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    The EU Clinical Trials Register currently displays   44298   clinical trials with a EudraCT protocol, of which   7352   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:2015-002997-18
    Sponsor's Protocol Code Number:53975
    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:2016-11-22
    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 number2015-002997-18
    A.3Full title of the trial
    Darbepoetin for Ischemic Neonatal Stroke to Augment Regeneration
    Darbepoëtine voor Ischemische Neonatale Stroke voor stimulatie van Regeneratie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Darbepoetin for neonatal stroke
    Darbepoëtine voor neonatale herseninfarcten
    A.3.2Name or abbreviated title of the trial where available
    DINOSAUR
    DINOSAUR
    A.4.1Sponsor's protocol code number53975
    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, the Netherlands
    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 supportCP Alliance
    B.4.2CountryAustralia
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Medical Center Utrecht, the Netherlands
    B.5.2Functional name of contact pointManager Research Div. Woman & Baby
    B.5.3 Address:
    B.5.3.1Street AddressP.O. Box 85500, internal mail number F.05.126
    B.5.3.2Town/ cityUtrecht
    B.5.3.3Post code3508 GA
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+31887557524
    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 Aranesp
    D.2.1.1.2Name of the Marketing Authorisation holderAmgen Europe B.V.
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 Solution for injection/infusion
    D.3.4.1Specific paediatric formulation Yes
    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 INNDARBEPOETIN ALFA
    D.3.9.1CAS number 209810-58-2
    D.3.9.4EV Substance CodeSUB12486MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10/0.4
    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) No
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection/infusion
    D.8.4Route of administration of the placeboIntravenous use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection/infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Perinatal Arterial Ischemic Stroke (PAIS)
    Perinataal arterieel ischemische stroke (PAIS)
    E.1.1.1Medical condition in easily understood language
    Neonatal stroke
    Neonataal herseninfarct
    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 perform a double-blind randomized placebo controlled multicenter study with darbepoetin in infants with MRI confirmed PAIS and to investigate whether darbepoetin can reduce brain injury in neonates who suffered from perinatal arterial ischemic stroke (PAIS). The ultimate goal of this study is therefore to develop a therapy using erythropoiesis-stimulating-agents (ESAs) such as darbepoetin to reduce or even prevent lifelong consequences of PAIS-related brain injury in this group of term newborns.
    Het uitvoeren van een dubbel-blind gerandomniseerd placebo-gecontroleerde multicenter studie met darbepoëtine in pasgeborenen met op de MRI bevestigde perinatale arteriële ischemische stroke (PAIS) en te onderzoeken of darbepoëtine hersenschade kan reduceren in pasgeborenen met PAIS. Het einddoel van de studie is daarom om door het gebruik van erytropoese-stimulerende factoren zoals darbepoëtine een therapie te ontwikkelen welke de levenslange consequenties van PAIS-gerelateerde hersenschade bij deze kwetsbare groep pasgeborenen reduceert dan wel voorkomt.
    E.2.2Secondary objectives of the trial
    Not applicable
    Niet van toepassing
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Newborns ≥ 36 weeks gestation, both male and female
    2. MRI confirmed diagnosis of acute PAIS , with involvement of the cortical spinal tract (e.g. PLIC or peduncles)
    3. Less than 4 days after the onset of clinical symptoms
    4. Written informed consent from custodial parent(s)
    1. Op tijd geboren pasgeborenen, geboren ≥ 36 weken zwangerschapsduur
    2. Een PAIS (met betrokkenheid van de corticospinale banen, bijvoorbeeld de PLIC en/of peduncles) welke is bevestigd met een MRI
    3. Minder dan 4 dagen na de initiële klinische symptomen
    4. Ouders hebben schriftelijk toestemming gegeven voor meedoen aan deze studie
    E.4Principal exclusion criteria
    - Moderate –severe HIE with or without hypothermia therapy ;
    - Any proven or suspected major congenital anomaly, chromosomal disorder, metabolic disorder;
    - Presence of a serious infection of the central nervous system;
    - No realistic prospect of survival, (e.g. severe brain injury), at the discretion of the attending physician;
    - Infant for whom withdrawal of supportive care is being considered.
