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| Name | Class |
|---|---|
| Vir Biotechnology, Inc. | INDUSTRY |
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This study will evaluate the efficacy and safety of the regimens containing BRII-179, BRII-835, and PEG-IFNα in adult participants with chronic hepatitis B virus (HBV) infection receiving nucleos(t)ide reverse transcriptase inhibitors (NRTIs) as background therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BRII-179 (longer dose interval) followed by BRII-835 + PEG-IFNα | Experimental | Participants will receive BRII-179 of a longer dose interval, followed by BRII-835 and PEG-IFNα combination therapy. |
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| BRII-179 (shorter dose interval) followed by BRII-835 + PEG-IFNα | Experimental | Participants will receive BRII-179 of a shorter dose interval, followed by BRII-835 and PEG-IFNα combination therapy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BRII-179 | Biological | BRII-179 will be given via intramuscular injection |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants achieving HBsAg seroclearance at 24 weeks post end of study treatment in anti-HBs responders compared with non-responders defined at protocol-specific timepoint | 24 weeks post end of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants achieving HBsAg seroclearance at 24 weeks post end of study treatment in anti-HBs responders compared with non-responders defined at protocol-specific timepoint (in participants with lower baseline HBsAg levels) | 24 weeks post end of treatment | |
| Percentage of participants with treatment-emergent adverse events (TEAEs) |
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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 86004 | Beijing | Beijing Municipality | 100000 | China | ||
| Investigative Site 86009 |
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| BRII-835 (VIR-2218) | Drug | BRII-835 will be given via subcutaneous injection |
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| PEG-IFNα | Biological | PEG-IFNα will be given via subcutaneous injection |
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| 24 weeks post NRTI discontinuation |
| Percentage of participants with serious adverse events (SAEs) | 24 weeks post NRTI discontinuation |
| Percentage of participants with abnormalities in hematology, chemistry, and/or coagulation parameters | 24 weeks post NRTI discontinuation |
| Appearance of anti-HBs at any timepoint | 24 weeks post NRTI discontinuation |
| Titers of anti-HBs at any timepoint | 24 weeks post NRTI discontinuation |
| Beijing |
| Beijing Municipality |
| 100000 |
| China |
| Investigative Site 86015 | Xiamen | Fujian | 361000 | China |
| Investigative Site 86012 | Foshan | Guangdong | 528000 | China |
| Investigative Site 86001 | Guangzhou | Guangdong | 510000 | China |
| Investigative Site 86013 | Guangzhou | Guangdong | 510000 | China |
| Investigative Site 86002 | Shenzhen | Guangdong | 518000 | China |
| Investigative Site 86003 | Shanghai | Shanghai Municipality | 200000 | China |
| Investigative Site 86008 | Shanghai | Shanghai Municipality | 200000 | China |
| Investigative Site 86007 | Chengdu | Sichuan | 610000 | China |
| Investigative Site 86011 | Chengdu | Sichuan | 610000 | China |
| Investigative Site 86005 | Hangzhou | Zhejiang | 310000 | China |