NCT03249207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
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 612
- 试验地点
- 17
- 主要终点
- Ordinal shift in modified Rankin Score (mRS)
研究概览
简要总结
This phase III trial will establish whether IL-1Ra, with sub-cutaneous (SC) administration twice daily for up to 21 days post aneurysmal subarachnoid haemorrhage (aSAH), improves clinical outcome as measured by ordinal shift in mRS at 6 months.
Patients with SAH transferred to a neurosurgical centre will be identified and approached for study participation. Following consent, patients will be randomised to receive either IL-1Ra or placebo for a maximum of 21 days from onset of symptoms. Patients who are found to be non-aneurysmal following randomisation will be withdrawn from the study treatment. Blood samples for plasma IL-6 will be obtained prior to randomisation and at day 3-5 post randomisation for IL-6 & IL-1 measurement. Safety will be measured at 30 days post randomisation and outcome assessed at 6 months post randomisation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
- •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.
- •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.
- •Male or female aged 18 years or above.
排除标准
- •Unconfirmed or uncertain diagnosis of spontaneous SAH.
- •Known active tuberculosis or active hepatitis.
- •Known active malignancy.
- •Known Still's Disease
- •Neutropenia (ANC <1.5 x 109/L ).
- •Abnormal renal function (creatinine clearance or estimated Glomerular Filtration Rate (eGFR) < 30 ml/minute) documented in the last 3 months prior to this SAH.
- •Live vaccinations within the last 10 days of this SAH.
- •Previous or concurrent treatment with IL-1Ra known at the time of trial entry or previous participation in this trial.
- •Current treatment with TNF antagonists.
- •Known to have participated in a clinical trial of an investigational agent or device in the 30 days prior to ictus.
- •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.
- •Known to be pregnant or breast feeding or inability to reliably confirm that the patient is not pregnant
- •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.
- •Known allergy to IL-1Ra or any of the excipients listed in the drug SmPC
- •Known allergy to other products that are produced by DNA technology using the micro-organism E. coli (e.g. E.coli derived protein).
- •Current treatment with IL-6 or IL-1 inhibitors or drugs affecting the IL-1 axis.
- •History of DRESS syndrome.
研究组 & 干预措施
IL-1Ra twice daily
Active Comparator
干预措施: IL-1Ra (Drug)
Placebo twice daily
Placebo Comparator
干预措施: IL-1Ra Placebo (Drug)
结局指标
主要结局
Ordinal shift in modified Rankin Score (mRS)
时间窗: 6 months post randomisation
次要结局
- Measurement of fatigue using Fatigue score(6 months post randomisation)
- Measurement of quality of life using EQ-5D-5L score(6 months post randomisation)
- Measurement of mood using HADS(6 months post randomisation)
研究者
研究点 (17)
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