Study to Investigate the Safety and Efficacy of BRII-835 and BRII-179 Combination Therapy Treating Chronic Hepatitis B Virus (HBV) Infection
A Phase 2 Multicenter, Randomized, Open-label Study to Investigate the Safety and Efficacy of BRII-835 (VIR-2218) and BRII-179 (VBI-2601) Combination Therapy for the Treatment of Chronic Hepatitis B Virus (HBV) Infection
1 other identifier
interventional
91
6 countries
28
Brief Summary
This is an open label, randomized, parallel-group study to evaluate the safety and efficacy of combination treatment BRII-835 (VIR-2218) and BRII-179 (VBI-2601) in adult participants with chronic HBV infection
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Apr 2021
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 7, 2021
CompletedFirst Posted
Study publicly available on registry
February 11, 2021
CompletedStudy Start
First participant enrolled
April 12, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 4, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
July 4, 2023
CompletedJune 18, 2024
June 1, 2024
2.2 years
February 7, 2021
June 16, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Percentage of participants with sustained HBsAg loss during the 48-week follow-up period after NrtI withdrawal
up to Week 96
Number of participants with Adverse Events (AE)
up to Week 96
Number of participants with Serious Adverse Events (SAE)
up to Week 96
Number of participants with abnormalities in clinical laboratory tests
up to Week 96
Study Arms (3)
Cohort A
EXPERIMENTALParticipants will receive BRII-835 (VIR-2218) for 32 weeks
Cohort B
EXPERIMENTALParticipants will receive BRII-835 (VIR-2218) and BRII-179 (VBI-2601) with IFN-α up to Week 40
Cohort C
EXPERIMENTALParticipant will receive BRII-835 (VIR-2218) and BRII-179 (VBI-2601) up to Week 40
Interventions
BRII-835 (VIR-2218) will be given by subcutaneous injection
BRII-179 (VBI-2601) with IFN-α will be co-administered by intramuscular injection
BRII-179 (VBI-2601) will be administered by intramuscular injection
Eligibility Criteria
You may qualify if:
- Male or female aged 18 - 60
- 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
You may not qualify if:
- Any clinically significant chronic or acute medical condition that makes the volunteer unsuitable for participation
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Brii Biosciences Limitedlead
- Vir Biotechnology, Inc.collaborator
- VBI Vaccines Inc.collaborator
Study Sites (28)
Investigative Site 61002
Kingswood, New South Wales, 2747, Australia
Investigative Site 61001
Westmead, New South Wales, 2145, Australia
Investigative Site 61004
Herston, Queensland, 4029, Australia
Investigative Site 88602
Changhua, Taiwan, 500, China
Investigative Site 85201
Hong Kong, China
Investigative Site 85202
Hong Kong, China
Investigative Site 85203
Hong Kong, China
Investigative Site 88601
Kaohsiung, Taiwan, 83301, China
Investigative Site 88604
Kaohsiung, Taiwan, China
Investigative Site 85204
NEW Territories, Hong Kong, China
Investigative Site 88603
Taichung, Taiwan, 40447, China
Investigative Site 88605
Taipei CITY, 10048, China
Investigative Site 64002
Dunedin Central, Dunedin, 9016, New Zealand
Investigative Site 64001
Auckland, 2025, New Zealand
Investigative Site 65001
Singapore, 169608, Singapore
Investigative Site 65002
Singapore, 529889, Singapore
Investigative Site 82004
Busan, 49241, South Korea
Investigative Site 82003
Seongnam-si, Gyeonggi-do, 13496, South Korea
Investigative Site 82001
Seoul, 3080, South Korea
Investigative Site 82005
Seoul, 3722, South Korea
Investigative Site 82002
Seoul, 5505, South Korea
Investigative Site 66001
Bangkok, 10330, Thailand
Investigative Site 66003
Chiang Mai, 50200, Thailand
Investigative Site 66002
Khon Kaen, 40002, Thailand
Investigative Site 66005
Nonthaburi, 11000, Thailand
Investigative Site 66006
Nonthaburi, 11000, Thailand
Investigative Site 66004
Pathum Thani, 12120, Thailand
Investigative Site 66007
Songkhla, 90110, Thailand
Related Publications (1)
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.
PMID: 40043858DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Xiaofei Chen
Brii Biosciences Limited
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 7, 2021
First Posted
February 11, 2021
Study Start
April 12, 2021
Primary Completion
July 4, 2023
Study Completion
July 4, 2023
Last Updated
June 18, 2024
Record last verified: 2024-06
Data Sharing
- IPD Sharing
- Will not share