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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04507269 | Study of VIR-2218 in Patients With Chronic Hepatitis B in Mainland China | PHASE2 | COMPLETED | 21 | — | — | Aug 18, 2020 | Sep 30, 2021 | Aug 26, 2024 | 2 | China |
Number of participants with treatment-emergent adverse events (TEAEs) as assessed by CTCAE v5.0 are summarized by cohort. Incidence is defined as the number of participants with TEAEs in relation to the total number of participants in the cohort. TEAEs are defined as any AEs with an onset date of on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug.
Number of participants with graded hematology, coagulation, chemistry abnormalities, and clinically significant abnormalities in vital signs and ECGs
| Arm | Type | Description |
|---|---|---|
| VIR-2218 | EXPERIMENTAL | Drug: VIR-2218 VIR-2218 given by subcutaneous injection |
| Placebo | PLACEBO_COMPARATOR | Drug: Placebo Saline given by subcutaneous injection |
| Name | Type | Description |
|---|---|---|
| VIR-2218 | DRUG | VIR-2218 given by subcutaneous injection |
| Placebo | DRUG | Saline given by subcutaneous injection |
Inclusion Criteria: * Male or female age 18 - 65; * Weight ≥ 40 kg to ≤ 125 kg; * 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; *...