Long-Term Follow-up Study for Subjects With CHB Previously Treated With Imdusiran (AB729)

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age20-70
SponsorArbutus Biopharma Corporation

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 volunteers

Qualifiers

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

Design model

Other

Time perspective

Other

Treatments tested in this trial

  • Non-interventional

    Other intervention

    This is a rollover study

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

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.

Time frame
Up to 96 weeks
2

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

Time frame
Up to 96 weeks
3

To evaluate the durability of effect of imdusiran on HBV parameters

Proportion of subjects who restart NA therapy, if applicable

Time frame
Up to 96 weeks

Secondary outcomes

Other outcomes

Sponsors and contacts

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