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

Recruiting

• Conditions: Long Term Follow-up

• Registration Number: NCT06277037
• Lead Sponsor: Arbutus Biopharma Corporation

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-02-14
• Study First Submitted QC: 2024-02-22
• Study First Posted: 2024-02-26
• Study Start: 2024-07-11
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-25
• Last Update Posted: 2024-11-27
• Primary Completion: 2029-08-30
• Study Completion: 2029-10-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the durability of effect of imdusiran on HBV parameters	Up to 96 weeks	Proportion of subjects who restart NA therapy, if applicable

Trial Locations

Locations (18)

Research and Education Inc.; 🇺🇸 San Diego, California, United States

University of Miami Miller School of Medicine; 🇺🇸 Miami, Florida, United States

Infectious Disease Care; 🇺🇸 Hillsborough, New Jersey, United States

The Alfred Hospital; 🇦🇺 Melbourne, Victoria, Australia

Fiona Stanley Hospital; 🇦🇺 Murdoch, Australia

Prince of Wales Hospital; 🇭🇰 Shatin, New Territories, Hong Kong

Queen Mary Hospital; 🇭🇰 Hong Kong, Hong Kong

Asan Medial Center; 🇰🇷 Seoul, Korea, Republic of

Arensia Exploratory Medicine Moldova; 🇲🇩 Chisinau, Moldova, Republic of

Changhua Christian Hospital; 🇨🇳 Changhua city, Taiwan

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