NL-OMON47535已完成不适用
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<br>Submassive Pulmonary Embolism. - DS1040-B-U107
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
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 (Heparin) [LMW (Heparin)] at the time of randomization but for no longer than 36 hours.
- •3. Able to provide written informed consent.
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 (eg, unfractionated heparin, LMW
- •heparin, Vitamin K antagonists or novel oral anticoagulants) for treatment of the index PE event
- •prior to randomization. Study drug infusion will ideally begin within 6 hours 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 a clinically significant elevated activated partial thromboplastin time (aPTT) that is not explained by use of LMWH;
- •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 SBP > 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 2 nd 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 immunodeficiency virus (HIV);
- •22. Subjects with active cancer defined as recurrent, regionally advanced, metastatic disease, or a
- •hematologic malignancy not in complete remission
- •and subjects with malignancy diagnosed
研究者
相似试验
进行中（未招募）
1 期
Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of DS-1040b when added to standard of care anticoagulation therapy in Subjects With Acute Submassive Pulmonary EmbolismDS-1040b is an inhibitor of the activated form of thrombin-activatable fibrinolysis inhibitor (TAFIa) intended to be used for the treatment of thrombotic diseases including Pulmonary Embolism (PE)MedDRA version: 20.0 Level: HLT Classification code 10037379 Term: Pulmonary embolism and thrombosis System Organ Class: 100000004866MedDRA version: 20.0 Level: PT Classification code 10037377 Term: Pulmonary embolism System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersEUCTR2015-005211-32-NLDaiichi Sankyo, Inc.116
招募中
1 期
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Multiple Subcutaneous Doses of OLP-1002.OsteoarthritisACTRN12620000782932OliPass Corporation30
已完成
1 期
A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of GRX-917 in Healthy SubjectsMental Health - DepressionAnxietyACTRN12621000160831Gaba Therapeutics Australia Pty Ltd a subsidiary of Gaba Therapeutics, Inc102
已完成
1 期
A Study of Clofazimine Inhalation Suspension (MNKD-101) in Healthy VolunteersPulmonary Nontuberculous Mycobacteria InfectionsInfection - Other infectious diseasesACTRN12621001702808MannKind Corporation40
进行中（未招募）
1 期
Clinical trial to investigate the safety and effect of a drug called B-701 given with another drug Docetaxel on certain typesof bladder cancer that do not respond to treatment with standard therapy.EUCTR2017-001319-36-CZBioClin Therapeutics, Inc.261