NCT06202378已完成2 期
A Multicenter, Randomized, Double Blind, Placebo Controlled Phase II Clinical Study to Evaluate the Safety and Efficacy of SHPL-49 Injection in the Treatment of Acute Ischemic Stroke
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 270
- 试验地点
- 16
- 主要终点
- Modified Rankin Scale (mRS), with scores of 0-1 at Day 90
研究概览
简要总结
This study is designed to determine the safety and efficacy of SHPL-49 intravenous infusion for 7 consecutive days in the treatment of acute ischemic stroke subjects.
详细描述
Trial Objectives:
The primary objective of this study is to determine the effectiveness of different doses of SHPL-49 intravenous infusion for 7 consecutive days in the treatment of acute ischemic stroke subjects within 8h after onset.
The secondary objective is to determine the safety of different doses of SHPL-49 intravenous infusion for 7 consecutive days in the treatment of acute ischemic stroke subjects within 8h after onset.
Trial Design:
This study is a Phase II, multicenter, randomized, double Blind, placebo-Controlled design. Participants receive twice daily dosing for 7 consecutive days, or once on Days 1 and Day 8 and twice daily on Days 2 to Day 7, with each subject scheduled to receive 14 doses throughout the clinical trial. 270 Participants will be randomized 1:1:1 to SHPL-49 injection treated group (3 ampoules of SHPL-49 injections, Bis in die（BID）), SHPL-49 injection treated group (6 ampoules of SHPL-49 injections , BID) and placebo group (BID).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-80 years old (including upper and lower limits);
- •Clinically diagnosed as acute ischemic stroke according to the latest guidelines;
- •Patients with acute ischemic stroke who plan to receive or have received standard intravenous thrombolysis in hospital (this research center) within 8h after the onset of the disease;
- •Participants who have NIHSS ≥5 and ≤ 22 before thrombolysis;
- •Pre-stroke mRS Score ≤1;
- •Participants or legally authorized representatives who are able and willing to sign informed consent.
排除标准
- •Complicated with intracranial hemorrhagic diseases, including hemorrhagic stroke, epidural hematoma, intracranial hematoma, ventricular hemorrhage, subarachnoid hemorrhage, etc.;
- •Severe disturbance of consciousness: patients with NIHSS 1a consciousness level item score ≥2;
- •Cerebral Computed tomography (CT) or Magnetic resonance imaging (MRI) indicated a large anterior circulation cerebral infarction (ASPECT score < 6 or infarct area greater than 1/3 of the middle cerebral artery blood supply area);
- •Stroke with rapid improvement of symptoms before intravenous thrombolysis, or acute ischemic symptoms suspected to be caused by other causes;
- •Patients who are ready to receive or have receive intravascular therapy;
- •After the onset of the disease, drugs with neuroprotective effects have been applied in the instructions. Such as commercially available Edaravone, Edaravone and Dexborneol Concentrated Solution for Injection, Butylphthalide, Nimodipine, Ganglioside, Citicoline, Piracetam, Oxiracetam, Human Urinary Kallidinogenase, Cinepazide, Mouse Nerve Growth Factor For Injection, Cerebrolysin, Deproteinised Calf Blood Serum Injection, Deproteinised Calf Blood Extractives Injection, etc.;
- •Severe hypertension: systolic blood pressure ≥185mmHg or diastolic blood pressure ≥110mmHg after taking antihypertensive drugs before thrombolysis;
- •Severe renal insufficiency: serum creatinine >2 times the upper limit of normal or creatinine clearance (CLcr)< 30mL/min (Cockcroft-Gault formula), or other known severe renal insufficiency; (Note: Cockcroft-Gault formula: ① Male: CLcr (mL/min) = [140 - age (yrs)]× body weight (kg) / [0.814 × serum creatinine (μmol/L)]; (2) female: CLcr (mL/min) = {[140 - age (years old)] by weight (kg) / [0.814 x serum creatinine (μmol/L)]} x 0.85)
- •Severe liver function impairment: Alanine aminotransferase (ALT) or Aspartate aminotransferase(AST)>3 times the upper limit of normal, or other known liver diseases such as acute and chronic hepatitis, cirrhosis, etc.;
- •Patients with a heart function rating above Class II (according to the New York Heart Association (NYHA) heart function rating) or a history of congestive heart failure;
- •Patients with concurrent malignant tumors or undergoing anti-tumor therapy;
- •Allergic to experimental drugs or similar ingredients or materials used in imaging examinations;
- •Patients during pregnancy, breastfeeding or planning pregnancy;
- •Patients who have a history of epilepsy or have had seizure-like symptoms at the onset of stroke, or suffer from serious mental disorders, intellectual disabilities or dementia;
- •Suspected or confirmed alcohol dependence, or drinking more than 3 units (male) or 2 units (female) of alcohol within 24 hours prior to onset (1 unit =360 mL beer or 45 mL liquor with 40% alcohol or 150 mL wine);
- •Patients have participated in or are participating in another clinical study within the 3 months before singing informed consent;
- •Patients who are judged unsuitable for participation by the investigators in the study.
研究组 & 干预措施
SHPL-49 Injection，3 ampoules
Experimental
1mL/ampoule
干预措施: 3 ampoules of SHPL-49 Injection (Drug)
SHPL-49 Injection，6 ampoules
Experimental
1mL/ampoule
干预措施: 6 ampoules of SHPL-49 Injection (Drug)
Placebo
Placebo Comparator
1mL/ampoule
干预措施: 0.9% Sodium Chloride Injection (Drug)
结局指标
主要结局
Modified Rankin Scale (mRS), with scores of 0-1 at Day 90
时间窗: 90±7 days
Proportion of participants with mRS scores of 0-1 at Day 90
次要结局
- Shift analysis/ Ordinal analysis(90±7 days)
- Modified Rankin Scale (mRS), with scores of 0-1 at Day 30(30±3 days)
- Modified Rankin Scale (mRS), with scores of 0-2 at Day 30(30±3 days)
- Modified Rankin Scale (mRS), with scores of 0-2 at Day 90(90±7 days)
- National Institute of Health stroke scale (NIHSS) on day 7or 8(7 days or 8 days)
- National Institute of Health stroke scale (NIHSS) at Day 14 or at discharge(14±2 days or at discharge)
- Barthel index (BI) at Day 30(30±3 days)
- Barthel inde (BI) at Day 90(90±7 days)
- Symptomatic intracranial hemorrhage(22-36h after thrombolysis)
- Mortality(90±7 days)
- Serious adverse events(90±7 days)
- Adverse events(90±7 days)
- Changes in laboratory test indicators(7 days or 8 days，14±2 days，90±7 days)
- Changes in vital signs before and after administration(7 days or 8 days，14±2 days，90±7 days)
- 12-lead electrocardiogram(90±7 days)
- Vital signs(90±7 days)
- Physical examination(90±7 days)
- Laboratory test indicators(90±7 days)
研究者
研究点 (16)
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