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Completed

NCT Number: NCT04980482

Open-Label Study of AB-729, Nucleos(t)Ide Analogue and Pegylated Interferon Alfa-2a in Subjects With Chronic Hepatitis B Infection

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.

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Key information

Conditions

Chronic Hepatitis B Blood-Borne Infections Chronic Disease Communicable Diseases DNA Virus Infections Digestive System Diseases Disease Attributes Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis B, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Virus Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Nepean Hospital, Kingswood, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AB-729

Drug

subcutaneous injection

Peg-IFNα-2a

Drug

subcutaneous injection

Other names: pegylated interferon alpha 2a

Primary outcomes

  1. 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

    Time frame: Up to 124 weeks

Secondary outcomes

  1. Change From Baseline in HBsAg and Other Virologic Markers at Each Time Point

    Time frame: Up to 124 weeks

  2. Proportion of Subjects With HBsAb Seroconversion at Each Timepoint

    Time frame: Up to 124 weeks

  3. Proportion of Subjects Who Are Eligible to Stop NA After Week 24 of Follow up

    Time frame: Up to 76 weeks

  4. Proportion of Subjects Who Discontinue NA and Subsequently Restart NA Therapy After Meeting Criteria

    Time frame: Up to 124 weeks

  5. 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

    Time frame: Up to 124 weeks

  6. 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

    Time frame: Up to 40 weeks

Sponsors and collaborators

Lead sponsor

Arbutus Biopharma Corporation

Industry

Registry information

Official study title

A Randomized, Open-Label, Multicenter Study Investigating AB-729, Nucleos(t)Ide Analogue and Pegylated Interferon Alfa-2a Treatment in Subjects With Chronic Hepatitis B Infection

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Jul 28, 2021
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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