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 | 14.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10042316 |
E.1.2 | Term | Subarachnoid haemorrhage |
E.1.2 | System Organ Class | 10029205 - Nervous system disorders |
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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 |
What effect does the specific anti-inflammatory drug (IL-1Ra) have on the levels of a specific inflammatory protein (IL-6) in blood between 3-8 days after a brain haemorrhage? |
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E.2.2 | Secondary objectives of the trial |
Secondary question 1. What effect does the specific anti-inflammatory drug (IL-1Ra) have on the levels of other inflammatory proteins in blood between 3-8 days after a brain haemorrhage? Secondary question 2. What effect does the specific anti-inflammatory drug (IL-1Ra) have on the levels of inflammatory proteins in blood at days 14 and 21 days after a brain haemorrhage? Secondary question 3. What effect does the specific anti-inflammatory drug (IL-1Ra) have on recovery from brain haemorrhage? Secondary Objective 4. Confirmation that blood levels of the anti-inflammatory drug (IL-1Ra), when given twice daily remain consistently within the expected range. Secondary objective 5. Confirmation that the chosen method of administration (injection under skin, twice a day) is safe, feasible and well tolerated by patients following brain haemorrhage. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Inclusion:Patients with confirmed spontaneous aSAH who are admitted to the neurosurgical department at SRFT where consent can be obtained and drug administered within 72 hours. No concomitant health problems that, in the opinion of the Principal Investigator (PI) or designee, would interfere with participation, administration of study treatment or assessment of outcomes including safety, for example, pre-existing malignancy. Renal function within normal limits (< 177 µmol/l). Willing and able to give informed consent or consent available from a patient representative (personal) for study inclusion including agreement in principle to receive study intervention and undergo all study assessments. Aged 18 years or above. |
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E.4 | Principal exclusion criteria |
Unconfirmed or uncertain diagnosis of spontaneous aSAH. Known or suspected infection in the preceeding 2 weeks or at the time of consideration for the study. 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 recombinant IL-1Ra known at the time of study entry. Previous or current treatment with medication suspected of interacting with recombinant IL-1Ra, such as TNF-α inhibitors. 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 or planned pregnancy (pregnancy test to be performed in women of child-bearing potential) or breast-feeding. Clinically significant concurrent medical condition, at the PI’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. Likely to be transferred from the centre within eight days of admission. |
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E.5 End points |
E.5.1 | Primary end point(s) |
To determine area under curve (AUC) of IL-6 concentration from day 3 to day 8 post-ictus, in patients receiving IL-1Ra relative to those who do not. |
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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 | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
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 | Yes |
E.6.13.1 | Other scope of the trial description |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
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 | Yes |
E.8.1.4 | Double blind | No |
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 | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
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E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
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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The End of Study will be completion of the last patient assessment. |
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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 | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 0 |