A Study of JNJ 73763989+JNJ 56136379+Nucleos(t)Ide Analog (NA) Regimen Compared to NA Alone in e Antigen Negative Virologically Suppressed Participants With Chronic Hepatitis B Virus Infection
A Study of JNJ 73763989+JNJ 56136379+Nucleos(t)Ide Analog (NA) Regimen Compared to NA Alone in e Antigen Negative Virologically Suppressed Participants With Chronic Hepatitis B Virus Infection
The purpose of this study is to evaluate the efficacy of 48-week study intervention with
 JNJ-73763989+JNJ-56136379+nucleos(t)ide analog (NA) regimen compared to NA alone assessed by
 HBsAg levels. This study is part of HepB Wings Platform Trial (PLATFORMPAHPB2001).
Hepatitis B virus (HBV) is a small deoxyribonucleic acid (DNA) virus that infects the liver
 and can cause either acute or chronic infection. It consists of a so-called nucleocapsid in
 which viral DNA is packed with hepatitis B core protein (HBc) and membranous envelope
 containing hepatitis B surface antigen (HBsAg). Chronic HBV infection may lead to serious
 illnesses like cirrhosis and hepatocellular carcinoma (HCC). Oral treatment with NAs is
 effective at suppressing viral DNA formation and lowering virus concentration in blood to
 levels below lower limit of quantification (LLOQ). JNJ-73763989 is a liver-targeted antiviral
 therapeutic for subcutaneous injection designed to treat chronic HBV infection via
 ribonucleic acid interference mechanism but rarely lead to functional cure defined as
 sustained loss of HBs Ag and HBV DNA in serum. JNJ-56136379 is an orally administered capsid
 assembly modulator that is being developed for treatment of chronic HBV infection. The aim of
 study is to evaluate efficacy of 48-week study intervention with JNJ-3989+JNJ-6379+NA regimen
 compared to NA alone, assessed by HBsAg seroclearance at Week 72 (i.e., 24 weeks after
 completion of all study interventions at Week 48) without restarting NA treatment in HBeAg
 negative virologically suppressed chronic hepatitis B (CHB) infected participants who
 received NA treatment for at least 2 years prior to screening. The study will be 2.3 years
 and will be conducted in 3 phases: a screening phase (4 weeks), a study intervention phase
 (48 weeks), and a follow-up phase (48 weeks). Safety will be evaluated by AEs including AEs
 of special interest to any of the study interventions, clinical laboratory tests, ECGs, vital
 signs, and physical examinations.
Inclusion Criteria:

 -  Medically stable based on physical examination, medical history, vital signs,
 electrocardiogram (ECG) at screening

 -  Chronic hepatitis B virus (HBV) infection with documentation at least 6 months prior
 to screening

 -  Hepatitis B e (antigen) (HBeAg)-negative on stable nucleotide analogue (NA) treatment
 for at least 24 months prior to screening

 -  Hepatitis B surface antigen (HBsAg) greater than (>) 100 International Units per
 Milliliter (IU/mL) at screening

 -  Body mass index (BMI) between 18.0 and 35 kilogram per meter square (kg/m^2), extremes
 included

 -  Highly effective contraceptive measures in place for female participants of
 childbearing potential or male participants with female partners of childbearing
 potential

 -  Liver fibrosis stage 0-2 (Metavir) or Fibroscan less than (<) 9 Kilopascal (kPa) at
 screening

 Exclusion Criteria:

 -  Evidence of infection with hepatitis A, C, D or E virus infection or evidence of human
 immunodeficiency, virus type 1 (HIV-1) or HIV-2 infection at screening

 -  History or evidence of clinical signs/symptoms of hepatic decompensation including but
 not limited to: portal hypertension, ascites, hepatic encephalopathy, esophageal
 varices or any laboratory abnormalities indicating a reduced liver function as defined
 in the protocol

 -  Evidence of liver disease of non-HBV etiology

 -  History or signs of cirrhosis or portal hypertension (nodules, no smooth liver
 contour, no normal portal vein, spleen size ≥12 cm) or signs of hepatocellular
 carcinoma (HCC)

 -  Significant laboratory abnormalities as defined in the protocol at screening

 -  Participants with a history of malignancy within 5 years before screening

 -  Abnormal sinus rhythm or ECG parameters at screening as defined in the protocol

 -  History of or current cardiac arrhythmia or history or clinical evidence of
 significant or unstable cardiac disease

 -  Participants with any current or previous illness for which, in the opinion of the
 investigator and/or sponsor, participation would not be in the best interest of the
 participant

 -  History of or current clinically significant skin disease or drug rash

 -  Known allergies, hypersensitivity, or intolerance to JNJ-73763989 and JNJ-56136379 or
 their excipients or to placebo content

 -  Contraindications to the use of entecavir (ETV), tenofovir disoproxil fumarate (TDF),
 or tenofovir alafenamide (TAF) per local prescribing information

 -  Participants who have taken any therapies disallowed per protocol