0.201 |
| Part A: JNJ-56136379 75 mg + NA | Plasma Concentrations of ETV in Virologically Suppressed Population | Week 1: 0 hours | 0.464 ng/mL | Standard Deviation 0.143 |
| Part B: JNJ-56136379 250 mg (Open Label) | Plasma Concentrations of ETV in Virologically Suppressed Population | Week 48: 0 hours | 0.537 ng/mL | Standard Deviation 0.105 |
| Part B: JNJ-56136379 250 mg (Open Label) | Plasma Concentrations of ETV in Virologically Suppressed Population | Week 2: 0 hours | 0.469 ng/mL | Standard Deviation 0.0835 |
| Part B: JNJ-56136379 250 mg (Open Label) | Plasma Concentrations of ETV in Virologically Suppressed Population | Week 32: 0 hours | 0.489 ng/mL | Standard Deviation 0.144 |
| Part B: JNJ-56136379 250 mg (Open Label) | Plasma Concentrations of ETV in Virologically Suppressed Population | Week 4: 0 hours | 0.539 ng/mL | Standard Deviation 0.108 |
| Part B: JNJ-56136379 250 mg (Open Label) | Plasma Concentrations of ETV in Virologically Suppressed Population | Week 12: 0 hours | 0.548 ng/mL | Standard Deviation 0.0535 |
| Part B: JNJ-56136379 250 mg (Open Label) | Plasma Concentrations of ETV in Virologically Suppressed Population | Follow-up: Week 2 | 0.433 ng/mL | Standard Deviation 0.117 |
| Part B: JNJ-56136379 250 mg (Open Label) | Plasma Concentrations of ETV in Virologically Suppressed Population | Week 20: 0 hours | 0.537 ng/mL | Standard Deviation 0.109 |
| Part B: JNJ-56136379 250 mg (Open Label) | Plasma Concentrations of ETV in Virologically Suppressed Population | Day 1: 2 hours | 1.89 ng/mL | Standard Deviation 0.429 |
| Part B: JNJ-56136379 250 mg (Open Label) | Plasma Concentrations of ETV in Virologically Suppressed Population | Week 24: 0 hours | 0.576 ng/mL | Standard Deviation 0.121 |
| Part B: JNJ-56136379 250 mg (Open Label) | Plasma Concentrations of ETV in Virologically Suppressed Population | Week 1: 0 hours | 0.472 ng/mL | Standard Deviation 0.12 |
| Part B: JNJ-56136379 250 mg (Open Label) | Plasma Concentrations of ETV in Virologically Suppressed Population | Week 8: 0 hours | 0.493 ng/mL | Standard Deviation 0.0816 |
| Part B: JNJ-56136379 250 mg (Open Label) | Plasma Concentrations of ETV in Virologically Suppressed Population | Week 36: 0 hours | 0.526 ng/mL | Standard Deviation 0.109 |
| Part B: JNJ-56136379 250 mg (Open Label) | Plasma Concentrations of ETV in Virologically Suppressed Population | Week 28: 0 hours | 0.519 ng/mL | Standard Deviation 0.153 |
| Part B: JNJ-56136379 250 mg (Open Label) | Plasma Concentrations of ETV in Virologically Suppressed Population | Week 44: 0 hours | 0.517 ng/mL | Standard Deviation 0.121 |
| Part B: JNJ-56136379 250 mg (Open Label) | Plasma Concentrations of ETV in Virologically Suppressed Population | Follow-up: Week 4 | 0.725 ng/mL | Standard Deviation 0.598 |
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.
Time frame: 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
Population: The PK analysis set included data for all participants with available plasma concentrations. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure and 'n' (number analyzed) represents number of participants evaluable for the specified timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Plasma Concentrations of JNJ-56136379 in Currently Not Treated Population | Follow-up: Week 2 | 916 ng/mL | Standard Deviation 930 |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Plasma Concentrations of JNJ-56136379 in Currently Not Treated Population | Day 1: 0 hour | NA ng/mL | — |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Plasma Concentrations of JNJ-56136379 in Currently Not Treated Population | Follow-up: Week 4 | 242 ng/mL | Standard Deviation 359 |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Plasma Concentrations of JNJ-56136379 in Currently Not Treated Population | Week 24: 0 hours | 3613 ng/mL | Standard Deviation 813 |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Plasma Concentrations of JNJ-56136379 in Currently Not Treated Population | Week 12: 0 hours | 4130 ng/mL | Standard Deviation 1145 |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Plasma Concentrations of JNJ-56136379 in Currently Not Treated Population | Week 20: 0 hours | 3754 ng/mL | Standard Deviation 1132 |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Plasma Concentrations of JNJ-56136379 in Currently Not Treated Population | Week 8: 0 hours | 4617 ng/mL | Standard Deviation 1195 |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Plasma Concentrations of JNJ-56136379 in Currently Not Treated Population | Week 4: 0 hours | 4116 ng/mL | Standard Deviation 941 |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Plasma Concentrations of JNJ-56136379 in Currently Not Treated Population | Week 2: 0 hours | 3424 ng/mL | Standard Deviation 845 |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Plasma Concentrations of JNJ-56136379 in Currently Not Treated Population | Week 1: 0 hours | 2269 ng/mL | Standard Deviation 597 |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Plasma Concentrations of JNJ-56136379 in Currently Not Treated Population | Day 1: 2 hour | 709 ng/mL | Standard Deviation 307 |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Plasma Concentrations of JNJ-56136379 in Currently Not Treated Population | Week 28: 0 hours | 4733 ng/mL | Standard Deviation 350 |
| Part A: JNJ-56136379 75 mg (Open Label) | Plasma Concentrations of JNJ-56136379 in Currently Not Treated Population | Follow-up: Week 4 | 494 ng/mL | Standard Deviation 427 |
| Part A: JNJ-56136379 75 mg (Open Label) | Plasma Concentrations of JNJ-56136379 in Currently Not Treated Population | Week 8: 0 hours | 13697 ng/mL | Standard Deviation 3702 |
| Part A: JNJ-56136379 75 mg (Open Label) | Plasma Concentrations of JNJ-56136379 in Currently Not Treated Population | Week 28: 0 hours | 12025 ng/mL | Standard Deviation 3229 |
| Part A: JNJ-56136379 75 mg (Open Label) | Plasma Concentrations of JNJ-56136379 in Currently Not Treated Population | Week 36: 0 hours | 11289 ng/mL | Standard Deviation 2973 |
| Part A: JNJ-56136379 75 mg (Open Label) | Plasma Concentrations of JNJ-56136379 in Currently Not Treated Population | Week 44: 0 hours | 11198 ng/mL | Standard Deviation 2749 |
| Part A: JNJ-56136379 75 mg (Open Label) | Plasma Concentrations of JNJ-56136379 in Currently Not Treated Population | Week 48: 0 hours | 11797 ng/mL | Standard Deviation 2482 |
| Part A: JNJ-56136379 75 mg (Open Label) | Plasma Concentrations of JNJ-56136379 in Currently Not Treated Population | Day 1: 0 hour | NA ng/mL | — |
| Part A: JNJ-56136379 75 mg (Open Label) | Plasma Concentrations of JNJ-56136379 in Currently Not Treated Population | Day 1: 2 hour | 2143 ng/mL | Standard Deviation 1300 |
| Part A: JNJ-56136379 75 mg (Open Label) | Plasma Concentrations of JNJ-56136379 in Currently Not Treated Population | Week 1: 0 hours | 7339 ng/mL | Standard Deviation 2040 |
| Part A: JNJ-56136379 75 mg (Open Label) | Plasma Concentrations of JNJ-56136379 in Currently Not Treated Population | Week 2: 0 hours | 10894 ng/mL | Standard Deviation 2631 |
| Part A: JNJ-56136379 75 mg (Open Label) | Plasma Concentrations of JNJ-56136379 in Currently Not Treated Population | Week 4: 0 hours | 12827 ng/mL | Standard Deviation 3104 |
| Part A: JNJ-56136379 75 mg (Open Label) | Plasma Concentrations of JNJ-56136379 in Currently Not Treated Population | Week 12: 0 hours | 12676 ng/mL | Standard Deviation 3431 |
| Part A: JNJ-56136379 75 mg (Open Label) | Plasma Concentrations of JNJ-56136379 in Currently Not Treated Population | Week 20: 0 hours | 12757 ng/mL | Standard Deviation 4298 |
| Part A: JNJ-56136379 75 mg (Open Label) | Plasma Concentrations of JNJ-56136379 in Currently Not Treated Population | Week 24: 0 hours | 12626 ng/mL | Standard Deviation 3396 |
| Part A: JNJ-56136379 75 mg (Open Label) | Plasma Concentrations of JNJ-56136379 in Currently Not Treated Population | Week 32: 0 hours | 12162 ng/mL | Standard Deviation 2780 |
| Part A: JNJ-56136379 75 mg (Open Label) | Plasma Concentrations of JNJ-56136379 in Currently Not Treated Population | Follow-up: Week 2 | 2459 ng/mL | Standard Deviation 1529 |
| Part A: JNJ-56136379 75 mg + NA | Plasma Concentrations of JNJ-56136379 in Currently Not Treated Population | Follow-up: Week 4 | 320 ng/mL | Standard Deviation 276 |
| Part A: JNJ-56136379 75 mg + NA | Plasma Concentrations of JNJ-56136379 in Currently Not Treated Population | Week 20: 0 hours | 4648 ng/mL | Standard Deviation 1528 |
| Part A: JNJ-56136379 75 mg + NA | Plasma Concentrations of JNJ-56136379 in Currently Not Treated Population | Week 12: 0 hours | 4976 ng/mL | Standard Deviation 1302 |
| Part A: JNJ-56136379 75 mg + NA | Plasma Concentrations of JNJ-56136379 in Currently Not Treated Population | Week 4: 0 hours | 4368 ng/mL | Standard Deviation 1216 |
| Part A: JNJ-56136379 75 mg + NA | Plasma Concentrations of JNJ-56136379 in Currently Not Treated Population | Week 36: 0 hours | 4463 ng/mL | Standard Deviation 1444 |
| Part A: JNJ-56136379 75 mg + NA | Plasma Concentrations of JNJ-56136379 in Currently Not Treated Population | Week 44: 0 hours | 4507 ng/mL | Standard Deviation 1121 |
| Part A: JNJ-56136379 75 mg + NA | Plasma Concentrations of JNJ-56136379 in Currently Not Treated Population | Follow-up: Week 2 | 1330 ng/mL | Standard Deviation 887 |
| Part A: JNJ-56136379 75 mg + NA | Plasma Concentrations of JNJ-56136379 in Currently Not Treated Population | Week 1: 0 hours | 2264 ng/mL | Standard Deviation 455 |
| Part A: JNJ-56136379 75 mg + NA | Plasma Concentrations of JNJ-56136379 in Currently Not Treated Population | Day 1: 2 hour | 520 ng/mL | Standard Deviation 279 |
| Part A: JNJ-56136379 75 mg + NA | Plasma Concentrations of JNJ-56136379 in Currently Not Treated Population | Week 32: 0 hours | 4677 ng/mL | Standard Deviation 646 |
| Part A: JNJ-56136379 75 mg + NA | Plasma Concentrations of JNJ-56136379 in Currently Not Treated Population | Week 28: 0 hours | 4300 ng/mL | Standard Deviation 1355 |
| Part A: JNJ-56136379 75 mg + NA | Plasma Concentrations of JNJ-56136379 in Currently Not Treated Population | Week 24: 0 hours | 4650 ng/mL | Standard Deviation 1461 |
| Part A: JNJ-56136379 75 mg + NA | Plasma Concentrations of JNJ-56136379 in Currently Not Treated Population | Day 1: 0 hour | NA ng/mL | — |
| Part A: JNJ-56136379 75 mg + NA | Plasma Concentrations of JNJ-56136379 in Currently Not Treated Population | Week 2: 0 hours | 3094 ng/mL | Standard Deviation 892 |
| Part A: JNJ-56136379 75 mg + NA | Plasma Concentrations of JNJ-56136379 in Currently Not Treated Population | Week 8: 0 hours | 5006 ng/mL | Standard Deviation 1528 |
| Part B: JNJ-56136379 250 mg (Open Label) | Plasma Concentrations of JNJ-56136379 in Currently Not Treated Population | Week 2: 0 hours | 3702 ng/mL | Standard Deviation 1028 |
| Part B: JNJ-56136379 250 mg (Open Label) | Plasma Concentrations of JNJ-56136379 in Currently Not Treated Population | Day 1: 2 hour | 806 ng/mL | Standard Deviation 306 |
| Part B: JNJ-56136379 250 mg (Open Label) | Plasma Concentrations of JNJ-56136379 in Currently Not Treated Population | Week 1: 0 hours | 2368 ng/mL | Standard Deviation 695 |
| Part B: JNJ-56136379 250 mg (Open Label) | Plasma Concentrations of JNJ-56136379 in Currently Not Treated Population | Follow-up: Week 2 | 909 ng/mL | Standard Deviation 740 |
| Part B: JNJ-56136379 250 mg (Open Label) | Plasma Concentrations of JNJ-56136379 in Currently Not Treated Population | Week 4: 0 hours | 4697 ng/mL | Standard Deviation 1474 |
| Part B: JNJ-56136379 250 mg (Open Label) | Plasma Concentrations of JNJ-56136379 in Currently Not Treated Population | Week 20: 0 hours | 4698 ng/mL | Standard Deviation 1661 |
| Part B: JNJ-56136379 250 mg (Open Label) | Plasma Concentrations of JNJ-56136379 in Currently Not Treated Population | Week 8: 0 hours | 4719 ng/mL | Standard Deviation 1465 |
| Part B: JNJ-56136379 250 mg (Open Label) | Plasma Concentrations of JNJ-56136379 in Currently Not Treated Population | Week 12: 0 hours | 4582 ng/mL | Standard Deviation 1324 |
| Part B: JNJ-56136379 250 mg (Open Label) | Plasma Concentrations of JNJ-56136379 in Currently Not Treated Population | Follow-up: Week 4 | 226 ng/mL | Standard Deviation 236 |
| Part B: JNJ-56136379 250 mg (Open Label) | Plasma Concentrations of JNJ-56136379 in Currently Not Treated Population | Week 24: 0 hours | 4767 ng/mL | Standard Deviation 1601 |
| Part B: JNJ-56136379 250 mg (Open Label) | Plasma Concentrations of JNJ-56136379 in Currently Not Treated Population | Week 28: 0 hours | 4439 ng/mL | Standard Deviation 1446 |
| Part B: JNJ-56136379 250 mg (Open Label) | Plasma Concentrations of JNJ-56136379 in Currently Not Treated Population | Week 32: 0 hours | 4825 ng/mL | Standard Deviation 2429 |
| Part B: JNJ-56136379 250 mg (Open Label) | Plasma Concentrations of JNJ-56136379 in Currently Not Treated Population | Week 36: 0 hours | 4144 ng/mL | Standard Deviation 1599 |
| Part B: JNJ-56136379 250 mg (Open Label) | Plasma Concentrations of JNJ-56136379 in Currently Not Treated Population | Week 44: 0 hours | 3430 ng/mL | Standard Deviation 1346 |
| Part B: JNJ-56136379 250 mg (Open Label) | Plasma Concentrations of JNJ-56136379 in Currently Not Treated Population | Week 48: 0 hours | NA ng/mL | — |
| Part B: JNJ-56136379 250 mg (Open Label) | Plasma Concentrations of JNJ-56136379 in Currently Not Treated Population | Day 1: 0 hour | NA ng/mL | — |
| Part B: JNJ-56136379 250 mg + NA | Plasma Concentrations of JNJ-56136379 in Currently Not Treated Population | Week 12: 0 hours | 11347 ng/mL | Standard Deviation 1754 |
| Part B: JNJ-56136379 250 mg + NA | Plasma Concentrations of JNJ-56136379 in Currently Not Treated Population | Week 2: 0 hours | 9381 ng/mL | Standard Deviation 2168 |
| Part B: JNJ-56136379 250 mg + NA | Plasma Concentrations of JNJ-56136379 in Currently Not Treated Population | Week 32: 0 hours | 9840 ng/mL | Standard Deviation 3770 |
| Part B: JNJ-56136379 250 mg + NA | Plasma Concentrations of JNJ-56136379 in Currently Not Treated Population | Day 1: 0 hour | NA ng/mL | — |
| Part B: JNJ-56136379 250 mg + NA | Plasma Concentrations of JNJ-56136379 in Currently Not Treated Population | Week 28: 0 hours | 11753 ng/mL | Standard Deviation 2719 |
| Part B: JNJ-56136379 250 mg + NA | Plasma Concentrations of JNJ-56136379 in Currently Not Treated Population | Follow-up: Week 4 | 572 ng/mL | Standard Deviation 624 |
| Part B: JNJ-56136379 250 mg + NA | Plasma Concentrations of JNJ-56136379 in Currently Not Treated Population | Week 1: 0 hours | 6461 ng/mL | Standard Deviation 2014 |
| Part B: JNJ-56136379 250 mg + NA | Plasma Concentrations of JNJ-56136379 in Currently Not Treated Population | Week 36: 0 hours | 11350 ng/mL | Standard Deviation 3439 |
| Part B: JNJ-56136379 250 mg + NA | Plasma Concentrations of JNJ-56136379 in Currently Not Treated Population | Week 24: 0 hours | 10888 ng/mL | Standard Deviation 1576 |
| Part B: JNJ-56136379 250 mg + NA | Plasma Concentrations of JNJ-56136379 in Currently Not Treated Population | Day 1: 2 hour | 2287 ng/mL | Standard Deviation 946 |
| Part B: JNJ-56136379 250 mg + NA | Plasma Concentrations of JNJ-56136379 in Currently Not Treated Population | Week 44: 0 hours | 11570 ng/mL | Standard Deviation 2674 |
| Part B: JNJ-56136379 250 mg + NA | Plasma Concentrations of JNJ-56136379 in Currently Not Treated Population | Follow-up: Week 2 | 1922 ng/mL | Standard Deviation 1628 |
| Part B: JNJ-56136379 250 mg + NA | Plasma Concentrations of JNJ-56136379 in Currently Not Treated Population | Week 4: 0 hours | 10760 ng/mL | Standard Deviation 2162 |
| Part B: JNJ-56136379 250 mg + NA | Plasma Concentrations of JNJ-56136379 in Currently Not Treated Population | Week 48: 0 hours | 11220 ng/mL | Standard Deviation 2464 |
| Part B: JNJ-56136379 250 mg + NA | Plasma Concentrations of JNJ-56136379 in Currently Not Treated Population | Week 8: 0 hours | 11027 ng/mL | Standard Deviation 2009 |
| Part B: JNJ-56136379 250 mg + NA | Plasma Concentrations of JNJ-56136379 in Currently Not Treated Population | Week 20: 0 hours | 10517 ng/mL | Standard Deviation 2031 |
| Part B: JNJ-56136379 250 mg + NA (TDF) | Plasma Concentrations of JNJ-56136379 in Currently Not Treated Population | Day 1: 2 hour | 2021 ng/mL | Standard Deviation 893 |
| Part B: JNJ-56136379 250 mg + NA (TDF) | Plasma Concentrations of JNJ-56136379 in Currently Not Treated Population | Week 2: 0 hours | 10588 ng/mL | Standard Deviation 3568 |
| Part B: JNJ-56136379 250 mg + NA (TDF) | Plasma Concentrations of JNJ-56136379 in Currently Not Treated Population | Week 12: 0 hours | 12524 ng/mL | Standard Deviation 4756 |
| Part B: JNJ-56136379 250 mg + NA (TDF) | Plasma Concentrations of JNJ-56136379 in Currently Not Treated Population | Follow-up: Week 4 | 1025 ng/mL | Standard Deviation 1523 |
| Part B: JNJ-56136379 250 mg + NA (TDF) | Plasma Concentrations of JNJ-56136379 in Currently Not Treated Population | Week 48: 0 hours | 10740 ng/mL | Standard Deviation 2400 |
| Part B: JNJ-56136379 250 mg + NA (TDF) | Plasma Concentrations of JNJ-56136379 in Currently Not Treated Population | Week 20: 0 hours | 11425 ng/mL | Standard Deviation 3719 |
| Part B: JNJ-56136379 250 mg + NA (TDF) | Plasma Concentrations of JNJ-56136379 in Currently Not Treated Population | Week 44: 0 hours | 11016 ng/mL | Standard Deviation 4277 |
| Part B: JNJ-56136379 250 mg + NA (TDF) | Plasma Concentrations of JNJ-56136379 in Currently Not Treated Population | Week 1: 0 hours | 7138 ng/mL | Standard Deviation 2280 |
| Part B: JNJ-56136379 250 mg + NA (TDF) | Plasma Concentrations of JNJ-56136379 in Currently Not Treated Population | Week 32: 0 hours | 12119 ng/mL | Standard Deviation 4062 |
| Part B: JNJ-56136379 250 mg + NA (TDF) | Plasma Concentrations of JNJ-56136379 in Currently Not Treated Population | Week 8: 0 hours | 13037 ng/mL | Standard Deviation 4394 |
| Part B: JNJ-56136379 250 mg + NA (TDF) | Plasma Concentrations of JNJ-56136379 in Currently Not Treated Population | Week 24: 0 hours | 11625 ng/mL | Standard Deviation 5087 |
| Part B: JNJ-56136379 250 mg + NA (TDF) | Plasma Concentrations of JNJ-56136379 in Currently Not Treated Population | Follow-up: Week 2 | 2192 ng/mL | Standard Deviation 1535 |
| Part B: JNJ-56136379 250 mg + NA (TDF) | Plasma Concentrations of JNJ-56136379 in Currently Not Treated Population | Week 28: 0 hours | 11746 ng/mL | Standard Deviation 4752 |
| Part B: JNJ-56136379 250 mg + NA (TDF) | Plasma Concentrations of JNJ-56136379 in Currently Not Treated Population | Day 1: 0 hour | NA ng/mL | — |
| Part B: JNJ-56136379 250 mg + NA (TDF) | Plasma Concentrations of JNJ-56136379 in Currently Not Treated Population | Week 4: 0 hours | 12513 ng/mL | Standard Deviation 4229 |
| Part B: JNJ-56136379 250 mg + NA (TDF) | Plasma Concentrations of JNJ-56136379 in Currently Not Treated Population | Week 36: 0 hours | 11192 ng/mL | Standard Deviation 5191 |
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.
Time frame: 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
Population: The PK analysis set included data for all participants with available plasma concentrations. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure and 'n' (number analyzed) represents number of participants evaluable for the specified timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Plasma Concentrations of JNJ-56136379 in Virologically Suppressed Population | Day 1: 2 hour | 857 ng/mL | Standard Deviation 238 |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Plasma Concentrations of JNJ-56136379 in Virologically Suppressed Population | Week 1: 0 hours | 2144 ng/mL | Standard Deviation 553 |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Plasma Concentrations of JNJ-56136379 in Virologically Suppressed Population | Week 28: 0 hours | 4259 ng/mL | Standard Deviation 1083 |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Plasma Concentrations of JNJ-56136379 in Virologically Suppressed Population | Week 8: 0 hours | 3917 ng/mL | Standard Deviation 1131 |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Plasma Concentrations of JNJ-56136379 in Virologically Suppressed Population | Week 2: 0 hours | 3193 ng/mL | Standard Deviation 1017 |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Plasma Concentrations of JNJ-56136379 in Virologically Suppressed Population | Week 4: 0 hours | 3689 ng/mL | Standard Deviation 1178 |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Plasma Concentrations of JNJ-56136379 in Virologically Suppressed Population | Week 20: 0 hours | 3948 ng/mL | Standard Deviation 1151 |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Plasma Concentrations of JNJ-56136379 in Virologically Suppressed Population | Follow-up: Week 4 | 89.8 ng/mL | Standard Deviation 102 |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Plasma Concentrations of JNJ-56136379 in Virologically Suppressed Population | Week 32: 0 hours | 3788 ng/mL | Standard Deviation 841 |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Plasma Concentrations of JNJ-56136379 in Virologically Suppressed Population | Week 44: 0 hours | 3998 ng/mL | Standard Deviation 1139 |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Plasma Concentrations of JNJ-56136379 in Virologically Suppressed Population | Week 24: 0 hours | 3989 ng/mL | Standard Deviation 957 |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Plasma Concentrations of JNJ-56136379 in Virologically Suppressed Population | Week 36: 0 hours | 3801 ng/mL | Standard Deviation 1170 |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Plasma Concentrations of JNJ-56136379 in Virologically Suppressed Population | Week 48: 0 hours | 3918 ng/mL | Standard Deviation 1259 |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Plasma Concentrations of JNJ-56136379 in Virologically Suppressed Population | Follow-up: Week 2 | 621 ng/mL | Standard Deviation 607 |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Plasma Concentrations of JNJ-56136379 in Virologically Suppressed Population | Day 1: 0 hour | NA ng/mL | — |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Plasma Concentrations of JNJ-56136379 in Virologically Suppressed Population | Week 12: 0 hours | 4194 ng/mL | Standard Deviation 1279 |
| Part A: JNJ-56136379 75 mg (Open Label) | Plasma Concentrations of JNJ-56136379 in Virologically Suppressed Population | Week 2: 0 hours | 3206 ng/mL | Standard Deviation 710 |
| Part A: JNJ-56136379 75 mg (Open Label) | Plasma Concentrations of JNJ-56136379 in Virologically Suppressed Population | Day 1: 2 hour | 616 ng/mL | Standard Deviation 385 |
| Part A: JNJ-56136379 75 mg (Open Label) | Plasma Concentrations of JNJ-56136379 in Virologically Suppressed Population | Follow-up: Week 4 | 204 ng/mL | Standard Deviation 209 |
| Part A: JNJ-56136379 75 mg (Open Label) | Plasma Concentrations of JNJ-56136379 in Virologically Suppressed Population | Week 8: 0 hours | 3998 ng/mL | Standard Deviation 1376 |
| Part A: JNJ-56136379 75 mg (Open Label) | Plasma Concentrations of JNJ-56136379 in Virologically Suppressed Population | Week 36: 0 hours | 3535 ng/mL | Standard Deviation 964 |
| Part A: JNJ-56136379 75 mg (Open Label) | Plasma Concentrations of JNJ-56136379 in Virologically Suppressed Population | Week 1: 0 hours | 2301 ng/mL | Standard Deviation 639 |
| Part A: JNJ-56136379 75 mg (Open Label) | Plasma Concentrations of JNJ-56136379 in Virologically Suppressed Population | Week 24: 0 hours | 3836 ng/mL | Standard Deviation 1160 |
| Part A: JNJ-56136379 75 mg (Open Label) | Plasma Concentrations of JNJ-56136379 in Virologically Suppressed Population | Week 44: 0 hours | 3784 ng/mL | Standard Deviation 1056 |
| Part A: JNJ-56136379 75 mg (Open Label) | Plasma Concentrations of JNJ-56136379 in Virologically Suppressed Population | Day 1: 0 hour | NA ng/mL | — |
| Part A: JNJ-56136379 75 mg (Open Label) | Plasma Concentrations of JNJ-56136379 in Virologically Suppressed Population | Week 4: 0 hours | 3694 ng/mL | Standard Deviation 815 |
| Part A: JNJ-56136379 75 mg (Open Label) | Plasma Concentrations of JNJ-56136379 in Virologically Suppressed Population | Follow-up: Week 2 | 912 ng/mL | Standard Deviation 585 |
| Part A: JNJ-56136379 75 mg (Open Label) | Plasma Concentrations of JNJ-56136379 in Virologically Suppressed Population | Week 28: 0 hours | 3506 ng/mL | Standard Deviation 1032 |
| Part A: JNJ-56136379 75 mg (Open Label) | Plasma Concentrations of JNJ-56136379 in Virologically Suppressed Population | Week 12: 0 hours | 3813 ng/mL | Standard Deviation 945 |
| Part A: JNJ-56136379 75 mg (Open Label) | Plasma Concentrations of JNJ-56136379 in Virologically Suppressed Population | Week 48: 0 hours | NA ng/mL | — |
| Part A: JNJ-56136379 75 mg (Open Label) | Plasma Concentrations of JNJ-56136379 in Virologically Suppressed Population | Week 20: 0 hours | 4134 ng/mL | Standard Deviation 1375 |
| Part A: JNJ-56136379 75 mg (Open Label) | Plasma Concentrations of JNJ-56136379 in Virologically Suppressed Population | Week 32: 0 hours | 3721 ng/mL | Standard Deviation 1088 |
| Part A: JNJ-56136379 75 mg + NA | Plasma Concentrations of JNJ-56136379 in Virologically Suppressed Population | Follow-up: Week 4 | 389 ng/mL | Standard Deviation 384 |
| Part A: JNJ-56136379 75 mg + NA | Plasma Concentrations of JNJ-56136379 in Virologically Suppressed Population | Week 2: 0 hours | 8485 ng/mL | Standard Deviation 2269 |
| Part A: JNJ-56136379 75 mg + NA | Plasma Concentrations of JNJ-56136379 in Virologically Suppressed Population | Week 8: 0 hours | 11295 ng/mL | Standard Deviation 3829 |
| Part A: JNJ-56136379 75 mg + NA | Plasma Concentrations of JNJ-56136379 in Virologically Suppressed Population | Week 20: 0 hours | 10761 ng/mL | Standard Deviation 3980 |
| Part A: JNJ-56136379 75 mg + NA | Plasma Concentrations of JNJ-56136379 in Virologically Suppressed Population | Week 24: 0 hours | 10219 ng/mL | Standard Deviation 3370 |
| Part A: JNJ-56136379 75 mg + NA | Plasma Concentrations of JNJ-56136379 in Virologically Suppressed Population | Week 28: 0 hours | 9959 ng/mL | Standard Deviation 2929 |
| Part A: JNJ-56136379 75 mg + NA | Plasma Concentrations of JNJ-56136379 in Virologically Suppressed Population | Week 32: 0 hours | 10189 ng/mL | Standard Deviation 3160 |
| Part A: JNJ-56136379 75 mg + NA | Plasma Concentrations of JNJ-56136379 in Virologically Suppressed Population | Week 44: 0 hours | 9634 ng/mL | Standard Deviation 3707 |
| Part A: JNJ-56136379 75 mg + NA | Plasma Concentrations of JNJ-56136379 in Virologically Suppressed Population | Week 48: 0 hours | NA ng/mL | — |
| Part A: JNJ-56136379 75 mg + NA | Plasma Concentrations of JNJ-56136379 in Virologically Suppressed Population | Day 1: 2 hour | 2103 ng/mL | Standard Deviation 1400 |
| Part A: JNJ-56136379 75 mg + NA | Plasma Concentrations of JNJ-56136379 in Virologically Suppressed Population | Week 1: 0 hours | 5758 ng/mL | Standard Deviation 1081 |
| Part A: JNJ-56136379 75 mg + NA | Plasma Concentrations of JNJ-56136379 in Virologically Suppressed Population | Week 4: 0 hours | 10106 ng/mL | Standard Deviation 2838 |
| Part A: JNJ-56136379 75 mg + NA | Plasma Concentrations of JNJ-56136379 in Virologically Suppressed Population | Week 12: 0 hours | 10404 ng/mL | Standard Deviation 4246 |
| Part A: JNJ-56136379 75 mg + NA | Plasma Concentrations of JNJ-56136379 in Virologically Suppressed Population | Week 36: 0 hours | 10036 ng/mL | Standard Deviation 2786 |
| Part A: JNJ-56136379 75 mg + NA | Plasma Concentrations of JNJ-56136379 in Virologically Suppressed Population | Follow-up: Week 2 | 1919 ng/mL | Standard Deviation 1359 |
| Part B: JNJ-56136379 250 mg (Open Label) | Plasma Concentrations of JNJ-56136379 in Virologically Suppressed Population | Day 1: 2 hour | 2083 ng/mL | Standard Deviation 1022 |
| Part B: JNJ-56136379 250 mg (Open Label) | Plasma Concentrations of JNJ-56136379 in Virologically Suppressed Population | Week 8: 0 hours | 13352 ng/mL | Standard Deviation 6072 |
| Part B: JNJ-56136379 250 mg (Open Label) | Plasma Concentrations of JNJ-56136379 in Virologically Suppressed Population | Day 1: 0 hour | NA ng/mL | — |
| Part B: JNJ-56136379 250 mg (Open Label) | Plasma Concentrations of JNJ-56136379 in Virologically Suppressed Population | Follow-up: Week 4 | 1066 ng/mL | Standard Deviation 2319 |
| Part B: JNJ-56136379 250 mg (Open Label) | Plasma Concentrations of JNJ-56136379 in Virologically Suppressed Population | Week 28: 0 hours | 11344 ng/mL | Standard Deviation 4482 |
| Part B: JNJ-56136379 250 mg (Open Label) | Plasma Concentrations of JNJ-56136379 in Virologically Suppressed Population | Week 12: 0 hours | 12776 ng/mL | Standard Deviation 5191 |
| Part B: JNJ-56136379 250 mg (Open Label) | Plasma Concentrations of JNJ-56136379 in Virologically Suppressed Population | Week 48: 0 hours | 15080 ng/mL | Standard Deviation 8060 |
| Part B: JNJ-56136379 250 mg (Open Label) | Plasma Concentrations of JNJ-56136379 in Virologically Suppressed Population | Week 44: 0 hours | 14853 ng/mL | Standard Deviation 7977 |
| Part B: JNJ-56136379 250 mg (Open Label) | Plasma Concentrations of JNJ-56136379 in Virologically Suppressed Population | Week 32: 0 hours | 12099 ng/mL | Standard Deviation 6301 |
| Part B: JNJ-56136379 250 mg (Open Label) | Plasma Concentrations of JNJ-56136379 in Virologically Suppressed Population | Week 24: 0 hours | 11542 ng/mL | Standard Deviation 4612 |
| Part B: JNJ-56136379 250 mg (Open Label) | Plasma Concentrations of JNJ-56136379 in Virologically Suppressed Population | Week 36: 0 hours | 12227 ng/mL | Standard Deviation 5396 |
| Part B: JNJ-56136379 250 mg (Open Label) | Plasma Concentrations of JNJ-56136379 in Virologically Suppressed Population | Week 20: 0 hours | 12432 ng/mL | Standard Deviation 4249 |
| Part B: JNJ-56136379 250 mg (Open Label) | Plasma Concentrations of JNJ-56136379 in Virologically Suppressed Population | Week 2: 0 hours | 10077 ng/mL | Standard Deviation 2886 |
| Part B: JNJ-56136379 250 mg (Open Label) | Plasma Concentrations of JNJ-56136379 in Virologically Suppressed Population | Follow-up: Week 2 | 3190 ng/mL | Standard Deviation 4462 |
| Part B: JNJ-56136379 250 mg (Open Label) | Plasma Concentrations of JNJ-56136379 in Virologically Suppressed Population | Week 4: 0 hours | 12167 ng/mL | Standard Deviation 4271 |
| Part B: JNJ-56136379 250 mg (Open Label) | Plasma Concentrations of JNJ-56136379 in Virologically Suppressed Population | Week 1: 0 hours | 7280 ng/mL | Standard Deviation 2098 |
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.
Time frame: 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
Population: The PK analysis set included data for all participants with available plasma concentrations. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure and 'n' (number analyzed) represents number of participants evaluable for the specified timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Plasma Concentrations of TDF in Virologically Suppressed Population | Week 36: 0 hours | 80.2 ng/mL | Standard Deviation 50.3 |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Plasma Concentrations of TDF in Virologically Suppressed Population | Week 44: 0 hours | 72.7 ng/mL | Standard Deviation 54.9 |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Plasma Concentrations of TDF in Virologically Suppressed Population | Week 48: 0 hours | 87.6 ng/mL | Standard Deviation 58.5 |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Plasma Concentrations of TDF in Virologically Suppressed Population | Day 1: 2 hours | 274 ng/mL | Standard Deviation 153 |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Plasma Concentrations of TDF in Virologically Suppressed Population | Week 28: 0 hours | 81.7 ng/mL | Standard Deviation 37.7 |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Plasma Concentrations of TDF in Virologically Suppressed Population | Follow-up: Week 2 | 86.5 ng/mL | Standard Deviation 73.8 |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Plasma Concentrations of TDF in Virologically Suppressed Population | Week 4: 0 hours | 83.1 ng/mL | Standard Deviation 54.8 |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Plasma Concentrations of TDF in Virologically Suppressed Population | Week 1: 0 hours | 76.8 ng/mL | Standard Deviation 40.8 |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Plasma Concentrations of TDF in Virologically Suppressed Population | Week 24: 0 hours | 78.3 ng/mL | Standard Deviation 33.4 |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Plasma Concentrations of TDF in Virologically Suppressed Population | Follow-up: Week 4 | 74.7 ng/mL | Standard Deviation 47.6 |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Plasma Concentrations of TDF in Virologically Suppressed Population | Week 20: 0 hours | 99.6 ng/mL | Standard Deviation 85 |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Plasma Concentrations of TDF in Virologically Suppressed Population | Week 2: 0 hours | 82.0 ng/mL | Standard Deviation 53 |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Plasma Concentrations of TDF in Virologically Suppressed Population | Week 32: 0 hours | 75.5 ng/mL | Standard Deviation 54.8 |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Plasma Concentrations of TDF in Virologically Suppressed Population | Week 12: 0 hours | 98.8 ng/mL | Standard Deviation 73.6 |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Plasma Concentrations of TDF in Virologically Suppressed Population | Week 8: 0 hours | 84.0 ng/mL | Standard Deviation 54.1 |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Plasma Concentrations of TDF in Virologically Suppressed Population | Day 1: 0 hours | NA ng/mL | — |
| Part A: JNJ-56136379 75 mg (Open Label) | Plasma Concentrations of TDF in Virologically Suppressed Population | Week 36: 0 hours | 80.2 ng/mL | Standard Deviation 31.2 |
| Part A: JNJ-56136379 75 mg (Open Label) | Plasma Concentrations of TDF in Virologically Suppressed Population | Week 20: 0 hours | 64.8 ng/mL | Standard Deviation 23.3 |
| Part A: JNJ-56136379 75 mg (Open Label) | Plasma Concentrations of TDF in Virologically Suppressed Population | Day 1: 0 hours | NA ng/mL | — |
