A Multicenter Study to Determine the Depth and Duration of Hepatitis B Surface Antigen (HBsAg) Reduction After Single or Multiple Doses of ARC-520, in Combination With Entecavir in Patients With Chronic Hepatitis B Virus (HBV) Infection
Condition: Hepatitis B, Chronic
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis
Intervention: ARC-520; Placebo; entecavir; chlorpheniramine
Intervention description: In all cohorts, each participant received an 8 mg dose of oral chlorpheniramine 2 hours prior to each administration of ARC-520 Injection.
Intervention MeSH terms: Chlorpheniramine; Entecavir
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 58.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: HBV; Hepatitis

Summary:

      The purpose of this study is to determine whether ARC-520 in combination with entecavir is
      effective in the treatment of patients with chronic HBV Infection.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Diagnosis of HBeAg negative and immune active chronic HBV infection (Cohorts 1-4, 8)

          -  Diagnosis of HBeAg positive and immune active chronic HBV infection (Cohorts 5-6, 9)

          -  Diagnosis of HBeAg negative or HBeAg positive and immune active or tolerant chronic
             HBV infection (Cohorts 7, 10, 11 & 12)

          -  Patients with > 6 months of continuous, 0.5 mg/day oral entecavir, and a willingness
             to continue taking entecavir throughout the study (Cohorts 1-6, 8-9).

          -  Patients naive to entecavir (never on entecavir or on entecavir <30 days prior to
             screening) and a willingness to take entecavir and willingness to continue taking
             entecavir throughout the study (Cohorts 7, 11 & 12).

        Key Exclusion Criteria:

          -  Female patients that have a positive pregnancy test or are lactating.

          -  Acute signs of hepatitis/other infection (eg, moderate fever, jaundice, nausea,
             vomiting, and abdominal pain) evident within 4 weeks of screening and/or at the
             screening examination.

          -  Patients with antiviral therapy other than entecavir within 3 months of screening or
             prior treatment with interferon or a toll receptor agonist in the last 5 years.

          -  Use within the last 6 months or an anticipated requirement for anticoagulants,
             corticosteroids, immunomodulators, or immunosuppressants.

          -  Has any history of autoimmune disease especially autoimmune hepatitis.

          -  Has human immunodeficiency virus (HIV) infection, as shown by the presence of anti-HIV
             antibody (sero-positive).

          -  Is sero-positive for hepatitis C virus (HCV), and/or a history of delta virus
             hepatitis.

          -  Has a history of allergy to bee venom or history of hypersensitivity reaction
             requiring an emergency visit to a physician or hospital and/or requirement for
             treatment with steroids and/or epinephrine.