Phase 2
Completed N=43
Open-Label Study of AB-729, Nucleos(t)Ide Analogue and Pegylated Interferon Alfa-2a in Subjects With Chronic Hepatitis B Infection
Source: ClinicalTrials.gov NCT04980482 ↗Enrolled (actual)
43
Serious AEs
2.3%
Results posted
Apr 2026
Primary outcomePrimary: The Frequency and Severity of Treatment Emergent Adverse Events (TEAEs), Discontinuations Due to AEs and Lab Abnormalities After Dosing With AB-729 Plus Peg-IFNα-2a — 23; 11; 11; 8 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Frequency and Severity of Treatment Emergent Adverse Events (TEAEs), Discontinuations Due to AEs and Lab Abnormalities After Dosing With AB-729 Plus Peg-IFNα-2a |
23; 11; 11; 8; 9; 0 | — |
| SECONDARY Change From Baseline in HBsAg and Other Virologic Markers at Each Time Point |
— | — |
| SECONDARY Proportion of Subjects With HBsAb Seroconversion at Each Timepoint |
— | — |
| SECONDARY Proportion of Subjects Who Are Eligible to Stop NA After Week 24 of Follow up |
— | — |
| SECONDARY Proportion of Subjects Who Discontinue NA and Subsequently Restart NA Therapy After Meeting Criteria |
— | — |
| SECONDARY Proportion of Subjects Who Discontinue NA and Subsequently Meet Protocol Defined Clinical Relapse Criteria. Proportion of Subjects Who Discontinue NA and Subsequently Meet Protocol Defined Viral Relapse Criteria |
— | — |
| SECONDARY Post-dose Plasma Concentrations of AB-729 Anti-sense (AS), AB-729 AS(N-1)3', and AB-729 AS(N-2)3' at Selected Timepoints |
— | — |
Eligibility Criteria
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 <LLOQ at Screening
- HBsAg between 100 and 5, 000 IU/mL at Screening
- 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.
Data sourced from ClinicalTrials.gov (NCT04980482). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.