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

Description

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).

Conditions

Long Term Follow-up

Study Overview

Study Details

Study overview

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).

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

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

Condition
Long Term Follow-up
Intervention / Treatment

-

Contacts and Locations

San Diego

Research and Education Inc., San Diego, California, United States, 92105

Miami

University of Miami Miller School of Medicine, Miami, Florida, United States, 33136

Hillsborough

Infectious Disease Care, Hillsborough, New Jersey, United States, 08844

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * Not applicable

Ages Eligible for Study

20 Years to 70 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Arbutus Biopharma Corporation,

Study Record Dates

2029-10-30