EUCTR2018-000249-38-GB进行中（未招募）1 期
Phase II trial of interleukin-1 receptor antagonist in intracerebral haemorrhage: BLOcking the Cytokine IL-1 in ICH - BLOC-ICH - BLOcking the Cytokine IL-1 in ICH
niversity of Manchester0 个研究点目标入组 80 人开始时间: 2019年6月24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
- 80
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
入选标准
- •1. Patients with spontaneous, primary, supratentorial ICH admitted to a participating centre within 8 hours of symptom onset.
- •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 (no upper age limit).
- •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 27
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 53
排除标准
- •1. Severe ICH, unlikely to survive to 72 hours scan (defined as Glasgow Coma Scale score 6 at any time prior to consent);
- •2. Confirmed or suspected structural abnormality as cause of ICH (including tumour, vascular malformation);
- •3. Confirmed or suspected haemorrhagic transformation of an arterial or venous infarct;
- •4. Acute neurosurgery planned within 72 hours of admission;
- •5. Known active tuberculosis or active hepatitis;
- •6. Known active malignancy;
- •7. Neutropenia (neutrophil count (ANC) <1.5 x 10^9 );
- •8. Abnormal renal function (previous eGFR<30 mL/min in 3 months prior to this ICH*
- •9. Live vaccinations within the last 10 days prior to this ICH;
- •10. Previous or concurrent treatment with IL-1Ra known at the time of trial entry or previous participation in this trial.
- •11. Previous or current treatment with etanercept or any other TNF-a antagonist
- •12. Known to have participated in a clinical trial of an investigational agent or device in the 30 days prior to symptom onset;
- •13. 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 symptom onset;
- •14. Known to be pregnant or breast-feeding or inability to reliably confirm that the patient is
- •not pregnant (Please see further guidance on pregnancy prevention in section 7.2.1).
- •15. Known diagnosis of Still’s disease;
- •16. Clinically significant serious concurrent medical condition, premorbid illnesses, or
- •concurrent serious infection, at the PI’s (or designee’s) discretion, which could affect the safety
- •or tolerability of the intervention. Please see precaution of use section 8.1.5 for further
- •17. Known allergy to IL-1Ra or any of the excipients listed in the drug SmPC (please
- •section 8.1.4).
- •18.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
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