BLOC-ICH; Could a new treatment improve recovery for patients who have had an intracerebral haemorrhage
- Conditions
- intracerebral haemorrhageMedDRA version: 20.0 Level: LLT Classification code 10022753 Term: Intracerebral haemorrhage System Organ Class: 100000004852Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2018-000249-38-GB
- Lead Sponsor
- niversity of Manchester
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Not specified
- Target Recruitment
- 80
1. Patients with spontaneous, primary, supratentorial ICH admitted to a participating centre within 8 hours of symptom onset.
2. No concomitant health problems that, in the opinion of the PI or designee, would interfere with participation, administration of study drug or assessment of outcomes including safety.
3. Willing and able to give informed consent or consent available from a patient
representative for trial inclusion including agreement in principle to receive study drug and undergo all study assessments.
4. Male or female aged 18 years or above (no upper age limit).
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 27
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 53
1. Severe ICH, unlikely to survive to 72 hours scan (defined as Glasgow Coma Scale score 6 at any time prior to consent);
2. Confirmed or suspected structural abnormality as cause of ICH (including tumour, vascular malformation);
3. Confirmed or suspected haemorrhagic transformation of an arterial or venous infarct;
4. Acute neurosurgery planned within 72 hours of admission;
5. Known active tuberculosis or active hepatitis;
6. Known active malignancy;
7. Neutropenia (neutrophil count (ANC) <1.5 x 10^9 );
8. Abnormal renal function (previous eGFR<30 mL/min in 3 months prior to this ICH*
9. Live vaccinations within the last 10 days prior to this ICH;
10. Previous or concurrent treatment with IL-1Ra known at the time of trial entry or previous participation in this trial.
11. Previous or current treatment with etanercept or any other TNF-a antagonist
12. Known to have participated in a clinical trial of an investigational agent or device in the 30 days prior to symptom onset;
13. Known to have participated in a clinical trial of an investigational agent or device within 5 half-lives (of the previous agent or device) prior to symptom onset;
14. Known to be pregnant or breast-feeding or inability to reliably confirm that the patient is
not pregnant (Please see further guidance on pregnancy prevention in section 7.2.1).
15. Known diagnosis of Still’s disease;
16. Clinically significant serious concurrent medical condition, premorbid illnesses, or
concurrent serious infection, at the PI’s (or designee’s) discretion, which could affect the safety
or tolerability of the intervention. Please see precaution of use section 8.1.5 for further
guidance.
17. Known allergy to IL-1Ra or any of the excipients listed in the drug SmPC (please
section 8.1.4).
18.Known allergy to other products that are produced by DNA technology using
the micro-organism E. coli (e.g. E.coli derived protein).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary end point(s): The primary outcome for the trial will be perihaematomal oedema on CT scan at 72 hours as measured by the ‘oedema extension distance’ (OED), which equates to the average distance that oedema extends beyond the haematoma border. ;Timepoint(s) of evaluation of this end point: 3 months from date of randomisation;<br> Main Objective: Does an anti-inflammatory drug (IL-1Ra) reduce inflammation after brain haemorrhage when given as an injection into the skin?<br> ;<br> Secondary Objective: 1. If IL-1Ra reduces inflammation after brain haemorrhage, does this improve recovery?<br> 2. Is IL-1Ra given as an injection into the skin for 3 days after brain haemorrhage safe?<br>
- Secondary Outcome Measures
Name Time Method