Long-Term Follow-up Study for Subjects With CHB Previously Treated With Imdusiran (AB729)
Recruiting · NCT06277037 · Observational (researchers observe without assigning treatment) · Lead sponsor: Arbutus Biopharma Corporation
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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).
Who can take part
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
Where it is running
18 locations listed across 3 US states.
- 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
- University Hospital of Wales, Cardiff - Cardiff, United Kingdom
- Changhua Christian Hospital - Changhua, Taiwan
- Chia-Yi Christian Hospital - Chiayi City, Taiwan
- Arensia Exploratory Medicine Moldova - Chisinau, Moldova
- Queen Mary Hospital - Hong Kong, Hong Kong
- Kaohsiung Medical University Chung-Ho Memorial Hospital - Kaohsiung City, Taiwan
- E-Da Hospital - Kaohsiung City, Taiwan
- Royal London Hospital - London, United Kingdom
- King's College Hospital - London, United Kingdom
- Fiona Stanley Hospital - Murdoch, Australia
- Asan Medial Center - Seoul, South Korea
- Taichung Veterans General Hospital - Taichung, Taiwan
- Chang Gung Medical Foundation Linkou - Taoyuan, Taiwan
- Prince of Wales Hospital - Shatin, New Territories, Hong Kong
- The Alfred Hospital - Melbourne, Victoria, Australia