NCT00442234已完成4 期
Pharmacokinetic/Pharmacodynamic Study of Monteplase ("Cleactor") in Acute Pulmonary Embolism
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Eisai Inc.
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Monteplase antigen levels in plasma; Monteplase activity in plasma; parameters of coagulating and fibrinolytic system (Plasminogen activity, a2-PI, PIC, fibrinogen, D-dimer).
研究概览
简要总结
To investigate PK and coagulating and fibrinolytic parameter profiles (PD) at the approved dose (13,750 - 27,500 IU/kg) in patients with acute pulmonary embolism accompanying hemodynamic instability.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1) Patients who consent for study participation and submit written informed consent with free will by patient or legally authorized representative.
- •2) Patients aged between 20 years or above and under 75 years old at the time of obtaining informed consent.
- •3) Patients with acute pulmonary embolism within 5 days after the onset.
- •4) Patients with acute pulmonary embolism with hemodynamic instability and fulfill all of the following 4 items:
- •Confirmed to have thrombi, emboli, or disorders in pulmonary circulation detected by pulmonary angiography or computed tomography.
- •Confirmed to have any of the following right ventricular overloads by echocardiography:
- •i) Dilation of right ventricular cavity or hypokinesis in ventricular wall
- •ii) Floating thrombi in pulmonary artery and right heart
- •iii) Paradoxical motion in the interventricular septum
- •iv) Disparity of tricuspid regurgitation pressure
- •v) Enlargement of pulmonary artery
- •Mean pulmonary arterial pressure (PAP) is 20 mmHg or above
- •PaO2 is 65 mmHg or below (confirmed by blood gas analysis)
排除标准
- •Patients with concurrent hemorrhage (e.g., gastrointestinal bleeding, urinary tract bleeding, retroperitoneal bleeding, intracranial bleeding, or hemoptysis).
- •Patients who underwent intracranial or spinal operation or injury within 2 months prior to study treatment.
- •Patients with intracranial tumor, arteriovenous malformation, or aneurysm
- •Patients with hemorrhagic diathesis (e.g., vascular purpura, thrombocytopenia, hemophilia)
- •Patients with hypertension of systolic blood pressure >=180 mmHg or diastolic pressure >= 110 mmHg.
- •Patients with a history of cerebrovascular disorder (e.g., cerebral infarction, intracerebral hemorrhage).
- •Patients with severe hepatic disorder (e.g., cirrhosis, severe hepatitis) or severe renal disorder (e.g., renal failure).
- •Patients received thrombolytic drug (t-PA or urokinase) within 7 days prior to study treatment.
- •Patients with pulmonary cardiac arrest (CPA).
- •Patients with a history of hypersensitivity to monteplase or protein preparations.
- •Pregnant women, women suspected of being pregnant, women who desire to become pregnant during a period between obtaining informed consent to the final observation, or lactating women.
- •Patients who are judged to be ineligible for study entry by the investigator or subinvestigator.
结局指标
主要结局
Monteplase antigen levels in plasma; Monteplase activity in plasma; parameters of coagulating and fibrinolytic system (Plasminogen activity, a2-PI, PIC, fibrinogen, D-dimer).
次要结局
- Symptoms and signs of acute pulmonary embolism; pulmonary thrombosis; echocardiography; pulmonary arterial pressure; blood gas; vital signs; laboratory tests (e.g., hematology and blood chemistry); adverse events; concomitant therapies; dosing regimen.
研究者
研究点 (2)
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