| Part A: JNJ-56136379 75 mg (Open Label) | Plasma Concentrations of TDF in Virologically Suppressed Population | Week 24: 0 hours | 73.8 ng/mL | Standard Deviation 33 |
| Part A: JNJ-56136379 75 mg (Open Label) | Plasma Concentrations of TDF in Virologically Suppressed Population | Follow-up: Week 4 | 59.7 ng/mL | Standard Deviation 23.4 |
| Part A: JNJ-56136379 75 mg (Open Label) | Plasma Concentrations of TDF in Virologically Suppressed Population | Week 28: 0 hours | 70.6 ng/mL | Standard Deviation 28.1 |
| Part A: JNJ-56136379 75 mg (Open Label) | Plasma Concentrations of TDF in Virologically Suppressed Population | Week 48: 0 hours | 66.2 ng/mL | Standard Deviation 22.1 |
| Part A: JNJ-56136379 75 mg (Open Label) | Plasma Concentrations of TDF in Virologically Suppressed Population | Week 8: 0 hours | 65.5 ng/mL | Standard Deviation 28.9 |
| Part A: JNJ-56136379 75 mg (Open Label) | Plasma Concentrations of TDF in Virologically Suppressed Population | Week 32: 0 hours | 61.2 ng/mL | Standard Deviation 21.2 |
| Part A: JNJ-56136379 75 mg (Open Label) | Plasma Concentrations of TDF in Virologically Suppressed Population | Day 1: 2 hours | 311 ng/mL | Standard Deviation 92.5 |
| Part A: JNJ-56136379 75 mg (Open Label) | Plasma Concentrations of TDF in Virologically Suppressed Population | Week 1: 0 hours | 59.2 ng/mL | Standard Deviation 15.7 |
| Part A: JNJ-56136379 75 mg (Open Label) | Plasma Concentrations of TDF in Virologically Suppressed Population | Follow-up: Week 2 | 51.9 ng/mL | Standard Deviation 23.4 |
| Part A: JNJ-56136379 75 mg (Open Label) | Plasma Concentrations of TDF in Virologically Suppressed Population | Week 4: 0 hours | 66.9 ng/mL | Standard Deviation 20.3 |
| Part A: JNJ-56136379 75 mg (Open Label) | Plasma Concentrations of TDF in Virologically Suppressed Population | Week 2: 0 hours | 65.9 ng/mL | Standard Deviation 18.9 |
| Part A: JNJ-56136379 75 mg (Open Label) | Plasma Concentrations of TDF in Virologically Suppressed Population | Week 12: 0 hours | 63.5 ng/mL | Standard Deviation 21.6 |
| Part A: JNJ-56136379 75 mg (Open Label) | Plasma Concentrations of TDF in Virologically Suppressed Population | Week 44: 0 hours | 93.0 ng/mL | Standard Deviation 64.2 |
| Part A: JNJ-56136379 75 mg + NA | Plasma Concentrations of TDF in Virologically Suppressed Population | Week 32: 0 hours | 43.2 ng/mL | Standard Deviation 36.4 |
| Part A: JNJ-56136379 75 mg + NA | Plasma Concentrations of TDF in Virologically Suppressed Population | Week 36: 0 hours | 101 ng/mL | Standard Deviation 33.1 |
| Part A: JNJ-56136379 75 mg + NA | Plasma Concentrations of TDF in Virologically Suppressed Population | Week 2: 0 hours | 97.5 ng/mL | Standard Deviation 34 |
| Part A: JNJ-56136379 75 mg + NA | Plasma Concentrations of TDF in Virologically Suppressed Population | Week 48: 0 hours | 114 ng/mL | Standard Deviation 31.7 |
| Part A: JNJ-56136379 75 mg + NA | Plasma Concentrations of TDF in Virologically Suppressed Population | Follow-up: Week 2 | 73.2 ng/mL | Standard Deviation 18.5 |
| Part A: JNJ-56136379 75 mg + NA | Plasma Concentrations of TDF in Virologically Suppressed Population | Follow-up: Week 4 | 71.2 ng/mL | Standard Deviation 33 |
| Part A: JNJ-56136379 75 mg + NA | Plasma Concentrations of TDF in Virologically Suppressed Population | Week 44: 0 hours | 109 ng/mL | Standard Deviation 53.4 |
| Part A: JNJ-56136379 75 mg + NA | Plasma Concentrations of TDF in Virologically Suppressed Population | Day 1: 0 hours | 68.9 ng/mL | Standard Deviation 10.1 |
| Part A: JNJ-56136379 75 mg + NA | Plasma Concentrations of TDF in Virologically Suppressed Population | Day 1: 2 hours | 306 ng/mL | Standard Deviation 145 |
| Part A: JNJ-56136379 75 mg + NA | Plasma Concentrations of TDF in Virologically Suppressed Population | Week 1: 0 hours | 97.9 ng/mL | Standard Deviation 38 |
| Part A: JNJ-56136379 75 mg + NA | Plasma Concentrations of TDF in Virologically Suppressed Population | Week 12: 0 hours | 99.4 ng/mL | Standard Deviation 33.8 |
| Part A: JNJ-56136379 75 mg + NA | Plasma Concentrations of TDF in Virologically Suppressed Population | Week 4: 0 hours | 96.9 ng/mL | Standard Deviation 25 |
| Part A: JNJ-56136379 75 mg + NA | Plasma Concentrations of TDF in Virologically Suppressed Population | Week 20: 0 hours | 120 ng/mL | Standard Deviation 30.1 |
| Part A: JNJ-56136379 75 mg + NA | Plasma Concentrations of TDF in Virologically Suppressed Population | Week 24: 0 hours | 104 ng/mL | Standard Deviation 29.9 |
| Part A: JNJ-56136379 75 mg + NA | Plasma Concentrations of TDF in Virologically Suppressed Population | Week 28: 0 hours | 110 ng/mL | Standard Deviation 43.2 |
| Part A: JNJ-56136379 75 mg + NA | Plasma Concentrations of TDF in Virologically Suppressed Population | Week 8: 0 hours | 118 ng/mL | Standard Deviation 48 |
| Part B: JNJ-56136379 250 mg (Open Label) | Plasma Concentrations of TDF in Virologically Suppressed Population | Follow-up: Week 4 | 95.8 ng/mL | Standard Deviation 83.6 |
| Part B: JNJ-56136379 250 mg (Open Label) | Plasma Concentrations of TDF in Virologically Suppressed Population | Day 1: 0 hours | 63.3 ng/mL | Standard Deviation 27.4 |
| Part B: JNJ-56136379 250 mg (Open Label) | Plasma Concentrations of TDF in Virologically Suppressed Population | Week 2: 0 hours | 114 ng/mL | Standard Deviation 51 |
| Part B: JNJ-56136379 250 mg (Open Label) | Plasma Concentrations of TDF in Virologically Suppressed Population | Week 4: 0 hours | 110 ng/mL | Standard Deviation 41.4 |
| Part B: JNJ-56136379 250 mg (Open Label) | Plasma Concentrations of TDF in Virologically Suppressed Population | Week 8: 0 hours | 109 ng/mL | Standard Deviation 32.2 |
| Part B: JNJ-56136379 250 mg (Open Label) | Plasma Concentrations of TDF in Virologically Suppressed Population | Week 44: 0 hours | 129 ng/mL | Standard Deviation 73.6 |
| Part B: JNJ-56136379 250 mg (Open Label) | Plasma Concentrations of TDF in Virologically Suppressed Population | Day 1: 2 hours | 364 ng/mL | Standard Deviation 260 |
| Part B: JNJ-56136379 250 mg (Open Label) | Plasma Concentrations of TDF in Virologically Suppressed Population | Week 1: 0 hours | 97.1 ng/mL | Standard Deviation 36.8 |
| Part B: JNJ-56136379 250 mg (Open Label) | Plasma Concentrations of TDF in Virologically Suppressed Population | Week 12: 0 hours | 130 ng/mL | Standard Deviation 87.8 |
| Part B: JNJ-56136379 250 mg (Open Label) | Plasma Concentrations of TDF in Virologically Suppressed Population | Week 20: 0 hours | 127 ng/mL | Standard Deviation 64.9 |
| Part B: JNJ-56136379 250 mg (Open Label) | Plasma Concentrations of TDF in Virologically Suppressed Population | Week 24: 0 hours | 113 ng/mL | Standard Deviation 47.6 |
| Part B: JNJ-56136379 250 mg (Open Label) | Plasma Concentrations of TDF in Virologically Suppressed Population | Week 28: 0 hours | 155 ng/mL | Standard Deviation 107 |
| Part B: JNJ-56136379 250 mg (Open Label) | Plasma Concentrations of TDF in Virologically Suppressed Population | Week 32: 0 hours | 139 ng/mL | Standard Deviation 93.3 |
| Part B: JNJ-56136379 250 mg (Open Label) | Plasma Concentrations of TDF in Virologically Suppressed Population | Week 36: 0 hours | 132 ng/mL | Standard Deviation 90.2 |
| Part B: JNJ-56136379 250 mg (Open Label) | Plasma Concentrations of TDF in Virologically Suppressed Population | Week 48: 0 hours | 133 ng/mL | Standard Deviation 117 |
| Part B: JNJ-56136379 250 mg (Open Label) | Plasma Concentrations of TDF in Virologically Suppressed Population | Follow-up: Week 2 | 136 ng/mL | Standard Deviation 95.5 |
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.
