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    The EU Clinical Trials Register currently displays   43854   clinical trials with a EudraCT protocol, of which   7284   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:2014-002997-35
    Sponsor's Protocol Code Number:OVG2014/05
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2014-12-23
    Trial 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 number2014-002997-35
    A.3Full title of the trial
    A phase III multi-centre randomised, double blind, placebo controlled trial to assess the role of intravenous immunoglobulin in the management of children with encephalitis (The IgNiTE study)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    IgNITE: Immunoglobulin in the treatment of encephalitis
    A.3.2Name or abbreviated title of the trial where available
    IgNiTE: Immunoglobulin in the treatment of encephalitis
    A.4.1Sponsor's protocol code numberOVG2014/05
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorUniversity of Oxford
    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 Privigen
    D.2.1.1.2Name of the Marketing Authorisation holderCSL Behring GmbH, Marbug, Germany
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameImmunoglobulin
    D.3.4Pharmaceutical form Infusion
    D.3.4.1Specific paediatric formulation No
    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 INNImmunoglobulin
    D.3.9.1CAS number 9007-83-4
    D.3.9.2Current sponsor codeN/A
    D.3.9.3Other descriptive namePrivigen
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10 to 0
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
    D.3.11.7Plasma derived medicinal product Yes
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboInfusion
    D.8.4Route of administration of the placeboIntravenous use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Encephalitis
    E.1.1.1Medical condition in easily understood language
    Brain inflammation
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level LLT
    E.1.2Classification code 10014594
    E.1.2Term Encephalitis infection
    E.1.2System Organ Class 100000004862
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The aim of this study is to find out whether the early use(given within 120 hours of hospitalisation) of IVIG treatment will improve neurological outcomes at 12 months post treatment, for children with encephalitis.
    E.2.2Secondary objectives of the trial
    A) To determine if the early administration of IVIG has a beneficial effect on the following:

    (i)Clinical and neurological outcomes in children encephalitis at the discharge, and approximately 12 months post randomisation

    (ii)Brain imaging findings at approximately 6 months post randomisation

    B) To confirm the safety of IVIG treatment for children with encephalitis

    C) To determine the proportion of participants with immune mediated encephalitis

    D) To determine the effect of IVIG treatment on auto-antibody levels in children with immune mediated encephalitis.

    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) 6 weeks to 16 years of age (day before 17th birthday)
    AND
    2) Acute (within 24 hours) or sub-acute (between 24 hours and 4 weeks) onset of altered mental state (reduced or altered conscious level, irritability, altered personality or behaviour, lethargy) not attributable to a metabolic cause
    AND
    3) At least two of:

    (a) fever >38oC within 72 hours before or after presentation to hospital
    (b) brain imaging evidence consistent with encephalitis or immune-mediated
    encephalopathy that is either new from prior studies or appears acute in onset
    (c) CSF pleocytosis >4 white blood cells (WBCs)/microlitre
    (d) generalised or partial seizures not fully attributable to a pre-existing
    seizure disorder
    (e) new onset focal neurological signs (including movement disorders) for >6 hours
    (f) abnormality on EEG that is consistent with encephalitis and not clearly
    attributable to another cause.
    AND
    4) Parent/guardian/ legal representative/child (if 16 years at the time of enrolment and has capacity to give consent) able to give informed consent and assent (if <16 years and has capacity)
    E.4Principal exclusion criteria
    •high clinical suspicion of bacterial meningitis or TB meningitis (for example: presence of frankly
    purulent CSF; CSF WBCs >1000/microlitre; bacteria on Gram stain and/or culture)
    •Traumatic brain injury
    •Known metabolic encephalopathy
    •Toxic encephalopathy (i.e. encephalopathy secondary to exposure to intoxicants, including alcohol,prescription or recreational drugs)
    •hypertensive encephalopathy/posterior reversible encephalopathy syndrome
    •pre-existing demyelinating disorder; pre-existing antibody mediated CNS disorder; pre-existing CSF diversion
    •ischaemic or haemorrhagic stroke
    •children with a contraindication to IVIG or albumin (i.e. history of anaphylactic reaction to either products, known IgA deficiency and history of hypersensitisation)
    •Known hypercoagulable state
    •significant renal impairment defined as GFR of 29mls/min/1.73m2 and below (Chronic Kidney
    Disease Stage 4)
    •Known hyperprolinaemia
    •Known to be pregnant
    •Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the
    participant’s ability to participate in the trial
    •participants who are actively being followed up in another research trial involving an investigational product thought to
    have an immunomodulatory or neuroprotective effect
    •Administration of study drug not feasible within 120 hours of hospital admission as determined by the study team
    • Any other condition which, in the opinion of the investigator, may interfere with the ability to fulfil study requirements, especially relating to the primary objective of the study (this include plans to be outside the UK for more than 12 months after enrolment)
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome is “Good recovery”, defined by GOS-E-Peds score of 2 or lower, at 12 months from randomisation.This will be analysed using a Generalised Linear Mixed effect model utilising data collected at discharge, 6 and 12 months from randomisation.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At 12 months post randomisation
    E.5.2Secondary end point(s)
    NEUROLOGICAL

