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

January 19, 2024 updated by: Arbutus Biopharma Corporation

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

43

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Kingswood, New South Wales, Australia, 2747
        • Nepean Hospital
    • Victoria
      • Melbourne, Victoria, Australia, 3065
        • St Vincent's Hospital Melbourne
  • Hong Kong
      • Hong Kong, Hong Kong
        • Queen Mary Hospital
      • Hong Kong, Hong Kong
        • Prince of Wales Hospital, The Chinese University of Hong Kong
  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Asan Medical Center
    • Republic Of Korea
      • Pusan, Republic Of Korea, Korea, Republic of, 49241
        • Pusan National University Hospital
  • Moldova, Republic of
      • Chisinau, Moldova, Republic of, 2025
        • Arensia Exploratory Medicine Moldova
  • Taiwan
      • Chiayi City, Taiwan, 60002
        • Chia-Yi Christian Hospital
      • Kaohsiung, Taiwan, 83301
        • Kaohsiung Chang Gung Memorial Hospital
      • Kaohsiung, Taiwan, 83301
        • Chung-Ho Memorial Hospital
  • Ukraine
      • Kyiv, Ukraine, 01135
        • Medical Center of Limited Liability Company Harmoniya Krasy
  • United States
    • Arizona
      • Chandler, Arizona, United States, 85224
        • Arizona Liver Health
      • Tucson, Arizona, United States, 85712
        • Arizona Liver Health
    • California
      • San Diego, California, United States, 92105
        • Research and Education, Inc.
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami Miller School of Medicine
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Health System
    • New Jersey
      • Hillsborough, New Jersey, United States, 08844
        • ID Care

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: AB-729
subcutaneous injection
Drug: Peg-IFNα-2a
subcutaneous injection
Other Names:
  • pegylated interferon alpha 2a
Experimental: 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.
Drug: AB-729
subcutaneous injection
Drug: Peg-IFNα-2a
subcutaneous injection
Other Names:
  • pegylated interferon alpha 2a
Experimental: 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.
Drug: AB-729
subcutaneous injection
Drug: Peg-IFNα-2a
subcutaneous injection
Other Names:
  • pegylated interferon alpha 2a
Experimental: 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.
Drug: AB-729
subcutaneous injection
Drug: Peg-IFNα-2a
subcutaneous injection
Other Names:
  • pegylated interferon alpha 2a

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The frequency and severity of treatment emergent adverse events (TEAEs), discontinuations due to adverse events (AEs), and laboratory abnormalities after dosing with AB-729 plus Peg-IFNα-2a
Time Frame: Up to 124 weeks
Up to 124 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in HBsAg and other virologic markers at each time point
Time Frame: Up to 124 weeks
Up to 124 weeks
Proportion of subjects with HBsAb seroconversion at each timepoint
Time Frame: Up to 124 weeks
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
Up to 76 weeks
Proportion of subjects who discontinue NA and subsequently restart NA therapy after meeting criteria
Time Frame: Up to 124 weeks
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
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
Up to 40 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Arbutus Biopharma Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 29, 2021

Primary Completion (Estimated)

May 30, 2024

Study Completion (Estimated)

April 1, 2025

Study Registration Dates

First Submitted

July 19, 2021

First Submitted That Met QC Criteria

July 19, 2021

First Posted (Actual)

July 28, 2021

Study Record Updates

Last Update Posted (Actual)

January 22, 2024

Last Update Submitted That Met QC Criteria

January 19, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AB-729-201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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