Studying anakinra to reduce secondary brain damage after spontaneous haemorrhagic stroke

Phase 1

• Conditions: Spontaneous supratentorial intracerebral haemorrhage; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2021-000324-36-NL
• Lead Sponsor: Radboudumc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-03-16
• Last Update Posted: 4 April 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

1. Age = 18 years;
2. Supratentorial non-traumatic ICH confirmed by CT, without a confirmed causative lesion on admission CT-angiography (e.g. aneurysm, AVM, DAVF, cerebral venous sinus thrombosis) or other known underlying lesion (e.g. tumour, cavernoma);
3. Minimal intracerebral haemorrhage volume of 10 mL
4. Intervention can be started within 8 hours from symptoms onset;
5. Patient’s or legal representative’s informed consent.
Are the trial subjects under 18? no
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 25
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion Criteria

1. Severe ICH, unlikely to survive the first 72 hours (defined as Glasgow Coma Scale score < 6 at time of consent);
2. Confirmed or suspected haemorrhagic transformation of an arterial or venous infarct;
3. Planned neurosurgical haematoma evacuation;
4. Severe infection at admission, requiring antibiotic treatment;
5. Known active tuberculosis or active hepatitis;
6. Use of immunosuppressive or immune-modulating therapy at admission;
7. Neutropenia (Absolute Neutrophil Count (ANC) <1.5 x 109/L );
8. Pre-stroke modified Rankin Scale score = 3;
9. Pregnancy or breast-feeding;
10. Standard contraindications to MRI;
11. Known prior allergic reaction to gadolinium contrast or one of the constituents of its solution for administration;
12. Known allergy to anakinra or other products that are produced by DNA technology using the micro-organism E. coli;
13. Live vaccinations within the last 10 days prior to this ICH;
14. Severe renal impairment (eGFR <30ml/min/1.73m);
15. Known active malignancy

Study & Design

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