ISRCTN12961797进行中（未招募）3 期
Does Interleukin-1 Receptor Antagonist Improve Outcome following aneurysmal Subarachnoid Haemorrhage (aSAH)? A Phase III trial
适应症
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 612
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. Patients with CT positive spontaneous SAH admitted to a participating neurosurgical centre where written informed consent can be obtained and study drug can be 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 or assessment of outcomes including safety
- •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 and undergo all study assessments
- •4. Male or female aged 18 years or above
排除标准
- •Current participant exclusion criteria as of 14/08/2023:
- •1. Unconfirmed or uncertain diagnosis of spontaneous SAH
- •2. Known active tuberculosis or active hepatitis
- •3. Known active malignancy
- •4. Known Still's Disease
- •5. Neutropenia (ANC <1.5 x 109/L )
- •6. Abnormal renal function (creatinine clearance or estimated Glomerular Filtration Rate (eGFR) < 30 ml/minute) documented in the last 3 months prior to this SAH
- •7. Live vaccinations within the last 10 days of this SAH
- •8. Previous or concurrent treatment with IL-1Ra known at the time of trial entry or previous participation in this trial
- •9. Current treatment with TNF antagonists
- •10. Known to have participated in a clinical trial of an investigational agent or device in the 30 days prior to ictus
- •11. Known to have participated in a clinical trial of an investigational agent or device within 5 half-lives (of the previous agent or device) prior to ictus
- •12. Known to be pregnant or breastfeeding or inability to reliably confirm that the patient is not pregnant
- •13. Clinically significant serious concurrent medical condition, pre-morbid illnesses, or concurrent serious infection (including confirmed or suspected COVID-19 infection), at the PI’s (or designee’s) discretion, which could affect the safety or tolerability of the intervention
- •14. Known allergy to IL-1Ra or any of the excipients listed in the drug SmPC
- •15. Known allergy to other products that are produced by DNA technology using the microorganism E. coli (e.g. E.coli derived protein)
- •16. Current treatment with IL-6 or IL-1 inhibitors or drugs affecting the IL-1 axis
- •17. History of DRESS syndrome
- •Previous participant exclusion criteria:
- •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
- •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
研究者
相似试验
进行中（未招募）
1 期
Does reducing inflammation after subarachnoid brain haemorrhage with Kineret improve levels of disability at 6 months?subarachnoid haemorrhageMedDRA version: 20.1Level: PTClassification code 10042316Term: Subarachnoid haemorrhageSystem Organ Class: 10022117 - Injury, poisoning and procedural complicationsEUCTR2016-003725-42-GBniversity of Manchester1,000
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