Safety, Tolerability and Antiviral Activity of Selgantolimod in Virally-Suppressed Participants With Chronic Hepatitis B
Condition: Chronic Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis; Hepatitis, Chronic
Intervention: Selgantolimod; Placebo; Hepatitis B virus (HBV) OAV Therapy
Intervention description: Tablet(s) administered orally once weekly; Placebo to match (PTM) selgantolimod tablet(s) administered orally once weekly; Commercially available HBV OAV therapy could include one of the following:
Tenofovir disoproxil fumarate (TDF; Viread®) Entecavir (Baraclude®) Adefovir (Hepsera®) Lamivudine (Epivir® ) Telbivudine (Tyzeka®) Tenofovir alafenamide (TAF; Vemlidy®)
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 48.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The primary objectives of this study are to evaluate the safety, tolerability and antiviral
      activity of selgantolimod (formerly GS-9688) in virally suppressed chronic hepatitis B (CHB)
      adults on oral antiviral (OAV) agents.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Must have the ability to understand and sign a written informed consent form, which
             must be obtained prior to initiation of study procedures

          -  Adult males and non-pregnant, non-lactating females

          -  Documented evidence of chronic HBV infection with detectable hepatitis B surface
             antigen (HBsAg) levels

          -  On commercially available HBV OAV treatment(s) for at least 6 months with no change in
             regimen for 3 months prior to screening

          -  HBV Deoxyribonucleic acid (DNA) ≤ 20 IU/mL for 6 or more months prior to screening

          -  Screening Electrocardiogram (ECG) without clinically significant abnormalities

        Key Exclusion Criteria:

          -  Extensive bridging fibrosis or cirrhosis

          -  Adults meeting any of the protocol defined exclusionary laboratory parameters at
             screening:

               -  Alanine aminotransferase (ALT) > 3x Upper Limit of Normal (ULN)

               -  International normalized ratio (INR) > ULN unless the adult is stable on an
                  anticoagulant regimen

               -  Albumin < 3.5 g/dL

               -  Direct bilirubin > 1.5x ULN

               -  Platelet Count < 100,000/uL

               -  Estimated creatinine clearance < 60 mL/min (using the Cockcroft-Gault method)

          -  Co-infection with human immunodeficiency virus, hepatitis C virus or hepatitis D virus

          -  Prior history of hepatocellular carcinoma (HCC) or screening alpha-fetoprotein ≥ 50
             ng/mL without imaging

          -  Diagnosis of autoimmune disease, poorly controlled diabetes mellitus, significant
             psychiatric illness, severe chronic obstructive pulmonary disease, hemoglobinopathy,
             retinal disease, or are immunosuppressed.

          -  Chronic liver disease of a non-HBV etiology, except for non-alcoholic fatty liver
             disease

          -  Received solid organ or bone marrow transplant

          -  Received prolonged therapy with immunomodulators or biologics within 3 months of
             screening

          -  Use of another investigational agent within 90 days of screening, unless allowed by
             the Sponsor

        NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.