Long Term Follow-upNCT06277037
Long-Term Follow-up Study for Subjects With CHB Previously Treated With Imdusiran (AB729)
An observational study of Long Term Follow-up, run by Arbutus Biopharma Corporation at 18 sites in 7 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Long Term Follow-up
- What is being tested?
- Non-interventional
- How many people
- 50 participants
- Where
- 18 sitesin 7 countries
- Study dates
- 11 Jul 2024to 30 Oct 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Not applicable
Trial locations and contacts
18 sites in 7 countries. Contact the study team or a site near you to ask about taking part.
18 sites in 7 countries
Taiwan6 sites, 6 recruiting
- Recruiting
Changhua Christian Hospital
Changhua, 600566
Pei-Yuan Su
- Recruiting
Chia-Yi Christian Hospital
Chiayi City, 60002
Chi-Yi Chen
- Recruiting
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 80756
Wan-Long Chuang
- Recruiting
E-Da Hospital
Kaohsiung City, 82445
Gin-Ho Lo
- Recruiting
Taichung Veterans General Hospital
Taichung, 40705
Sheng-Shun Yang
- Recruiting
Chang Gung Medical Foundation Linkou
Taoyuan, 33305
Chao-Wei Hsu
United States3 sites, 3 recruiting
- Recruiting
Infectious Disease Care
Hillsborough, New Jersey, 08844
Ronald Nahass
- Not yet recruiting
University of Miami Miller School of Medicine
Miami, Florida, 33136
Kalyan Bhamidimarri
- Recruiting
Research and Education Inc.
San Diego, California, 92105
Tuan Nguyen
United Kingdom3 sites, 3 recruiting
- Not yet recruiting
University Hospital of Wales, Cardiff
Cardiff, CF144XW
Jonathan Underwood
- Not yet recruiting
Royal London Hospital
London, E11FR
Patrick Kennedy
- Not yet recruiting
King's College Hospital
London, SE59RS
Kosh Agarwal
Australia2 sites, 2 recruiting
- Recruiting
The Alfred Hospital
Melbourne, Victoria, 3004
Stuart Roberts
S.Roberts@alfred.org.au
- Not yet recruiting
Fiona Stanley Hospital
Murdoch, 6150
Sam Galhenage
Hong Kong2 sites, 2 recruiting
- Recruiting
Queen Mary Hospital
Hong Kong
Man Fung Yuen
- Recruiting
Prince of Wales Hospital
Shatin, New Territories
Grace Wong
Moldova1 site, 1 recruiting
- Recruiting
Arensia Exploratory Medicine Moldova
Chisinau
Tatiana Burda
South Korea1 site, 1 recruiting
- Not yet recruiting
Asan Medial Center
Seoul, 05505
Young Suk Lim
About this study
Official title: A Long-Term Follow-up Study for Subjects With Chronic Hepatitis B Previously Treated With Imdusiran (AB-729)
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).
- Conditions
- Long Term Follow-up
- Being tested
- Non-interventional
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-interventionalOther
This is a rollover study
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 96 weeks
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
Measured: Up to 96 weeks
To evaluate the durability of effect of imdusiran on HBV parameters
Proportion of subjects who restart NA therapy, if applicable
Measured: Up to 96 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2024
- Study start11 Jul 2024
- Primary completion30 Aug 2029 (estimated)
- Study completion30 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Long Term Follow-upStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Arbutus Biopharma Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06277037
- Sponsor's protocol ID
- AB-729-204
- Status last verified
- Nov 2024
- First submitted
- 14 Feb 2024
- Last updated
- 27 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Long-Term Follow-up Study for Subjects With Chronic Hepatitis B Previously Treated With Imdusiran (AB-729)
- ClinicalTrials.gov ID
- NCT06277037
- Acronym / sponsor ID
- AB-729-204
- Conditions
- Long Term Follow-up
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Arbutus Biopharma CorporationIndustry (pharma, biotech, devices)
- Study start
- 11 Jul 2024 (actual)
- Primary completion
- 30 Aug 2029 (estimated)
- Study completion
- 30 Oct 2029 (estimated)
- First posted
- 26 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Not applicable
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-interventionalThis is a rollover study | Other | – |
Primary outcome
To evaluate the durability of effect of imdusiran on HBV parameters
Time frame: Up to 96 weeks
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
Time frame: Up to 96 weeks
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
Time frame: Up to 96 weeks
Proportion of subjects who restart NA therapy, if applicable
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
18 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Long Term Follow-up, run by Arbutus Biopharma Corporation at 18 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Taiwan, United States, United Kingdom, Australia, Hong Kong and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michael Child (267-332-6213, mchild@arbutusbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the durability of effect of imdusiran on HBV parameters (time frame: Up to 96 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2024; AzTrials last refreshed its copy on 26 Oct 2026.