Prospective, Open-label Study of Andexanet Alfa in Patients Receiving a Factor Xa Inhibitor who Have Acute Major Bleeding (ANNEXA-4). - ANNEXA-4

Portola Pharmaceuticals, Inc.0 个研究点目标入组 350 人开始时间: 2015年9月17日最近更新: 2020年11月16日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: Portola Pharmaceuticals, Inc.
入组人数: 350

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional clinical trial of medicinal product

入排标准

性别: All

入选标准

•1) Either the patient or his or her medical proxy (or legally acceptable designee) has been adequately informed of the nature and risks of the study and has given written informed consent prior to Screening;
•2) The patient must be at least 18 years old at the time of Screening;
•3) The patient must have an acute overt major bleeding episode requiring urgent reversal of anticoagulation; Acute major bleeding requiring urgent reversal of anticoagulation is defined by at least ONE of the following:
•- Acute overt bleeding that is potentially life-threatening, e.g., with signs or symptoms of haemodynamic compromise, such as severe hypotension, poor skin perfusion, mental confusion, low urine output that cannot be otherwise explained;
•- Acute overt bleeding associated with a fall in haemoglobin level by = 2 g/dL, OR a Hgb = 8 g/dL if no baseline Hgb is available;
•- Acute bleeding in a critical area or organ, such as, intra-spinal, pericardial or intracranial.
•4) The patient, for whom the bleeding is intracranial must have undergone a head CT or MRI scan demonstrating the intracranial bleeding. Note: Patients with bleeding at non-intracranial locations do not require a head CT or MRI;
•5) The patient received or is believed to have received one of the following within 18 hours prior to andexanet administration: apixaban, rivaroxaban, edoxaban or enoxaparin (dose of enoxaparin =1mg/kg/d).
•6) For patients with ICH, there must be a reasonable expectation that andexanet treatment will commence within 2 hours of the baseline imaging evaluation.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 105
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 245

排除标准

•1) The patient is scheduled to undergo surgery in less than 12 hours with the exception of minimally invasive surgery/procedures (e.g., endoscopy, bronchoscopy, central lines, Burr holes);
•2) A patient with ICH has any of the following:
•- Glasgow coma score < 7
•- Estimated intracerebral haematoma volume >60 cc as assessed by the CT or MRI.
•3) Patients with visible, musculoskeletal, or intra-articular bleeding as the qualifying bleed.
•4) The patient has an expected survival of less than 1 month;
•5) The patient has a recent history (within 2 weeks) of a diagnosed thrombotic event (TE) as follows: venous thromboembolism (VTE; e.g., deep venous thrombosis, pulmonary embolism, cerebral venous thrombosis), myocardial infarction, disseminated intravascular coagulation (DIC), cerebral vascular accident, transient ischemic attack, unstable angina pectoris hospitalization, or severe peripheral vascular disease within 2 weeks prior to Screening;
•6) The patient has severe sepsis or septic shock at the time of Screening;
•7) The patient is pregnant or a lactating female;
•8) The patient has received any of the following drugs or blood products within 7 days or Screening:
•Vitamin K antagonist (VKA) (e.g., warfarin);
•Dabigatran;
•Prothrombin Complex Concentrate products (PCC, e.g., Kcentra®) or recombinant factor VIIa (rfVIIa) (e.g., NovoSeven®);
•Whole blood, plasma fractions
•Note: Administration of platelets or packed red blood cells (PRBCs) is not an exclusion criterion;
•9) The patient was treated with an investigational drug <30 days prior to Screening.
•10) Planned administration of PCC, fresh frozen plasma (FFP), or rfVIIa from Screening until within 12 hours after the end of the andexanet infusion.

研究者

发起方

Portola Pharmaceuticals, Inc.

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NL-OMON45055PORTOLA PHARMACEUTICALS, INC.8

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