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Antithrombin III

Phase 2

Acquired Antithrombin III Deficiency | Small molecule | Hematology |Grifols, S.A.|Last Updated: Sep 20, 2016

Success Probability

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Market & Valuation

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Trial Design

RandomizedNO_TREATMENT_CONTROLLED
Total Trials1
Total Enrollment200

FDA Designations

No designations recorded

Clinical trial landscape

Antithrombin III · 1 trial · 2 indications

Phase 2 1
NCT00823082Use of Antithrombin in Cardiac Surgery With Cardiopulmonary BypassAcquired Antithrombin III Deficiency
COMPLETED200 Analytics
PHASE2COMPLETED
Use of Antithrombin in Cardiac Surgery With Cardiopulmonary Bypass
Acquired Antithrombin III DeficiencyUnlock trial analytics

Study Endpoints

Primary Endpoints

Postoperative ATIII Levels at the ICU Admission
ICU admission

Measurement of postoperative ATIII functional activity at ICU admission

Percentage of Subjects With ATIII Levels of 58% or Higher at ICU Admission
ICU admission

Percentage of subjects with ATIII levels of 58% functional activity or higher at ICU admission

Secondary Endpoints

Percentage of Subjects With Postoperative Myocardial Infarction
During ICU stay (maximum 70 days)
Percentage of Subjects With Adverse Neurologic Outcome
During ICU stay (maximum 70 days)
Percentage of Patients With Thromboembolic Events
During ICU stay (maximum 70 days)
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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Antithrombin III treatment groupEXPERIMENTALPreoperative ATIII supplementation administered immediately after anesthesia induction
Control groupNO_INTERVENTIONNo preoperative ATIII supplementation administered

Interventions

NameTypeDescription
Antithrombin IIIDRUGSingle dose of antithrombin III sufficient to achieve a preoperative level of 120%
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Male or female * At least 18 years of age * Subject needed elective cardiac surgery with cardiopulmonary bypass except for heart transplantation * Subject had a baseline ATIII level of less than 100% and equal to or above 60% * Subject signed the informed consent form * Subjec...

Countries:Italy
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Frequently asked questions about Antithrombin III

What is Anti-thrombin III used for?

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.

Who makes Anti-thrombin III?

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.

What phase is Anti-thrombin III in?

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.

What clinical trials is Anti-thrombin III in?

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.

Is Anti-thrombin III the same as Antithrombin III?

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.