Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04749368 | Study to Investigate the Safety and Efficacy of BRII-835 and BRII-179 Combination Therapy Treating Chronic Hepatitis B Virus (HBV) Infection | PHASE2 | COMPLETED | 91 | — | — | Apr 12, 2021 | Jul 4, 2023 | Jun 18, 2024 | 28 | Australia, China +4 |
| Arm | Type | Description |
|---|---|---|
| Cohort A | EXPERIMENTAL | Participants will receive BRII-835 (VIR-2218) for 32 weeks |
| Cohort B | EXPERIMENTAL | Participants will receive BRII-835 (VIR-2218) and BRII-179 (VBI-2601) with IFN-α up to Week 40 |
| Cohort C | EXPERIMENTAL | Participant will receive BRII-835 (VIR-2218) and BRII-179 (VBI-2601) up to Week 40 |
| Name | Type | Description |
|---|---|---|
| BRII-835 (VIR-2218) | DRUG | BRII-835 (VIR-2218) will be given by subcutaneous injection |
| BRII-179 (VBI-2601) with IFN-α | BIOLOGICAL | BRII-179 (VBI-2601) with IFN-α will be co-administered by intramuscular injection |
| BRII-179 (VBI-2601) | BIOLOGICAL | BRII-179 (VBI-2601) will be administered by intramuscular injection |
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...