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

November 25, 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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Australia
      • Murdoch, Australia, 6150
        • Not yet recruiting
        • Fiona Stanley Hospital
        • Contact:
          • Sam Galhenage
    • Victoria
      • Melbourne, Victoria, Australia, 3004
  • Hong Kong
      • Hong Kong, Hong Kong
        • Recruiting
        • Queen Mary Hospital
        • Contact:
          • Man Fung Yuen
    • New Territories
      • Shatin, New Territories, Hong Kong
        • Recruiting
        • Prince of Wales Hospital
        • Contact:
          • Grace Wong
  • Korea, Republic of
      • Seoul, Korea, Republic of, 05505
        • Not yet recruiting
        • Asan Medial Center
        • Contact:
          • Young Suk Lim
  • Moldova, Republic of
      • Chisinau, Moldova, Republic of
        • Recruiting
        • Arensia Exploratory Medicine Moldova
        • Contact:
          • Tatiana Burda
  • Taiwan
      • Changhua city, Taiwan, 600566
        • Recruiting
        • Changhua Christian Hospital
        • Contact:
          • Pei-Yuan Su
      • Chiayi City, Taiwan, 60002
        • Recruiting
        • Chia-Yi Christian Hospital
        • Contact:
          • Chi-Yi Chen
      • Kaohsiung, Taiwan, 80756
        • Recruiting
        • Kaohsiung Medical University Chung-Ho Memorial Hospital
        • Contact:
          • Wan-Long Chuang
      • Kaohsiung, Taiwan, 82445
        • Recruiting
        • E-Da Hospital
        • Contact:
          • Gin-Ho Lo
      • Taichung, Taiwan, 40705
        • Recruiting
        • Taichung Veterans General Hospital
        • Contact:
          • Sheng-Shun Yang
      • Taoyuan, Taiwan, 33305
        • Recruiting
        • Chang Gung Medical Foundation Linkou
        • Contact:
          • Chao-Wei Hsu
  • United Kingdom
      • Cardiff, United Kingdom, CF144XW
        • Not yet recruiting
        • University Hospital of Wales, Cardiff
        • Contact:
          • Jonathan Underwood
      • London, United Kingdom, SE59RS
        • Not yet recruiting
        • King's College Hospital
        • Contact:
          • Kosh Agarwal
      • London, United Kingdom, E11FR
        • Not yet recruiting
        • Royal London Hospital
        • Contact:
          • Patrick Kennedy
  • United States
    • California
      • San Diego, California, United States, 92105
        • Recruiting
        • Research and Education Inc.
        • Contact:
          • Tuan Nguyen
    • Florida
      • Miami, Florida, United States, 33136
        • Not yet recruiting
        • University of Miami Miller School of Medicine
        • Contact:
          • Kalyan Bhamidimarri
    • New Jersey
      • Hillsborough, New Jersey, United States, 08844
        • Recruiting
        • Infectious Disease Care
        • Contact:
          • Ronald Nahass

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 11, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 30, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 30, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 14, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 22, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 26, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 27, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 25, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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