E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10042316 |
E.1.2 | Term | Subarachnoid haemorrhage |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To determine whether intravenously administered Kineret causes a decrease in the concentration of central inflammatory biomarkers following subarchnoid haemorrhage compared to placebo |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients with confirmed spontaneous SAH who have had an intracranial access device inserted as part of their clinical care. The intracranial access device must be expected to remain in situ for more than 48 h. Patients likely to remain resident within the centre for the next seven days. No concomitant health problems that, in the opinion of the Principal Investigator or Chief Investigator or designee, would interfere with participation, administration of study treatment or assessment of outcomes including safety, for example, pre-existing malignancy. No confirmed or suspected serious infection at the time of study entry. Renal function within normal limits (serum creatinine < 177 µmol/l). Willing and able to give informed consent or consent available from a patient representative (personal, usually the next of kin) for study inclusion including agreement in principle to receive study intervention and undergo all study assessments. Aged 16 years or above.
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E.4 | Principal exclusion criteria |
Unconfirmed or uncertain diagnosis of spontaneous SAH. Known or suspected infection at the time of consideration for the study. Impaired renal function defined as serum creatinine > 177 µmol/l. Known allergy to E. coli or any of the constituents of the study medication as established from the patient themselves, reliable representative and clinical records. Previous or concurrent treatment with Anakinra or Kineret®, known at the time of study entry. Previous or current treatment with medication suspected of interacting with Kineret®, such as TNF-α inhibitors. Evidence of serious infection. Known to have participated in a clinical trial of an investigational agent or device in the previous 30 days or for the period determined by the protocol of the study the patient has taken part in. Known pregnancy or breast-feeding. Clinically significant concurrent medical condition, at the Chief Investigator’s (or designee’s) discretion, which could affect the safety, tolerability, or efficacy in this study. Previous inclusion in the current study (known prior to inclusion). Inability or unwillingness of patient or patient’s personal representative to give written informed consent. Aged below 16.
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E.5 End points |
E.5.1 | Primary end point(s) |
Decrease in concentrations of central inflammatory biomarkers. The area under curve (AUC) for IL-6 in plasma and CSF will be compared between the two groups of patients, i.e. Kineret® vs placebo. Similar analysis will be done for other biomarkers of inflammation including CRP (plasma).
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Yes |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description |
Study to assess dosage levels of, and response to, a medicinal product |
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E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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Analysis of data on 32 completed participants. Completed participants are those receiving the full 24 hour infusion who do not have a greater than 1 hour gap between each 12 hour infusion and from whom all samples up to 72 hours after the bolus injection are obtained. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |