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

Arbutus Biopharma

Status and phase: Active, not recruiting; Phase 2

Conditions: Chronic Hepatitis b

Treatments: Drug: AB-729; Drug: Peg-IFNα-2a

Study type: Interventional

Funder types: Industry

Identifiers

NCT04980482

AB-729-201

Details and patient eligibility

About

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.

Enrollment: 43 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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43 participants in 4 patient groups

Cohort A, Group 1

Experimental group

Description:

AB-729 60 mg SC every 8 weeks + NA for 24 weeks, then randomized to: AB-729 60 mg SC every 8 weeks + NA + Peg-IFNα-2a 180 mcg SC every week for 24 weeks.

Treatment:

Drug: Peg-IFNα-2a

Drug: AB-729

Cohort A, Group 2

Experimental group

Description:

AB-729 60 mg SC every 8 weeks + NA for 24 weeks, then randomized to: NA + Peg-IFNα-2a 180 mcg SC every week for 24 weeks.

Treatment:

Drug: Peg-IFNα-2a

Drug: AB-729

Cohort B, Group 1

Experimental group

Description:

AB-729 60 mg SC every 8 weeks + NA for 24 weeks, then randomized to: AB-729 60 mg SC every 8 weeks + NA + Peg-IFNα-2a 180 mcg SC every week for 12 weeks.

Treatment:

Drug: Peg-IFNα-2a

Drug: AB-729

Cohort B, Group 2

Experimental group

Description:

AB-729 60 mg SC every 8 weeks + NA for 24 weeks, then randomized to: NA + Peg-IFNα-2a 180 mcg SC every week for 12 weeks.

Treatment:

Drug: Peg-IFNα-2a

Drug: AB-729