EUCTR2013-001757-28-GB进行中（未招募）1 期
Does subcutaneous interleukin-1 receptor antagonist reduce inflammation following ischaemic stroke compared to placebo? - SC IL-1Ra in Stroke Study
Salford Royal NHS Foundation Trust0 个研究点目标入组 120 人开始时间: 2013年10月10日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 120
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
- •PATIENT GROUP
- •Patients with confirmed ischaemic stroke who are admitted to the Comprehensive Stroke Centre at Salford Royal NHS Foundation Trust (SRFT) where consent can be obtained and drug administered within 6 hours.
- •National Institutes of Health stroke scale (NIHSS) score between 4 – 26.
- •No concomitant health problems that, in the opinion of the Principal Investigator (PI) or designee, would interfere with participation, administration of study treatment or assessment of outcomes including safety, for example, pre-existing malignancy.
- •Renal function within normal limits (< 177 µmol/l).
- •Willing and able to give informed consent or consent available from a patient representative (personal-legal) for study inclusion including agreement in principle to receive study intervention and undergo all study assessments.
- •Aged 18 years or above.
- •HEALTHY VOLUNTEERS (recruited to provide a one-off 20ml blood sample only)
- •Between 18 and 80 years, in good health.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 60
排除标准
- •PATIENT GROUP
- •Unconfirmed or uncertain diagnosis of ischaemic stroke or rapid improving symptoms.
- •Haemorrhagic stroke.
- •NIHSS <4 or >26
- •Known allergy to E. coli or any of the constituents of the study medication as established from the patient themselves, reliable representative and clinical records.
- •Previous or concurrent treatment with recombinant IL-1Ra known at the time of study entry.
- •Previous or current treatment with medication suspected of interacting with recombinant IL-1Ra, such as TNF-a inhibitors.
- •Known to have participated in a clinical trial of an investigational agent or device in the previous 30 days or for the period determined by the protocol of the study the patient has taken part in.
- •Known or planned pregnancy (pregnancy test to be performed in women of child-bearing potential) or breast-feeding.
- •Clinically significant concurrent medical condition, at the PI’s (or designee’s) discretion, which could affect the safety, tolerability, or efficacy in this study.
- •Previous inclusion in the current study (known prior to inclusion).
- •Evidence of current infection or infection within the past 4 wk.
- •Inability or unwillingness of patient or patient’s personal representative to give written informed consent.
- •HEALTHY VOLUNTEERS (recruited to provide a one-off 20ml blood sample only to act as controls to study participants - no drug will be administered to healthy volunteers)
- •Current acute medical problems or taking medication for chronic conditions.
研究者
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