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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).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-interventional | Other | This is a rollover study |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Key Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michael Child | Contact | 267-332-6213 | mchild@arbutusbio.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research and Education Inc. | Recruiting | San Diego | California | 92105 | United States |
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| University of Miami Miller School of Medicine | Not yet recruiting | Miami | Florida | 33136 | United States |
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| Infectious Disease Care | Recruiting | Hillsborough | New Jersey | 08844 | United States |
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| The Alfred Hospital | Recruiting | Melbourne | Victoria | 3004 | Australia |
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| Fiona Stanley Hospital | Not yet recruiting | Murdoch | 6150 | Australia |
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| Prince of Wales Hospital | Recruiting | Shatin | New Territories | Hong Kong |
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| Queen Mary Hospital | Recruiting | Hong Kong | Hong Kong |
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| Arensia Exploratory Medicine Moldova | Recruiting | Chisinau | Moldova |
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| Asan Medial Center | Not yet recruiting | Seoul | 05505 | South Korea |
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| Changhua Christian Hospital | Recruiting | Changhua | 600566 | Taiwan |
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| Chia-Yi Christian Hospital | Recruiting | Chiayi City | 60002 | Taiwan |
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| Kaohsiung Medical University Chung-Ho Memorial Hospital | Recruiting | Kaohsiung City | 80756 | Taiwan |
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| E-Da Hospital | Recruiting | Kaohsiung City | 82445 | Taiwan |
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| Taichung Veterans General Hospital | Recruiting | Taichung | 40705 | Taiwan |
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| Chang Gung Medical Foundation Linkou | Recruiting | Taoyuan | 33305 | Taiwan |
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| University Hospital of Wales, Cardiff | Not yet recruiting | Cardiff | CF144XW | United Kingdom |
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| Royal London Hospital | Not yet recruiting | London | E11FR | United Kingdom |
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| King's College Hospital | Not yet recruiting | London | SE59RS | United Kingdom |
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