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

NCT ID: NCT06277037

Last Updated: 2024-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-07-11

Study Completion Date

2029-10-30

Brief Summary

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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

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Conditions

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Long Term Follow-up

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Interventions

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Non-interventional

This is a rollover study

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Arbutus Biopharma Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Research and Education Inc.

San Diego, California, United States

Site Status RECRUITING

University of Miami Miller School of Medicine

Miami, Florida, United States

Site Status NOT_YET_RECRUITING

Infectious Disease Care

Hillsborough, New Jersey, United States

Site Status RECRUITING

The Alfred Hospital

Melbourne, Victoria, Australia

Site Status RECRUITING

Fiona Stanley Hospital

Murdoch, , Australia

Site Status NOT_YET_RECRUITING

Prince of Wales Hospital

Shatin, New Territories, Hong Kong

Site Status RECRUITING

Queen Mary Hospital

Hong Kong, , Hong Kong

Site Status RECRUITING

Arensia Exploratory Medicine Moldova

Chisinau, , Moldova

Site Status RECRUITING

Asan Medial Center

Seoul, , South Korea

Site Status NOT_YET_RECRUITING

Changhua Christian Hospital

Changhua, , Taiwan

Site Status RECRUITING

Chia-Yi Christian Hospital

Chiayi City, , Taiwan

Site Status RECRUITING

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, , Taiwan

Site Status RECRUITING

E-Da Hospital

Kaohsiung City, , Taiwan

Site Status RECRUITING

Taichung Veterans General Hospital

Taichung, , Taiwan

Site Status RECRUITING

Chang Gung Medical Foundation Linkou

Taoyuan District, , Taiwan

Site Status RECRUITING

University Hospital of Wales, Cardiff

Cardiff, , United Kingdom

Site Status NOT_YET_RECRUITING

Royal London Hospital

London, , United Kingdom

Site Status NOT_YET_RECRUITING

King's College Hospital

London, , United Kingdom

Site Status NOT_YET_RECRUITING

Countries

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United States Australia Hong Kong Moldova South Korea Taiwan United Kingdom

Central Contacts

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Michael Child

Role: CONTACT

[email protected]
267-332-6213

Facility Contacts

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Tuan Nguyen

Role: primary

Kalyan Bhamidimarri

Role: primary

Ronald Nahass

Role: primary

Stuart Roberts

Role: primary

Role: backup

[email protected]

Sam Galhenage

Role: primary

Grace Wong

Role: primary

Man Fung Yuen

Role: primary

Tatiana Burda

Role: primary

Young Suk Lim

Role: primary

Pei-Yuan Su

Role: primary

Chi-Yi Chen

Role: primary

Wan-Long Chuang

Role: primary

Gin-Ho Lo

Role: primary

Sheng-Shun Yang

Role: primary

Chao-Wei Hsu

Role: primary

Jonathan Underwood

Role: primary

Patrick Kennedy

Role: primary

Kosh Agarwal

Role: primary

Other Identifiers

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AB-729-204

Identifier Type: -

Identifier Source: org_study_id