Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AT-III · 1 trial · 2 indications
Major morbidity composite defined as a composite of any one or more of the following: 1. Postoperative mortality (deaths occurring within 30 days of the operation or occurring during the primary hospitalization). 2. Stroke (clinical diagnosis of focal or global neurological deficit of abrupt onset caused by disturbance in cerebral blood supply). 3. Acute kidney injury (increase of serum creatinine levels to \>2.0 mg/dL and twice the baseline level or a new requirement for dialysis postoperatively). 4. Surgical reexploration (return to operating room because of bleeding, tamponade, graft occlusion or other cardiac reason). 5. Arterial or venous thromboembolic event (perioperative myocardial or mesenteric infarction, peripheral thromboembolism, acute coronary graft thrombosis, intracardiac thrombosis, deep vein thrombosis, pulmonary embolism). 6. Prolonged mechanical ventilation (\>24 hours). 7. Infection (deep sternal-wound infection and/or bloodstream infections).
| Arm | Type | Description |
|---|---|---|
| AT-III (Human) | EXPERIMENTAL | Single intravenous dose of AT-III (Human) sufficient to achieve an absolute increase of 20% (percentage points) above pretreatment AT levels according the following formula: AT-III (Human) dose (IU) required = (20) × (subject weight in kg) / 1.4 |
| Placebo | PLACEBO_COMPARATOR | Single intravenous administration of placebo at a volume equivalent to the volume for the calculated AT-III (Human) dose. |
| Name | Type | Description |
|---|---|---|
| AT-III (Human) | BIOLOGICAL | AT-III (Human) is an antithrombin concentrate prepared from pooled human plasma. AT-III (Human) is provided as a freeze-dried preparation for intravenous use. The AT-III (Human) preparation is reconstituted in 10 or 20 mL of sterile water for injection prior to intravenous administration. |
| Placebo | OTHER | 0.9% Sodium Chloride for Injection, United States Pharmacopeia |
Inclusion Criteria: 1. Male or female. 2. At least 18 years of age. 3. Subject needed non-emergency cardiac surgery with CPB. 4. Types of cardiac operations permitted: complex/combined procedures (CABG+valve), double/triple valve repair/replacement, ascending aorta/aortic arch surgeries. Isolated C...
AT-III is an investigational monoclonal antibody being studied for use in cardiac surgery, specifically to evaluate the safety and efficacy of preoperative antithrombin supplementation in patients undergoing high-risk cardiopulmonary bypass. It is intended to address complications associated with this procedure, though it remains in clinical development and is not yet approved.
AT-III targets antithrombin, a protein that regulates blood clotting. By supplementing antithrombin levels before surgery, the drug aims to manage coagulation during cardiopulmonary bypass. This mechanism is being investigated to potentially reduce bleeding or thrombotic complications in high-risk cardiac surgery patients.
AT-III is being developed by Grifols, S.A., a biopharmaceutical company. Grifols is conducting clinical trials to evaluate the drug's safety and efficacy for cardiac surgery patients. The company's work on this asset is part of its broader research in cardiovascular therapeutics.
AT-III is in Phase 2 clinical development. It has completed one Phase 2 trial, which was a randomized, double-blind, placebo-controlled study. The drug is still investigational and has not received FDA approval, as it continues to undergo clinical evaluation for its intended use in cardiac surgery.
AT-III has one completed clinical trial, NCT02037555, titled 'Safety and Efficacy of Preoperative Antithrombin Supplementation in Patients Undergoing High-Risk Cardiopulmonary Bypass.' This Phase 2 study enrolled 425 participants in the United States and was randomized, double-blind, and placebo-controlled. The trial has been completed.
AT-III is a drug product being developed by Grifols, and it is designed to supplement antithrombin, a natural protein in the body that helps control blood clotting. While the drug's name reflects its target, AT-III itself is an investigational monoclonal antibody, distinct from the endogenous protein it aims to supplement.