Does reducing inflammation after subarachnoid brain haemorrhage with Kineret improve levels of disability at 6 months?

Phase 1

• Conditions: subarachnoid haemorrhage; MedDRA version: 20.1Level: PTClassification code 10042316Term: Subarachnoid haemorrhageSystem Organ Class: 10022117 - Injury, poisoning and procedural complications; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2016-003725-42-GB
• Lead Sponsor: niversity of Manchester

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-06-21
• Last Update Posted: 23 July 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

1.Patients with confirmed spontaneous SAH admitted to a participating neurosurgical centre where consent can be obtained and study drug / placebo 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 / placebo or assessment of outcomes including safety, for example, pre-existing active malignancy.
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 / placebo and undergo all study assessments.
4.Aged 18 years or above.

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 700
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 300

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 (please see section 8.1.4 for the prohibited medication).
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).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified