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

• Status: Recruiting
• Trial end date: 2024-08-01
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Arbutus Biopharma Corporation
• Treatments: Interferon alpha-2; Interferon-alpha; Interferons; Peginterferon alfa-2a

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- 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 or Peg-IFNα-2a