Does subcutaneous interleukin-1 receptor antagonist reduce inflammation following subarachnoid haemorrhage? - SC IL-1Ra in SAH

Phase 1

• Conditions: Subarachnoid haemorrhage; MedDRA version: 14.0 Level: PT Classification code 10042316 Term: Subarachnoid haemorrhage System Organ Class: 10029205 - Nervous system disorders

• Registration Number: EUCTR2011-001855-35-GB
• Lead Sponsor: Salford Royal NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-06-23
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 140

Inclusion Criteria

Inclusion:Patients with confirmed spontaneous aSAH who are admitted to the neurosurgical department at SRFT where consent can be obtained and drug administered within 72 hours. No concomitant health problems that, in the opinion of the Principal Investigator (PI) or designee, would interfere with participation, administration of study treatment or assessment of outcomes including safety, for example, pre-existing malignancy. Renal function within normal limits (< 177 µmol/l). Willing and able to give informed consent or consent available from a patient representative (personal) for study inclusion including agreement in principle to receive study intervention and undergo all study assessments. Aged 18 years or above.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Unconfirmed or uncertain diagnosis of spontaneous aSAH. Known or suspected infection in the preceeding 2 weeks or at the time of consideration for the study. Known allergy to E. coli or any of the constituents of the study medication as established from the patient themselves, reliable representative and clinical records. Previous or concurrent treatment with recombinant IL-1Ra known at the time of study entry. Previous or current treatment with medication suspected of interacting with recombinant IL-1Ra, such as TNF-a inhibitors. Known to have participated in a clinical trial of an investigational agent or device in the previous 30 days or for the period determined by the protocol of the study the patient has taken part in. Known or planned pregnancy (pregnancy test to be performed in women of child-bearing potential) or breast-feeding. Clinically significant concurrent medical condition, at the PI’s (or designee’s) discretion, which could affect the safety, tolerability, or efficacy in this study. Previous inclusion in the current study (known prior to inclusion). Inability or unwillingness of patient or patient’s personal representative to give written informed consent. Likely to be transferred from the centre within eight days of admission.

Study & Design

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