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

Completed · Phase 2

Conditions studied: Chronic Hepatitis b

In brief

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.

Key facts

Study ID

NCT04980482

Run by

Arbutus Biopharma Corporation

People needed

43

Starts

2021-10-29

Expected to finish

2025-05-21

Last updated by the study team

2026-04-29

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Arizona Liver Health — Chandler, Arizona, United States
• Arizona Liver Health — Tucson, Arizona, United States
• Research and Education, Inc. — San Diego, California, United States
• University of Miami Miller School of Medicine — Miami, Florida, United States
• Henry Ford Health System — Detroit, Michigan, United States
• ID Care — Hillsborough, New Jersey, United States
• Nepean Hospital — Kingswood, New South Wales, Australia
• St Vincent's Hospital Melbourne — Melbourne, Victoria, Australia
• Prince of Wales Hospital, The Chinese University of Hong Kong — Hong Kong, Hong Kong
• Queen Mary Hospital — Hong Kong, Hong Kong
• Arensia Exploratory Medicine Moldova — Chisinau, Moldova
• Pusan National University Hospital — Pusan, Republic of Korea, South Korea
• Asan Medical Center — Seoul, South Korea
• Chia-Yi Christian Hospital — Chiayi City, Taiwan
• Chung-Ho Memorial Hospital — Kaohsiung City, Taiwan
• Kaohsiung Chang Gung Memorial Hospital — Kaohsiung City, Taiwan
• Medical Center of Limited Liability Company Harmoniya Krasy — Kyiv, Ukraine

Full record on ClinicalTrials.gov

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