Long Term Follow-up
Conditions
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).
Interventions
OTHERNon-interventional
This is a rollover study
Sponsors
Arbutus Biopharma Corporation
Study design
Observational model
OTHER
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the durability of effect of imdusiran on HBV parameters | Up to 96 weeks | Change from pre-parent study baseline and over time in HBsAg, HBV DNA, and hepatitis B surface antibody (HBsAb) at each timepoint. |
Countries
Australia, Hong Kong, Moldova, South Korea, Taiwan, United Kingdom, United States
Contacts
Primary ContactMichael Child
Outcome results
None listed