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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04269551 | A Safety and Tolerability Study of BIVV020 in Adults With Cold Agglutinin Disease | PHASE1 | COMPLETED | 12 | — | — | Jun 15, 2020 | Jan 6, 2022 | Sep 22, 2025 | 10 | United States, Germany +4 |
Number of participants with adverse events (AEs)
| Arm | Type | Description |
|---|---|---|
| BIVV020 IV | EXPERIMENTAL | Single administration dose 1, plus two optional doses of BIVV020 administered intravenously. |
| Name | Type | Description |
|---|---|---|
| BIVV020 | DRUG | Pharmaceutical form:solution for injection Route of administration: intravenous |
Inclusion criteria : * Male and/or female patients, ≥ 18 years of age with cold agglutinin disease as defined by: 1. Chronic hemolysis per Investigator's judgement, 2. Polyspecific direct antiglobulin test (DAT) positive, 3. Monospecific DAT strongly positive for C3d, 4. Cold agglutinin (C...