EUCTR2021-002148-56-DE进行中（未招募）1 期
A RANDOMIZED, DOUBLE BLIND, MULTICENTER, MULTINATIONAL, PLACEBO CONTROLLED, PARALLEL GROUP, SINGLE DOSE, ADAPTIVE EFFICACY AND SAFETY STUDY OF GLENZOCIMAB USED AS AN ADD-ON THERAPY ON TOP OF STANDARD OF CARE IN THE 4.5 HOURS FOLLOWING AN ACUTE ISCHEMIC STROKE - ACTISAVE
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 400
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
- 性别
- All
入选标准
- •1. Adult male or female patients = 18 years (i.e., at least 18 years old at time of randomization),
- •2. Having given their own written consent, or legal representative consent, or emergency consent, and in any case, in strict accordance with country-specific legal requirements,
- •3. Presenting with an acute disabling ischemic stroke either in the anterior or in posterior circulation, with or without visible occlusion, with a known time of onset, that is = 4.5 hrs,
- •4. Presenting with a pre-IVT NIHSS = 6,
- •5. In whom IVT is or has been initiated, whether or not patients are additionally eligible to mechanical thrombectomy (MT + IVT), according to the last recommendations of the last guidelines (ASA and ESO recommendations)
- •6. Women of childbearing potential (WOCBP) must have a negative serum/urine pregnancy test at baseline. Women of childbearing
- •potential, i.e., fertile, are defined as women following menarche and until becoming post-menopausal unless permanently sterile, i.e.,
- •having undergone hysterectomy, bilateral salpingectomy and bilateral oophorectomy.
- •7. Post-menopausal women defined as not having menses for 12 months without an alternative medical cause. For WOCBP, a highly effective birth control method should be in place that can achieve a failure rate of less than 1% per year that should last for at least 2 months after IMP administration.
- •Birth control methods which may be considered as highly effective in WOCBP include:
- •-combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (intravaginal, transdermal),
- •-progestogen-only hormonal contraception associated with inhibition of ovulation (injectable, implantable)
- •-intrauterine device (IUD),
- •-intrauterine hormone-releasing system (IUS),
- •-bilateral tubal occlusion,
- •-vasectomized partner.
- •Birth control methods which may be considered as highly effective for men and that should last for 4 months after IMP administration include:
- •- vasectomy,
- •- use of condom combined with a highly effective birth control method for their WOCBP partner.
- •Please note that hormonal contraception is a risk factor for thromboembolic events and attention should be called to reconsider it passed the acute stroke phase.
- •8. Patients affiliated to a health insurance – modality depending on country legal requirement
- •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 133
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 267
排除标准
- •1. Coma, or NIHSS >25,
- •2. Patients < 18 years,
- •3. Protected adults under guardianship or curatorship,
- •4. Prior ischemic stroke within the past 3 months,
- •5. mRS pre-stroke known to be = 2,
- •6. Large (more than 1/3 of the middle cerebral artery) regions of clear hypodensity on Baseline Computed Tomography Angiography (CTA) or Magnetic Resonance Imaging (MRI) or with vascular injection (MRA),
- •7. Significant mass effect with midline shift,
- •8. Stroke of hemorrhagic origin,
- •9. Patients likely to require dual antiplatelet therapy (DAPT) within the first 24 hrs after cessation of glenzocimab or placebo infusion for
- •e.g., carotid stenting,
- •10. Known renal insufficiency (Grades 4-5 – severe or terminal), with a creatinine clearance < 30 mL/Mn using Cockroft formula)
- •11. Known allergic reaction to contrast agents,
- •12. Patients under anti-coagulant therapy, except preventative doses of injectable low molecular weight heparin (LMWH),
- •13. Known ongoing treatment with a mAb,
- •14. Prior cardiopulmonary resuscitation < 10 days,
- •15. Childbirth within < 10 days,
- •16. Seizures at stroke onset if it precludes obtaining an accurate baseline (pre-IVT) NIHSS,
- •17. Life expectancy (except for stroke) < 3 months,
- •18. Pregnancy or breastfeeding,
- •19. Females of childbearing potential not using effective birth control methods,
- •20. Known current participation in another clinical investigation with experimental drug
研究者
相似试验
进行中（未招募）
1 期
ADAPTIVE EFFICACY AND SAFETY STUDY OF GLENZOCIMAB USED AS AN ADD-ON THERAPY ON TOP OF STANDARD OF CARE IN THE 4.5 HOURS FOLLOWING AN ACUTE ISCHEMIC STROKEAcute ischemic strokeMedDRA version: 22.1Level: LLTClassification code 10055221Term: Ischemic strokeSystem Organ Class: 100000004852EUCTR2021-002148-56-FRACTICOR BIOTECH1,000
进行中（未招募）
1 期
ADAPTIVE EFFICACY AND SAFETY STUDY OF GLENZOCIMAB USED AS AN ADD-ON THERAPY ON TOP OF STANDARD OF CARE IN THE 4.5 HOURS FOLLOWING AN ACUTE ISCHEMIC STROKEAcute ischemic strokeMedDRA version: 22.1Level: LLTClassification code 10055221Term: Ischemic strokeSystem Organ Class: 100000004852EUCTR2021-002148-56-SKACTICOR BIOTECH400
进行中（未招募）
1 期
ADAPTIVE EFFICACY AND SAFETY STUDY OF GLENZOCIMAB USED AS AN ADD-ON THERAPY ON TOP OF STANDARD OF CARE IN THE 4.5 HOURS FOLLOWING AN ACUTE ISCHEMIC STROKEAcute ischemic strokeMedDRA version: 22.1Level: LLTClassification code 10055221Term: Ischemic strokeSystem Organ Class: 100000004852EUCTR2021-002148-56-ESACTICOR BIOTECH1,000
进行中（未招募）
1 期
ADAPTIVE EFFICACY AND SAFETY STUDY OF GLENZOCIMAB USED AS AN ADD-ON THERAPY ON TOP OF STANDARD OF CARE IN THE 4.5 HOURS FOLLOWING AN ACUTE ISCHEMIC STROKEEUCTR2021-002148-56-DKACTICOR BIOTECH400
进行中（未招募）
1 期
ADAPTIVE EFFICACY AND SAFETY STUDY OF GLENZOCIMAB USED AS AN ADD-ON THERAPY ON TOP OF STANDARD OF CARE IN THE 4.5 HOURS FOLLOWING AN ACUTE ISCHEMIC STROKEAcute ischemic strokeMedDRA version: 22.1Level: LLTClassification code 10055221Term: Ischemic strokeSystem Organ Class: 100000004852EUCTR2021-002148-56-CZACTICOR BIOTECH1,000