Chronic Hepatitis B Virus Infection
Conditions
Brief summary
This study will evaluate the efficacy and safety of PEG-IFNα alone or in combination with different dose levels of BRII-835 (VIR-2218) in participants with chronic hepatitis B virus (HBV) infection.
Interventions
BIOLOGICALPEG-IFNα
PEG-IFNα will be given via subcutaneous injection
DRUGBRII-835
BRII-835 will be given via subcutaneous injection
Sponsors
Vir Biotechnology, 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/m2 and ≤ 32 kg/m2. * Chronic HBV infection for ≥ 6 months. * On NRTI therapy for at least 6 months.
Exclusion criteria
* Any clinically significant chronic or acute medical condition that makes the participant unsuitable for participation. * Significant liver fibrosis or cirrhosis. * History or evidence of drug or alcohol abuse. * History of intolerance to SC injection. * History of chronic liver disease from any cause other than chronic HBV infection. * History of hepatic decompensation. * Contraindications to the use of Peg-IFNα.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of participants with HBsAg loss at end of treatment | Up to Week 48 |
| Proportion of participants with HBsAg loss at 24 weeks post-end of treatment | Up to Week 72 |
| Proportion of participants with treatment-emergent adverse events (TEAEs) | Up to Week 72 |
| Proportion of participants with serious adverse events (SAEs) | Up to Week 72 |
Countries
Australia, China, Singapore, South Korea, Thailand
Outcome results
None listed