About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Not applicable
Trial population
CHB subjects who have received imdusiran treatment in a prior clinical trial, stopped NA therapy during that trial, and remain off therapy at the end of study visit.
Trial design
Other
Other
Treatments tested in this trial
Non-interventional
Other interventionThis is a rollover study
Treatment groups
Trial outcomes
Primary outcomes
To evaluate the durability of effect of imdusiran on HBV parameters
Change from pre-"parent" study baseline and over time in HBsAg, HBV DNA, and hepatitis B surface antibody (HBsAb) at each timepoint.
To evaluate the durability of effect of imdusiran on HBV parameters
Proportion of subjects who remain off NA therapy and duration off NA therapy, if applicable
To evaluate the durability of effect of imdusiran on HBV parameters
Proportion of subjects who restart NA therapy, if applicable
Sponsors and contacts
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