An Efficacy, Safety, and Pharmacokinetics Study of JNJ-56136379 in Participants With Chronic Hepatitis B Virus Infection

Hepatitis B Clinical Trial

Official title:

A Phase 2a, Randomized, Partially-blind, Placebo-controlled Study to Assess the Efficacy, Safety, and Pharmacokinetics of Treatment With Multiple Doses of JNJ-56136379 as Monotherapy and in Combination With a Nucleos(t)Ide Analog in Subjects With Chronic Hepatitis B Virus Infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03361956
• Other study ID #: CR108410
• Secondary ID: 2017-001110-2956
• Status: Completed
• Phase: Phase 2
• Start date: February 13, 2018
• Est. completion date: August 13, 2020

Study information

• Verified date: October 2022
• Source: Janssen Sciences Ireland UC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 232
• Est. completion date: August 13, 2020
• Est. primary completion date: September 5, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic
• Herpesviridae Infections
• Virus Diseases

Intervention

Drug:
• JNJ-56136379
Participants will receive JNJ-56136379 tablet orally.
• Placebo
Participants will receive matching placebo tablet orally.
• NA (ETV or TDF)
Participants will receive NA (ETV or TDF) tablet orally as per approved label.

Locations

Country	Name	City	State
Belgium	SGS Clinical Pharmacology Unit (located in ZNA Stuivenberg)	Antwerpen
Belgium	Cliniques Universitaires Saint-Luc	Bruxelles
Belgium	UZ Antwerpen	Edegem
Canada	University of Calgary	Calgary	Alberta
Canada	McGill University Health Centre	Montreal	Quebec
Canada	Toronto General Hospital	Toronto
Canada	GI Research Institute (G.I.R.I.)	Vancouver	British Columbia
Canada	Vancouver ID Research and Care Centre Society	Vancouver	British Columbia
China	Beiijing Friendship Hospital, Capital Medical University	Beijing
China	Peking University People's Hospital	Beijing
China	The First Hospital of Jilin University	Changchun
China	Nanfang Hospital	Guangzhou
France	Hôpital Beaujon	Clichy
France	Hopital de La Croix Rousse	Lyon
France	Hopital Saint-Antoine	Paris
France	Hopital Paul Brousse	Villejuif
Germany	Zentrum für Infektiologie Berlin Prenzlauer Berg GmbH	Berlin
Germany	Universitatsklinikum Essen	Essen
Germany	Universitätsklinikum Johann Wolfgang Goethe- Universität Frankfurt Medizinische Klinik 1	Frankfurt
Germany	Asklepios Klinik St. Georg, Haus Lifi - Studien und Projekte GmbH	Hamburg
Hong Kong	Queen Mary Hospital, University of Hong Kong	Hong Kong
Hong Kong	The Chinese University of Hong Kong	Shatin
Italy	ASST Grande Ospedale Metropolitano Niguarda	Milano
Italy	Irccs Ospedale Maggiore Di Milano	Milano
Italy	Azienda Ospedaliero Universitaria Pisana	Pisa
Japan	Hiroshima University Hospital	Hiroshima-shi
Japan	Musashino Red Cross Hospital	Musashino
Japan	National Hospital Organization Nagasaki Medical Center	Nagasaki
Japan	Nagoya City University Hospital	Nagoya
Japan	Osaka University Hospital	Suita-shi
Korea, Republic of	Pusan National University Hospital	Busan
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Severance Hospital, Yonsei University Health System	Seoul
Malaysia	Hospital Sultanah Bahiyah	Alor Setar
Malaysia	University Malaya Medical Centre	Kuala Lumpur
Poland	Szpital Specjalistyczny w Chorzowie	Chorzow
Poland	Wojewodzki Szpital Zespolony	Kielce
Poland	ID Clinic	Myslowice
Poland	SP ZOZ Wroclawskie Centrum Zdrowia	Wroclaw
Russian Federation	Sverdlovsk Regional Clinical Hospital #1	Ekaterinburg
Russian Federation	Medical Center SibNovoMed LLC	Novosibirsk
Russian Federation	Medical Company Hepatolog Ltd	Samara
Russian Federation	Stavropol State Medical University	Stavropol
Spain	Hosp. Clinic I Provincial de Barcelona	Barcelona
Spain	Hosp. Univ. Vall D Hebron	Barcelona
Spain	Hosp. Univ. Ramon Y Cajal	Madrid
Spain	Hosp. Univ. Marques de Valdecilla	Santander
Spain	Hosp. Virgen Del Rocio	Sevilla
Taiwan	Kaohsiung Medical University Chung-Ho Memorial Hospital	Kaohsiung
Taiwan	Taichung Veterans General Hospital	Taichung
Taiwan	National Cheng Kung University Hospital	Tainan
Taiwan	Chang Gung Memorial Hospital Linkou Branch	Tao-Yuan
Thailand	King Chulalongkorn Memorial Hospital	Bangkok
Thailand	Siriraj Hospital	Bangkok
Thailand	Chiang Mai University Hospital	Chiang Mai
Thailand	Prince Of Songkla University	Songkla
Turkey	Istanbul University Cerrahpasa Medical Faculty	Istanbul
Turkey	Saglik Bilimleri University Sisli Trainig and Research Hospital,Department of Gastroenterology	Istanbul
Turkey	Ege University Medical of Faculty, Department of Gastroenterology	Izmir
Turkey	Karadeniz Teknik University Medical Faculty	Trabzon
Ukraine	Kharkiv National Medical University, Regional Clinical Infectious Hospital	Kharkiv
Ukraine	SE 'National institute therapy named L.T. Maloi NAMS of Ukraine'	Kharkiv
Ukraine	Odessa Regional Clinical Hospital	Odessa
Ukraine	Vinnytsia City Clinical Hospital #1, Department of Infectious Diseases #1	Vinnytsya
United Kingdom	North Manchester General Hospital	Crumpsall
United Kingdom	Grahame Hayton Unit	London
United Kingdom	Newcastle upon Tyne Hospitals NHS Foundation Trust	Newcastle upon Tyne
United Kingdom	Nottingham University Hospitals NHS Trust	Nottingham
United States	The Office of Franco Felizarta, MD	Bakersfield	California
United States	Rush University Medical Center	Chicago	Illinois
United States	I.D. Care, Inc.	Hillsborough	New Jersey
United States	Tulane Medical Center (TMC)	New Orleans	Louisiana
United States	NYU Hepatology Associates	New York	New York
United States	Orlando Immunology Center	Orlando	Florida
United States	UPMC Center For Liver Diseases	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Sciences Ireland UC

Countries where clinical trial is conducted

United States,  Belgium,  Canada,  China,  France,  Germany,  Hong Kong,  Italy,  Japan,  Korea, Republic of,  Malaysia,  Poland,  Russian Federation,  Spain,  Taiwan,  Thailand,  Turkey,  Ukraine,  United Kingdom, 

Outcome

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