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

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).

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Long Term Follow-Up

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The Alfred Hospital, Melbourne, Victoria, Australia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Non-Interventional

Other

This is a rollover study

Primary outcomes

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.
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
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

Study contacts

Contact information is provided by the study sponsor or research team.

Michael Child

CONTACT

[email protected]

267-332-6213

Sponsors and collaborators

Lead sponsor

Arbutus Biopharma Corporation

Industry

Registry information

Official study title

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

Important dates

Study start: 2024
Primary completion: 2029
Study completion: 2029
First posted: Feb 26, 2024
Registry last updated: Nov 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Recruiting