Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43857   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).

    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 ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2019-004297-26
    Sponsor's Protocol Code Number:C19-29
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-01-21
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2019-004297-26
    A.3Full title of the trial
    Prophylactic treatment of the ductus arteriosus in preterm infants by acetaminophen
    Trattamento profilattico del dotto arterioso nei neonati pretermine con acetaminofene
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Prophylactic treatment of the ductus arteriosus in preterm infants by paracetamol
    Trattamento profilattico del dotto arterioso nei neonati pretermine con paracetamolo
    A.3.2Name or abbreviated title of the trial where available
    TREOCAPA
    TREOCAPA
    A.4.1Sponsor's protocol code numberC19-29
    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 SponsorINSERM-ANRS
    B.1.3.4CountryFrance
    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 supportInnovative Medicines Initiative 2 (H2020 programme)
    B.4.2CountryEuropean Union
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationINSERM-ANRS
    B.5.2Functional name of contact pointSandrine Couffin-Cadiergues
    B.5.3 Address:
    B.5.3.1Street Address8 rue de la Croix jarry
    B.5.3.2Town/ cityFrancia
    B.5.3.3Post code75013
    B.5.3.4CountryFrance
    B.5.4Telephone number0033144236416
    B.5.6E-mailrqrc.siege@inserm.fr
    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 Paracetamolo B.Braun
    D.2.1.1.2Name of the Marketing Authorisation holderB. BRAUN MELSUNGEN AG
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameNA
    D.3.2Product code [NA]
    D.3.4Pharmaceutical form Solution 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 INNPARACETAMOLO
    D.3.9.1CAS number 103-90-2
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive nameacetaminophen
    D.3.9.4EV Substance CodeSUB09611MIG
    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 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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    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 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for 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
    Patent ductus arteriosus
    pervietà del dotto arterioso
    E.1.1.1Medical condition in easily understood language
    In many extremely preterm infants, the ductus arteriosus does not constrict itself. The ductus arteriosus is open.
    In molti neonati estremamente pretermine, il dotto arterioso non si restringe. Il dotto arterioso è aperto.
    E.1.1.2Therapeutic area Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10034129
    E.1.2Term Patent ductus arteriosis
    E.1.2System Organ Class 100000004850
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective is an increase in surviving without severe morbidity at 36 weeks of post menstrual age (or at discharge if it occurs before) from 50% (placebo group) to 60% in group receiving a prophylactic treatment by acetaminophen during the first 5 days of life.
    L'obiettivo primario è un aumento della sopravvivenza senza grave morbilità a 36 settimane di età post mestruale (o alla dimissione se si verifica prima) dal 50% (gruppo placebo) al 60% nel gruppo che riceve un trattamento profilattico con acetaminofene durante i primi 5 giorni di vita.
    E.2.2Secondary objectives of the trial
    - Early prophylactic treatment by acetaminophen decreases pain score and opiate consumption during the first 5 days of life
    - Early prophylactic treatment by acetaminophen reduces the number of back-up treatment of PDA (NSAIDs, surgery, trans-catheter procedure)
    - Early prophylactic treatment by acetaminophen reduces catecholamines, opioid and parenteral nutrition requirements
    - Pharmacokinetics of acetaminophen (in 50 preterms).
    - Il trattamento profilattico precoce con acetaminofene riduce il livello del dolore e il consumo di oppiacei durante i primi 5 giorni di vita
    - Il trattamento profilattico precoce con acetaminofene riduce il numero di trattamenti di backup del PDA (FANS, chirurgia, procedura trans catetere)
    - Il trattamento profilattico precoce con acetaminofene riduce le esigenze di catecolamine, oppioidi e nutrizione parenterale
    - Farmacocinetica dell’acetaminofene (in 50 neonati pretermine)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Birth between 23-28 W
    - Post natal age < 12 hours
    - Parental or Legal Authority Consent
    - Parents with a social security or health insurance (if applicable)
    - Nascita tra le 23-28 settimane
    - Età post natale < 12 ore
    - Consenso dei genitori o dell’autorità legale
    - Genitori con previdenza sociale o assicurazione sanitaria (se applicabile secondo la normativa locale)
    E.4Principal exclusion criteria
    - Birth defect / Congenital anomaly
    - Twin-to-twin transfusion syndrome
    - Suspicion of pulmonary hypoplasia
    - Suspicion of hepatic impairment (hemorrhagic syndrome and/or severe hypoglycemia)
    - Clinical instability that can lead to rapid death
    - Impossibility to start treatment before 12 hours of life
    - Parents placed under judicial protection
    - Participation in other clinical trial using acetaminophen during the first 5 days of life, indomethacin or ibuprofen during the first 3 days of life or using rescue treatment of PDA not recommended in the TREOCAPA trial
    - Difetto alla nascita/anomalia congenita
    - Sindrome trasfusionale da gemello a gemello
    - Sospetto di ipoplasia polmonare
    - Sospetto di insufficienza epatica (sindrome emorragica e /o grave ipoglicemia)
    - Instabilità clinica che può portare a morte rapida
    - Impossibilità di iniziare il trattamento prima delle 12 ore di vita
    - Genitori posti sotto protezione giudiziaria
    - Partecipazione ad altri studi clinici con acetaminofene durante i primi 5 giorni di vita, indometacina o ibuprofene durante i primi 3 giorni di vita o utilizzando un trattamento di salvataggio del PDA non raccomandato nello studio TREOCAPA
    E.5 End points
    E.5.1Primary end point(s)
    Primary endpoint is the survival without severe morbidity at 36 weeks of post menstrual age or at first discharge home, whichever comes first. The severe morbidities include bronchopulmonary dysplasia (BPD Grade 3 according to NIH consensus), necrotizing enterocolitis (NEC) of Bell's stage II or III, intraventricular hemorrhage (IVH) grade III-IV or cystic leukomalacia observed at any time up to 36 weeks of post menstrual age.
