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
Condition: Hepatitis B, Chronic
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Virus Diseases; Herpesviridae Infections; Hepatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      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).
    

Detailed description: 
      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.
    

Intervention name(s): JNJ-73763989; JNJ-56136379; Placebo for JNJ-73763989; Placebo for JNJ-56136379; Entecavir (ETV) monohydrate; Tenofovir disoproxil fumarate (TDF); Tenofovir alafenamide (TAF)
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): JNJ-73763989 injection will be administered subcutaneously once every 4 weeks up to 48 weeks.; JNJ-56136379 tablets will be administered orally once daily up to 48 weeks.; Matching placebo for JNJ-73763989 will be administered as subcutaneous injection up to 48 weeks.; Matching placebo for JNJ-56136379 tablets will be administered orally up to 48 weeks.; ETV tablet will be administered orally once daily up to 48 weeks as NA treatment.; TDF will be administered orally once daily up to 48 weeks as NA treatment.; TAF will be administered orally once daily up to 48 weeks as NA treatment.
Intervention MeSH terms: Tenofovir; Entecavir; JNJ-56136379
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment