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    Summary
    EudraCT Number:2020-004245-37
    Sponsor's Protocol Code Number:UCDCRC/20/05
    National Competent Authority:Ireland - HPRA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-10-30
    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 ConcernedIreland - HPRA
    A.2EudraCT number2020-004245-37
    A.3Full title of the trial
    Randomised Placebo-Controlled Trial of Early Targeted Treatment of Patent Ductus Arteriosus with Paracetamol in Extremely Low Birth Weight Infants (ETAPA)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Research study for early treatment of Patent Ductus Arteriosus, placebo against paracetamol in extremely low birth weight infants (ETAPA)
    A.3.2Name or abbreviated title of the trial where available
    ETAPA
    A.4.1Sponsor's protocol code numberUCDCRC/20/05
    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 College Dublin
    B.1.3.4CountryIreland
    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 supportFriends of the Coombe
    B.4.2CountryIreland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUCD
    B.5.2Functional name of contact pointMonitoring
    B.5.3 Address:
    B.5.3.1Street AddressBelfield
    B.5.3.2Town/ cityDublin
    B.5.3.3Post codeDublin 4
    B.5.3.4CountryIreland
    B.5.4Telephone number+35317164593
    B.5.6E-mailcrc.monitoring@ucd.ie
    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 Paracetamol
    D.2.1.1.2Name of the Marketing Authorisation holderB. Braun Melsungen AG
    D.2.1.2Country which granted the Marketing AuthorisationIreland
    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 nameParacetamol
    D.3.4Pharmaceutical form Solution for 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 INNParacetamol
    D.3.9.3Other descriptive namePARACETAMOL
    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 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
    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
    E.1.1.1Medical condition in easily understood language
    Medical condition in which the ductus arteriosus fails to close after birth
    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 PT
    E.1.2Classification code 10034130
    E.1.2Term Patent ductus arteriosus
    E.1.2System Organ Class 10010331 - Congenital, familial and genetic disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Our primary objective is to compare the efficacy of early targeted treatment of PDA, in ELBW infants, with intravenous paracetamol administration compared to placebo, in reducing the combined outcomes of PIVH, NEC and death before discharge.
    E.2.2Secondary objectives of the trial
    To investigate the efficacy of early targeted treatment of PDA, in ELBW infants, with intravenous paracetamol infusion compared with placebo, in preventing or reducing further known complications associated with PDA, as well as recording a number of known variables relating to prematurity from enrolment in the trial until discharge home from the hospital.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - They are inborn or transferred to a participating centre after birth and have a birth weight of <1000g established by weight assessment on admission to NICU.
    - The treating doctors plan to offer them intensive care.
    - Large PDA is present on fnECHO, defined as PDA with diameter greater than 1.5mm with non-restrictive flow (defined as diastolic flow less than 50% of systolic flow)(25), determined by targeted fnECHO between 6 and 12 hours of age.
    E.4Principal exclusion criteria
    - Infants with major congenital anomalies including neural tube defects, major structural cardiac anomalies (excluding PDA/ASD/PFO), abdominal wall defects and congenital diaphragmatic hernia and major dysmorphic features with an abnormal karyotype e.g. T21, T13, T18.
    - The treating clinician does not intend to offer the infant intensive care.
    - Bidirectional shunt of PDA on ECHO (defined as shunt exceeding 30% of the right to left proportion of the shunting).
    - Grade II – IV IVH on point of care CRUSS on screening (between six to twelve hours of age).
    - PH prior to study commencement.
    - Severe PPHN.
    - History or examination suggestive of liver failure prior to study commencement.
    - Written informed consent has not been obtained before the infant is 12 hours of age, or the infant’s parent(s)/guardian(s) withdraw consent prior to commencement of the trial processes or assessments.
    E.5 End points
    E.5.1Primary end point(s)
    • Combined outcome of periventricular/intraventricular haemorrhage (PIVH) ≥ grade II, NEC ≥ grade IIa (Bell's staging), and death before discharge.
    E.5.1.1Timepoint(s) of evaluation of this end point
    before discharge
    E.5.2Secondary end point(s)
    • PDA closure rate
    • PDA exposure i.e. duration of time lived with PDA
    • Pulmonary haemorrhage (PH)
    • Spontaneous intestinal perforation (SIP)
    • Chronic Lung Disease of prematurity (CLD) (defined as need of oxygen and/or ventilatory support at 36 weeks of gestation)
    • Retinopathy of Prematurity (ROP) ≥grade III
    • Ventilation parameters during and after the study period
    • Use of inotropes during the study period
    • PDA medical treatment after the study period
    • PDA surgical treatment after the study period
    • Liver function tests
    • Neonatal pain score during the study period
    • Developmental outcome at two years corrected gestational age, as assessed by Bayley assessment will be carried out (ETAPA phase 3).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Each endpoint will be measured through the course of the trial, as outlined in the endpoint list in section E.5.2
    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 Yes
    E.6.4Safety No
    E.6.5Efficacy No
    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 No
    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 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 Yes
    E.8.5.1Number of sites anticipated in the EEA4
    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
    The end of the trial will be when all infants have been recruited and the last baby has been discharged from hospital, in order to ensure all secondary outcomes have been recorded.
    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
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    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.1.1Number of subjects for this age range: 218
    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: 218
    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 No
    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
    Infants. Parents consent will be required
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 218
    F.4.2.2In the whole clinical trial 218
    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)
    The investigators will inform subjects and ensure that the appropriate follow-up is arranged for all involved.
    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 Decision2020-12-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-10-22
    P. End of Trial
    P.End of Trial StatusOngoing
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