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    The EU Clinical Trials Register currently displays   43866   clinical trials with a EudraCT protocol, of which   7287   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2007-002337-36
    Sponsor's Protocol Code Number:2007neuro07/R013630/S1
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-07-31
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2007-002337-36
    A.3Full title of the trial
    An open-labelled study of the cerebrospinal fluid pharmacokinetics of intravenous Kineret® in patients with subarachnoid haemorrhage
    A.3.2Name or abbreviated title of the trial where available
    IL-1RA in SAH PK STUDY 2
    A.4.1Sponsor's protocol code number2007neuro07/R013630/S1
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorSalford Royal NHS Foundation Trust
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Kineret
    D.2.1.1.2Name of the Marketing Authorisation holderAmgen Europe B.V
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameKineret
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNanakinra
    D.3.9.1CAS number 143090920
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    This is a pharmacokinetic study in patients who have had a Subarachnoid Haemorrhage and who have had an external ventricular drain inserted for clinical management reasons, must usually for the treatment of hydrocephalus.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10042316
    E.1.2Term Subarachnoid haemorrhage
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10052947
    E.1.2Term Ventricular drainage
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10020508
    E.1.2Term Hydrocephalus
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the administration regime of intravenous (iv) Kineret® that will achieve a cerebrospinal fluid (CSF) concentration of 100 ng/ml within 30 minutes of the start of treatment in subarachnoid haemorrhage (SAH) patients. This will inform potential Phase III studies of Kineret® in SAH and stroke
    E.2.2Secondary objectives of the trial
    • To define the dose relationship between central and peripheral concentrations of Kineret®
    • To explore the impact of varying concentrations of Kineret® on inflammatory biomarkers in blood and cerebrospinal Fluid.
    • To obtain further safety information on serious adverse events (SAEs) and adverse events (AEs) in SAH patients given iv infusion of Kineret®.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion criteria for study enrollment.
    • Patients with confirmed spontaneous SAH who are thought likely to, or are known to require,the placement of an EVD as part of their clinical care. Also, patients who have already had an EVD placed will be eligible.
    • 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 (usually next of kin) for study inclusion including agreement in principle to receive study intervention and undergo all study assessments.
    • Aged 16 years or above.

    Eligibility Criteria for Study Entry (to receive study intervention).
    In addition to meeting the requirements specified above, patients who are entered fully into the study will also meet the following criteria:
    Inclusion
    • EVD in place that is expected to remain in situ for the next 24-48 hours.
    • Likely to remain resident within the centre for the next seven days.
    • Willing to consent to inclusion in the study or consent available from the patient’s representative on the patient’s behalf.
    E.4Principal exclusion criteria
    Exclusion Criteria for Study Enrolment
    • 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 informed consent.
    • Aged below 16.

    Exclusion from full study entry (to receive study intervention).
    • EVD not placed.
    • EVD is expected to be removed within 24 h.
    • Likely to be transferred from the centre within the next seven days.
    • Unwilling to consent to inclusion in the study or consent unavailable from the patient’s representative on the patient’s behalf.
    E.5 End points
    E.5.1Primary end point(s)
    Primary endpoint:
    1. CSF and plasma concentrations of Kineret® at 30 minutes post-commencement of infusion
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    dose ranging/determination study
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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.8.4.1Number of sites anticipated in Member State concerned2
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.7Trial 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
    The end of the trial will be the last assessment visit for the final patient included in the study.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months24
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months24
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2007-07-31. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation Yes
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Patients with SAH will have changes in levels of consciousness and unable to consent on their own behalf. Having a SAH could be viewed as an emergency situation.
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state100
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 100
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Please see protocol. Patients included in the study will receive all usual care. They will undergo follow up assessments for up to 7 days following the end of the study infusion. If any patient has continuing adverse events at the planned final assessment, they will be followed-up or referred on until full information about the adverse events is obtained (e.g. it will be followed to resolution, stabilistation or full investigation).
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2007-07-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-06-06
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-01-13
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