Status:
UNKNOWN
SC IL-1Ra in SAH - Phase III Trial (SCIL)
Lead Sponsor:
University of Manchester
Collaborating Sponsors:
National Institute for Health Research, United Kingdom
Clinical Trials Unit, Manchester
Conditions:
Subarachnoid Hemorrhage
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 m...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 11 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2024
Estimated Enrollment :
612 Patients enrolled
Trial Details
Trial ID
NCT03249207
Start Date
October 11 2018
End Date
September 1 2024
Last Update
November 21 2023
Active Locations (17)
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1
Derriford Hospital
Plymouth, Devon, United Kingdom, PL6 8DH
2
Royal Hallamshire Hospital
Sheffield, South Yorkshire, United Kingdom, S10 2JF
3
University Hospital of Wales
Cardiff, Wales, United Kingdom, CF14 4XW
4
Leeds General Infirmary
Leeds, Yorkshire, United Kingdom, LS1 3EX