Study to Investigate the Safety and Efficacy of BRII-835 and BRII-179 Combination Therapy Treating Chronic Hepatitis B Virus (HBV) Infection
NCT04749368 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 91
Last updated 2024-06-18
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
Conditions
- Hepatitis B, Chronic
Interventions
- DRUG
-
BRII-835 (VIR-2218)
BRII-835 (VIR-2218) will be given by subcutaneous injection
- BIOLOGICAL
-
BRII-179 (VBI-2601) with IFN-α
BRII-179 (VBI-2601) with IFN-α will be co-administered by intramuscular injection
- BIOLOGICAL
-
BRII-179 (VBI-2601)
BRII-179 (VBI-2601) will be administered by intramuscular injection
Sponsors & Collaborators
-
Vir Biotechnology, Inc.
collaborator INDUSTRY -
VBI Vaccines Inc.
collaborator INDUSTRY -
Brii Biosciences Limited
lead INDUSTRY
Principal Investigators
-
Xiaofei Chen · Brii Biosciences Limited
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-04-12
- Primary Completion
- 2023-07-04
- Completion
- 2023-07-04
- FDA Drug
- Yes
Countries
- Australia
- China
- New Zealand
- Singapore
- South Korea
- Thailand
Study Locations
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