Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06277037




Registration number
NCT06277037
Ethics application status
Date submitted
14/02/2024
Date registered
26/02/2024
Date last updated
26/06/2024

Titles & IDs
Public title
Long-Term Follow-up Study for Subjects With CHB Previously Treated With Imdusiran (AB729)
Scientific title
A Long-Term Follow-up Study for Subjects With Chronic Hepatitis B Previously Treated With Imdusiran (AB-729)
Secondary ID [1] 0 0
AB-729-204
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Long Term Follow-up 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Other interventions - Non-interventional

Other interventions: Non-interventional
This is a rollover study
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To evaluate the durability of effect of imdusiran on HBV parameters
Timepoint [1] 0 0
Up to 96 weeks
Primary outcome [2] 0 0
To evaluate the durability of effect of imdusiran on HBV parameters
Timepoint [2] 0 0
Up to 96 weeks
Primary outcome [3] 0 0
To evaluate the durability of effect of imdusiran on HBV parameters
Timepoint [3] 0 0
Up to 96 weeks

Eligibility
Key inclusion criteria
Key

* 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.
Minimum age
20 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Not applicable

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
15/07/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/10/2029
Actual
Sample size
Target
35
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [2] 0 0
Fiona Stanley Hospital - Murdoch
Recruitment postcode(s) [1] 0 0
3004 - Melbourne
Recruitment postcode(s) [2] 0 0
6150 - Murdoch
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
New Jersey
Country [4] 0 0
Hong Kong
State/province [4] 0 0
New Territories
Country [5] 0 0
Hong Kong
State/province [5] 0 0
Hong Kong
Country [6] 0 0
Korea, Republic of
State/province [6] 0 0
Seogu
Country [7] 0 0
Korea, Republic of
State/province [7] 0 0
Seoul
Country [8] 0 0
Moldova, Republic of
State/province [8] 0 0
Chisinau
Country [9] 0 0
Taiwan
State/province [9] 0 0
Changhua city
Country [10] 0 0
Taiwan
State/province [10] 0 0
Chiayi City
Country [11] 0 0
Taiwan
State/province [11] 0 0
Kaohsiung
Country [12] 0 0
Taiwan
State/province [12] 0 0
Taichung
Country [13] 0 0
Taiwan
State/province [13] 0 0
Taoyuan
Country [14] 0 0
United Kingdom
State/province [14] 0 0
Cardiff
Country [15] 0 0
United Kingdom
State/province [15] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Arbutus Biopharma Corporation
Address
Country

Ethics approval
Ethics application status

Summary
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).
Trial website
https://clinicaltrials.gov/study/NCT06277037
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Michael Child
Address 0 0
Country 0 0
Phone 0 0
267-332-6213
Fax 0 0
Email 0 0
mchild@arbutusbio.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06277037