An open-labelled study of the cerebrospinal fluid pharmacokinetics of intravenous Kineret® in patients with subarachnoid haemorrhage - IL-1RA in SAH PK STUDY 2

Phase 1

• Conditions: 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 Term: Ventricular drainage; MedDRA version: 9.1 Level: LLT Classification code 10020508 Term: Hydrocephalus

• Registration Number: EUCTR2007-002337-36-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: 2007-07-31
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 100

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< 177 µmol/l).
•Willing and able to give informed consent or consent available from a patient representative (usually next of kin) for study inclusion including agreement in principle to receive study intervention and undergo all study assessments.
•Aged 16 years or above.

Eligibility Criteria for Study Entry (to receive study intervention).
In addition to meeting the requirements specified above, patients who are entered fully into the study will also meet the following criteria:
Inclusion
•EVD in place that is expected to remain in situ for the next 24-48 hours.
•Likely to remain resident within the centre for the next seven days.
•Willing to consent to inclusion in the study or consent available from the patient’s representative on the patient’s behalf.

Are the trial subjects under 18? yes
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

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.

Study & Design

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