Investigate the Efficacy and Safety of BRII-835 (VIR-2218) and PEG-IFNα Combination Therapy in Chronic HBV Patients
NCT ID: NCT05970289
Last Updated: 2025-09-05
Study Results
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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ACTIVE_NOT_RECRUITING
PHASE2
86 participants
INTERVENTIONAL
2023-08-22
2026-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cohort 1
Participants will receive multiple doses of PEG-IFNα for 48 weeks.
PEG-IFNα
PEG-IFNα will be given via subcutaneous injection
Cohort 2
Participants will receive multiple doses of higher dose level of BRII-835 + PEG-IFNα for 48 weeks.
PEG-IFNα
PEG-IFNα will be given via subcutaneous injection
BRII-835
BRII-835 will be given via subcutaneous injection
Cohort 3
Participants will receive multiple doses of lower dose level of BRII-835 + PEG-IFNα for 48 weeks.
PEG-IFNα
PEG-IFNα will be given via subcutaneous injection
BRII-835
BRII-835 will be given via subcutaneous injection
Cohort 4
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).
PEG-IFNα
PEG-IFNα will be given via subcutaneous injection
BRII-835
BRII-835 will be given via subcutaneous injection
Interventions
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PEG-IFNα
PEG-IFNα will be given via subcutaneous injection
BRII-835
BRII-835 will be given via subcutaneous injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Body mass index ≥ 18 kg/m2 and ≤ 32 kg/m2.
* Chronic HBV infection for ≥ 6 months.
* On NRTI therapy for at least 6 months.
Exclusion Criteria
* Significant liver fibrosis or cirrhosis.
* History or evidence of drug or alcohol abuse.
* History of intolerance to SC injection.
* History of chronic liver disease from any cause other than chronic HBV infection.
* History of hepatic decompensation.
* Contraindications to the use of Peg-IFNα.
18 Years
60 Years
ALL
No
Sponsors
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Vir Biotechnology, Inc.
INDUSTRY
Brii Biosciences Limited
INDUSTRY
Responsible Party
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Principal Investigators
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Xiaofei Chen
Role: STUDY_DIRECTOR
Brii Biosciences Limited
Locations
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Investigative Site 61001
Kingswood, New South Wales, Australia
Investigative Site 61002
Birtinya, Queensland, Australia
Investigative Site 61003
Melbourne, Victoria, Australia
Investigative Site 86001
Beijing, Beijing Municipality, China
Investigative Site 86001
Beijing, Beijing Municipality, China
Investigative Site 86007
Beijing, Beijing Municipality, China
Investigative Site 86004
Chongqing, Chongqing Municipality, China
Investigative Site 86006
Guangzhou, Guangdong, China
Investigative Site 85201
Hong Kong, HONG KONG, China
Investigative Site 85202
Hong Kong, HONG KONG, China
Investigative Site 86008
Changchun, Jilin, China
Investigative Site 86013
Shanghai, Shanghai Municipality, China
Investigative Site 88601
Kaohsiung, Taiwan, China
Investigative Site 88602
Taipei, Taiwan, China
Investigative Site 88603
Taipei, Taiwan, China
Investigative Site 86011
Hangzhou, Zhengjiang, China
Investigative Site 65001
Singapore, , Singapore
Investigative Site 65002
Singapore, , Singapore
Investigative Site 82002
Chuncheon, Chuncheon-si, South Korea
Investigative Site 82001
Busan, , South Korea
Investigative Site 82004
Daegu, , South Korea
Investigative Site 82005
Seoul, , South Korea
Investigative Site 82003
Seoul, , South Korea
Investigative Site 82006
Soeul, , South Korea
Investigative Site 66003
Bangkok, , Thailand
nvestigative Site 66007
Chiang Mai, , Thailand
Investigative Site 66005
Khon Kaen, , Thailand
Investigative Site 66006
Nonthaburi, , Thailand
Investigative Site 66008
Songkhla, , Thailand
Countries
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Other Identifiers
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BRII-835-002
Identifier Type: -
Identifier Source: org_study_id
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