A Study Evaluating ABI-H0731 as Adjunctive Therapy in Participants With Chronic Hepatitis B Infection
Condition: Chronic Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis; Hepatitis, Chronic
Intervention: ABI-H0731; SOC NUC; Placebo Oral Tablet
Intervention description: Participants will receive ABI-H0731 300 mg tablets orally once daily (QD).; Participants will continue on their SOC NUC (ETV, TDF or TAF) tablet orally as per approved package insert.; Participants will receive placebo matching ABI-0731 tablets orally QD.
Intervention MeSH terms: Tenofovir; Entecavir
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 73.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Chronic hepatitis B; HBV; HBeAg-positive; hepatitis B; HBeAg-negative; vebicorvir; VBR

Summary:

      The purpose of this study is to determine if ABI-H0731 given in combination with a standard
      of care (SOC) hepatitis B virus (HBV) nucleos(t)ide reverse transcriptase inhibitor (NUC)
      medication is safe and effective in participants with chronic hepatitis B virus infection
      (cHBV).
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Male or female between ages 18 and 70 years

          -  Virologically-suppressed (defined as HBV DNA ≤limit of quantitation (LOQ) for at least
             6 months before screening on SOC NUC therapy

          -  HBeAg-positive or HBeAg-negative at screening

          -  In good general health except for cHBV

        Key Exclusion Criteria:

          -  Co-infection with HIV, hepatitis C virus (HCV), hepatitis E virus (HEV) or hepatitis D
             virus (HDV)

          -  History or evidence of hepatic decompensation (including gastrointestinal bleeding or
             esophageal varices) at any time prior to or at time of screening

          -  Clinically significant cardiac or pulmonary disease, chronic or recurrent renal or
             urinary tract disease, liver disease other than HBV, endocrine disorder, autoimmune
             disorder, diabetes mellitus requiring treatment with insulin or hypoglycemic agents,
             neuromuscular, musculoskeletal, or mucocutaneous conditions requiring frequent
             treatment, seizure disorders requiring treatment, or other medical conditions
             requiring frequent medical management or pharmacologic or surgical treatment that in
             the opinion of the Investigator or the Sponsor makes the participant unsuitable for
             the study

          -  Previous treatment with an investigational agent for HBV other than ABI-H0731 in the
             last 6 months before screening

          -  History of hepatocellular carcinoma (HCC)

          -  Females who are lactating or pregnant or wish to become pregnant are excluded from the
             study

          -  Exclusionary laboratory parameters at screening include:

               -  Platelet count <100,000/mm3

               -  Albumin <lower limit of normal (LLN)

               -  Direct bilirubin >1.2×upper limit of normal (ULN)

               -  Alanine aminotransferase (ALT) >5×ULN at screening

               -  International Normalized Ratio (INR) >1.5×ULN

               -  Glomerular filtration rate (GFR) <60 mL/min/1.73 m2 by Chronic Kidney Disease
                  Epidemiology Collaboration (CKD-EPI) equation