EUCTR2015-005211-32-NL进行中（未招募）1 期
A Phase 1b, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Single Ascending Dose Study to Assess the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of DS-1040b when Added to Standard of Care Anticoagulation Therapy in Subjects with Acute Submassive Pulmonary Embolism
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 116
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
入选标准
- •1. Male or female subjects, age 18 to 75 years and body weight between 50 and 130 kg, inclusive;
- •2. Subjects admitted to the hospital with a clinical diagnosis of acute PE with an onset of symptoms in the 5 days prior to diagnosis categorized as low risk or intermediate-risk or submassive PE and for whom catheter-based therapy is not planned;
- •a. Subjects must have a CTA scan confirming the PE diagnosis and with at least one measurable index lesion in a segmental or larger pulmonary artery prior to randomization;
- •b. Subjects should be in otherwise satisfactory health in the opinion of the Investigator;
- •c. Subjects may have concurrent DVT and have an inferior vena cava (IVC) filter placed prior to randomization;
- •d. Subjects may already be on SOC low molecular weight LMW heparin at the time of randomization but for no longer than 36 hours.
- •3. Able to provide written informed consent.
- •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 75
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 75
排除标准
- •1. Subjects with acute PE categorized as high-risk or massive, or who are hemodynamically unstable, evidenced by a heart rate > 120 /min and a systolic blood pressure (SBP) of < 90 mmHg for more than 15 consecutive minutes or a drop in SBP of > 40 mmHg since presentation;
- •2. Subjects for whom use of a thrombolytic, either systemic or via catheter, is planned;
- •3. Subjects with PE lesions only in the sub-segmental or smaller arteries, which due to limitations of the imaging method may not be consistently identified and measured;
- •4. Subjects unable or unwilling to take the required SOC anticoagulation therapy;
- •5. Subjects receiving more than 36 hours of SOC anticoagulants for treatment of the index PE event prior to randomization. Study drug infusion will ideally begin within 6hr after randomization
- •6. Subjects who had prior intracranial hemorrhage, known arteriovenous malformation or aneurysm, or evidence of active bleeding;
- •7. Subjects with bleeding diathesis, a platelet count < 100,000, international normalized ratio (INR) > 1.7, or clinically significant elevated activated partial thromboplastin time (aPTT) that is not explained by use of LMW heparin;
- •8. Subjects with active endocarditis;
- •9. Subjects with < 6 month history of acute coronary syndrome (ACS) whether or not they have undergone percutaneous coronary intervention (PCI);
- •10. Subjects who require ongoing dual antiplatelet therapy or treatment with aspirin alone in a dosage of more than 100 mg/per day;
- •11. Chronic treatment with non-aspirin non-steroidal anti-inflammatory drugs (NSAIDs) including both cyclooxygenase-1 (COX-1) and cyclooxygenase-2 (COX-2) inhibitors for = 4 days/week anticipated to continue during the study;
- •12. Subjects with uncontrolled hypertension at randomization, evidenced by systolic blood pressure > 180 mm Hg or diastolic blood pressure>120 mmHg, or who require parenteral medication to maintain blood pressure below these limits;
- •13. Subjects who within 3 months prior to randomization have had intracranial surgery, clinically significant head trauma (in the opinion of the Principal Investigator), a stroke, or have received thrombolytic treatment;
- •14. Subjects with ECG evidence of 2nd degree or higher atrioventricular (AV) block or with QTcB or QTcF >450 ms;
- •15. Subjects who within 21 days prior to randomization have had gastrointestinal or genitourinary bleeding;
- •16. Subjects who within 14 days prior to randomization have had major surgery or a lumbar puncture (or epidural steroid injection);
- •17. Subjects with hemoglobin < 10 g/dL;
- •18. Subjects with an estimated creatinine clearance < 60 mL/min;
- •19. Subjects with diagnosed active liver disease or with elevation of liver enzymes/bilirubin:
- •a. Alanine transaminase (ALT) or aspartate transaminase (AST) = 2 times upper limit of normal (ULN)
- •b. Total bilirubin (TBL) = 1.5 times ULN (except due to confirmed Gilbert’s syndrome)
- •20. Subjects with known history of testing positive for Hepatitis B antigen or Hepatitis C antibody before randomization;
- •21. Subjects with known history of testing positive for the human immunodeficienc
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