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

NCT ID: NCT04980482

Last Updated: 2025-10-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-29

Study Completion Date

2025-05-21

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Hepatitis b

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cohort A, Group 1

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.

Group Type EXPERIMENTAL

AB-729

Intervention Type DRUG

subcutaneous injection

Peg-IFNα-2a

Intervention Type DRUG

subcutaneous injection

Cohort A, Group 2

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.

Group Type EXPERIMENTAL

AB-729

Intervention Type DRUG

subcutaneous injection

Peg-IFNα-2a

Intervention Type DRUG

subcutaneous injection

Cohort B, Group 1

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.

Group Type EXPERIMENTAL

AB-729

Intervention Type DRUG

subcutaneous injection

Peg-IFNα-2a

Intervention Type DRUG

subcutaneous injection

Cohort B, Group 2

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.

Group Type EXPERIMENTAL

AB-729

Intervention Type DRUG

subcutaneous injection

Peg-IFNα-2a

Intervention Type DRUG

subcutaneous injection

Interventions

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AB-729

subcutaneous injection

Intervention Type DRUG

Peg-IFNα-2a

subcutaneous injection

Intervention Type DRUG

Other Intervention Names

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pegylated interferon alpha 2a

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Arbutus Biopharma Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Arizona Liver Health

Chandler, Arizona, United States

Site Status

Arizona Liver Health

Tucson, Arizona, United States

Site Status

Research and Education, Inc.

San Diego, California, United States

Site Status

University of Miami Miller School of Medicine

Miami, Florida, United States

Site Status

Henry Ford Health System

Detroit, Michigan, United States

Site Status

ID Care

Hillsborough, New Jersey, United States

Site Status

Nepean Hospital

Kingswood, New South Wales, Australia

Site Status

St Vincent's Hospital Melbourne

Melbourne, Victoria, Australia

Site Status

Prince of Wales Hospital, The Chinese University of Hong Kong

Hong Kong, , Hong Kong

Site Status

Queen Mary Hospital

Hong Kong, , Hong Kong

Site Status

Arensia Exploratory Medicine Moldova

Chisinau, , Moldova

Site Status

Pusan National University Hospital

Pusan, Republic of Korea, South Korea

Site Status

Asan Medical Center

Seoul, , South Korea

Site Status

Chia-Yi Christian Hospital

Chiayi City, , Taiwan

Site Status

Chung-Ho Memorial Hospital

Kaohsiung City, , Taiwan

Site Status

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, , Taiwan

Site Status

Medical Center of Limited Liability Company Harmoniya Krasy

Kyiv, , Ukraine

Site Status

Countries

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United States Australia Hong Kong Moldova South Korea Taiwan Ukraine

Other Identifiers

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AB-729-201

Identifier Type: -

Identifier Source: org_study_id

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