Long-Term Follow-up Study for Subjects With CHB Previously Treated With Imdusiran (AB729)

March 29, 2024 updated by: Arbutus Biopharma Corporation

A Long-Term Follow-up Study for Subjects With Chronic Hepatitis B Previously Treated With Imdusiran (AB-729)

This is a long term follow-up study for chronic hepatitis B (CHB) subjects who have received imdusiran treatment in a prior clinical trial, stopped NA therapy during that trial, and remain off therapy. Subjects may enroll after completing the end of study visit (baseline visit within 12 weeks ± 1 week from the end of study [EOS] visit) from their imdusiran clinical trial (the "parent study"). No interventions will be performed in this study other than blood sample collections, review of current medications, and reporting of any adverse events related to study procedures or NA therapy if restarted. Study participation will be for approximately 2 years (to complete a total of at least 3 years of follow-up while off NA therapy, inclusive of parent study participation).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

35

Contacts and Locations

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

Study Contact

Study Locations

  • Australia
      • Murdoch, Australia, 6150
        • Fiona Stanley Hospital
        • Contact:
          • Sam Galhenage
    • Victoria
      • Melbourne, Victoria, Australia, 3004
  • Hong Kong
      • Hong Kong, Hong Kong
        • Queen Mary Hospital
      • Shatin, Hong Kong
        • Prince of Wales Hospital
        • Contact:
          • Grace Wong
  • Taiwan
      • Changhua city, Taiwan, 600566
        • Changhua Christian Hospital
      • Chiayi City, Taiwan, 60002
        • Chia-Yi Christian Hospital
        • Contact:
          • Chi-Yi Chen
      • Kaohsiung, Taiwan, 80756
        • Kaohsiung Medical University Chung-Ho Memorial Hospital
        • Contact:
          • Wan-Long Chuang
      • Kaohsiung, Taiwan, 82445
        • E-DA Hospital
        • Contact:
          • Gin-Ho Lo
      • Taichung, Taiwan, 40705
        • Taichung Veterans General Hospital
        • Contact:
          • Sheng-Shun Yang
      • Taoyuan, Taiwan, 33305
        • Chang Gung Medical Foundation Linkou
        • Contact:
          • Chao-Wei Hsu
  • United Kingdom
      • Cardiff, United Kingdom, CF144XW
        • University Hospital of Wales, Cardiff
        • Contact:
          • Jonathan Underwood
      • London, United Kingdom, SE59RS
        • King's College Hospital
        • Contact:
          • Kosh Agarwal
      • London, United Kingdom, E11FR
        • Royal London Hospital

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

CHB subjects who have received imdusiran treatment in a prior clinical trial, stopped NA therapy during that trial, and remain off therapy at the end of study visit.

Description

Key Inclusion Criteria:

  • Have participated in a prior imdusiran clinical trial,
  • Have discontinued NA therapy in that trial and remain off NA therapy,
  • Have completed less than 3 years of follow-up visits after NA discontinuation in the parent study.
  • Have the ability to review and provide signed informed consent which includes compliance with all protocol-specified visit schedules and requirements.

Exclusion Criteria:

  • Not applicable

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To evaluate the durability of effect of imdusiran on HBV parameters
Time Frame: Up to 96 weeks
Change from pre-"parent" study baseline and over time in HBsAg, HBV DNA, and hepatitis B surface antibody (HBsAb) at each timepoint.
Up to 96 weeks
To evaluate the durability of effect of imdusiran on HBV parameters
Time Frame: Up to 96 weeks
Proportion of subjects who remain off NA therapy and duration off NA therapy, if applicable
Up to 96 weeks
To evaluate the durability of effect of imdusiran on HBV parameters
Time Frame: Up to 96 weeks
Proportion of subjects who restart NA therapy, if applicable
Up to 96 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 (Estimated)

July 15, 2024

Primary Completion (Estimated)

August 30, 2029

Study Completion (Estimated)

October 30, 2029

Study Registration Dates

First Submitted

February 14, 2024

First Submitted That Met QC Criteria

February 22, 2024

First Posted (Actual)

February 26, 2024

Study Record Updates

Last Update Posted (Actual)

April 1, 2024

Last Update Submitted That Met QC Criteria

March 29, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • AB-729-204

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

No

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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