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AT-III

Phase 2

Cardiac Surgery | Monoclonal antibody | Other |Grifols, S.A.|Last Updated: Mar 15, 2019

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment425
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02037555Safety and Efficacy of Preoperative Antithrombin Supplementation in Patients Undergoing High-Risk Cardiopulmonary BypassPHASE2 COMPLETED 425Jun 26, 2014Jan 25, 2018Mar 15, 201941 United States
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Study Endpoints
Primary Endpoints
Percentage of Subjects With Any Component of a Major Morbidity Composite
Up to Day 30 +/- 4 days

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).

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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
AT-III (Human)EXPERIMENTALSingle 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
PlaceboPLACEBO_COMPARATORSingle intravenous administration of placebo at a volume equivalent to the volume for the calculated AT-III (Human) dose.
Interventions
NameTypeDescription
AT-III (Human)BIOLOGICALAT-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.
PlaceboOTHER0.9% Sodium Chloride for Injection, United States Pharmacopeia
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites41

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...

Countries:United States
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