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| Name | Class |
|---|---|
| Vir Biotechnology, Inc. | INDUSTRY |
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This study will evaluate the efficacy and safety of PEG-IFNα alone or in combination with different dose levels of BRII-835 (VIR-2218) in participants with chronic hepatitis B virus (HBV) infection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | Participants will receive multiple doses of PEG-IFNα for 48 weeks. |
|
| Cohort 2 | Experimental | Participants will receive multiple doses of higher dose level of BRII-835 + PEG-IFNα for 48 weeks. |
|
| Cohort 3 | Experimental | Participants will receive multiple doses of lower dose level of BRII-835 + PEG-IFNα for 48 weeks. |
|
| Cohort 4 | Experimental | Participants will receive multiple doses of lower dose level of BRII-835 + PEG-IFNα for 48 weeks (participants who received BRII-179 in a previous study will roll over into this cohort). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PEG-IFNα | Biological | PEG-IFNα will be given via subcutaneous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants with HBsAg loss at end of treatment | Up to Week 48 | |
| Proportion of participants with HBsAg loss at 24 weeks post-end of treatment | Up to Week 72 | |
| Proportion of participants with treatment-emergent adverse events (TEAEs) | Up to Week 72 | |
| Proportion of participants with serious adverse events (SAEs) | Up to Week 72 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xiaofei Chen | Brii Biosciences Limited | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigative Site 61001 | Kingswood | New South Wales | 2747 | Australia | ||
| Investigative Site 61002 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41203919 | Derived | Wong GL, Yuen MF, Lin B, Douglas MW, Hu P, Xie Q, Lv F, Tak WY, Leerapun A, Kim DJ, Tangkijvanich P, Lim YS, Dai CY, O'Beirne J, Weltman M, Khemnark S, Piratvisuth T, Manasirisuk W, Chen X, Liu CJ, Heo J, Lee J, Niu J, Kumar R, Kumar R, Zhu C, Cao K, Tian A, Chen X, Zhu Q, Margolis D, Jia J, Hong Z. Elebsiran and PEG-IFNalpha for chronic hepatitis B infection: a partially randomized, open-label, phase 2 trial. Nat Med. 2026 Jan;32(1):151-159. doi: 10.1038/s41591-025-04049-z. Epub 2025 Nov 7. |
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| BRII-835 | Drug | BRII-835 will be given via subcutaneous injection |
|
| Birtinya |
| Queensland |
| 4575 |
| Australia |
| Investigative Site 61003 | Melbourne | Victoria | 3004 | Australia |
| Investigative Site 86001 | Beijing | Beijing Municipality | 100000 | China |
| Investigative Site 86001 | Beijing | Beijing Municipality | 100050 | China |
| Investigative Site 86007 | Beijing | Beijing Municipality | 100069 | China |
| Investigative Site 86004 | Chongqing | Chongqing Municipality | 400010 | China |
| Investigative Site 86006 | Guangzhou | Guangdong | 510630 | China |
| Investigative Site 85201 | Hong Kong | HONG KONG | 999077 | China |
| Investigative Site 85202 | Hong Kong | HONG KONG | 999077 | China |
| Investigative Site 86008 | Changchun | Jilin | 130021 | China |
| Investigative Site 86013 | Shanghai | Shanghai Municipality | 200025 | China |
| Investigative Site 88601 | Kaohsiung | Taiwan | 80756 | China |
| Investigative Site 88602 | Taipei | Taiwan | 10041 | China |
| Investigative Site 88603 | Taipei | Taiwan | 11217 | China |
| Investigative Site 86011 | Hangzhou | Zhengjiang | 310016 | China |
| Investigative Site 65001 | Singapore | 169856 | Singapore |
| Investigative Site 65002 | Singapore | 529889 | Singapore |
| Investigative Site 82002 | Chuncheon | Chuncheon-si | 24253 | South Korea |
| Investigative Site 82001 | Busan | 49241 | South Korea |
| Investigative Site 82004 | Daegu | 41566 | South Korea |
| Investigative Site 82005 | Seoul | 13496 | South Korea |
| Investigative Site 82003 | Seoul | 6351 | South Korea |
| Investigative Site 82006 | Soeul | 05505 | South Korea |
| Investigative Site 66003 | Bangkok | 10330 | Thailand |
| nvestigative Site 66007 | Chiang Mai | 50200 | Thailand |
| Investigative Site 66005 | Khon Kaen | 40002 | Thailand |
| Investigative Site 66006 | Nonthaburi | 11000 | Thailand |
| Investigative Site 66008 | Songkhla | 90110 | Thailand |
| ID | Term |
|---|---|
| D019694 | Hepatitis B, Chronic |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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