    L'endpoint primario è la sopravvivenza senza grave morbilità a 36 settimane di età post mestruale o alla prima dimissione a casa, a seconda di quale evento si verifichi per primo. Le gravi patologie comprendono displasia broncopolmonare (grado BPD 3 secondo consenso NIH), enterocolite necrotizzante (NEC) dello stadio II o III di Bell, emorragia intraventricolare (IVH) grado III-IV o leucomalacia cistica osservata in qualsiasi momento fino a 36 settimane di età post mestruale.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Primary endpoint is evaluate at 36 weeks of post menstrual age or at first discharge home.
    L'endpoint primario è valutato a 36 settimane di età post mestruale o alla prima dimissione a casa.
    E.5.2Secondary end point(s)
    - Number of rescue treatment to close ductus by non steroid antinflamatory drugs (NSAIDs) or by surgery or by transcatheter.
    - Diastolic systemic arterial pressure during the first week
    - Early and all Pulmonary hemorrhage
    - Cathecholamines, and opiate consumption during the first week of life
    - Volume of enteral nutrition during the first week of life
    - Interaction between parent involvement during the first week of life and medical care; - Diastolic systemic arterial pressure during the first week; Early and all Pulmonary hemorrhage; - Volume of enteral nutrition during the first week of life; - Interaction between parent involvement during the first week of life and medical care; - Cathecholamines, and opiate consumption during the first week of life
    - Numero di trattamenti di salvataggio per chiudere il dotto con farmaci antinfiammatori non steroidei (FANS) o mediante chirurgia o transcatetere
    - Pressione arteriosa sistemica diastolica durante la prima settimana
    - Emorragia polmonare precoce
    - Catecolamine e consumo di oppiacei durante la prima settimana di vita
    - Volume di nutrizione enterale durante la prima settimana di vita
    - Interazione tra coinvolgimento dei genitori durante la prima settimana di vita e cure mediche; - Pressione arteriosa sistemica diastolica durante la prima settimana; - Emorragia polmonare precoce e tutta; - Volume di nutrizione enterale durante la prima settimana di vita; - Interazione tra coinvolgimento dei genitori durante la prima settimana di vita e cure mediche; - Catecolamine e consumo di oppiacei durante la prima settimana di vita
    E.5.2.1Timepoint(s) of evaluation of this end point
    At 36 weeks of post menstrual age or at first discharge home; At 36 weeks of post menstrual age or at first discharge home; At 36 weeks of post menstrual age or at first discharge home; At 36 weeks of post menstrual age or at first discharge home; At 36 weeks of post menstrual age or at first discharge home; At 36 weeks of post menstrual age or at first discharge home
    A 36 settimane di età post mestruale o alla prima dimissione a casa; A 36 settimane di età post mestruale o alla prima dimissione a casa; A 36 settimane di età post mestruale o alla prima dimissione a casa; A 36 settimane di età post mestruale o alla prima dimissione a casa; A 36 settimane di età post mestruale o alla prima dimissione a casa; A 36 settimane di età post mestruale o alla prima dimissione a casa
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA650
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Austria
    Belgium
    Denmark
    Estonia
    Finland
    France
    Greece
    Hungary
    Ireland
    Italy
    Norway
    Poland
    Portugal
    Spain
    Sweden
    Switzerland
    United Kingdom
    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 study is defined as the date of completion of the last visit or procedure of the last participant.
    La fine dello studio è definita come la data di completamento dell'ultima visita o procedura dell'ultimo partecipante.
    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 months7
    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 months7
    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) Yes
    F.1.1.2.1Number of subjects for this age range: 794
    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) 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
    Patients included in this trial are extremely preterm infants (23-28 weeks of gestation)
    I pazienti inclusi in questo studio sono neonati estremamente pretermine (23-28 settimane di gestazione)
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state53
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 650
    F.4.2.2In the whole clinical trial 794
    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)
    A follow-up study will be done in 2020. The main objective will be to examine whether early prophylactic treatment by acetaminophen in very preterm infants is associated with a better outcome at 18 months of corrected age from a neurodevelopmental point of view
    Uno studio di follow-up verrà effettuato nel corso 2020. L'obiettivo principale sarà quello di esaminare se il trattamento profilattico precoce con paracetamolo in neonati estremamente pretermine fornisce un risultato migliore da un punto di vista dello sviluppo neurologico a 18 mesi di età
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation European Foundation for the Care of Newborn Infants (EFCNI)
    G.4.3.4Network Country Germany
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-06-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-01-14
    P. End of Trial
    P.End of Trial StatusOngoing
    For support, Contact us.
    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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Tue Apr 23 20:35:22 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA