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    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   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:2021-000324-36
    Sponsor's Protocol Code Number:NL76607.091.21
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-03-16
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2021-000324-36
    A.3Full title of the trial
    Anakinra in Cerebral haemorrhage to Target secondary Injury resulting from Neuroinflammation - a phase II clinical trial
    Het gebruik van Anakinra om hersenschade door inflammatie na een intracerebrale bloeding te bestrijden – een fase II klinische studie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Studying anakinra to reduce secondary brain damage after spontaneous haemorrhagic stroke
    A.3.2Name or abbreviated title of the trial where available
    ACTION
    A.4.1Sponsor's protocol code numberNL76607.091.21
    A.5.4Other Identifiers
    Name:PaNaMaNumber:109883
    Name:Clinicaltrials.govNumber:NCT04834388
    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 SponsorRadboudumc
    B.1.3.4CountryNetherlands
    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 supportHartstichting Nederland
    B.4.2CountryNetherlands
    B.4.1Name of organisation providing supportSwedish Orphan Biovitrum AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRadboudumc
    B.5.2Functional name of contact pointMaaike Cliteur
    B.5.3 Address:
    B.5.3.1Street AddressReinier Postlaan 4
    B.5.3.2Town/ cityNijmegen
    B.5.3.3Post code6525 GC
    B.5.3.4CountryNetherlands
    B.5.4Telephone number00310243616600
    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 (anakinra)
    D.2.1.1.2Name of the Marketing Authorisation holderSwedish Orphan Biovitrum AB
    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 Suspension for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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) No
    D.3.11.7Plasma derived medicinal product No
    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.IMP: 2
    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 (anakinra)
    D.2.1.1.2Name of the Marketing Authorisation holderSwedish Orphan Biovitrum AB
    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 Suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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) No
    D.3.11.7Plasma derived medicinal product No
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Spontaneous supratentorial intracerebral haemorrhage
    Spontane supratentoriële intraparenchymateuze hersenbloeding
    E.1.1.1Medical condition in easily understood language
    Spontaneous haemorrhagic stroke
    Spontane hersenbloeding
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    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 effect of high-dose versus low-dose anakinra compared to standard medical management on cerebral oedema development after spontaneous supratentorial intracerebral haemorrhage.
    Doel van deze studie is het effect van hoog- versus laaggedoseerd anakinra op de ontwikkeling van hersenoedeem na een spontane supratentoriele hersenbloeding te vergelijken met standaard zorg.
    E.2.2Secondary objectives of the trial
    Study the safety profile of anakinra in ICH patients
    Determine the effect of anakinra on serum inflammatory markers
    Assess the effect on the blood brain barrier integrity
    Estimate the effect of anakinra on functional outcome
    Het veiligheidsprofiel van anakinra bepalen in patienten met een hersenbloeding
    Bepalen wat het effect van anakinra op serum ontstekingsmarkers is
    Onderzoeken wat het effect van anakinra is op de doorlaatbaarheid van de bloed-hersen-barriere
    Een schatting maken van het effect van anakinra op de functionele uitkomst
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age ≥ 18 years;
    2. Supratentorial non-traumatic ICH confirmed by CT, without a confirmed causative lesion on admission CT-angiography (e.g. aneurysm, AVM, DAVF, cerebral venous sinus thrombosis) or other known underlying lesion (e.g. tumour, cavernoma);
    3. Minimal intracerebral haemorrhage volume of 10 mL
    4. Intervention can be started within 8 hours from symptoms onset;
    5. Patient’s or legal representative’s informed consent.
    1. Leeftijd ≥ 18 jaar;
    2. Supratentoriële, niet-traumatische intracraniële bloeding welke middels CT is bevestigd waarbij op CT-a ten tijde van initiële presentatie geen onderliggende macrovasculaire (zoals een arterioveneuze malformatie, aneurysmata, durale arterioveneuze fistel of veneuze sinus trombose) of andere oorzakelijke laesies (zoals een tumor of cavernoom) werden vastgesteld;
