Extension Study of the Safety and Efficacy of Multi-dose Intravenous ARC-520 in Patients With Chronic Hepatitis B (HBV) Infection
Condition: Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis
Intervention: ARC-520 Injection; entecavir; tenofovir; antihistamine
Intervention description: IV injection; All participants will take entecavir or tenofovir throughout the study. Participants will be instructed to take their medication daily.; All participants will take entecavir or tenofovir throughout the study. Participants will be instructed to take their medication daily.; All participants will be pretreated with an oral antihistamine. The antihistamine used should in general be an H1>H2 receptor blocker and would include diphenhydramine 50 mg, cetirizine 10 mg, chlorpheniramine 8 mg or hydroxyzine 50 mg. The Investigator is free to choose any of these antihistamines available locally and consistent with their country's Marketing Authorisation.
Intervention MeSH terms: Tenofovir; Entecavir; Histamine Antagonists; Histamine H1 Antagonists
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      Chronic HBV patients will receive 9 doses of open-label ARC-520 once every 4 weeks and be
      evaluated for safety and efficacy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient showed a ½ log or greater reduction in serum HBsAg levels from baseline to Day
             71 ± 3 days or Day 99 ± 3 days in the primary Heparc-2002 or Heparc-2003 study.

          -  Able to have first dose within 2 months of day 113 end-of-study visit in the primary
             Heparc-2002 or Heparc-2003 study.

          -  Able to provide written informed consent prior to the performance of any study
             specific procedures.

          -  Have no abnormalities in 12-lead ECG assessment that, in the opinion of the
             investigator, may compromise patient safety

          -  Willing and able to comply with all study assessments and adhere to the protocol
             schedule.

          -  Have no new abnormal finding of clinical relevance at the screening evaluation.

          -  Using 2 effective methods of contraception (double barrier contraception or hormonal
             contraceptive along with a barrier contraceptive) (both male and female partners)
             during the study and for 3 months following the last dose of (ARC 520).

        Exclusion Criteria:

          -  Pregnant or lactating.

          -  Acute signs of hepatitis/other infection within 4 weeks of screening and/or at the
             screening examination.

          -  Use of prescription medication (including anticoagulants) within 14 days prior to
             administration of ARC-520.

          -  Has had major surgery within 3 months of screening.

          -  Has evidence of severe systemic acute inflammation, sepsis, or hemolysis.

          -  Diagnosed with a significant psychiatric disorder that would prevent participation in
             the study.

          -  Unable or unwilling to return for all scheduled study visits.

          -  Has any other condition that, in the opinion of the investigator, would render the
             patient unsuitable for enrollment, or could interfere with his/her participation in
             the study.