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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00888940 | Outcomes and Safety Trial Investigating Ecallantide's Effect on Reducing Surgical Blood Loss Volume in Subjects at High Risk of Bleeding Exposed to Cardio-pulmonary Bypass During Cardiac Surgery | PHASE2 | COMPLETED | 243 | — | — | Jun 1, 2009 | Jan 1, 2010 | Aug 10, 2015 | 34 | United States, Germany +1 |
| NCT00816023 | A Dose-ranging Safety and Efficacy Study of Ecallantide to Reduce Surgical Blood Loss Volume | PHASE2 | COMPLETED | 276 | — | — | Mar 1, 2009 | Jan 1, 2010 | Aug 11, 2015 | 29 | United States, Canada |
| Arm | Type | Description |
|---|---|---|
| ecallantide | EXPERIMENTAL | - |
| Cyklokapron(R) | ACTIVE_COMPARATOR | - |
| Ecallantide Low Dose | EXPERIMENTAL | target steady state concentration of 0.15 mg/L |
| Ecallantide Medium Dose | EXPERIMENTAL | target steady state concentration of 0.75 mg/L |
| Ecallantide High Dose | EXPERIMENTAL | target steady state concentration of 2.25 mg/L |
| Placebo | PLACEBO_COMPARATOR | placebo |
| Name | Type | Description |
|---|---|---|
| Ecallantide | DRUG | 2.25 mg/L pump prime, 0.13 mg/kg loading dose, 2.25 mg/L constant infusion |
| Cyklokapron(R) | DRUG | 1000-mg loading dose followed by a continuous infusion of 400 mg/hr with an additional 500 mg added to the pump prime |
| placebo | DRUG | solution for IV infusion over the duration of the surgical\>\> procedure |
Inclusion Criteria: * Written informed consent (by study subject) prior to any study-related procedure not part of normal medical care; * Male or female between the ages of 18 and 85 years old, inclusive; and * Planned cardiac surgery using cardio-pulmonary bypass, for one of the following procedur...