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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05970289 | Investigate the Efficacy and Safety of BRII-835 (VIR-2218) and PEG-IFNα Combination Therapy in Chronic HBV Patients | PHASE2 | ACTIVE NOT_RECRUITING | 86 | — | — | Aug 22, 2023 | Feb 1, 2026 | Sep 5, 2025 | 29 | Australia, China +3 |
| Arm | Type | Description |
|---|---|---|
| Cohort 1 | EXPERIMENTAL | Participants will receive multiple doses of PEG-IFNα for 48 weeks. |
| Cohort 2 | EXPERIMENTAL | Participants will receive multiple doses of higher dose level of BRII-835 + PEG-IFNα for 48 weeks. |
| Cohort 3 | EXPERIMENTAL | Participants will receive multiple doses of lower dose level of BRII-835 + PEG-IFNα for 48 weeks. |
| Cohort 4 | EXPERIMENTAL | Participants will receive multiple doses of lower dose level of BRII-835 + PEG-IFNα for 48 weeks (participants who received BRII-179 in a previous study will roll over into this cohort). |
| Name | Type | Description |
|---|---|---|
| PEG-IFNα | BIOLOGICAL | PEG-IFNα will be given via subcutaneous injection |
| BRII-835 | DRUG | BRII-835 will be given via subcutaneous injection |
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 ...