    - Matige- tot ernstige HIE met of zonder hypothermie behandeling;
    - Bewezen of verdachte ernstige congenitale afwijking, chromosomale stoornis of metabole stoornis;
    - Aanwezigheid van ernstige infectie aan het centraal zenuwstelsel;
    - Geen realistische levensverwachting (bijv. ernstige hersenschade), beoordeeld door de behandelend arts;
    - Pasgeborenen waarbij overwogen wordt tot staken van de behandeling.
    E.5 End points
    E.5.1Primary end point(s)
    Our primary objective is to determine whether there is a difference in the degree in stroke tissue loss between darbepoetin and placebo treatment, which will be measured by the change in lesion size and brain growth between the time of onset of the insult and 6-8 weeks of age. Additionally we will assess whether there are differences between darbepoetin and placebo treatment in DTI parameters of selected regions of interest. Primairy endpoints will be estimated using advanced volumetric magnetic resonance (MRI) techniques and diffusion tensor imaging (DTI) MRI techniques, performed within 3 days after clinical presentation and at 6-8 weeks of age.
    Onze primaire uitkomstmaat is om te bepalen of er een verschil is in de mate van hersenschade en weefselverlies tussen de met darbepoetin en met placebo behandelde groep. Dit zal worden bepaald door de verandering in infarctgrootte en hersengroei tussen het moment van diagnose en de leeftijd van 6-8 weken te meten en te vergelijken tussen de groepen. Daarnaast zullen we kijken naar verschillen tussen de met darbepoetin en met placebo behandelde groepen wat betreft DTI parameters in verschillende regio's. Primaire eindpunten worden gemeten met behulp van geavanceerde volumetrische MRI-technieken en diffusion tensor imaging (DTI) MRI technieken, gemaakt binnen 3 dagen na klinische presentatie en op de leeftijd van6-8 weken.
    E.5.1.1Timepoint(s) of evaluation of this end point
    6-8 weeks postnatal age.
    6-8 weken postnatale leeftijd.
    E.5.2Secondary end point(s)
    We will assess development of USCP, and cognitive development at 18 months of age using the BSID-III and PSOM scores as well as a full neurological assessment including Gross Motor Function Classification system (GMFCS) and several handfunction tests such as Manual Ability Classification System (MACS), the Hand Assessment of Infants (HAI) and Assisting Hand Assessment (AHA) and compare them between groups (darbepoetin vs placebo).
    We zullen de neuromotore ontwikkeling vergelijken tussen de darbepoetine en met placebo behandelde groep. Hierbij zal worden gekeken naar de ontwikkeling van unilaterale spastische cerebrale parese (USCP) en de cognitieve ontwikkeling op de leeftijd van 18 maanden. Deze zullen worden onderzocht met behulp van de Bayley Scales of Infant Development (BSID) versie 3 en de Pediatric Stroke Outcome Measure (PSOM) Daarnaast zal op de leeftijd van 18 maanden ook een volledig neurologisch onderzoek inclusief de Gross Motor Function Classification system (GMFCS) en verschillende handfunctietesten zoals de Manual Ability Classification System (MACS), the Hand Assessment of Infants (HAI) and Assisting Hand Assessment (AHA) plaatsvinden.
    E.5.2.1Timepoint(s) of evaluation of this end point
    18 months postnatal age.
    18 maanden postnataal.
    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 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 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 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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA1
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Canada
    Netherlands
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years7
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years7
    E.8.9.2In all countries concerned by the trial months9
    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: 80
    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) Yes
    F.1.1.3.1Number of subjects for this age range: 80
    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) No
    F.1.3Elderly (>=65 years) No
    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
    Neonates in the first week of life.
    Pasgeborenen in de eerste levensweek.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    F.4.2.2In the whole clinical trial 80
    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)
    None, standard care.
    Geen, 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 Decision2016-11-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-03-14
    P. End of Trial
    P.End of Trial StatusOngoing
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