2022-503012-16-00招募中3 期
TAK-330-3001 - A Phase 3, Prospective, Randomized, Open-label, Adaptive Group Sequential, Multicenter Trial with Blinded Endpoint Assessment to Evaluate the Efficacy and Safety of TAK-330 for the Reversal of Direct Oral Factor Xa Inhibitor-induced Anticoagulation in Patients Requiring Urgent Surgery/Invasive Procedure
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 204
- 试验地点
- 36
- 主要终点
- Occurrence of intraoperative effective hemostasis assessed at the end of the surgery/invasive procedure based on the assessment of the PI, the surgeon or a qualified member of the surgical team using the Four Point Intraoperative Hemostatic Efficacy Scale (Section 8.2.2.1).
研究概览
简要总结
To evaluate intraoperative efficacy of TAK-330 in comparison with standard of care (SOC) 4F-PCC, for reversal of anticoagulation in patients receiving direct oral Factor Xa inhibitors and requiring urgent surgery/invasive procedure within 15 hours from the last dose of Factor Xa inhibitor or at any time after that if their specific DOAC calibrated (apixaban, rivaroxaban or edoxaban) anti-FXa levels were > 75ng/mL or heparin-calibrated anti FXa assay level of > 0.5 IU/mL at screening.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Patient or legally authorized representative willing to sign e-consent/written informed consent form (ICF).
- •Patients ≥ 18 years of age at enrollment.
- •Patient currently on treatment with oral Factor Xa inhibitor (rivaroxaban, apixaban, edoxaban).
- •In the opinion of the surgeon, the patient requires urgent surgery/procedure that is associated with high-risk of intraoperative bleeding within 15 hours of the last Factor Xa inhibitor dose and requires a reversal agent for suspected direct oral Factor Xa inhibitor-related coagulopathy. In patients who are beyond the 15-hour window, eligibility requires proof of elevated plasma anti FXa levels using either specific DOAC-calibrated (apixaban, rivaroxaban or edoxaban) anti-FXa levels of > 75ng/mL, or heparin-calibrated anti-FXa assay levels of > 0.5 IU/mL at screening.
- •Women of childbearing potential should have a negative pregnancy test documented prior to enrollment.
排除标准
- •The patient has an expected survival of less than 30 days even with best available medical and surgical care.
- •Planned use of procoagulant drugs (e.g., Vitamin K, non-study PCCs, recombinant Factor VIIa) or blood products (transfusion of whole blood, FFP, cryoglobulins, plasma fractions, or platelets) after enrollment but before the 24±4 hours hemostatic assessment (Key secondary endpoint). Planned administration of TXA or aminocaproic acid after randomization but before the start of IP infusion, should be noted during randomization to properly stratify these patients in the IRT. Planned administration of TXA or aminocaproic acid after start of IP infusion but before the 24±4 hours hemostatic assessment is prohibited. Administration of any of the above products before the 24±4 hours hemostatic assessment will impact the assessment of hemostasis. Administration of PRBCs for hemoglobin correction, is not an exclusion criterion.
- •Administration of unfractionated heparin within 2 hours before randomization or low molecular weight heparin within 6 hours before randomization.
- •Hypersensitivity to PCC constituents, or any excipient of TAK-
- •Patients with history of confirmed immunoglobulin A (IgA) deficiency with hypersensitivity reaction and antibodies to IgA.
- •Septic shock as defined by persistent hypotension requiring vasopressors to maintain mean arterial pressure (MAP) ≥ 65mmHg and having blood lactate > 2 mmol despite adequate volume resuscitation.
- •Acute or chronic liver failure (hepatic cirrhosis Child-PUGH score C).
- •Renal failure requiring dialysis.
- •Any other condition that could, in the opinion of the investigator, put the patient at undue risk of harm if the patient were to participate in the study.
- •Participation in another clinical study involving an investigational product or device within 30 days prior to study enrollment, or planned participation in another clinical study involving an investigational product or device during the course of this study. Participation in an observational study is not an exclusion criterion.
- •The use of PROTHROMPLEX TOTAL as SOC 4F-PCC.
- •Recent history (within 90 days prior to screening) of venous thromboembolism, myocardial infarction (MI), DIC, ischemic stroke, transient ischemic attack, hospitalization for unstable angina pectoris or severe or critical coronavirus 2 (SARS-CoV-2) infection.
- •Women who are breastfeeding at the time of enrollment.
- •Active major bleeding defined as bleeding that requires surgery or transfusion of > 2 units of PRBC or intracranial hemorrhage with the exception of subacute and chronic subdural hemorrhages with a Glasgow Coma Score (GCS) ≥
- •Polytrauma for which reversal of Factor Xa-inhibition alone would not be sufficient to achieve hemostasis.
- •Known prothrombotic disorder including primary antiphospholipid syndrome, antithrombin-3 deficiency, homozygous protein C deficiency, homozygous protein S deficiency, and homozygous factor V Leiden.
- •Known bleeding disorders (e.g., platelet function disorders, hemophilia, Von Willebrand disease, coagulation factor deficiency).
- •Platelet count < 50,000/μL.
- •History of heparin-induced thrombocytopenia.
- •Administration of procoagulant drugs (e.g., non-study PCCs, recombinant Factor VIIa) or blood products (transfusion of whole blood, fresh frozen plasma (FFP), cryoglobulins, plasma fractions, or platelets) within 7 days before enrollment (Note: administration of packed red blood cells (PRBCs) for hemoglobin correction, tranexamic acid or aminocaproic acid are not exclusion criteria).
结局指标
主要结局
Occurrence of intraoperative effective hemostasis assessed at the end of the surgery/invasive procedure based on the assessment of the PI, the surgeon or a qualified member of the surgical team using the Four Point Intraoperative Hemostatic Efficacy Scale (Section 8.2.2.1).
Occurrence of intraoperative effective hemostasis assessed at the end of the surgery/invasive procedure based on the assessment of the PI, the surgeon or a qualified member of the surgical team using the Four Point Intraoperative Hemostatic Efficacy Scale (Section 8.2.2.1).
次要结局
- Key Secondary Endpoint: Occurrence of postoperative effective hemostasis assessed at 24 hours after the end of investigational product infusion (TAK-330 or comparator 4F-PCC) based on the assessment of the PI, the surgeon or a qualified member of the surgical team using the Four Point Postoperative Hemostatic Efficacy Scale (Section 8.2.2.1).
- • Occurrence of intraoperative effective hemostasis assessed at the end of the surgery/invasive procedure based on the assessment of the PI, the surgeon or a qualified member of the surgical team using the Hemostatic Efficacy Rating Algorithm (Section 8.2.2.2).
- • Usage of blood products or non-study hemostatic agents for bleeding control within 24 hours after the end of investigational product infusion.
- • Number of units of packed red blood cells (PRBCs) administered to achieve bleeding control within 24 hours after the end of investigational product infusion.
- • Occurrence of serious adverse events (SAEs), and/or adverse events (AEs), treatment emergent AEs (TEAEs), and adverse events of special interest (AESIs) within 30 days after the end of the surgery/invasive procedure.
- • Occurrence of thrombotic events within 30 days after the end of the surgery/invasive procedure.
- • All-cause deaths within 30 days post-surgery/invasive procedure.
研究者
Takeda
Scientific
Takeda Development Center Americas Inc.
研究点 (36)
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