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

Salford Royal NHS Foundation Trust0 sites100 target enrollmentJuly 31, 2007

Overview

Phase: Phase 1
Intervention: Not specified
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.
Sponsor: Salford Royal NHS Foundation Trust
Enrollment: 100
Status: Active, not recruiting
Last Updated: 6 years ago

No summary available.

Registry

who.int

Start Date

July 31, 2007

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Sponsor

Salford Royal NHS Foundation Trust

•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:
•EVD in place that is expected to remain in situ for the next 24\-48 hours.

•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.