Long-term follow-up for chronic hepatitis B patients treated with imdusiran

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

This study looks at how chronic hepatitis B patients feel and what happens to them after stopping their previous treatment with imdusiran for about two years.

Quick facts

• Study type: Observational
• Enrollment: 50 (estimated)
• Ages: 20 Years to 70 Years
• Sex: All
• Sponsor: Arbutus Biopharma Corporation (Industry-sponsored)
• Locations: 18 sites (San Diego, California and 17 other locations)
• Trial ID: NCT06277037 on ClinicalTrials.gov

What this trial studies

This observational study focuses on the long-term follow-up of chronic hepatitis B (CHB) patients who previously received imdusiran treatment and have stopped nucleos(t)ide analog (NA) therapy. Participants will be monitored for approximately two years after completing their prior clinical trial, during which no new interventions will be administered. The study will involve blood sample collections, medication reviews, and reporting of any adverse events related to study procedures or NA therapy if it is restarted. The goal is to gather data on the long-term effects of imdusiran treatment in these patients.

Who should consider this trial

Good fit: Ideal candidates are individuals who have participated in a prior imdusiran clinical trial and have discontinued NA therapy while remaining off therapy.

Not a fit: Patients who have not participated in an imdusiran clinical trial or who are currently on NA therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the long-term outcomes of CHB patients after imdusiran treatment, potentially informing future treatment strategies.

How similar studies have performed: While this study is observational and focuses on long-term follow-up, similar studies have shown the importance of monitoring long-term outcomes in chronic hepatitis B treatments.

Eligibility criteria

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

Where this trial is running

San Diego, California and 17 other locations

• Research and Education Inc. — San Diego, California, United States (Recruiting)
• University of Miami Miller School of Medicine — Miami, Florida, United States (Not_yet_recruiting)
• Infectious Disease Care — Hillsborough, New Jersey, United States (Recruiting)
• The Alfred Hospital — Melbourne, Victoria, Australia (Recruiting)
• Fiona Stanley Hospital — Murdoch, Australia (Not_yet_recruiting)
• Prince of Wales Hospital — Shatin, New Territories, Hong Kong (Recruiting)
• Queen Mary Hospital — Hong Kong, Hong Kong (Recruiting)
• Arensia Exploratory Medicine Moldova — Chisinau, Moldova (Recruiting)
• Asan Medial Center — Seoul, South Korea (Not_yet_recruiting)
• Changhua Christian Hospital — Changhua, Taiwan (Recruiting)
• Chia-Yi Christian Hospital — Chiayi City, Taiwan (Recruiting)
• Kaohsiung Medical University Chung-Ho Memorial Hospital — Kaohsiung City, Taiwan (Recruiting)
• E-Da Hospital — Kaohsiung City, Taiwan (Recruiting)
• Taichung Veterans General Hospital — Taichung, Taiwan (Recruiting)
• Chang Gung Medical Foundation Linkou — Taoyuan, Taiwan (Recruiting)
• University Hospital of Wales, Cardiff — Cardiff, United Kingdom (Not_yet_recruiting)
• Royal London Hospital — London, United Kingdom (Not_yet_recruiting)
• King's College Hospital — London, United Kingdom (Not_yet_recruiting)

Study contacts

• Study coordinator: Michael Child

Conditions Long Term Follow-up