A Study Evaluating ABI-H0731+ Entecavir vs Entecavir Alone for the Treatment of Viremic HBeAg-positive Participants With Chronic Hepatitis B Virus Infection (cHBV)
Condition: Chronic Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis; Hepatitis, Chronic
Intervention: ABI-H0731; SOC ETV; Placebo Oral Tablet
Intervention description: Participants will receive 300mg QD of ABI-H0731 tablets orally.; Participants will receive SOC ETV (0.5 mg QD) orally as per approved package insert.; Participants will receive matching QD placebo tablets orally.
Intervention MeSH terms: Entecavir
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 25.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: cHBV; HBV; HBeAg-positive; hepatitis B; vebicorvir; VBR

Summary:

      The purpose of this study is to determine if ABI-H0731 given in combination with a standard
      of care (SOC) entecavir (ETV) is safe and effective in participants with chronic hepatitis B
      infection (cHBV)
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Male or female between ages 18 and 70 years

          -  HBeAg-positive at screening

          -  In good general health except for cHBV

          -  HBV viral load ≥2×105 IU/mL

          -  Hepatitis B surface antigen (HBsAg) >1000 IU/mL at screening

        Key Exclusion Criteria:

          -  Any prior treatment with lamivudine or telbivudine, previous treatment with an
             investigational agent for HBV other than ABI-H0731; or any other SOC treatment for >4
             weeks

          -  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:

               -  Platelet count <100,000/mm3

               -  Albumin <lower limit of normal (LLN)

               -  Direct bilirubin >1.2×upper limit of normal (ULN)

               -  Alanine aminotransferase (ALT) >10×ULN at screening

               -  Serum alpha fetoprotein (AFP) ≥100 ng/mL. If AFP at Screening is >ULN but <100
                  ng/mL, participant is eligible if a hepatic imaging study prior to the initiation
                  of study drug reveals no lesions suspicious of possible HCC

               -  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