Approval Probability
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Anti-thrombin III · 1 trial · 1 indication
Evidence of decreased activation of the coagulation and fibrinolytic systems represented by a difference in the mean and Standard Deviation (SD) of the Calibrated Automated Thrombography (CAT) measurements of the control and ATIII groups at Time 5 (on arrival in ICU).
| Arm | Type | Description |
|---|---|---|
| Anti-thrombin III | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Anti-thrombin III | DRUG | Intraoperatively- (correcting to 100%) according to the following formula: Units required = ((100%- baseline ATIII level\*%) X body weight)/1.4 * expressed as a % normal level based on functional ATIII assay |
| Placebo | OTHER | Normal saline placebo |
Inclusion Criteria: * All patients less than 7 months of age going for cardiac surgery that will require cardiopulmonary bypass (CPB) with a documented ATIII level below 70% Exclusion Criteria: * Less than 2.5kg * Known or suspected hereditary ATIII deficiency (family history of venous thrombosis...
Anti-thrombin III is used for ATIII Deficiency and Acquired Antithrombin III Deficiency. It is being studied in cardiac surgery with cardiopulmonary bypass and in children undergoing open congenital cardiac surgery. The drug is in Phase 2 clinical development.
Anti-thrombin III is developed by Grifols, S.A., a biopharmaceutical company. The company's stock ticker is GRFS. The drug is currently in Phase 2 clinical trials for ATIII Deficiency and Acquired Antithrombin III Deficiency.
Anti-thrombin III is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Two Phase 2 trials have been completed, one with 200 participants and another with 45 participants.
Anti-thrombin III has been studied in two completed Phase 2 trials. NCT00823082 examined its use in cardiac surgery with cardiopulmonary bypass in Italy, enrolling 200 participants. NCT02103114 studied it versus placebo in children under 7 months undergoing open congenital cardiac surgery in the United States, enrolling 45 participants.
Anti-thrombin III is also known as Antithrombin III. The drug is being developed by Grifols, S.A. for ATIII Deficiency and Acquired Antithrombin III Deficiency. It is currently in Phase 2 clinical trials.