Study to Investigate the Safety and Efficacy of BRII-835 and BRII-179 Combination Therapy Treating Chronic Hepatitis B Virus (HBV) Infection
NCT ID: NCT04749368
Last Updated: 2024-06-18
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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COMPLETED
PHASE2
91 participants
INTERVENTIONAL
2021-04-12
2023-07-04
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 A
Participants will receive BRII-835 (VIR-2218) for 32 weeks
BRII-835 (VIR-2218)
BRII-835 (VIR-2218) will be given by subcutaneous injection
Cohort B
Participants will receive BRII-835 (VIR-2218) and BRII-179 (VBI-2601) with IFN-α up to Week 40
BRII-835 (VIR-2218)
BRII-835 (VIR-2218) will be given by subcutaneous injection
BRII-179 (VBI-2601) with IFN-α
BRII-179 (VBI-2601) with IFN-α will be co-administered by intramuscular injection
Cohort C
Participant will receive BRII-835 (VIR-2218) and BRII-179 (VBI-2601) up to Week 40
BRII-835 (VIR-2218)
BRII-835 (VIR-2218) will be given by subcutaneous injection
BRII-179 (VBI-2601)
BRII-179 (VBI-2601) will be administered by intramuscular injection
Interventions
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BRII-835 (VIR-2218)
BRII-835 (VIR-2218) will be given by subcutaneous injection
BRII-179 (VBI-2601) with IFN-α
BRII-179 (VBI-2601) with IFN-α will be co-administered by intramuscular injection
BRII-179 (VBI-2601)
BRII-179 (VBI-2601) will be administered by intramuscular injection
Eligibility Criteria
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Inclusion Criteria
* Body mass index ≥ 18 kg/m\^2 and ≤ 32 kg/m\^2
* Chronic HBV infection as defined by a positive serum HBsAg for ≥ 6 months
Exclusion Criteria
* Significant fibrosis or cirrhosis
* History or evidence of drug or alcohol abuse
* History of intolerance to SC or IM injection
* History of chronic liver disease from any cause other than chronic HBV infection
* History of hepatic decompensation
18 Years
60 Years
ALL
No
Sponsors
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Vir Biotechnology, Inc.
INDUSTRY
VBI Vaccines 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 61002
Kingswood, New South Wales, Australia
Investigative Site 61001
Westmead, New South Wales, Australia
Investigative Site 61004
Herston, Queensland, Australia
Investigative Site 88602
Changhua, Taiwan, , China
Investigative Site 85201
Hong Kong, , China
Investigative Site 85202
Hong Kong, , China
Investigative Site 85203
Hong Kong, , China
Investigative Site 88601
Kaohsiung, Taiwan, , China
Investigative Site 88604
Kaohsiung, Taiwan, , China
Investigative Site 85204
NEW Territories, Hong Kong, , China
Investigative Site 88603
Taichung, Taiwan, , China
Investigative Site 88605
Taipei CITY, , China
Investigative Site 64002
Dunedin Central, Dunedin, New Zealand
Investigative Site 64001
Auckland, , New Zealand
Investigative Site 65001
Singapore, , Singapore
Investigative Site 65002
Singapore, , Singapore
Investigative Site 82004
Busan, , South Korea
Investigative Site 82003
Seongnam-si, Gyeonggi-do, , South Korea
Investigative Site 82001
Seoul, , South Korea
Investigative Site 82005
Seoul, , South Korea
Investigative Site 82002
Seoul, , South Korea
Investigative Site 66001
Bangkok, , Thailand
Investigative Site 66003
Chiang Mai, , Thailand
Investigative Site 66002
Khon Kaen, , Thailand
Investigative Site 66005
Nonthaburi, , Thailand
Investigative Site 66006
Nonthaburi, , Thailand
Investigative Site 66004
Pathum Thani, , Thailand
Investigative Site 66007
Songkhla, , Thailand
Countries
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References
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Ji Y, Le Bert N, Lai-Hung Wong G, Douglas MW, Lee A, Zhu C, Wang B, Lv J, Li D, Tan Y, Ma H, Chen J, Chen X, Zhu Q, Yuen MF, Bertoletti A. The Impact of Hepatitis B Surface Antigen Reduction via Small Interfering RNA Treatment on Natural and Vaccine (BRII-179)-Induced Hepatitis B Virus-Specific Humoral and Cellular Immune Responses. Gastroenterology. 2025 Jul;169(1):136-149. doi: 10.1053/j.gastro.2025.02.016. Epub 2025 Mar 3.
Other Identifiers
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BRII-179-835-001
Identifier Type: -
Identifier Source: org_study_id
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