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Also known as AT-III (Human)
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 being developed for use in cardiac surgery, specifically for patients undergoing high-risk cardiopulmonary bypass. It is intended as a preoperative antithrombin supplementation therapy. The drug is being studied to assess its safety and efficacy in this surgical setting.
AT-III is being developed by Grifols, S.A., a global healthcare company. Grifols trades on the Nasdaq under the ticker symbol GRFS. The company is responsible for the clinical development of this investigational therapy.
AT-III is in Phase 2 clinical development. It has not been approved by the FDA and remains an investigational therapy. The Phase 2 trial has been completed, and no active trials are currently listed for this drug.
AT-III has been studied in one completed Phase 2 clinical trial, NCT02037555, titled "Safety and Efficacy of Preoperative Antithrombin Supplementation in Patients Undergoing High-Risk Cardiopulmonary Bypass." The trial enrolled 425 patients in the United States and was randomized, double-blind, and placebo-controlled.
Yes, AT-III is also known as AT-III (Human). These names refer to the same investigational drug candidate being developed by Grifols, S.A. for use in cardiac surgery.