A Study of Different Combination Regimens Including JNJ-73763989 and/or JNJ-56136379 for the Treatment of 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 establish the dose-response relationship for antiviral
      activity of 3 dose levels of JNJ-73763989+nucleos(t)ide analog (NA) and to evaluate the
      efficacy of combination regimens of JNJ-73763989+NA (with and without JNJ-56136379) and of
      JNJ-56136379+NA.
    

Detailed description: 
      Hepatitis B virus (HBV) is a small deoxyribonucleic acid virus that specifically infects the
      human liver. The acute phase of infection is either followed by an immune controlled state or
      progresses to chronic hepatitis B. The worldwide estimated prevalence of chronic HBV
      infection is about 292 million people affected. Hepatitis B surface antigen (HBsAg)
      seroclearance is currently considered to be associated with the most thorough suppression of
      HBV replication (termed functional cure). With current available NA treatment strategies,
      rate of HBsAg seroclearance remains very low (around 3 percent [%]) even under long-term
      treatment. Also, with the persistently high global prevalence of HBV-associated mortality,
      there is a medical need for more effective finite treatment options that lead to sustained
      HBsAg seroclearance. JNJ-73763989 is a liver-targeted antiviral therapeutic for subcutaneous
      injection designed to treat chronic HBV infection via ribonucleic acid interference
      mechanism. JNJ-56136379 is an orally administered capsid assembly modulator that is being
      developed for the treatment of chronic HBV infection. The aim of the study is to evaluate
      efficacy as measured by proportion of participants who completed 48-week study intervention
      and qualified for stopping NA treatment at Week 48. The study includes: Screening phase (4
      weeks), Double-blind study intervention phase (from Day 1 up to Week 48), and Follow-up phase
      (48 weeks after end of investigational intervention with a maximum duration of 96 weeks). The
      duration of individual study participation will be between 100 and 150 weeks. Safety and
      tolerability (including adverse events [AEs] and Serious AEs, laboratory assessments,
      electrocardiogram [ECG], vital signs, physical examination), efficacy (including HBsAg
      seroclearance), and pharmacokinetics will be assessed throughout the study.
    

Intervention name(s): JNJ-73763989; Placebo for JNJ-73763989; JNJ-56136379; Placebo for JNJ-56136379; Nucleos(t)ide Analog (NA)
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): JNJ-73763989 will be administered as medium dose (Arms 1 and 3), high dose (Arm 2), and low dose (Arm 4) as subcutaneous injection.; Placebo for JNJ-73763989 will be administered as subcutaneous injection.; JNJ-56136379 tablets will be administered orally.; Placebo for JNJ-56136379 tablets will be administered orally.; NA treatment that is either of ETV, TDF or TAF tablets will be administered orally.
Intervention MeSH terms: JNJ-56136379
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment