A Study of ABI-H0731 + Nucleos(t)Ide as Finite Treatment for Chronic Hepatitis B Patients
Condition: Chronic Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis; Hepatitis, Chronic
Intervention: standard of care (SOC) Nucleoside reverse transcriptase inhibitor (NrtI)
Intervention description: Participants will continue on their SOC NrtI, Entecavir (ETV), Tenofovir Disoproxil Fumarate (TDF) or Tenofovir Alafenamide (TAF) tablet QD (once daily) orally as per approved package insert.
Intervention MeSH terms: Tenofovir; Entecavir; Reverse Transcriptase Inhibitors
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 92.0
Sex: All
Minimum age: 18 Years
Maximum age: 71 Years
Healthy volunteers: No
Keywords: CHB (chronic hepatitis B infection); HBV (hepatitis B virus); HBeAg positive (hepatitis B "e" antigen - positive); HBeAg negative (hepatitis B "e" antigen - negative); Hepatitis B (hepatitis B virus); Hepatitis B virus (HBV); SVR (sustained viral response)

Summary:

      Open-label, extension study to evaluate the safety and efficacy of combination therapy and
      its effect on sustained viral response biomarkers.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Willing and able to provide informed consent.

          2. Previously enrolled on Study ABI-H0731-201 (NCT03576066) or ABI-H0731-202
             (NCT03577171) and completed the treatment period, with demonstrated compliance in the
             opinion of the investigator.

          3. Female subjects must agree to use an effective birth control method for the duration
             of the study and follow-up, or be surgically sterile for at least 6 months, or at
             least 2 years postmenopausal with serum follicle-stimulating hormone (FSH) levels
             consistent with a postmenopausal status. Effective birth control methods include male
             or female condom (may not be used together due to increased risk of breakage),
             vasectomy, intrauterine device (IUD), diaphragm, or cervical cap. Female subjects of
             childbearing potential must have a negative serum pregnancy test.

          4. All heterosexually active male subjects must agree to use an effective birth control
             method for the duration of the study and follow-up. Effective birth control methods
             include male or female condom (may not be used together due to increased risk of
             breakage), vasectomy, hormone-based contraception (only female partner of a male
             subject), IUD, diaphragm, or cervical cap.

          5. Agreement to adhere to Lifestyle Considerations (including abstaining from alcohol
             abuse [defined as alcohol consumption exceeding 2 standard drinks per day on average
             (1 standard drink = 10 grams of alcohol)] and the use of illicit substances, herbal or
             other substances, or unnecessary over-the-counter medications throughout study
             duration.

          6. In good general health except for chronic HBV infection.

          7. Have the ability to take oral medication and be willing to adhere to the ABI-H0731-211
             regimen in the opinion of the Investigator.

        Exclusion Criteria:

          1. Must not have had evidence of HBV resistance-associated variants (RAVs) or lack of
             compliance on a previous study of ABI H0731.

          2. Must not have had a treatment-emergent adverse event or laboratory abnormalities
             deemed clinically significant and possibly or probably related to drug while on a
             previous study of ABI-H0731, that in the opinion of the Investigator or the Sponsor
             makes the subject unsuitable for this study.

          3. Current 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 subject
             unsuitable for the study.

          4. Females who are lactating or pregnant or wish to become pregnant within the duration
             of the ABI-H0731-211 study.