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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00631878 | Safety and Pharmacokinetics Study in VLBW Neonates With BSYX-A110 | PHASE1 | COMPLETED | 53 | — | — | Nov 1, 2001 | Aug 1, 2003 | Mar 10, 2008 | 1 | United States |
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | - |
| 10 mg/kg | EXPERIMENTAL | 10 mg/kg was given on Days 0, 14 |
| 30 mg/kg | EXPERIMENTAL | 30 mg/kg was given on Days 0, 14 |
| 60 mg/kg | EXPERIMENTAL | 60 mg/kg was given on Days 0, 14 |
| 90 mg/kg | EXPERIMENTAL | 90 mg/kg was given on Days 0, 14 |
| Name | Type | Description |
|---|---|---|
| Pagibaximab (formerly BSYX-A110) | DRUG | Pagibaximab at 10, 30, 60, 90 mg/kg intravenously at Days 0 and 14. |
Inclusion Criteria: Patients must meet all of the following criteria at the time of first infusion (Day 0): 1. 3-7 days of age, inclusive 2. Birth weight of 700-1300 grams 3. Survival expected for at least 1 week after infusion 4. Inpatient in a Neonatal Intensive Care Unit with intravenous access...