SC IL-1Ra in SAH - Phase III Trial (SCIL) (NCT03249207) | Clinical Trial Compass
UnknownPhase 3
SC IL-1Ra in SAH - Phase III Trial (SCIL)
United Kingdom612 participantsStarted 2018-10-11
Plain-language summary
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 Patients who are found to be non-aneurysmal following randomisation will be withdrawn from the study treatment.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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. Unconfirmed or uncertain diagnosis of spontaneous SAH.
✕. Known active tuberculosis or active hepatitis.
✕. 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.