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Trial record 1 of 1 for:    scil | Subarachnoid Hemorrhage
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SC IL-1Ra in SAH - Phase III Trial (SCIL) (SCIL)

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ClinicalTrials.gov Identifier: NCT03249207
Recruitment Status : Recruiting
First Posted : August 15, 2017
Last Update Posted : May 20, 2022
Sponsor:
Collaborators:
National Institute for Health Research, United Kingdom
Manchester Academic Health Science Centre
Northern Care Alliance NHS Foundation Trust
Information provided by (Responsible Party):
Kayle-Anne Sands, University of Manchester

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 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 Patients who are found to be non-aneurysmal following randomisation will be withdrawn from the study treatment.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.


Condition or disease Intervention/treatment Phase
Subarachnoid Hemorrhage Drug: IL-1Ra Drug: IL-1Ra Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Does Interleukin-1 Receptor Antagonist Improve Outcome Following Aneurysmal Subarachnoid Haemorrhage (aSAH)? A Phase III Trial
Actual Study Start Date : October 11, 2018
Estimated Primary Completion Date : April 2024
Estimated Study Completion Date : September 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding
Drug Information available for: Anakinra

Arm Intervention/treatment
Active Comparator: IL-1Ra twice daily Drug: 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 Comparator: Placebo twice daily Drug: 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).




Primary Outcome Measures :
  1. Ordinal shift in modified Rankin Score (mRS) [ Time Frame: 6 months post randomisation ]

Secondary Outcome Measures :
  1. Measurement of mood using HADS [ Time Frame: 6 months post randomisation ]
  2. Measurement of fatigue using Fatigue score [ Time Frame: 6 months post randomisation ]
  3. Measurement of quality of life using EQ-5D-5L score [ Time Frame: 6 months post randomisation ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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.
  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:

  1. Unconfirmed or uncertain diagnosis of spontaneous SAH.
  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03249207


Contacts
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Contact: Kayle-Anne Sands, BSc, MSc 0161 306 3196 scil@manchester.ac.uk
Contact: Andrew King andrew.king@manchester.ac.uk

Locations
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United Kingdom
Derriford Hospital Recruiting
Plymouth, Devon, United Kingdom, PL6 8DH
Contact: Peter Whitfield         
Royal Hallamshire Hospital Recruiting
Sheffield, South Yorkshire, United Kingdom, S10 2JF
Contact: Yahia Al-Tamimi         
University Hospital of Wales Recruiting
Cardiff, Wales, United Kingdom, CF14 4XW
Contact: James Galea       james.galea@manchester.ac.uk   
Leeds General Infirmary Recruiting
Leeds, Yorkshire, United Kingdom, LS1 3EX
Contact: Ian Anderson         
Royal Sussex County Hospital Recruiting
Brighton, United Kingdom, BN2 5BE
Contact: Giles Critchley         
Addenbrookes Hospital Recruiting
Cambridge, United Kingdom, CB2 0QQ
Contact: Matthew Guilfoyle         
The Walton Centre Recruiting
Liverpool, United Kingdom, L9 7LJ
Contact: Catherine McMahon         
St George's Hospital Recruiting
London, United Kingdom, SW17 0QT
Contact: Marios Papadopoulos         
National Hospital for Neurology and Neurosurgery, Queen Square Recruiting
London, United Kingdom, WC1N 3BG
Contact: Ahmed Toma         
Salford Royal NHS Foundation Trust Recruiting
Manchester, United Kingdom
Contact: Hiren Patel, MBBS FRCS       hiren.patel@nca.nhs.uk   
Queens Medical Centre Recruiting
Nottingham, United Kingdom, NG7 2UH
Contact: Surajit Basu         
Southampton General Hospital Recruiting
Southampton, United Kingdom, SO16 6YD
Contact: Diederik Bulters         
Sponsors and Collaborators
University of Manchester
National Institute for Health Research, United Kingdom
Manchester Academic Health Science Centre
Northern Care Alliance NHS Foundation Trust
Investigators
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Principal Investigator: Andrew King University of Manchester
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Responsible Party: Kayle-Anne Sands, Clinical Trials Manager, University of Manchester
ClinicalTrials.gov Identifier: NCT03249207    
Other Study ID Numbers: R121178
First Posted: August 15, 2017    Key Record Dates
Last Update Posted: May 20, 2022
Last Verified: May 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kayle-Anne Sands, University of Manchester:
Aneurysmal
Additional relevant MeSH terms:
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Subarachnoid Hemorrhage
Hemorrhage
Intracranial Hemorrhages
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Interleukin 1 Receptor Antagonist Protein
Antirheumatic Agents