Clinical trial NCT06277037: Long-Term Follow-up Study for Subjects With CHB Previously Treated With Imdusiran (AB729)
Official title: A Long-Term Follow-up Study for Subjects With Chronic Hepatitis B Previously Treated With Imdusiran (AB-729)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Long Term Follow-up
Lead sponsor: Arbutus Biopharma Corporation
Sponsor class: INDUSTRY
First posted: 2024-02-26
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study 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.

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).


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

Primary outcomes:
measure: To evaluate the durability of effect of imdusiran on HBV parameters
timeFrame: Up to 96 weeks
measure: To evaluate the durability of effect of imdusiran on HBV parameters
timeFrame: Up to 96 weeks
measure: To evaluate the durability of effect of imdusiran on HBV parameters
timeFrame: Up to 96 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Research and Education Inc.
state: California
city: Miami
country: United States
facility: University of Miami Miller School of Medicine
state: Florida
city: Hillsborough
country: United States
facility: Infectious Disease Care
state: New Jersey
city: Melbourne
country: Australia
facility: The Alfred Hospital
state: Victoria
city: Murdoch
country: Australia
facility: Fiona Stanley Hospital
city: Shatin
country: Hong Kong
facility: Prince of Wales Hospital
state: New Territories
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medial Center
city: Chisinau
country: Moldova, Republic of
facility: Arensia Exploratory Medicine Moldova
city: Changhua city
country: Taiwan
facility: Changhua Christian Hospital
city: Chiayi City
country: Taiwan
facility: Chia-Yi Christian Hospital
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital
city: Kaohsiung
country: Taiwan
facility: E-Da Hospital
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Taoyuan
country: Taiwan
facility: Chang Gung Medical Foundation Linkou
city: Cardiff
country: United Kingdom
facility: University Hospital of Wales, Cardiff
city: London
country: United Kingdom
facility: Royal London Hospital
city: London
country: United Kingdom
facility: King's College Hospital
Study officials:
References: