EUCTR2016-003725-42-GB进行中（未招募）1 期
Does Interleukin-1 Receptor Antagonist Improve Outcome following aneurysmal Subarachnoid Haemorrhage (aSAH)? A Phase III trial - SC IL-1Ra in SAH - phase III trial
niversity of Manchester0 个研究点目标入组 1,000 人开始时间: 2018年6月21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
- 1,000
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.Patients with confirmed spontaneous SAH admitted to a participating neurosurgical centre where consent can be obtained and study drug / placebo administered within 72 hours of ictus.
- •2.No concomitant health problems that, in the opinion of the PI or designee, would interfere with participation, administration of study drug / placebo or assessment of outcomes including safety, for example, pre-existing active malignancy.
- •3.Willing and able to give informed consent or consent available from a patient representative for trial inclusion including agreement in principle to receive study drug / placebo and undergo all study assessments.
- •4.Aged 18 years or above.
- •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 700
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 300
排除标准
- •1. Unconfirmed or uncertain diagnosis of spontaneous SAH.
- •2. Known active tuberculosis or active hepatitis.
- •3. Known active malignancy.
- •4. Neutropenia (ANC <1.5 x 109/L ).
- •5. Abnormal renal function (creatinine clearance or estimated Glomerular Filtration Rate (eGFR) < 30 ml/minute) documented in the last 3 months prior to this SAH.
- •6. Live vaccinations within the last 10 days of this SAH.
- •7. Previous or concurrent treatment with IL-1Ra known at the time of trial entry or previous participation in this trial.
- •8. Previous or current treatment with medication suspected of interacting with IL-1Ra, listed in the drug SmPC (please see section 8.1.4 for the prohibited medication).
- •9. Known to have participated in a clinical trial of an investigational agent or device in the previous 30 days or 5 half-lives of enrolment (whichever is longer) of ictus, or for the period determined by the protocol of the trial / study the patient has taken part in.
- •10. Known to be pregnant or breast feeding or inability to reliably confirm that the patient is not pregnant.
- •11. Clinically significant serious concurrent medical condition, pre morbid illnesses, or concurrent serious infection, at the PI’s (or designee’s) discretion, which could affect the safety or tolerability of the intervention.
- •12. Known allergy to IL-1Ra or any of the excipients listed in the drug SmPC.
- •13. Known allergy to other products that are produced by DNA technology using the micro-organism E. coli (e.g. E.coli derived protein).
研究者
相似试验
进行中（未招募）
3 期
Can IL-1ra reduce inflammation and improve clinical outcome following aneurysmal SAH?Nervous System DiseasesStrokeISRCTN12961797The University of Manchester612
招募中
不适用
The effect of interleukin-1 receptor antagonist on insulin secretion in subjects with β-cell dysfunction.Insulin secretion10018424NL-OMON34308niversitair Medisch Centrum Sint Radboud16
进行中（未招募）
1 期
The effect of interleukin-1 receptor antagonist on insulin secretion - Anakinra and insulin secretioBeta-cell dysfunctionMedDRA version: 12.1Level: LLTClassification code 10052341Term: Impaired insulin secretionEUCTR2010-019660-36-NLMC St Radboud16
已完成
不适用
Effect of Interleukin-1 receptor antagonist on insulin sensitivity in obese, insulin resistant individualsmaturity-onset diabetestype 2 diabetes mellitus10018424NL-OMON33714niversitair Medisch Centrum Sint Radboud12
进行中（未招募）
1 期
Effect of Interleukin-1 receptor antagonist on insulin sensitivity in subjects with type 1 diabetes mellitus. - Effect of IL-1RA on insulin sensitivityMedDRA version: 12.1Level: LLTClassification code 10012601Term: Diabetes mellitusdiabetes mellitusEUCTR2010-023479-24-NLRadboud University Nijmegen Medical Centre16