Chronic Hepatitis bPhase 2NCT04980482
Open-Label Study of AB-729, Nucleos(t)Ide Analogue and Pegylated Interferon Alfa-2a in Subjects With Chronic Hepatitis B Infection
A Phase 2 study testing AB-729 and Peg-IFNα-2a in people with Chronic Hepatitis b, run by Arbutus Biopharma Corporation at 17 sites in 7 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Chronic Hepatitis b
- What is being tested?
- AB-729 and Peg-IFNα-2a
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 17 sitesin 7 countries
- Study dates
- 29 Oct 2021to 21 May 2025
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
17 sites in 7 countries.
17 sites in 7 countries
United States6 sites
Arizona Liver Health
Chandler, Arizona, 85224
Henry Ford Health System
Detroit, Michigan, 48202
ID Care
Hillsborough, New Jersey, 08844
University of Miami Miller School of Medicine
Miami, Florida, 33136
Research and Education, Inc.
San Diego, California, 92105
Arizona Liver Health
Tucson, Arizona, 85712
Taiwan3 sites
Chia-Yi Christian Hospital
Chiayi City, 60002
Chung-Ho Memorial Hospital
Kaohsiung City, 83301
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, 83301
Australia2 sites
Nepean Hospital
Kingswood, New South Wales, 2747
St Vincent's Hospital Melbourne
Melbourne, Victoria, 3065
Hong Kong2 sites
Prince of Wales Hospital, The Chinese University of Hong Kong
Hong Kong
Queen Mary Hospital
Hong Kong
South Korea2 sites
Pusan National University Hospital
Pusan, Republic of Korea, 49241
Asan Medical Center
Seoul
Ukraine1 site
Medical Center of Limited Liability Company Harmoniya Krasy
Kyiv, 01135
About this study
Official title: A Randomized, Open-Label, Multicenter Study Investigating AB-729, Nucleos(t)Ide Analogue and Pegylated Interferon Alfa-2a Treatment in Subjects With Chronic Hepatitis B Infection
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.
- Conditions
- Chronic Hepatitis b
- Being tested
- AB-729, Peg-IFNα-2a
- Keywords
- Hepatitis B virus, Chronic hepatitis B, HBV, Hepatitis, CHB
- Medical subject headings
- Hepatitis B, Chronic, Hepatitis B, Hepatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AB-729Drug
subcutaneous injection
Peg-IFNα-2aDrug
Also called pegylated interferon alpha 2a
subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Cohort A, Group 1 | Experimental | 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. Receives: Drug: AB-729; Drug: Peg-IFNα-2a |
| Cohort A, Group 2 | Experimental | 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. Receives: Drug: AB-729; Drug: Peg-IFNα-2a |
| Cohort B, Group 1 | Experimental | 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. Receives: Drug: AB-729; Drug: Peg-IFNα-2a |
| Cohort B, Group 2 | Experimental | 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. Receives: Drug: AB-729; Drug: Peg-IFNα-2a |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Frequency and Severity of Treatment Emergent Adverse Events (TEAEs), Discontinuations Due to AEs and Lab Abnormalities After Dosing With AB-729 Plus Peg-IFNα-2a
Measured: Up to 124 weeks
Secondary outcomes (6)
Change From Baseline in HBsAg and Other Virologic Markers at Each Time Point
Measured: Up to 124 weeks
Proportion of Subjects With HBsAb Seroconversion at Each Timepoint
Measured: Up to 124 weeks
Proportion of Subjects Who Are Eligible to Stop NA After Week 24 of Follow up
Measured: Up to 76 weeks
Proportion of Subjects Who Discontinue NA and Subsequently Restart NA Therapy After Meeting Criteria
Measured: Up to 124 weeks
Proportion of Subjects Who Discontinue NA and Subsequently Meet Protocol Defined Clinical Relapse Criteria. Proportion of Subjects Who Discontinue NA and Subsequently Meet Protocol Defined Viral Relapse Criteria
Measured: Up to 124 weeks
