This is a pharmacokinetic study in patients who have had a Subarachnoid Haemorrhage and who have had an external ventricular drain inserted for clinical management reasons, must usually for the treatment of hydrocephalus. MedDRA version: 9.1 Level: LLT Classification code 10042316 Term: Subarachnoid haemorrhage MedDRA version: 9.1 Level: LLT Classification code 10052947
Conditions
Interventions
Trade Name: Kineret
Product Name: Kineret
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: anakinra
CAS Number: 143090920
Sponsors
Salford Royal NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria for study enrollment. • Patients with confirmed spontaneous SAH who are thought likely to, or are known to require,the placement of an EVD as part of their clinical care. Also, patients who have already had an EVD placed will be eligible. • No concomitant health problems that, in the opinion of the Principal Investigator or Chief Investigator or designee, would interfere with participation, administration of study treatment or assessment of outcomes including safety, for example, pre-existing malignancy. • No confirmed or suspected serious infection at the time of study entry. • Renal function within normal limits (serum creatinine=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion Criteria for Study Enrolment • Unconfirmed or uncertain diagnosis of spontaneous SAH. • Known or suspected infection at the time of consideration for the study. • Impaired renal function defined as serum Creatinine > 177 µmol/l. • 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 anakinra or Kineret®, known at the time of study entry. • Previous or current treatment with medication suspected of interacting with Kineret®, such as TNF-a inhibitors. • Evidence of serious infection. • 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 pregnancy or breast-feeding. • Clinically significant concurrent medical condition, at the Chief Investigator’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 informed consent. • Aged below 16. Exclusion from full study entry (to receive study intervention). • EVD not placed. • EVD is expected to be removed within 24 h. • Likely to be transferred from the centre within the next seven days. • Unwilling to consent to inclusion in the study or consent unavailable from the patient’s representative on the patient’s behalf.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the administration regime of intravenous (iv) Kineret® that will achieve a cerebrospinal fluid (CSF) concentration of 100 ng/ml within 30 minutes of the start of treatment in subarachnoid haemorrhage (SAH) patients. This will inform potential Phase III studies of Kineret® in SAH and stroke; Secondary Objective: • To define the dose relationship between central and peripheral concentrations of Kineret® • To explore the impact of varying concentrations of Kineret® on inflammatory biomarkers in blood and cerebrospinal Fluid. • To obtain further safety information on serious adverse events (SAEs) and adverse events (AEs) in SAH patients given iv infusion of Kineret®. ; Primary end point(s): Primary endpoint: 1. CSF and plasma concentrations of Kineret® at 30 minutes post-commencement of infusion | — |
Countries
United Kingdom
Outcome results
None listed