Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial Summary
This is a randomized, open label, multicenter Phase 2 study investigating the safety and
antiviral activity of AB-729 in combination with ongoing NA therapy and short courses of
Peg-IFNα-2a in subjects with CHB.
Phase
Phase 2
Funding Agency/Sponsor
Industry
Disease
Hepatitis B
Enrollment Eligibility
Inclusion Criteria:
- Chronic hepatitis B virus infection with documentation at least 6 months prior to
screening
- Subjects must have been receiving either TAF, TDF (or equivalent), or ETV consistently
for ≥12 months prior to dosing Day 1
- HBV DNA
- Subjects must be HBeAg-negative at Screening
- Fibroscan® result of ≤8.5 kPa within 6 months prior to dosing Day 1
- Medically stable based on physical examination, medical history, vital signs,
laboratory values, and 12-lead Electrocardiogram (ECG) at screening
Exclusion Criteria:
- Evidence of co-infection with hepatitis A, C, D or E virus or human immunodeficiency
virus (HIV) at screening
- History of any clinically significant medical condition associated with chronic liver
disease, cirrhosis, evidence of decompensated liver disease, or findings suggestive of
hepatocellular carcinoma (HCC) at any time
- Contraindications to the use of Peg-IFNα-2a or incapable of self-administration or
assisted administration of Peg-IFNα-2a
- Previous treatment with an experimental HBV-directed RNA-interference or antisense
oligonucleotide product.