Post-dose Plasma Concentrations of AB-729 Anti-sense (AS), AB-729 AS(N-1)3', and AB-729 AS(N-2)3' at Selected Timepoints
Measured: Up to 40 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2021
- Study start29 Oct 2021
- Primary completion13 Mar 2025
- Study completion21 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic Hepatitis bStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arbutus Biopharma Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04980482
- Sponsor's protocol ID
- AB-729-201
- Status last verified
- Apr 2026
- First submitted
- 19 Jul 2021
- Last updated
- 29 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label, Multicenter Study Investigating AB-729, Nucleos(t)Ide Analogue and Pegylated Interferon Alfa-2a Treatment in Subjects With Chronic Hepatitis B Infection
- ClinicalTrials.gov ID
- NCT04980482
- Acronym / sponsor ID
- AB-729-201
- Conditions
- Chronic Hepatitis b
- Keywords
- Hepatitis B virus, Chronic hepatitis B, HBV, Hepatitis, CHB
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Arbutus Biopharma CorporationIndustry (pharma, biotech, devices)
- Study start
- 29 Oct 2021 (actual)
- Primary completion
- 13 Mar 2025 (actual)
- Study completion
- 21 May 2025 (actual)
- First posted
- 28 Jul 2021 (actual)
- Results
- Posted 29 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort A, Group 1 | Experimental | Drug: AB-729, Drug: Peg-IFNα-2aAB-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. |
| Cohort A, Group 2 | Experimental | Drug: AB-729, Drug: Peg-IFNα-2aAB-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. |
| Cohort B, Group 1 | Experimental | Drug: AB-729, Drug: Peg-IFNα-2aAB-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. |
| Cohort B, Group 2 | Experimental | Drug: AB-729, Drug: Peg-IFNα-2aAB-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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AB-729subcutaneous injection | Drug | Cohort A, Group 1, Cohort A, Group 2, Cohort B, Group 1, Cohort B, Group 2 |
| Peg-IFNα-2aAlso: pegylated interferon alpha 2asubcutaneous injection | Drug | Cohort A, Group 1, Cohort A, Group 2, Cohort B, Group 1, Cohort B, Group 2 |
Primary outcome
The Frequency and Severity of Treatment Emergent Adverse Events (TEAEs), Discontinuations Due to AEs and Lab Abnormalities After Dosing With AB-729 Plus Peg-IFNα-2a
Time frame: Up to 124 weeks
6 secondary outcomes
Change From Baseline in HBsAg and Other Virologic Markers at Each Time Point
Time frame: Up to 124 weeks
Proportion of Subjects With HBsAb Seroconversion at Each Timepoint
Time frame: Up to 124 weeks
Proportion of Subjects Who Are Eligible to Stop NA After Week 24 of Follow up
Time frame: Up to 76 weeks
Proportion of Subjects Who Discontinue NA and Subsequently Restart NA Therapy After Meeting Criteria
Time frame: Up to 124 weeks
Proportion of Subjects Who Discontinue NA and Subsequently Meet Protocol Defined Clinical Relapse Criteria. Proportion of Subjects Who Discontinue NA and Subsequently Meet Protocol Defined Viral Relapse Criteria
Time frame: Up to 124 weeks
Post-dose Plasma Concentrations of AB-729 Anti-sense (AS), AB-729 AS(N-1)3', and AB-729 AS(N-2)3' at Selected Timepoints
Time frame: Up to 40 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
17 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AB-729 and Peg-IFNα-2a in people with Chronic Hepatitis b, run by Arbutus Biopharma Corporation at 17 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States, Taiwan, Australia, Hong Kong, South Korea and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Frequency and Severity of Treatment Emergent Adverse Events (TEAEs), Discontinuations Due to AEs and Lab Abnormalities After Dosing With AB-729 Plus Peg-IFNα-2a (time frame: Up to 124 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.