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The European Union Clinical Trials Register   allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   43881   clinical trials with a EudraCT protocol, of which   7295   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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
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    EudraCT Number:2017-004307-51
    Sponsor's Protocol Code Number:NL63723.041.17
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-01-10
    Trial results
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedNetherlands - Competent Authority
    A.2EudraCT number2017-004307-51
    A.3Full title of the trial
    Complement C5 Antibodies for decreasing brain injury after aneurysmal Subarachnoid Hemorrhage: safety and proof-of-concept.
    Complement C5 antilichamen om hersenschade na een aneurysmatische subarachnoïdale bloeding te verminderen: effectiviteits- en veiligheidsonderzoek.

    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Inflammation inhibitors to reduce brain injury after a hemorrhagic stroke.
    Ontstekingsremmers om schade na bloeding tussen hersenvliezen te verminderen.
    A.3.2Name or abbreviated title of the trial where available
    A.4.1Sponsor's protocol code numberNL63723.041.17
    A.5.4Other Identifiers
    Name:Netherlands Trial RegistryNumber:6752
    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 Medical Center Utrecht
    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 supportZonMW/Hersenstichting
    B.4.1Name of organisation providing supportAlexion Pharmaceuticals
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Medical Center Utrecht
    B.5.2Functional name of contact pointNeurology department
    B.5.3 Address:
    B.5.3.1Street Address Heidelberglaan 100
    B.5.3.2Town/ cityUtrecht
    B.5.3.3Post code3584 CX
    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. name Soliris
    D. of the Marketing Authorisation holderAlexion Europe SAS
    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.3.4Pharmaceutical form Powder for 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 INNECULIZUMAB
    D.3.9.1CAS number 219685-50-4
    D.3.9.2Current sponsor codeh5G1.1-mAb
    D.3.9.3Other descriptive nameSoliris
    D.3.9.4EV Substance CodeSUB25187
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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 No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    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
    Aneurysmal subarachnoid hemorrhage
    Aneurysmatische subarachnoïdale bloeding
    E.1.1.1Medical condition in easily understood language
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10042320
    E.1.2Term Subarachnoid hemorrhage
    E.1.2System Organ Class 100000004852
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    This study aims to investigate the biological efficacy and safety of eculizumab in patients with aneurysmal SAH.
    Het doel van deze studie is om de biologische effectiviteit en veiligheid van eculizumab te onderzoeken in patiënten met een aneurysmatische subarachnoïdale bloeding.
    E.2.2Secondary objectives of the trial
    The secondary outcome measures are the occurrence of adverse events (AEs) and serious adverse events (SAEs), plasma and cerebrospinal fluid (CSF) parameters of inflammation, quality of life (QoL), functional, and cognitive outcomes, and the presence and volume of cerebral infarction
    De secundaire uitkomstmaten zijn het voorkomen van AEs en SAEs, plasma en liquor inflammatie parameters, kwaliteit van leven, functionele- en cognitieve uitkomsten en de aanwezigheid en het volume van cerebrale infarcten.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Confirmed aneurysmal SAH
    2) Admission to either the UMCU or Erasmus MC within 11.5 hours after ictus
    3) Age 18 years and older
    1) Bevestigde aneurysmatische subarachnoïdale bloeding
    2) Opname in het UMCU of Erasmus MC binnen 11.5 uur na ictus
    3) Leeftijd van 18 jaar en ouder
    E.4Principal exclusion criteria
    1) Life expectancy < 10 days;
    2) Pregnant or breast-feeding women;
    3) Participation in another clinical therapeutic study;
    4) History of splenectomy or asplenia (potentially increased risk of meningococcal infection);
    5) Hematologic malignancy;
    6) Patients receiving chemotherapy;
    7) Patients who will undergo or underwent an organ transplantation;
    8) Patients with myasthenia gravis, glucose-6-phosphate dehydrogenase (G6PD) deficiency, or tuberculosis;
    9) Patients who are or will be treated by plasmapheresis or hemodialysis;
    10) Patient with a creatinine clearance of <30 or serum creatinine levels of >169 μmol/l
    11) Patients with a known hereditary complement deficiency;
    12) Patients allergic to eculizumab, proteins derived from mouse products or other monoclonal antibodies;
    13) Patients allergic to (prophylactic) antibiotic treatment for Neisseria meningitidis (quinolones or ceftriaxone (therapeutic));
    14) If on admission, it is likely that the aneurysm can only be treated with extracranial-intracranial bypass surgery;
    15) If based on head imaging, it will be unlikely that CSF can be obtained 48-72 hours after ictus;
    16) Patients with an ongoing infection on admission which is not appropriately treated;
    17) Patients who were treated >4 times with antibiotics during the last year;
    18) Patients on immunosuppressive therapy.
