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
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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COMPLETED
PHASE2
43 participants
INTERVENTIONAL
2021-10-29
2025-05-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
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.
AB-729
subcutaneous injection
Peg-IFNα-2a
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.
AB-729
subcutaneous injection
Peg-IFNα-2a
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.
AB-729
subcutaneous injection
Peg-IFNα-2a
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.
AB-729
subcutaneous injection
Peg-IFNα-2a
subcutaneous injection
Interventions
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AB-729
subcutaneous injection
Peg-IFNα-2a
subcutaneous injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
60 Years
ALL
No
Sponsors
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Arbutus Biopharma Corporation
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Other Identifiers
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AB-729-201
Identifier Type: -
Identifier Source: org_study_id
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