DOUBLE-BLIND PLACEBO-CONTROLLED RANDOMISED CLINICAL DOSE-RANGING STUDY TREATING MODERATE-SEVERE TRAUMATIC BRAIN INJURY PATIENTS WITH RECOMBINANT HUMAN INTERLEUKIN 1 RECEPTOR ANTAGONIST. - IL1ra-TBI

Cambridge University Hospitals NHS Foundation Trust and the University of Cambridge0 个研究点目标入组 60 人开始时间: 2019年6月20日最近更新: 2020年10月13日

适应症

试验速览

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•Have given written informed consent to participate provided by the patient's legal representative or by agreement with an independent health provider (as the patient will initially lack capacity).
•Aged 18-64 years.
•Head injury patients (Glasgow Coma Scale 3-13), requiring ventilation, sedation and a cranial access device for their clinical management for at least 72 hours.
•Head injury should be compatible with survival.
•Possible to deliver the first dose of IMP within 12 hours after trauma.
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 60
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range 0

•Head injury unlikely to survive 5 days (CT evidence of above as judged by clinical team, bilateral fixed and dilated
•Not able to provide the initial dose of IMP within 12 hour after trauma.
•Follow up not possible
•Not suitable for insertion of Cranial Access Device (bleeding diathesis)
•Participation in other CTIMP
•- As per the SmPC
•Immunosuppression (evidence of neutropenia (ANC <1.5 x 109/l), immunosuppression secondary to immunomodulatory medications, chemotherapy or radiation therapy in the 3 months preceding study entry)
•Severe Renal Insufficiency or End Stage Renal Disease (defined as a creatinine clearance <30 ml/min)
•Pregnancy/Nursing mothers
•Known hypersensitivity to E. coli derived products
•Administration of live vaccine
•Known presence or suspicion of active bacterial, fungal or viral infections, including tuberculosis, or HIV infection or hepatitis B or C infection.
•Uncontrolled clinically significant hematologic, pulmonary, endocrine, metabolic, gastrointestinal, or hepatic disease as judged by the investigator.
•Concurrent treatment with TNF-alpha antagonists (Etanercept®).

发起方

Cambridge University Hospitals NHS Foundation Trust and the University of Cambridge