Study to Investigate the Safety and Efficacy of BRII-835 and BRII-179 Combination Therapy Treating Chronic Hepatitis B Virus (HBV) Infection
- Conditions
- Hepatitis B, Chronic
- Interventions
- Drug: BRII-835 (VIR-2218)Biological: BRII-179 (VBI-2601) with IFN-αBiological: BRII-179 (VBI-2601)
- Registration Number
- NCT04749368
- Lead Sponsor
- Brii Biosciences Limited
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 91
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort A BRII-835 (VIR-2218) Participants will receive BRII-835 (VIR-2218) for 32 weeks Cohort B BRII-179 (VBI-2601) with IFN-α Participants will receive BRII-835 (VIR-2218) and BRII-179 (VBI-2601) with IFN-α up to Week 40 Cohort B BRII-835 (VIR-2218) Participants will receive BRII-835 (VIR-2218) and BRII-179 (VBI-2601) with IFN-α up to Week 40 Cohort C BRII-835 (VIR-2218) Participant will receive BRII-835 (VIR-2218) and BRII-179 (VBI-2601) up to Week 40 Cohort C BRII-179 (VBI-2601) Participant will receive BRII-835 (VIR-2218) and BRII-179 (VBI-2601) up to Week 40
- Primary Outcome Measures
Name Time Method 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 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (28)
Investigative Site 61004
🇦🇺Herston, Queensland, Australia
Investigative Site 88601
🇨🇳Kaohsiung, Taiwan, China
Investigative Site 82003
🇰🇷Seongnam-si, Gyeonggi-do, Korea, Republic of
Investigative Site 66002
🇹🇭Khon Kaen, Thailand
Investigative Site 85203
🇨🇳Hongkong, China
Investigative Site 88602
🇨🇳Changhua, Taiwan, China
Investigative Site 61002
🇦🇺Kingswood, New South Wales, Australia
Investigative Site 61001
🇦🇺Westmead, New South Wales, Australia
Investigative Site 85201
🇨🇳Hongkong, China
Investigative Site 85202
🇨🇳Hongkong, China
Investigative Site 88603
🇨🇳Taichung, Taiwan, China
Investigative Site 88605
🇨🇳Taipei CITY, China
Investigative Site 88604
🇨🇳Kaohsiung, Taiwan, China
Investigative Site 85204
🇨🇳NEW Territories, Hong Kong, China
Investigative Site 82004
🇰🇷Busan, Korea, Republic of
Investigative Site 64001
🇳🇿Auckland, New Zealand
Investigative Site 82001
🇰🇷Seoul, Korea, Republic of
Investigative Site 82002
🇰🇷Seoul, Korea, Republic of
Investigative Site 82005
🇰🇷Seoul, Korea, Republic of
Investigative Site 64002
🇳🇿Dunedin Central, Dunedin, New Zealand
Investigative Site 65001
🇸🇬Singapore, Singapore
Investigative Site 66004
🇹🇭Pathumthani, Thailand
Investigative Site 66003
🇹🇭Chiang Mai, Thailand
Investigative Site 65002
🇸🇬Singapore, Singapore
Investigative Site 66005
🇹🇭Nonthaburi, Thailand
Investigative Site 66001
🇹🇭Bangkok, Thailand
Investigative Site 66006
🇹🇭Nonthaburi, Thailand
Investigative Site 66007
🇹🇭Songkhla, Thailand