For Healthcare Professionals

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

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About the study

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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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Inclusion Criteria:


  1. Chronic hepatitis B virus infection with documentation at least 6 months prior to screening
  2. Subjects must have been receiving either TAF, TDF (or equivalent), or ETV consistently for ≥12 months prior to dosing Day 1
  3. HBV DNA
  4. HBsAg between 100 and 5,000 IU/mL at Screening
  5. Subjects must be HBeAg-negative at Screening
  6. Fibroscan® result of ≤8.5 kPa within 6 months prior to dosing Day 1
  7. Medically stable based on physical examination, medical history, vital signs, laboratory values, and 12-lead Electrocardiogram (ECG) at screening

EXCLUSION CRITERIA

Exclusion Criteria:


  1. Evidence of co-infection with hepatitis A, C, D or E virus or human immunodeficiency virus (HIV) at screening
  2. 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
  3. Contraindications to the use of Peg-IFNα-2a or incapable of self-administration or assisted administration of Peg-IFNα-2a
  4. Previous treatment with an experimental HBV-directed RNA-interference or antisense oligonucleotide product.

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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.

Study’s details


Contition

Chronic Hepatitis b

Age (in years)

18 - 60

Phase

Phase 2

Participants needed

43

Est. Completion Date

Mar 31, 2025

Treatment type

Interventional


Sponsor

Arbutus Biopharma Corporation

ClinicalTrials.gov identifier

NCT04980482

Study number

AB-729-201

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