Long-Term Follow-up Study for Subjects With CHB Previously Treated With Imdusiran (AB729)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Non-interventional.
- Who it may be relevant to
- Registry conditions: Long Term Follow-up. Basic parameters: 20 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Australia, Hong Kong, Moldova, South Korea +2
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Long-Term Follow-up Study for Subjects With Chronic Hepatitis B Previously Treated With Imdusiran (AB-729)
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).
Interventions
- Other Non-interventional
This is a rollover study
Primary outcome measures
- To evaluate the durability of effect of imdusiran on HBV parameters [Time frame: Up to 96 weeks]
- To evaluate the durability of effect of imdusiran on HBV parameters [Time frame: Up to 96 weeks]
- To evaluate the durability of effect of imdusiran on HBV parameters [Time frame: Up to 96 weeks]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
Taiwan · 6 centers
- Changhua Christian Hospital — Changhua
- Chia-Yi Christian Hospital — Chiayi City
- Kaohsiung Medical University Chung-Ho Memorial Hospital — Kaohsiung City
- E-Da Hospital — Kaohsiung City
- Taichung Veterans General Hospital — Taichung
- Chang Gung Medical Foundation Linkou — Taoyuan
United States · 3 centers
- Research and Education Inc. — San Diego
- University of Miami Miller School of Medicine — Miami
- Infectious Disease Care — Hillsborough
United Kingdom · 3 centers
- University Hospital of Wales, Cardiff — Cardiff
- Royal London Hospital — London
- King's College Hospital — London
Australia · 2 centers
- The Alfred Hospital — Melbourne
- Fiona Stanley Hospital — Murdoch
Hong Kong · 2 centers
- Prince of Wales Hospital — Shatin
- Queen Mary Hospital — Hong Kong
Moldova · 1 center
- Arensia Exploratory Medicine Moldova — Chisinau
South Korea · 1 center
- Asan Medial Center — Seoul
Identifiers
NCT: NCT06277037 · AB-729-204