Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Ecallantide · 2 trials · 2 indications
| 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...
Ecallantide is an investigational small molecule being developed to reduce surgical blood loss. It is being studied in patients undergoing surgical procedures, including those at high risk of bleeding during cardiac surgery with cardiopulmonary bypass. The drug is currently in Phase 2 clinical development and is not yet approved.
Ecallantide is being developed by Merck & Company, Inc., which trades under the ticker symbol MRK. The company is conducting clinical trials to evaluate the drug's safety and efficacy in reducing surgical blood loss.
Ecallantide is in Phase 2 clinical development. Two Phase 2 trials have been completed, both investigating the drug's effect on reducing surgical blood loss volume. The drug is investigational and has not been approved by regulatory authorities.
Ecallantide has been studied in two completed Phase 2 trials. NCT00816023 was a dose-ranging study with 276 participants to reduce surgical blood loss. NCT00888940 enrolled 243 subjects at high risk of bleeding during cardiac surgery with cardiopulmonary bypass. Both trials were randomized, double-blind, and active-controlled.
Ecallantide is a small molecule that targets the plasma protein kallikrein, an enzyme involved in the coagulation and inflammation pathways. By inhibiting kallikrein, the drug aims to reduce excessive bleeding during surgical procedures, thereby decreasing blood loss volume.