RecruitingNCT06277037

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)


Sponsor

Arbutus Biopharma Corporation

Enrollment

50 participants

Start Date

Jul 11, 2024

Study Type

OBSERVATIONAL

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).


Eligibility

Min Age: 20 YearsMax Age: 70 Years

Inclusion Criteria4

  • 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 Criteria1

  • Not applicable

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Interventions

OTHERNon-interventional

This is a rollover study


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

Arensia Exploratory Medicine Moldova

Chisinau, Moldova

Asan Medial Center

Seoul, South Korea

Changhua Christian Hospital

Changhua, Taiwan

Chia-Yi Christian Hospital

Chiayi City, Taiwan

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan

E-Da Hospital

Kaohsiung City, Taiwan

Taichung Veterans General Hospital

Taichung, Taiwan

Chang Gung Medical Foundation Linkou

Taoyuan, Taiwan

University Hospital of Wales, Cardiff

Cardiff, United Kingdom

Royal London Hospital

London, United Kingdom

King's College Hospital

London, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT06277037