Trial treating brain injured patients with the anti-inflammatory drug Kineret: IL1ra-TBI

Phase 1

• Conditions: We wish to study the drug Kineret in patients suffering from moderate-to-severe traumatic brain injury; MedDRA version: 20.1Level: LLTClassification code 10060690Term: Traumatic brain injurySystem Organ Class: 100000004863; MedDRA version: 20.1Level: PTClassification code 10051288Term: Central nervous system inflammationSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2016-004974-16-GB
• Lead Sponsor: Cambridge University Hospitals NHS Foundation Trust and the University of Cambridge

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-06-20
• Last Update Posted: 13 October 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

•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

Exclusion Criteria

• Head injury unlikely to survive 5 days (CT evidence of above as judged by clinical team, bilateral fixed and dilated
pupils).
• 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®).

Study & Design

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