Long-Term Follow-up Study for Subjects With CHB Previously Treated With Imdusiran (AB729)
- Conditions
- Long Term Follow-up
- Registration Number
- NCT06277037
- Lead Sponsor
- Arbutus Biopharma Corporation
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 50
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the durability of effect of imdusiran on HBV parameters Up to 96 weeks Proportion of subjects who restart NA therapy, if applicable
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (18)
Research and Education Inc.
🇺🇸San Diego, California, United States
University of Miami Miller School of Medicine
🇺🇸Miami, Florida, United States
Infectious Disease Care
🇺🇸Hillsborough, New Jersey, United States
The Alfred Hospital
🇦🇺Melbourne, Victoria, Australia
Fiona Stanley Hospital
🇦🇺Murdoch, Australia
Prince of Wales Hospital
🇭🇰Shatin, New Territories, Hong Kong
Queen Mary Hospital
🇭🇰Hong Kong, Hong Kong
Asan Medial Center
🇰🇷Seoul, Korea, Republic of
Arensia Exploratory Medicine Moldova
🇲🇩Chisinau, Moldova, Republic of
Changhua Christian Hospital
🇨🇳Changhua city, Taiwan
Chia-Yi Christian Hospital
🇨🇳Chiayi City, Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
🇨🇳Kaohsiung, Taiwan
E-Da Hospital
🇨🇳Kaohsiung, Taiwan
Taichung Veterans General Hospital
🇨🇳Taichung, Taiwan
Chang Gung Medical Foundation Linkou
🇨🇳Taoyuan, Taiwan
University Hospital of Wales, Cardiff
🇬🇧Cardiff, United Kingdom
Royal London Hospital
🇬🇧London, United Kingdom
King's College Hospital
🇬🇧London, United Kingdom