IL1ra-TBI
Research type
Research Study
Full title
DOUBLE-BLIND PLACEBO-CONTROLLED RANDOMISED CLINICAL DOSE-RANGING STUDY TREATING MODERATE-SEVERE TRAUMATIC BRAIN INJURY PATIENTS WITH RECOMBINANT HUMAN INTERLEUKIN 1 RECEPTOR ANTAGONIST.
IRAS ID
185206
Contact name
Adel Helmy
Contact email
Sponsor organisation
Cambridge University Hospitals NHS Foundation Trust and The University of Cambridge
Eudract number
2016-004974-16
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
3 years, 0 months, 4 days
Research summary
Traumatic brain injury (TBI) is a common condition with high degree of disability and death. Following the initial trauma, due to the detrimental conditions in the injured brain, secondary processes commence, causing further
deterioration. This secondary injury, resulting in cell death, is driven in part by the immune system of the brain. The treatment of brain injury is to optimize recovery and to reduce the risk for these secondary injuries. However, there are
currently no approved drugs that target the underlying conditions for patients suffering from TBI.
One of the most prominent mediators of inflammation in the injured brain is called Interleukin-1 (IL-1). A drug has been developed that counter-acts the effect of IL-1 by binding to its receptor, a so called recombinant human IL-1
receptor antagonist (rhIL-1ra, Kineret). At the Department of Clinical Neurosciences, University of Cambridge, we studied this drug in a smaller study and seen a change in the inflammatory response in the brain, without any harmful
side-effects.
In order to fully understand, and potentially optimize, the effect of Kineret, we now wish to conduct a dose-response study by giving three groups (n=20 per group) either placebo, 1.5g or 3.0g of active substance administered intravenously in a double-blind, randomized setting. These concentrations have in previous studies not been shown to present any side-effects. The drug will be provided within 12 hours after trauma. Our main goal will be to provide a dose-response effect on the brain inflammatory response. As secondary goals, we will assess the brain damage by measuring brain proteins in blood and cerebrospinal fluid, functional outcome and inflammation in the brain by using radiological techniques.REC name
London - Harrow Research Ethics Committee
REC reference
18/LO/1480
Date of REC Opinion
8 Nov 2018
REC opinion
Further Information Favourable Opinion