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 being studied to reduce surgical blood loss in patients at high risk of bleeding, including those undergoing cardiac surgery with cardio-pulmonary bypass. It is an investigational small molecule developed by Merck & Company, Inc. (MRK) and has completed Phase 2 clinical trials in this indication.
Ecallantide targets KLKB1, also known as plasma prekallikrein. It acts as an inhibitor of this target. By inhibiting KLKB1, Ecallantide may help reduce blood loss during surgical procedures, though its efficacy and safety are still being evaluated in clinical trials.
Ecallantide is being developed by Merck & Company, Inc., which trades under the ticker symbol MRK. Merck is responsible for the clinical development of Ecallantide, including the completed Phase 2 trials in surgical blood loss.
Ecallantide is in Phase 2 of clinical development. It has completed two Phase 2 trials but is not yet approved by the FDA. The trials were randomized, double-blind, and active-controlled, and they enrolled a total of 519 participants.
Ecallantide has been studied in two completed Phase 2 clinical trials: NCT00888940, which investigated its effect on reducing surgical blood loss in subjects at high risk of bleeding exposed to cardio-pulmonary bypass during cardiac surgery, and NCT00816023, a dose-ranging safety and efficacy study to reduce surgical blood loss volume.