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This Phase 2, randomized, double-blind study will evaluate the clinical efficacy and safety of the combination therapy of BRII-179, BRII-835, plus PEG-IFNα compared to PEG-IFNα in adult participants with chronic HBV infection without cirrhosis receiving neucloes(t)ide reverse transcriptase inhibitors (NRTIs) as background therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Regimen 1: BRII-179 + BRII-835 + PEG-IFNα | Experimental | Participants will receive BRII-179, BRII-835 and PEG-IFNα as a combination therapy (Regimen 1). |
|
| Placebo of BRII-179 + Placebo of BRII-835 + PEG-IFNα | Active Comparator | Participants will receive placebo of BRII-179, placebo of BRII-835 and PEG-IFNα. |
|
| Regimen 2: BRII-179 + BRII-835 + PEG-IFNα | Experimental | Participants will receive BRII-179, BRII-835 and PEG-IFNα as a combination therapy (Regimen 2). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BRII-179 | Biological | BRII-179 will be given via intramuscular injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| The percentage of participants achieving HBsAg seroclearance. | Up to 48 weeks | |
| Percentage of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs). | Up to 96 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants achieving HBsAg seroconversion. | Up to 48 weeks | |
| Percentage of participants achieving HBsAg seroclearance. | Up to 72 weeks | |
| Percentage of participants achieving HBsAg seroconversion. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Research, Brii Biosciences | Contact | +86 10 6299 8808 | clinicaltrials@briibio.com |
| Name | Affiliation | Role |
|---|---|---|
| Xiaofei Chen | Brii Biosciences Limited | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigative Site 86001 | Recruiting | Beijing | Beijing Municipality | 100000 | China | |
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| BRII-835 (VIR-2218) | Drug | BRII-835 will be given via subcutaneous injection |
|
|
| PEG-IFNα | Biological | PEG-IFNα will be given via subcutaneous injection |
|
|
| Placebo of BRII-179 | Drug | Placebo of BRII-179 will be given via intramuscular injection |
|
| Placebo of BRII-835 | Drug | Placebo of BRII-835 will be given via subcutaneous injection |
|
| Up to 72 weeks |
| Percentage of participants achieving functional cure. | Up to 96 weeks |
| Investigative Site 86003 |
| Recruiting |
| Beijing |
| Beijing Municipality |
| 100000 |
| China |
| Investigative Site 86004 | Recruiting | Beijing | Beijing Municipality | 100000 | China |
| Investigative Site 86005 | Recruiting | Beijing | Beijing Municipality | 100000 | China |
| Investigative Site 86016 | Recruiting | Beijing | Beijing Municipality | 100000 | China |
| Investigative Site 86002 | Recruiting | Guangzhou | Guangdong | 510000 | China |
| Investigative Site 86013 | Recruiting | Guangzhou | Guangdong | 510000 | China |
| Investigative Site 86015 | Recruiting | Shenzhen | Guangdong | 518000 | China |
| Investigative Site 86006 | Recruiting | Shanghai | Shanghai Municipality | 200000 | China |
| Investigative Site 86007 | Recruiting | Shanghai | Shanghai Municipality | 200000 | China |
| Investigative Site 86010 | Recruiting | Chengdu | Sichuan | 610000 | China |
| Investigative Site 86011 | Recruiting | Chengdu | Sichuan | 610000 | China |
| Investigative Site 86012 | Recruiting | Chengdu | Sichuan | 610000 | China |
| Investigative Site 86009 | Recruiting | Hangzhou | Zhejiang | 310000 | China |
| ID | Term |
|---|---|
| D019694 | Hepatitis B, Chronic |
| D006509 | Hepatitis B |
| D007239 | Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| 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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