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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

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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
11/07/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/10/2029
Actual
Sample size
Target
50
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
Seoul
Country [7] 0 0
Moldova, Republic of
State/province [7] 0 0
Chisinau
Country [8] 0 0
Taiwan
State/province [8] 0 0
Changhua city
Country [9] 0 0
Taiwan
State/province [9] 0 0
Chiayi City
Country [10] 0 0
Taiwan
State/province [10] 0 0
Kaohsiung
Country [11] 0 0
Taiwan
State/province [11] 0 0
Taichung
Country [12] 0 0
Taiwan
State/province [12] 0 0
Taoyuan
Country [13] 0 0
United Kingdom
State/province [13] 0 0
Cardiff
Country [14] 0 0
United Kingdom
State/province [14] 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
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06277037