EUCTR2013-000954-23-FI进行中（未招募）1 期
PHASE 1/2a MULTICENTER, CONTROLLED, RANDOMIZED, OPEN LABEL, DOSE ESCALATION, SAFETY, TOLERABILITY, AND PHARMACOKINETIC STUDY COMPARING EG-1962 AND NIMODIPINE IN PATIENTS WITH ANEURYSMAL SUBARACHNOID HEMORRHAGE
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 96
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. Male or female between the ages of 18 to 75 years, inclusive;
- •2. WFNS Grade 2, 3, or 4 assessed after treatment of the aneurysm but prior to administration of EG-1962;
- •3. Ruptured saccular aneurysm confirmed by angiography (catheter or CTA) and treated by neurosurgical clipping or endovascular coiling;
- •4. Subarachnoid hemorrhage on baseline CT scan that is diffuse (clot present in both hemispheres) thick (>4 mm) or thin, or local thick;
- •5. External ventricular drain (EVD) in place;
- •6. The patient is able to receive EG-1962 within 60 hours of the onset of SAH. Onset of SAH is defined as the time the patient experiences the first symptom of SAH (e.g., severe headache or loss of consciousness reported either by the patient or by a witness). If found unconscious, the onset of SAH is defined as the last time the patient was seen at baseline neurological state;
- •7. Weight >45 kg;
- •8. Hemodynamically stable after resuscitation with SBP =90 mm Hg without the use of inotropic agents;
- •9. Signed informed consent from the patient or the patient’s legal representative after the completion of aneurysm repair and after all study criteria are confirmed; and
- •10. Female patients of child-bearing potential must have negative pregnancy test (urine or serum) at screening and must agree to use adequate birth control during the study and up to 1 month after the discontinuation of the study drug treatment. Female patients are considered to be not of child-bearing potential if they have a history of tubal ligation or hysterectomy or are post-menopausal with a minimum of 2 years without natural menstrual cycle. Male patients must agree to use adequate birth control during the study and up to 1 month after the discontinuation of the study drug treatment.
- •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 83
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 13
排除标准
- •1. Subarachnoid hemorrhage due to causes other than a saccular aneurysm (e.g., trauma or rupture of fusiform or infective aneurysm);
- •2. WFNS Grade 1 or 5 assessed after the completion of aneurysm repair but prior to administration of EG-1962;
- •3. Increased intracranial pressure (ICP) >30 mm Hg in sedated patients lasting >4 hours anytime since admission;
- •4. Intraventricular or intracerebral hemorrhage in absence of SAH or with only local, thin SAH;
- •5. Angiographic vasospasm prior to aneurysm repair procedure, as documented by catheter angiogram or CT angiogram;
- •6. Major complication during aneurysm repair such as, but not limited to, massive intraoperative hemorrhage, brain swelling, arterial occlusion, or inability to secure the ruptured aneurysm;
- •7. Aneurysm repair requiring flow diverting stent or stent-assisted coiling and dual antiplatelet therapy;
- •8. Hemodynamically unstable prior to administration of study drug
- •(i.e., SBP <90 mm Hg, requiring >6 L colloid or crystalloid fluid resuscitation);
- •9. Cardiopulmonary resuscitation was required following SAH;
- •10. Female patients with positive pregnancy test (blood or urine) at screening;
- •11. History within the past 6 months and/or physical finding on admission of decompensated heart failure (New York Heart Association [NYHA] Class III and IV or heart failure requiring hospitalization);
- •12. Acute myocardial infarction within 3 months prior to the administration of the study drug;
- •13. Symptoms or electrocardiogram (ECG)-based signs of acute myocardial infarction or unstable angina pectoris on admission;
- •14. Electrocardiogram evidence and/or physical findings compatible with second or third degree heart block or of cardiac arrhythmia associated with hemodynamic instability;
- •15. Echocardiogram, if performed as part of standard-of-care before treatment, revealing a left ventricular ejection fraction (LVEF) <40%;
- •16. Severe or unstable concomitant condition or disease (e.g., known significant neurologic deficit, cancer, hematologic, or coronary disease), or chronic condition (e.g., psychiatric disorder) that, in the opinion of the Investigator, may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results;
- •17. Patients who have received an investigational product or participated in another interventional clinical study within 30 days prior to randomization. Patients participating in a non-interventional study that has no bearing on assessment of EG-1962 or enteral nimodipine can be enrolled per guidelines of the local Institutional Review Board (IRB)/Independent Ethics Committee (IEC);
- •18. Kidney disease as defined by plasma creatinine =2.5 mg/dl (221 µmol/l); liver disease as defined by total bilirubin >3 mg/dl (51.3 µmol/l); and/or known diagnosis or clinical suspicion of liver cirrhosis; or
- •19. Known hypersensitivity to nimodipine or other dihydropyridine calcium channelantagonists, PLGA, or hyaluronic acid.
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