    1) Levensverwachting korter dan 10 dagen;
    2) Zwangere vrouwen of vrouwen die borstvoeding geven;
    3) Deelname aan een andere therapeutische studie;
    4) Een voorgeschiedenis van een splenectomie of asplenie (gezien een
    potentieel verhoogd risico op een meningococcen infectie);
    5) Hematologische maligniteit;
    6) Patiënten die chemotherapie krijgen;
    7) Patiënten die een orgaantransplantatie gaan krijgen of ondergaan hebben;
    8) Patiënten met myasthenia gravis, glucose-6-fosfaatdehydrogenase
    (G6PD) deficiëntie, of tuberculose;
    9) Patiënten die worden of behandeld gaan worden met plasmaferese of hemodialyse;
    10) Patiënten met een kreatinine klaring van <30 of serum creatinine
    waarde van >169 μmol/l;
    11) Patiënten bekend met een erfelijke complement deficiëntie;
    12) Patiënten die allergisch zijn voor eculizumab, eiwitten van muizen of
    andere monoklonale antistoffen;
    13) Patiënten die allergisch zijn voor (profylactische) antibiotica
    behandeling voor Neisseria meningitidis (quinolonen of ceftriaxon);
    14) Als het bij opname waarschijnlijk is dat het aneurysma alleen
    behandeld kan worden middels een extracraniële-intracraniële bypass;
    15) Als gebaseerd op de hersenscan, het onwaarschijnlijk is dat er liquor
    kan worden afgenomen 48-72 uur na ictus;
    16) Patiënten met een voortdurende infectie bij opname die niet
    adequaat wordt behandeld;
    17) Patiënten die >4 antibiotica kuren hebben gehad in het afgelopen jaar;
    18) Patiënten die behandeld worden met immunosuppresiva.
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome measure is biological effectivity determined by the concentration of C5a in CSF.
    De primaire uitkomstmaat is de biologische effectiviteit bepaald door middel van de C5a concentratie in de liquor.
    E.5.1.1Timepoint(s) of evaluation of this end point
    -48-72 hours after ictus
    -48-72 uur na ictus
    E.5.2Secondary end point(s)
    1) Occurrence of AEs and SAEs up until one month after ictus
    2) Blood plasma and CSF parameters of inflammation (e.g. CRP and cytokines);
    3) Concentration of eculizumab in blood plasma and CSF;
    4) Daily neurological condition during the first fourteen days of the hospital stay measured by Glasgow Coma Scale (GCS);
    5) Neurological condition measured by the National Institutes of Health Stroke Scale (NIHSS) and World Federation of Neurosurgical Societies (WFNS)score fourteen days after ictus;
    6) Cerebral infarction on brain Magnetic Resonance Imaging (MRI) at hospital discharge;
    7) Cognition and QoL ten weeks (+/- two weeks) after ictus;
    8) The modified Rankin Scale (mRS) thirteen weeks (+/- two weeks) after ictus.
    1) Voorkomen van AEs en SAEs tot een maand na ictus;
    2) Bloed plasma en liquor parameters van inflammatie (bijvoorbeeld CRP en cytokines);
    3) Concentratie van eculizumab in bloed plasma en liquor;
    4) Dagelijkse neurologische conditie gedurende de eerste veertien dagen van de ziekenhuisopname bepaald met behulp van de GCS;
    5) Neurologische conditie op dag 14 na ictus bepaald met behulp van de NIHSS en WFNS;
    6) Aanwezigheid en volume van cerebrale infarcten op de MRI-scan bij ontslag;
    7) Cognitie en kwaliteit van leven tien weken na ictus (+/- twee weken);
    8) mRS-score dertien weken na ictus (+/- twee weken).
    E.5.2.1Timepoint(s) of evaluation of this end point
    1) Four weeks;
    2 & 3) Blood plasma during hospital stay at multiple timepoints (on admission and on day 2, 4, 6, 9, 12 and 14). CSF 48-72 hours after ictus;
    4) Daily during the first fourteen days of the hospital stay;
    5) On day 14;
    6) At discharge;
    7) Ten weeks after ictus (+/- two week);
    8) Thirteen weeks after ictus (+/- two weeks).
    1) Vier weken
    2 & 3) Bloed plasma gedurende ziekenhuisopname op meerdere tijdstippen (bij opname en op dag 2, 4, 6, 9, 12 en 14). Liquor 48-72 uur na ictus;
    4) Dagelijks gedurende de eerste 14 dagen van de ziekenhuisopname;
    5) Op dag 14;
    6) Bij ontslag;
    7) Tien weken na ictus (+/- twee weken);
    8) Dertien weken na ontslag (+/- twee weken.
    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. trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 No
    E.8.2.3Other Yes
    E. description
    Regular SAH treatment
    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 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 No
    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
    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 months0
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    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) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 Yes
    F.3.3.6Subjects incapable of giving consent personally Yes
    F. of subjects incapable of giving consent
    Informed consent will be obtained from either the patient or a legally acceptable surrogate if the patient is incapacitated (in which case the patient will also be asked for informed consent as soon as the patient can give informed consent).
    Er zal toestemming worden gevraagd aan ofwel de patiënt of de wettelijk vertegenwoordiger van de patiënt voor deelname aan deze studie (waarna de patiënt zelf ook om toestemming gevraagd zal worden als hij/zij wederom wilsbekwaam is).
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state40
    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)
    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 Decision2018-01-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-06-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-08-16
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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