Time frame: 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
Population: The PK analysis set included data for all participants with available plasma concentrations. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure and 'n' (number analyzed) represents number of participants evaluable for the specified timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Plasma Concentrations of Tenofovir Disoproxil Fumarate (TDF) in Currently Not Treated Population | Week 4: 0 hours | 62.9 nanograms per milliliter (ng/mL) | Standard Deviation 17.7 |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Plasma Concentrations of Tenofovir Disoproxil Fumarate (TDF) in Currently Not Treated Population | Follow-up: Week 4 | 72.4 nanograms per milliliter (ng/mL) | Standard Deviation 32.1 |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Plasma Concentrations of Tenofovir Disoproxil Fumarate (TDF) in Currently Not Treated Population | Week 24: 0 hours | 75.9 nanograms per milliliter (ng/mL) | Standard Deviation 51 |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Plasma Concentrations of Tenofovir Disoproxil Fumarate (TDF) in Currently Not Treated Population | Week 20: 0 hours | 72.6 nanograms per milliliter (ng/mL) | Standard Deviation 34.2 |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Plasma Concentrations of Tenofovir Disoproxil Fumarate (TDF) in Currently Not Treated Population | Week 8: 0 hours | 66.3 nanograms per milliliter (ng/mL) | Standard Deviation 23.7 |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Plasma Concentrations of Tenofovir Disoproxil Fumarate (TDF) in Currently Not Treated Population | Week 36: 0 hours | 78.9 nanograms per milliliter (ng/mL) | Standard Deviation 55.8 |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Plasma Concentrations of Tenofovir Disoproxil Fumarate (TDF) in Currently Not Treated Population | Week 12: 0 hours | 67.5 nanograms per milliliter (ng/mL) | Standard Deviation 31.2 |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Plasma Concentrations of Tenofovir Disoproxil Fumarate (TDF) in Currently Not Treated Population | Week 48: 0 hours | 76.4 nanograms per milliliter (ng/mL) | Standard Deviation 40 |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Plasma Concentrations of Tenofovir Disoproxil Fumarate (TDF) in Currently Not Treated Population | Week 1: 0 hours | 79.6 nanograms per milliliter (ng/mL) | Standard Deviation 38.1 |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Plasma Concentrations of Tenofovir Disoproxil Fumarate (TDF) in Currently Not Treated Population | Follow-up: Week 2 | 73.8 nanograms per milliliter (ng/mL) | Standard Deviation 37.1 |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Plasma Concentrations of Tenofovir Disoproxil Fumarate (TDF) in Currently Not Treated Population | Week 44: 0 hours | 86.3 nanograms per milliliter (ng/mL) | Standard Deviation 30.8 |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Plasma Concentrations of Tenofovir Disoproxil Fumarate (TDF) in Currently Not Treated Population | Day 1: 0 hours | NA nanograms per milliliter (ng/mL) | — |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Plasma Concentrations of Tenofovir Disoproxil Fumarate (TDF) in Currently Not Treated Population | Week 2: 0 hours | 64.2 nanograms per milliliter (ng/mL) | Standard Deviation 34.5 |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Plasma Concentrations of Tenofovir Disoproxil Fumarate (TDF) in Currently Not Treated Population | Day 1: 2 hours | 277 nanograms per milliliter (ng/mL) | Standard Deviation 116 |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Plasma Concentrations of Tenofovir Disoproxil Fumarate (TDF) in Currently Not Treated Population | Week 32: 0 hours | 78.8 nanograms per milliliter (ng/mL) | Standard Deviation 59.6 |
| Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Plasma Concentrations of Tenofovir Disoproxil Fumarate (TDF) in Currently Not Treated Population | Week 28: 0 hours | 74.4 nanograms per milliliter (ng/mL) | Standard Deviation 38.1 |
| Part A: JNJ-56136379 75 mg (Open Label) | Plasma Concentrations of Tenofovir Disoproxil Fumarate (TDF) in Currently Not Treated Population | Week 36: 0 hours | 42.5 nanograms per milliliter (ng/mL) | Standard Deviation 19.3 |
| Part A: JNJ-56136379 75 mg (Open Label) | Plasma Concentrations of Tenofovir Disoproxil Fumarate (TDF) in Currently Not Treated Population | Day 1: 0 hours | NA nanograms per milliliter (ng/mL) | — |
| Part A: JNJ-56136379 75 mg (Open Label) | Plasma Concentrations of Tenofovir Disoproxil Fumarate (TDF) in Currently Not Treated Population | Day 1: 2 hours | 170 nanograms per milliliter (ng/mL) | Standard Deviation 114 |
| Part A: JNJ-56136379 75 mg (Open Label) | Plasma Concentrations of Tenofovir Disoproxil Fumarate (TDF) in Currently Not Treated Population | Week 1: 0 hours | 92.7 nanograms per milliliter (ng/mL) | Standard Deviation 134 |
| Part A: JNJ-56136379 75 mg (Open Label) | Plasma Concentrations of Tenofovir Disoproxil Fumarate (TDF) in Currently Not Treated Population | Week 2: 0 hours | 50.1 nanograms per milliliter (ng/mL) | Standard Deviation 14.1 |
| Part A: JNJ-56136379 75 mg (Open Label) | Plasma Concentrations of Tenofovir Disoproxil Fumarate (TDF) in Currently Not Treated Population | Week 4: 0 hours | 46.5 nanograms per milliliter (ng/mL) | Standard Deviation 10.5 |
| Part A: JNJ-56136379 75 mg (Open Label) | Plasma Concentrations of Tenofovir Disoproxil Fumarate (TDF) in Currently Not Treated Population | Week 8: 0 hours | 54.2 nanograms per milliliter (ng/mL) | Standard Deviation 18.3 |
| Part A: JNJ-56136379 75 mg (Open Label) | Plasma Concentrations of Tenofovir Disoproxil Fumarate (TDF) in Currently Not Treated Population | Week 12: 0 hours | 51.3 nanograms per milliliter (ng/mL) | Standard Deviation 15.9 |
| Part A: JNJ-56136379 75 mg (Open Label) | Plasma Concentrations of Tenofovir Disoproxil Fumarate (TDF) in Currently Not Treated Population | Week 20: 0 hours | 51.2 nanograms per milliliter (ng/mL) | Standard Deviation 13.8 |
| Part A: JNJ-56136379 75 mg (Open Label) | Plasma Concentrations of Tenofovir Disoproxil Fumarate (TDF) in Currently Not Treated Population | Week 24: 0 hours | 50.5 nanograms per milliliter (ng/mL) | Standard Deviation 20.1 |
| Part A: JNJ-56136379 75 mg (Open Label) | Plasma Concentrations of Tenofovir Disoproxil Fumarate (TDF) in Currently Not Treated Population | Week 28: 0 hours | 51.2 nanograms per milliliter (ng/mL) | Standard Deviation 19.9 |
| Part A: JNJ-56136379 75 mg (Open Label) | Plasma Concentrations of Tenofovir Disoproxil Fumarate (TDF) in Currently Not Treated Population | Week 44: 0 hours | 46.3 nanograms per milliliter (ng/mL) | Standard Deviation 26 |
| Part A: JNJ-56136379 75 mg (Open Label) | Plasma Concentrations of Tenofovir Disoproxil Fumarate (TDF) in Currently Not Treated Population | Week 48: 0 hours | 47.8 nanograms per milliliter (ng/mL) | Standard Deviation 18.6 |
| Part A: JNJ-56136379 75 mg (Open Label) | Plasma Concentrations of Tenofovir Disoproxil Fumarate (TDF) in Currently Not Treated Population | Week 32: 0 hours | 52.7 nanograms per milliliter (ng/mL) | Standard Deviation 26.1 |
| Part A: JNJ-56136379 75 mg (Open Label) | Plasma Concentrations of Tenofovir Disoproxil Fumarate (TDF) in Currently Not Treated Population | Follow-up: Week 2 | 52.1 nanograms per milliliter (ng/mL) | Standard Deviation 17.3 |
| Part A: JNJ-56136379 75 mg (Open Label) | Plasma Concentrations of Tenofovir Disoproxil Fumarate (TDF) in Currently Not Treated Population | Follow-up: Week 4 | 57.1 nanograms per milliliter (ng/mL) | Standard Deviation 13.6 |
| Part A: JNJ-56136379 75 mg + NA | Plasma Concentrations of Tenofovir Disoproxil Fumarate (TDF) in Currently Not Treated Population | Week 4: 0 hours | 90.2 nanograms per milliliter (ng/mL) | Standard Deviation 25.8 |
| Part A: JNJ-56136379 75 mg + NA | Plasma Concentrations of Tenofovir Disoproxil Fumarate (TDF) in Currently Not Treated Population | Week 24: 0 hours | 89.1 nanograms per milliliter (ng/mL) | Standard Deviation 30.1 |
| Part A: JNJ-56136379 75 mg + NA | Plasma Concentrations of Tenofovir Disoproxil Fumarate (TDF) in Currently Not Treated Population | Follow-up: Week 2 | 65.7 nanograms per milliliter (ng/mL) | Standard Deviation 29.5 |
| Part A: JNJ-56136379 75 mg + NA | Plasma Concentrations of Tenofovir Disoproxil Fumarate (TDF) in Currently Not Treated Population | Week 28: 0 hours | 99.0 nanograms per milliliter (ng/mL) | Standard Deviation 32.6 |
| Part A: JNJ-56136379 75 mg + NA | Plasma Concentrations of Tenofovir Disoproxil Fumarate (TDF) in Currently Not Treated Population | Week 2: 0 hours | 81.5 nanograms per milliliter (ng/mL) | Standard Deviation 22.6 |
| Part A: JNJ-56136379 75 mg + NA | Plasma Concentrations of Tenofovir Disoproxil Fumarate (TDF) in Currently Not Treated Population | Week 36: 0 hours | 96.0 nanograms per milliliter (ng/mL) | Standard Deviation 38.3 |
| Part A: JNJ-56136379 75 mg + NA | Plasma Concentrations of Tenofovir Disoproxil Fumarate (TDF) in Currently Not Treated Population | Week 1: 0 hours | 92.6 nanograms per milliliter (ng/mL) | Standard Deviation 37.4 |
| Part A: JNJ-56136379 75 mg + NA | Plasma Concentrations of Tenofovir Disoproxil Fumarate (TDF) in Currently Not Treated Population | Week 44: 0 hours | 81.8 nanograms per milliliter (ng/mL) | Standard Deviation 38.9 |
| Part A: JNJ-56136379 75 mg + NA | Plasma Concentrations of Tenofovir Disoproxil Fumarate (TDF) in Currently Not Treated Population | Day 1: 0 hours | NA nanograms per milliliter (ng/mL) | — |
| Part A: JNJ-56136379 75 mg + NA | Plasma Concentrations of Tenofovir Disoproxil Fumarate (TDF) in Currently Not Treated Population | Week 32: 0 hours | 89.6 nanograms per milliliter (ng/mL) | Standard Deviation 37.1 |
| Part A: JNJ-56136379 75 mg + NA | Plasma Concentrations of Tenofovir Disoproxil Fumarate (TDF) in Currently Not Treated Population | Day 1: 2 hours | 372 nanograms per milliliter (ng/mL) | Standard Deviation 478 |
| Part A: JNJ-56136379 75 mg + NA | Plasma Concentrations of Tenofovir Disoproxil Fumarate (TDF) in Currently Not Treated Population | Week 48: 0 hours | 89.5 nanograms per milliliter (ng/mL) | Standard Deviation 49.8 |
| Part A: JNJ-56136379 75 mg + NA | Plasma Concentrations of Tenofovir Disoproxil Fumarate (TDF) in Currently Not Treated Population | Week 8: 0 hours | 92.6 nanograms per milliliter (ng/mL) | Standard Deviation 25.7 |
| Part A: JNJ-56136379 75 mg + NA | Plasma Concentrations of Tenofovir Disoproxil Fumarate (TDF) in Currently Not Treated Population | Week 12: 0 hours | 92.6 nanograms per milliliter (ng/mL) | Standard Deviation 29.1 |
| Part A: JNJ-56136379 75 mg + NA | Plasma Concentrations of Tenofovir Disoproxil Fumarate (TDF) in Currently Not Treated Population | Week 20: 0 hours | 85.8 nanograms per milliliter (ng/mL) | Standard Deviation 30.6 |
| Part A: JNJ-56136379 75 mg + NA | Plasma Concentrations of Tenofovir Disoproxil Fumarate (TDF) in Currently Not Treated Population | Follow-up: Week 4 | 68.7 nanograms per milliliter (ng/mL) | Standard Deviation 54.3 |
| Part B: JNJ-56136379 250 mg (Open Label) | Plasma Concentrations of Tenofovir Disoproxil Fumarate (TDF) in Currently Not Treated Population | Week 48: 0 hours | 100 nanograms per milliliter (ng/mL) | Standard Deviation 29.9 |
| Part B: JNJ-56136379 250 mg (Open Label) | Plasma Concentrations of Tenofovir Disoproxil Fumarate (TDF) in Currently Not Treated Population | Week 8: 0 hours | 108 nanograms per milliliter (ng/mL) | Standard Deviation 36 |
| Part B: JNJ-56136379 250 mg (Open Label) | Plasma Concentrations of Tenofovir Disoproxil Fumarate (TDF) in Currently Not Treated Population | Week 24: 0 hours | 99.3 nanograms per milliliter (ng/mL) | Standard Deviation 37.8 |
| Part B: JNJ-56136379 250 mg (Open Label) | Plasma Concentrations of Tenofovir Disoproxil Fumarate (TDF) in Currently Not Treated Population | Week 2: 0 hours | 97.6 nanograms per milliliter (ng/mL) | Standard Deviation 23.7 |
| Part B: JNJ-56136379 250 mg (Open Label) | Plasma Concentrations of Tenofovir Disoproxil Fumarate (TDF) in Currently Not Treated Population | Follow-up: Week 4 | 68.4 nanograms per milliliter (ng/mL) | Standard Deviation 43.6 |
| Part B: JNJ-56136379 250 mg (Open Label) | Plasma Concentrations of Tenofovir Disoproxil Fumarate (TDF) in Currently Not Treated Population | Week 20: 0 hours | 115 nanograms per milliliter (ng/mL) | Standard Deviation 41.7 |
| Part B: JNJ-56136379 250 mg (Open Label) | Plasma Concentrations of Tenofovir Disoproxil Fumarate (TDF) in Currently Not Treated Population | Week 28: 0 hours | 108 nanograms per milliliter (ng/mL) | Standard Deviation 39 |
| Part B: JNJ-56136379 250 mg (Open Label) | Plasma Concentrations of Tenofovir Disoproxil Fumarate (TDF) in Currently Not Treated Population | Week 32: 0 hours | 88.5 nanograms per milliliter (ng/mL) | Standard Deviation 25.6 |
| Part B: JNJ-56136379 250 mg (Open Label) | Plasma Concentrations of Tenofovir Disoproxil Fumarate (TDF) in Currently Not Treated Population | Week 1: 0 hours | 97.8 nanograms per milliliter (ng/mL) | Standard Deviation 27.7 |
| Part B: JNJ-56136379 250 mg (Open Label) | Plasma Concentrations of Tenofovir Disoproxil Fumarate (TDF) in Currently Not Treated Population | Week 12: 0 hours | 102 nanograms per milliliter (ng/mL) | Standard Deviation 35.3 |
| Part B: JNJ-56136379 250 mg (Open Label) | Plasma Concentrations of Tenofovir Disoproxil Fumarate (TDF) in Currently Not Treated Population | Week 36: 0 hours | 101 nanograms per milliliter (ng/mL) | Standard Deviation 34.2 |
| Part B: JNJ-56136379 250 mg (Open Label) | Plasma Concentrations of Tenofovir Disoproxil Fumarate (TDF) in Currently Not Treated Population | Week 4: 0 hours | 99.6 nanograms per milliliter (ng/mL) | Standard Deviation 26.4 |
| Part B: JNJ-56136379 250 mg (Open Label) | Plasma Concentrations of Tenofovir Disoproxil Fumarate (TDF) in Currently Not Treated Population | Follow-up: Week 2 | 73.5 nanograms per milliliter (ng/mL) | Standard Deviation 23.2 |
| Part B: JNJ-56136379 250 mg (Open Label) | Plasma Concentrations of Tenofovir Disoproxil Fumarate (TDF) in Currently Not Treated Population | Day 1: 0 hours | NA nanograms per milliliter (ng/mL) | — |
| Part B: JNJ-56136379 250 mg (Open Label) | Plasma Concentrations of Tenofovir Disoproxil Fumarate (TDF) in Currently Not Treated Population | Week 44: 0 hours | 105 nanograms per milliliter (ng/mL) | Standard Deviation 33.5 |
| Part B: JNJ-56136379 250 mg (Open Label) | Plasma Concentrations of Tenofovir Disoproxil Fumarate (TDF) in Currently Not Treated Population | Day 1: 2 hours | 249 nanograms per milliliter (ng/mL) | Standard Deviation 96.9 |