    - Glasgow outcome score
    - Neurological examination findings
    - Performance using the following questionnaires
    (i) Glasgow outcome scale extended (pediatric version) GOS-E Peds
    (ii) Strength and Difficulties Questionnaire (SDQ)
    (iii) Adaptive Behaviours Assessent System-Second Edition (ABAS-II)
    (iv) Peds Quality of Life scoring algorithm
    (v) Gross Motor Function Classification System (GMFCS)
    (vi) Liverpool Outcome Score
    - New diagnosis of epilepsy
    - Anti-epileptic treatment since hospital discharge
    - Blinded neuropsychologist assessment of cognitive functioning

    CLINICAL

    - Glasgow coma score
    - Neurological examination findings
    - Duration of invasive ventilation (if ventilated)
    - Length of stay intensive care unit (ICU) stay in a subset of all children admitted to ICU
    - Duration of hospital admission

    IMMUNOLOGICAL

    - Auto-antibody testing on serum and/or CSF samples obtained prior to study treatment
    - Comparison of autoantibody levels in blood and/or CSF (where lumbar puncture is performed as part of routine care) at 6 months post randomisation to levels prior to study treatment

    RADIOLOGICAL

    Brain MRI at 6 months post randomisation scan to assess the following:
    - lesion resolution
    - presence of new lesions
    - distribution of persisting disease

    SAFETY

    - Collection of adverse events in the first five days from each dose of study drug
    - Serious adverse events from receipt of first dose of study drug up to 6 months post randomisation
    E.5.2.1Timepoint(s) of evaluation of this end point
    (i) Neurological outcomes:

    - At discharge, 6 and 12 months post randomisation

    (ii) Clinical outcomes:

    - During admission and at 6 and 12 months post randomisation

    (iii) Immunological outcomes:

    - During admission and at 6 months post randomisation

    (iii) Radiological outcome:

    - At six months post randomisation

    (iv) Safety outcomes:

    - Up to six months post randomisation
    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 Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    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) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 concerned30
    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 No
    E.8.7Trial has a data monitoring committee No
    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 trial will be after processing of the last laboratory sample for the last participant of the trial.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days1
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days1
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 308
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.4.1Number of subjects for this age range: 70
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 200
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 38
    F.1.2Adults (18-64 years) No
    F.1.2.1Number of subjects for this age range: 0
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    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 No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Children aged 16 years are able to give consent to participate in research. However, it is likely that because of their condition, they may unable to provide informed consent for themselves.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state308
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 0
    F.4.2.2In the whole clinical trial 308
    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)
    There will be no continued provision of treatment available after trial however participants are likely to be followed up by the hospital team as part of routine care.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-02-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-12-29
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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