Hepatitis B, Chronic
Conditions
Keywords
Hepatitis B Virus, Chronic Hepatitis B, HBV, Hepatitis
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
Interventions
BRII-835 (VIR-2218) will be given by subcutaneous injection
BIOLOGICALBRII-179 (VBI-2601) with IFN-α
BRII-179 (VBI-2601) with IFN-α will be co-administered by intramuscular injection
BIOLOGICALBRII-179 (VBI-2601)
BRII-179 (VBI-2601) will be administered by intramuscular injection
Sponsors
Vir Biotechnology, Inc.
VBI Vaccines Inc.
Brii Biosciences Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Australia, China, New Zealand, Singapore, South Korea, Thailand
Outcome results
None listed