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Trial record 43 of 194 for:    Hemorrhage AND SAH

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 : June 26, 2019
Sponsor:
Collaborators:
National Institute for Health Research, United Kingdom
Manchester Academic Health Science Centre
Salford Royal NHS Foundation Trust
Information provided by (Responsible Party):
Marianne Stewart, 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 Patients who are found to be non-aneurysmal following randomisation will be withdrawn from the study treatment.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 : 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

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. 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).

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: Sharon Hulme, RGN, BSc 0161 206 5755 ext 01613063144 sharon.hulme@manchester.ac.uk
Contact: Marianne Stewart 01613063144 scil@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         
Leeds General Infirmary Recruiting
Leeds, Yorkshire, United Kingdom, LS1 3EX
Contact: Ian Anderson         
Salford Royal NHS Foundation Trust Recruiting
Manchester, United Kingdom
Contact: Hiren Patel, MBBS FRCS       hiren.patel@srft.nhs.uk   
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

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Responsible Party: Marianne Stewart, Clinical Trial Project Manager, University of Manchester
ClinicalTrials.gov Identifier: NCT03249207     History of Changes
Other Study ID Numbers: R121178
First Posted: August 15, 2017    Key Record Dates
Last Update Posted: June 26, 2019
Last Verified: June 2019

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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 Marianne Stewart, University of Manchester:
Aneurysmal

Additional relevant MeSH terms:
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Hemorrhage
Subarachnoid 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