Long-Term Follow-up Study for Subjects With CHB Previously Treated With Imdusiran (AB729)

Long Term Follow-up Clinical Trial

Official title:

A Long-Term Follow-up Study for Subjects With Chronic Hepatitis B Previously Treated With Imdusiran (AB-729)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06277037
• Other study ID #: AB-729-204
• Status: Not yet recruiting
• Start date: July 15, 2024
• Est. completion date: October 30, 2029

Study information

• Verified date: April 2024
• Source: Arbutus Biopharma Corporation
• Contact: Michael Child
• Phone: 267-332-6213
• Email: mchild[@]arbutusbio.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 35
• Est. completion date: October 30, 2029
• Est. primary completion date: August 30, 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Long Term Follow-up

Intervention

Other:
• Non-interventional
This is a rollover study

Locations

Country	Name	City	State
Australia	The Alfred Hospital	Melbourne	Victoria
Australia	Fiona Stanley Hospital	Murdoch
Hong Kong	Queen Mary Hospital	Hong Kong
Hong Kong	Prince of Wales Hospital	Shatin	New Territories
Korea, Republic of	Pusan National University Hospital	Busan	Seogu
Moldova, Republic of	Arensia Exploratory Medicine Moldova	Chisinau
Taiwan	Changhua Christian Hospital	Changhua city
Taiwan	Chia-Yi Christian Hospital	Chiayi City
Taiwan	E-Da Hospital	Kaohsiung
Taiwan	Kaohsiung Medical University Chung-Ho Memorial Hospital	Kaohsiung
Taiwan	Taichung Veterans General Hospital	Taichung
Taiwan	Chang Gung Medical Foundation Linkou	Taoyuan
United Kingdom	University Hospital of Wales, Cardiff	Cardiff
United Kingdom	King's College Hospital	London
United Kingdom	Royal London Hospital	London
United States	Infectious Disease Care	Hillsborough	New Jersey
United States	University of Miami Miller School of Medicine	Miami	Florida
United States	Research and Education Inc.	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Arbutus Biopharma Corporation

Countries where clinical trial is conducted

United States,  Australia,  Hong Kong,  Korea, Republic of,  Moldova, Republic of,  Taiwan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	To evaluate the durability of effect of imdusiran on HBV parameters	Proportion of subjects who restart NA therapy, if applicable	Up to 96 weeks