Long-Term Follow-up Study for Subjects With CHB Previously Treated With Imdusiran (AB729)
A Long-Term Follow-up Study for Subjects With Chronic Hepatitis B Previously Treated With Imdusiran (AB-729)
1 other identifier
observational
50
7 countries
18
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jul 2024
Longer than P75 for all trials
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 14, 2024
CompletedFirst Posted
Study publicly available on registry
February 26, 2024
CompletedStudy Start
First participant enrolled
July 11, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 30, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 30, 2029
November 27, 2024
November 1, 2024
5.1 years
February 14, 2024
November 25, 2024
Conditions
Outcome Measures
Primary Outcomes (3)
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.
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
Up to 96 weeks
To evaluate the durability of effect of imdusiran on HBV parameters
Proportion of subjects who restart NA therapy, if applicable
Up to 96 weeks
Interventions
This is a rollover study
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- Not applicable
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
Research and Education Inc.
San Diego, California, 92105, United States
University of Miami Miller School of Medicine
Miami, Florida, 33136, United States
Infectious Disease Care
Hillsborough, New Jersey, 08844, United States
The Alfred Hospital
Melbourne, Victoria, 3004, Australia
Fiona Stanley Hospital
Murdoch, 6150, Australia
Prince of Wales Hospital
Shatin, New Territories, Hong Kong
Queen Mary Hospital
Hong Kong, Hong Kong
Arensia Exploratory Medicine Moldova
Chisinau, Moldova
Asan Medial Center
Seoul, 05505, South Korea
Changhua Christian Hospital
Changhua, 600566, Taiwan
Chia-Yi Christian Hospital
Chiayi City, 60002, Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 80756, Taiwan
E-Da Hospital
Kaohsiung City, 82445, Taiwan
Taichung Veterans General Hospital
Taichung, 40705, Taiwan
Chang Gung Medical Foundation Linkou
Taoyuan District, 33305, Taiwan
University Hospital of Wales, Cardiff
Cardiff, CF144XW, United Kingdom
Royal London Hospital
London, E11FR, United Kingdom
King's College Hospital
London, SE59RS, United Kingdom
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- OTHER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 14, 2024
First Posted
February 26, 2024
Study Start
July 11, 2024
Primary Completion (Estimated)
August 30, 2029
Study Completion (Estimated)
October 30, 2029
Last Updated
November 27, 2024
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will not share