Evaluating the Effects of Inarigivir on Immune Response and Viral Markers in Chronic Hepatitis B Patients

Exclusion Criteria

• •1. Any liver biopsy evidence of metavir F3 or F4 disease on any prior biopsy
• •2. Any history of decompensation of liver disease including history of ascites, encephalopathy, or varices
• •3. Evidence of advanced fibrosis at screening as defined by Fibroscan at the Screening Visit of ≥ 8 kilopascals
• •4. Laboratory parameters not within defined thresholds: ALT or AST ≥ 40 IU, white blood cells \< 4500 cells/μL (SI unit \< 4.5 × 109/L), hemoglobin (HgB) \< 12 g/dL (SI unit \< 120 g/L) for females, \< 13 g/dL (SI unit \< 130 g/L) for males, platelets \< 150,000 per μL (SI unit \< 150 × 109/L), albumin \< 3.5 g/dL (SI unit \< 35 g/L), international normalized ratio (INR) \> 1.5, total bilirubin \> 1.2 mg/dL (SI unit \> 20.52 μmol/L), or alpha-fetoprotein (AFP) \> 50 ng/mL (SI unit \> 180.25 nmol/L). Patients with an elevated indirect bilirubin and known Gilbert's disease can be included if direct bilirubin is within normal limits. Patients with an AFP \> 50 ng/mL but ˂ 500 ng/mL can be included if computed tomography (CT) scan or magnetic resonance imaging (MRI) performed within 3 months shows no evidence of hepatocellular carcinoma.
• •5. Creatinine \> 1.2 mg/dL (SI unit \> 106.08 μmol/L), creatinine clearance \< 50 mL/min (SI unit \< 0.83 L/s/m2)
• •6. Co-infection with hepatitis C virus, human immunodeficiency virus, or hepatitis D virus
• •7. Evidence or history of hepatocellular carcinoma
• •9. Significant cardiovascular, pulmonary, or neurological disease
• •10. Received solid organ or bone marrow transplant
• •11. Received within 3 months of Screening or expected to receive prolonged therapy with immunomodulators (e.g., corticosteroids) or biologics (e.g., monoclonal antibody, Interferon)
• •12. Patients currently taking medication(s) that are transported through organic anion transporting polypeptide 1 including, but not limited to, atazanavir, rifampin, cyclosporine, eltrombopag, gemfibrozil, lopinavir/ritonavir, and saquinavir
• •13. Use of any herbal medications or supplements during the study period
• •14. Use of another investigational agent within 3 months of Screening
• •15. Current alcohol or substance abuse judged by the Investigator to potentially interfere with compliance
• •16. Females who are pregnant or may wish to become pregnant during the study
• •17. If the Investigator believes the prospective patient will not be able to comply with the requirements of the protocol and complete the study
• •18. Any medical condition, in the opinion of the Investigator, that could interfere with evaluation of the study objectives or safety of the patients