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    The EU Clinical Trials Register currently displays   42758   clinical trials with a EudraCT protocol, of which   7042   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2020-000836-23
    Sponsor's Protocol Code Number:FentanylTH
    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:2020-10-21
    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 number2020-000836-23
    A.3Full title of the trial
    Continous fentanyl infusion in newborns with hypoxic ischemic encephalopathy treated with therapeutic hypothermia: pharmacokinetics study
    Fentanile in infusione continua in neonati con encefalopatia ipossico ischemica trattati con ipotermia terapeutica: studio di farmacocinetica
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Continous fentanyl infusion in newborns with hypoxic ischemic encephalopathy treated with therapeutic hypothermia: pharmacokinetics study
    Fentanile in infusione continua in neonati con encefalopatia ipossico ischemica trattati con ipotermia terapeutica: studio di farmacocinetica
    A.3.2Name or abbreviated title of the trial where available
    FentanylTH
    FentanylTH
    A.4.1Sponsor's protocol code numberFentanylTH
    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 SponsorAZIENDA OSPEDALIERO-UNIVERSITARIA DI MODENA
    B.1.3.4CountryItaly
    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 supportFondo Aziendale per la Ricerca - Azienda Ospedaliero-Universitaria di Modena
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAzienda Ospedaliero-Universitaria di Modena
    B.5.2Functional name of contact pointClinical Trial Quality Team
    B.5.3 Address:
    B.5.3.1Street AddressVia Del Pozzo 71
    B.5.3.2Town/ cityModena
    B.5.3.3Post code41124
    B.5.3.4CountryItaly
    B.5.4Telephone number0594225868
    B.5.5Fax number0594224369
    B.5.6E-mailricercainnovazione@aou.mo.it
    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 fentanyl-hameln
    D.2.1.1.2Name of the Marketing Authorisation holderHameln pharma plus gmbh
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameFentanyl-hameln
    D.3.2Product code [-]
    D.3.4Pharmaceutical form Solution for injection
    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.3.9.2Current sponsor code-
    D.3.10 Strength
    D.3.10.1Concentration unit Other
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Infants with perinatal asphyxiation and indication to hypothermic treatment with analgo-sedation performed with fentanyl
    Neonati con asfissia perinatale e indicazione di trattamento ipotermico con analgo-sedazione eseguito con fentanil
    E.1.1.1Medical condition in easily understood language
    Infants with perinatal asphyxiation and indication to hypothermic treatment with analgo-sedation performed with fentanyl
    Neonati con asfissia perinatale e indicazione di trattamento ipotermico con analgo-sedazione eseguito con fentanil
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10070512
    E.1.2Term Hypoxic-ischemic encephalopathy
    E.1.2System Organ Class 100000004852
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate pharmacokinetics of Fentanyl in asphyxiated infants treated with hypothermia, in a standard regimen of Fentanyl administration. Drug plasma concentrations at the end of the starting bolus, after 24-48-72 hours infusion and after 96 hours from starting bolus will be assessed. Maximun- minimun concentration (Cmax-min) and clearance of drug will be determined.
    Valutare la farmacocinetica di Fentanil nei neonati con encefalopatia ipossico-ischemica trattati con ipotermia, in un regime standard di somministrazione di Fentanil. Saranno valutate le concentrazioni plasmatiche del farmaco alla fine del bolo iniziale, dopo 24-48-72 ore di infusione e dopo 96 ore dall'inizio del bolo. Saranno determinate la concentrazione massima-minima (Cmax-min) e la clearance del farmaco.
    E.2.2Secondary objectives of the trial
    To evaluate the safety of the Fentanyl regimen (load of 1-2 mcg/Kg of Fentanyl followed by a continuous infusion of Fentanyl at dosage of 0,5-1 mcg/kg/h for TH and heating fase) by recording drug side effect
    Valutare la sicurezza del regime di Fentanil (carico di 1-2 mcg / Kg di Fentanil seguito da una infusione continua di Fentanil alla dose di 0,5-1 mcg / kg / h per TH e fase di riscaldamento) registrando le reazioni al farmaco
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Any newborn eligible for hypothermic treatment according to Italian Recommendation for the treatment of perinatal asphyxia (SIN raccomandation 2012):
    - a gestational age >= 35 weeks and a birth weight > 1.8 kg;
    - with Apgar Score at 5 min <= 5 or with continued resuscitation at 10 min postnatal or with 1 h postnatal blood gas analysis pH<7.0 or base deficit>12
    - clinical signs of encephalopathy
    - moderate to severe aEEG anomalies or seizures
    - neuroprotective treatment by controlled hypothermia <6 h postnatal life
    - parental written informed consent for participation in the study obtained
    - study analgesic treatment available
    - Neonati con asfissia perinatale e indicazione al trattamento ipotermico
    - Età gestionale >= 35 settimane e peso alla nascita >1,8 Kg
    - con Apgar score al 5 minuto <= 5 o con necessità ddi rianimazione al 10 minuto post-natale o con emogasanalisi a 1 ora di vita con pH < 7,0 o deficit di basi > 12mmol/L
    - segni clinici e aEEG di encefalopatia
    - Trattamento ipotermico neuroprotettivo iniziato entro le 6 ore di vita post natale
    Consenso informato dei genitori per lo studio
    -Trattamento analgesico in studio
    - posizionamento di linea venosa centrale
    E.4Principal exclusion criteria
    Neonates will not be recruited into the study if at least one of the following criteria is found:
    - Known genetic or chromosomal disorders or major malformation
    - No central venous line placement
    - No written parental consent to participate following informed consent interview
    I neonati non saranno reclutati nello studio se viene trovato almeno uno dei seguenti criteri:
    - Alterazioni cromosomiche e/o genetiche note o malformazioni maggiori
    - Assenza di linea venosa a doppio lume
    - Mancato consenso dei genitori alla partecipazione allo studio
    E.5 End points
    E.5.1Primary end point(s)
    Drug plasma concentrations at the end of the starting bolus, after 24-48-72 hours infusion and after 96 hours from starting bolus will be assessed. Maximun- minimun concentration (Cmax-min) and clearance of drug will be
    determined.
    Saranno valutate le concentrazioni plasmatiche del farmaco alla fine del bolo iniziale, dopo 24-48-72 ore di infusione e dopo 96 ore dall'inizio del bolo. Saranno valutate la concentrazione massima-minima (Cmax-min) e la Clearance del farmaco.
    E.5.1.1Timepoint(s) of evaluation of this end point
    after 24-48-72 hours infusion and after 96 hours from starting bolus
    dopo 24-48-72 ore infusione e dopo 96 ore dall'inizio del bolo
    E.5.2Secondary end point(s)
    To evaluate the safety of the Fentanyl regimen (load of 1-2 mcg/Kg of Fentanyl followed by a continuous infusion of Fentanyl at dosage of 0,5-1 mcg/kg/h for TH and heating fase) by recording drug side effect:
    - Rate of mechanically ventilated newborns during TH
    - Rate of apnea and/or need of respiratory support starting during TH
    - Need of resuscitation during TH
    - Need of opioid antagonist administration during TH
    - Incidence of hypotension during TH, defined as blood pressure below 10th centile for gestational age and postnatal age
    - Need of cardiovascular support drugs during TH
    - Rate of delayed intestinal passage (abdominal distension, gastric retention, absent/delayed evacuation, minimal enteral feeding intolerance)
    - Rate of bladdr globus, defined as loss of spontaneous urination with enlarged bladder and need for catheterisation
    - Site and severity of cerebral lesions detected by cerebral MRI
    The analgesic effect of Fentanyl administration, by the application of validated algometric scales for chronic pain (EDIN – Echelle Douleur Inconfort Nouveau-Nè) and acute pain (PIPP- Premature Infant Pain Profile).
    Efficacy of analgesic therapy is evaluated by the registration of the average heart rate of newborn during hypothermia and the presence of tremors.
    To evaluate drug plasma concentrations in relation to the degree of disease (moderate – severe asphyxia)
    Per valutare la sicurezza del regime di Fentanil (carico di 1-2 mcg / Kg di Fentanil seguito da una infusione continua di Fentanil alla dose di 0,5-1 mcg / kg / h per TH e fase di riscaldamento) registrando l'effetto collaterale del farmaco:
    - Tasso di neonati ventilati meccanicamente durante il TH
    - Tasso di apnea e / o necessità di supporto respiratorio a partire dal TH
    - Necessità di rianimazione durante TH
    - Necessità di somministrazione di antagonisti degli oppioidi durante il TH
    - Incidenza di ipotensione durante il TH, definita come pressione sanguigna inferiore al 10 ° centile per età gestazionale ed età postnatale
    - Necessità di farmaci per il supporto cardiovascolare durante il TH
    - Tasso di passaggio intestinale ritardato (distensione addominale, ritenzione gastrica, evacuazione assente / ritardata, minima intolleranza all'alimentazione enterale)
    - Tasso di bladdr globus, definito come perdita di minzione spontanea con vescica allargata e necessità di cateterizzazione
    - Sito e gravità delle lesioni cerebrali rilevate dalla risonanza magnetica cerebrale
    Effetto analgesico della somministrazione di Fentanil, mediante l'applicazione di scale algometriche convalidate per il dolore cronico (EDIN - Echelle Douleur Inconfort Nouveau-Nè) e il dolore acuto (PIPP - Profilo del dolore infantile prematuro).
    Efficacia della terapia analgesica valutata dalla registrazione della frequenza cardiaca media del neonato durante l'ipotermia e dalla presenza di tremori.
    Valutare le concentrazioni plasmatiche del farmaco in relazione al grado di malattia (asfissia da moderata a grave)
    E.5.2.1Timepoint(s) of evaluation of this end point
    during TH
    Durante il trattamente ipotermico
    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 No
    E.6.5Efficacy No
    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) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    pharmacokinetics study
    studio di farmacocinetica
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    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 No
    E.8.2.4Number of treatment arms in the trial1
    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 Information not present in EudraCT
    E.8.7Trial has a data monitoring committee No
    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 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.1.1.1In 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: 5
    F.1.1.3Newborns (0-27 days) Yes
    F.1.1.3.1Number of subjects for this age range: 20
    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 No
    F.3.3.7Others Yes
    F.3.3.7.1Details of other specific vulnerable populations
    newborns with hypoxic ischemic encephalopathy
    Neonati con encefalopatia ipossico ischemica
    F.4 Planned number of subjects to be included
    F.4.1In the member state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 20
    F.4.2.2In the whole clinical trial 20
    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 best supportive therapy available
    la migliore terapia di supporto disponibile al momento
    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 Decision2021-01-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-09-22
    P. End of Trial
    P.End of Trial StatusOngoing
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