Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
612 participants
INTERVENTIONAL
2018-10-11
2024-09-30
Brief Summary
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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 Patients who are found to be non-aneurysmal following randomisation will be withdrawn from the study treatment.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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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IL-1Ra twice daily
IL-1Ra
Doses to be administered subcutaneously (SC) twice daily (12 hourly) starting within 72 hours of ictus (onset of symptoms) for a maximum of 21 days from ictus (or sooner if discharged from neurosurgical centre).
Placebo twice daily
IL-1Ra Placebo
Doses to be administered subcutaneously (SC) twice daily (12 hourly) starting within 72 hours of ictus (onset of symptoms) for a maximum of 21 days from ictus (or sooner if discharged from neurosurgical centre).
Interventions
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IL-1Ra
Doses to be administered subcutaneously (SC) twice daily (12 hourly) starting within 72 hours of ictus (onset of symptoms) for a maximum of 21 days from ictus (or sooner if discharged from neurosurgical centre).
IL-1Ra Placebo
Doses to be administered subcutaneously (SC) twice daily (12 hourly) starting within 72 hours of ictus (onset of symptoms) for a maximum of 21 days from ictus (or sooner if discharged from neurosurgical centre).
Eligibility Criteria
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Inclusion Criteria
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.
Exclusion Criteria
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 breast feeding 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, 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 micro-organism 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.
18 Years
ALL
No
Sponsors
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National Institute for Health Research, United Kingdom
OTHER_GOV
Clinical Trials Unit, Manchester
OTHER
Northern Care Alliance NHS Foundation Trust
OTHER
University of Manchester
OTHER
Responsible Party
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Principal Investigators
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Andrew King
Role: PRINCIPAL_INVESTIGATOR
University of Manchester
Locations
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Derriford Hospital
Plymouth, Devon, United Kingdom
Royal Hallamshire Hospital
Sheffield, South Yorkshire, United Kingdom
University Hospital of Wales
Cardiff, Wales, United Kingdom
Leeds General Infirmary
Leeds, Yorkshire, United Kingdom
Royal Sussex County Hospital
Brighton, , United Kingdom
Southmead Hospital
Bristol, , United Kingdom
Addenbrookes Hospital
Cambridge, , United Kingdom
The Walton Centre
Liverpool, , United Kingdom
Royal London Hospital
London, , United Kingdom
St George's Hospital
London, , United Kingdom
Charing Cross Hospital
London, , United Kingdom
National Hospital for Neurology and Neurosurgery, Queen Square
London, , United Kingdom
Northern Care Alliance NHS Foundation Trust
Manchester, , United Kingdom
Queens Medical Centre
Nottingham, , United Kingdom
Royal Preston Hospital
Preston, , United Kingdom
Southampton General Hospital
Southampton, , United Kingdom
Royal Stoke University Hospital
Stoke-on-Trent, , United Kingdom
Countries
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Other Identifiers
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R121178
Identifier Type: -
Identifier Source: org_study_id
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