NCT04980482

Brief 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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Oct 2021

Typical duration for phase_2

Geographic Reach
7 countries

17 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 19, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 28, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

October 29, 2021

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 13, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 21, 2025

Completed
11 months until next milestone

Results Posted

Study results publicly available

April 29, 2026

Completed
Last Updated

April 29, 2026

Status Verified

April 1, 2026

Enrollment Period

3.4 years

First QC Date

July 19, 2021

Results QC Date

April 9, 2026

Last Update Submit

April 9, 2026

Conditions

Chronic Hepatitis b

Keywords

Hepatitis B virusChronic hepatitis BHBVHepatitisCHB

Outcome Measures

Primary Outcomes (1)

  • 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

    Up to 124 weeks

Secondary Outcomes (6)

  • Change From Baseline in HBsAg and Other Virologic Markers at Each Time Point

    Up to 124 weeks

  • Proportion of Subjects With HBsAb Seroconversion at Each Timepoint

    Up to 124 weeks

  • Proportion of Subjects Who Are Eligible to Stop NA After Week 24 of Follow up

    Up to 76 weeks

  • Proportion of Subjects Who Discontinue NA and Subsequently Restart NA Therapy After Meeting Criteria

    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

    Up to 124 weeks

  • +1 more secondary outcomes

Study Arms (4)

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.

Drug: AB-729Drug: 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.

Drug: AB-729Drug: 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.

Drug: AB-729Drug: 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.

Drug: AB-729Drug: Peg-IFNα-2a

Interventions

AB-729DRUG

subcutaneous injection

Cohort A, Group 1Cohort A, Group 2Cohort B, Group 1Cohort B, Group 2
Peg-IFNα-2aDRUG

subcutaneous injection

Also known as: pegylated interferon alpha 2a
Cohort A, Group 1Cohort A, Group 2Cohort B, Group 1Cohort B, Group 2

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

Arizona Liver Health

Chandler, Arizona, 85224, United States

Location

Arizona Liver Health

Tucson, Arizona, 85712, United States

Location

Research and Education, Inc.

San Diego, California, 92105, United States

Location

University of Miami Miller School of Medicine

Miami, Florida, 33136, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

ID Care

Hillsborough, New Jersey, 08844, United States

Location

Nepean Hospital

Kingswood, New South Wales, 2747, Australia

Location

St Vincent's Hospital Melbourne

Melbourne, Victoria, 3065, Australia

Location

Prince of Wales Hospital, The Chinese University of Hong Kong

Hong Kong, Hong Kong

Location

Queen Mary Hospital

Hong Kong, Hong Kong

Location

Arensia Exploratory Medicine Moldova

Chisinau, 2025, Moldova

Location

Pusan National University Hospital

Pusan, Republic of Korea, 49241, South Korea

Location

Asan Medical Center

Seoul, South Korea

Location

Chia-Yi Christian Hospital

Chiayi City, 60002, Taiwan

Location

Chung-Ho Memorial Hospital

Kaohsiung City, 83301, Taiwan

Location

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, 83301, Taiwan

Location

Medical Center of Limited Liability Company Harmoniya Krasy

Kyiv, 01135, Ukraine

Location

MeSH Terms

Conditions

Hepatitis B, ChronicHepatitis BHepatitis

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitis, ChronicLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Medical Monitor
Organization
Arbutus Biopharma
bd@arbutusbio.com
267-469-0914

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 19, 2021

First Posted

July 28, 2021

Study Start

October 29, 2021

Primary Completion

March 13, 2025

Study Completion

May 21, 2025

Last Updated

April 29, 2026

Results First Posted

April 29, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(6)UA(1)KR(2)MO(1)AU(2)HK(2)TW(3)