    3. Minimaal hematoom volume van 10mL;
    4. Interventie kan worden gestart binnen 8 uur na ontstaan van de eerste symptomen
    5. Informed consent getekend door patiënt of de wettelijk vertegenwoordiger.
    E.4Principal exclusion criteria
    1. Severe ICH, unlikely to survive the first 72 hours (defined as Glasgow Coma Scale score < 6 at time of consent);
    2. Confirmed or suspected haemorrhagic transformation of an arterial or venous infarct;
    3. Planned neurosurgical haematoma evacuation;
    4. Severe infection at admission, requiring antibiotic treatment;
    5. Known active tuberculosis or active hepatitis;
    6. Use of immunosuppressive or immune-modulating therapy at admission;
    7. Neutropenia (Absolute Neutrophil Count (ANC) <1.5 x 109/L );
    8. Pre-stroke modified Rankin Scale score ≥ 3;
    9. Pregnancy or breast-feeding;
    10. Standard contraindications to MRI;
    11. Known prior allergic reaction to gadolinium contrast or one of the constituents of its solution for administration;
    12. Known allergy to anakinra or other products that are produced by DNA technology using the micro-organism E. coli;
    13. Live vaccinations within the last 10 days prior to this ICH;
    14. Severe renal impairment (eGFR <30ml/min/1.73m);
    15. Known active malignancy
    1. Zeer ernstige hersenbloeding waarbij het onwaarschijnlijk is dat patiënt de eerste 72 uur zal overleven (gedefinieerd als een Glasgow Coma Scale score van <6 op moment van toestemming);
    2. Bekende of veronderstelde hemorrhagische transformatie van een veneus of arterieel herseninfarct;
    3. Geplande neurochirurgische hematoomevacuatie;
    4. Ernstige infectie op het moment van opname waarvoor antibiotische behandeling noodzakelijk is;
    5. Bekende actieve tuberculose of actieve hepatitis;
    6. Gebruik van immunosuppressieve of immuno-modulerende therapie op het moment van opname;
    7. Neutropenie (Absolute Neutrophil Count (ANC) <1.5 x 109/L );
    8. Modified Rankin Scale score ≥ 3 voor het optreden van de hersenbloeding;
    9. Zwangerschap of het geven van borstvoeding;
    10. Standaard contra indicaties voor MRI;
    11. Bekende allergie voor gadolinium contrast of een van de bestandsdelen hiervan;
    12. Bekende allergie voor anakinra of andere producten die worden geproduceerd middels recombinant E. coli DNA technologie;
    13. Vaccinatie met een levend vaccin in de laatste 10 dagen voorafgaand aan de hersenbloeding;
    14. Ernstige nierfunctiestoornissen (eGFR <30ml/min/1.73m);
    15. Bekende actieve maligniteit
    E.5 End points
    E.5.1Primary end point(s)
    Oedema extension distance (OED) determined with MRI.
    De 'oedema extension distance (OED)' gemeten met MRI.
    E.5.1.1Timepoint(s) of evaluation of this end point
    MRI will be performed on day 7±1 after ICH.
    MRI wordt verricht op dag 7±1 na de hersenbloeding.
    E.5.2Secondary end point(s)
    (serious) Adverse events
    Serum inflammatory markers IL-1β, IL-6, hsCRP, neutrophil and total white blood cell counts
    DCE-MRI measurement of BBB transfer constant (Ktrans)
    mRS, Barthel index and EQ-5D-5L score
    (serious) Adverse events
    Serum inflammatiemarkers IL-1β, IL-6, hsCRP, neutrofiel en totaal aantal witte bloedcellen
    DCE-MRI meting van de BBB doorlaatbaarheidsconstante (Ktrans)
    mRS, Barthel index and EQ-5D-5L score
    E.5.2.1Timepoint(s) of evaluation of this end point
    Adverse events will be registered up to 30 days after inclusion
    Blood samples will be obtained at day 1, 3 and 7 after ICH
    MRI will be performed at day 7±1 after ICH
    Functional outcome will be assessed at 90±7 days after ICH
    Adverse events geregistreerd tot 30 dagen na inclusie
    Bloedafnames vinden plaats op dag 1, 3 and 7 na de hersenbloeding
    MRIwordt verricht op dag 7±1 na de hersenbloeding
    Functionele uitkomst wordt bepaald op dag 90±7 na de hersenbloeding
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    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) 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) 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 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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Vergelijker is de standaard zorg
    Comparator is standard care
    E.8.2.4Number of treatment arms in the trial3
    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 concerned3
    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
    LVLS
    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 months3
    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: 25
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 2022-03-16. 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
    A large proportion of patients who suffer from ICH is incapacitated due to impaired consciousness or language deficits. To maintain a representative study population it is essential to include both legally capacitated and incapacitated patients.
    Veel patienten die lijden aan een hersenbloeding zijn niet wilsbekwaam vanwege bewustzijnsstoornissen of taalproblematiek. Om een representatieve studiepopulatie te behouden is het essentieel ook deze patienten in de studie te includeren.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state75
    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)
    Resume best standard-of-care.
    Hervatten van de standaard zorg.
    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 Decision2022-03-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-03-21
    P. End of Trial
    P.End of Trial StatusOngoing
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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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