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SC IL-1Ra in SAH - Phase III Trial (SCIL) (SCIL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03249207
Recruitment Status : Active, not recruiting
First Posted : August 15, 2017
Last Update Posted : June 2, 2020
Sponsor:
Collaborators:
National Institute for Health Research, United Kingdom
Manchester Academic Health Science Centre
Salford Royal NHS Foundation Trust
Information provided by (Responsible Party):
Helen Bradley, University of Manchester

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 Patients who are found to be non-aneurysmal following randomisation will be withdrawn from the study treatment.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

Study Design
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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 : October 2022
Estimated Study Completion Date : October 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding
Drug Information available for: Anakinra

Arms and Interventions
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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).


Outcome Measures
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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 ]

Eligibility Criteria
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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. Neutropenia (ANC <1.5 x 109/L ).
  5. Abnormal renal function (creatinine clearance or estimated Glomerular Filtration Rate (eGFR) < 30 ml/minute) documented in the last 3 months prior to this SAH.
  6. Live vaccinations within the last 10 days of this SAH.
  7. Previous or concurrent treatment with IL-1Ra known at the time of trial entry or previous participation in this trial.
  8. Previous or current treatment with medication suspected of interacting with IL-1Ra, listed in the drug SmPC
  9. Known to have participated in a clinical trial of an investigational agent or device in the previous 30 days or 5 half-lives of enrolment (whichever is longer) of ictus, or for the period determined by the protocol of the trial / study the patient has taken part in.
  10. Known to be pregnant or breast feeding or inability to reliably confirm that the patient is not pregnant
  11. 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.
  12. Known allergy to IL-1Ra or any of the excipients listed in the drug SmPC
  13. Known allergy to other products that are produced by DNA technology using the micro-organism E. coli (e.g. E.coli derived protein).
Contacts and Locations
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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


Locations
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United Kingdom
Derriford Hospital
Plymouth, Devon, United Kingdom, PL6 8DH
Royal Hallamshire Hospital
Sheffield, South Yorkshire, United Kingdom, S10 2JF
University Hospital of Wales
Cardiff, Wales, United Kingdom, CF14 4XW
Leeds General Infirmary
Leeds, Yorkshire, United Kingdom, LS1 3EX
Royal Sussex County Hospital
Brighton, United Kingdom, BN2 5BE
The Walton Centre
Liverpool, United Kingdom, L9 7LJ
St George's Hospital
London, United Kingdom, SW17 0QT
National Hospital for Neurology and Neurosurgery, Queen Square
London, United Kingdom, WC1N 3BG
Salford Royal NHS Foundation Trust
Manchester, United Kingdom
Queens Medical Centre
Nottingham, United Kingdom, NG7 2UH
Southampton General Hospital
Southampton, United Kingdom, SO16 6YD
Sponsors and Collaborators
University of Manchester
National Institute for Health Research, United Kingdom
Manchester Academic Health Science Centre
Salford Royal NHS Foundation Trust
Investigators
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Principal Investigator: Andrew King University of Manchester
More Information
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Responsible Party: Helen Bradley, 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: June 2, 2020
Last Verified: June 2020

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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 Helen Bradley, University of Manchester:
Aneurysmal
Additional relevant MeSH terms:
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Subarachnoid Hemorrhage
Hemorrhage
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Interleukin 1 Receptor Antagonist Protein
Antirheumatic Agents