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    Summary
    EudraCT Number:2010-021228-89
    Sponsor's Protocol Code Number:CICO-10-01
    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:2012-03-05
    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 number2010-021228-89
    A.3Full title of the trial
    Effect of L-Thyroxine supplementation in the first weeks of life on long-term neurodevelopmental outcome in infants with transient hypothyroxinemia born at or less than 28 weeks’ gestation
    Supplementazione con L-Tiroxina nelle prime settimane di vita in neonati con ipotiroxinemia transitoria di eta' gestazionale uguale/inferiore 28 settimane: effetti sullo sviluppo neuropsichico a lungo termine
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effect of L-Thyroxine supplementation in the first weeks of life on long-term neurodevelopmental outcome in infants with transient hypothyroxinemia born at or less than 28 weeks’ gestation
    Supplementazione con L-Tiroxina nelle prime settimane di vita in neonati con ipotiroxinemia transitoria di eta' gestazionale uguale/inferiore 28 settimane: effetti sullo sviluppo neuropsichico a lungo termine
    A.3.2Name or abbreviated title of the trial where available
    CICO-10-01
    CICO-10-01
    A.4.1Sponsor's protocol code numberCICO-10-01
    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 OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI
    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 supportAIFA (bandi per la ricerca indipendente)
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAOU di Bologna, Policlinico S.Orsola
    B.5.2Functional name of contact pointU.O. Pediatria (Cicognani)
    B.5.3 Address:
    B.5.3.1Street AddressVia Massarenti 9
    B.5.3.2Town/ cityBologna
    B.5.3.3Post code40138
    B.5.3.4CountryItaly
    B.5.4Telephone number0516364814
    B.5.5Fax number051379900
    B.5.6E-mailalessandro.cicognani@unibo.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 No
    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 nameL-Tyroxin sodium
    D.3.2Product code NA
    D.3.4Pharmaceutical form Solution for injection
    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 INNLevothyroxine sodium
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    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.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 No
    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 nameL-Tyroxin sodium
    D.3.2Product code NA
    D.3.4Pharmaceutical form Oral suspension
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLevothyroxine sodium
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.3Concentration number25
    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 placeboOral suspension
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    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
    infants with transient hypothyroxinemia born at or less than 28 weeks’ gestation
    neonati con ipotiroxinemia transitoria di eta' gestionale uguale/inferiore 28 settimane
    E.1.1.1Medical condition in easily understood language
    infants with transient hypothyroxinemia born at or less than 28 weeks’ gestation
    neonati con ipotiroxinemia transitoria di eta' gestionale uguale/inferiore 28 settimane
    E.1.1.2Therapeutic area Diseases [C] - Hormonal diseases [C19]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10043816
    E.1.2Term Thyroxine decreased
    E.1.2System Organ Class 10022891 - Investigations
    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 with a randomized, placebo-controlled trial the efficacy of thyroxine supplementation in the first weeks of life in term of psychomotor development and mental outcome at 24 months of corrected age in preterm infants with gestational age at or less 28 weeks
    Valutare mediante studio randomizzato, controllato con placebo, l’efficacia della somministrazione di L-Tiroxina nelle prime settimane di vita sullo sviluppo psicomotorio e mentale all’eta' di 24 mesi di eta' gestazionale corretta in neonati pretermine di eta' gestazionale inferiore/uguale a 28 settimane
    E.2.2Secondary objectives of the trial
    1) to evaluate the safety/tolerability of the experimental treatment 2) to evaluate on the selected population the effects of the therapy on thyroid hormone levels, on mortality and morbidity , on psychomotor and mental developmental at 6 and 12 months of corrected age 3) to evaluate the possible influence of gestational age, initial level of fT4, gender, intercurrent illness and iatrogenic effects on the therapeutic effectiveness of L-thyroxine
    1) Valutare la sicurazza/tollerabilita' del trattamento sperimentale 2) Valutare nella popolazione selezionata gli effetti del trattamento sui livelli sierici di ormoni tiroidei, sulla morbilita' e mortalita' nel periodo dello studio e sullo sviluppo psicomotorio e mentale a 6 e 12 mesi di eta' gestazionale corretta 3) Valutare l’eventuale impatto dei fattori eta' gestazionale, livelli iniziali di f-T4, sesso, malattie intercorrenti ed effetti iatrogeni sull’efficacia terapeutica della L-Tiroxina
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) gestational age at or less 28 weeks 2) postnatal serum fT4 levels below a cutoff value of appropriate ranges of cord levels corrected to an equivalent gestational age and TSH values less than 10 mU/L 3) obtained signed informed consent
    1) EG ≤ 28 settimane 2) Livelli sierici postnatali di fT4 determinati tra 48 e 72 ore di vita inferiori ad una soglia appropriata per l’eta' gestazionale e livelli sierici di TSH &lt; 10 mU/L. 3) Consenso informato scritto ottenuto da entrambi i genitori o dal rappresentante legale del minore
    E.4Principal exclusion criteria
    1) known or suspected hyperergia to the drug 2) severe congenital malformations or clinical conditions that contraindicate the participation in the trial 3) known adrenal insufficiency 4) maternal thyroid disease or illicit-drug use by the mother
    1) Nota o sospetta ipersensibilita' al farmaco o alla classe farmacologica in studio 2) Gravi malformazioni congenite o gravi condizioni cliniche che, a giudizio dello sperimentatore, controindicano la partecipazione del paziente allo studio 3) Insufficienza surrenalica 4) Malattie tiroidee o uso di droghe nella madre
    E.5 End points
    E.5.1Primary end point(s)
    mental and psychomotor development scores (assessed by Griffiths Mental Developmental Scales) at the final assessment at 24 months of corrected age significantly better in thyroxine-treated infants than in placebo group.
    Gli scores dello sviluppo psicomotorio e mentale a 24 mesi di eta' gestazionale corretta (valutati mediante Griffiths Mental Developmental Scales) . Tali scorse devono risultare significativamente superiori nel gruppo di pazienti trattati con L-Tiroxina rispetto al gruppo di pazienti trattati con placebo
    E.5.1.1Timepoint(s) of evaluation of this end point
    pharmacological treatment 6 weeks, follow-up 2 years
    Trattamento farmacologico: massimo 6 settimane. Follow-up: 2 anni
    E.5.2Secondary end point(s)
    Na
    Na
    E.5.2.1Timepoint(s) of evaluation of this end point
    Na
    Na
    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 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) 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 No
    E.8.1.3Single blind Yes
    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 concerned7
    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 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
    Last patient last follow-up visit (24 mesi di follow-up dopo ultima somministrazione di tiroxina)
    Last patient last follow-up visit (24 mesi di follow-up dopo ultima somministrazione di tiroxina)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months60
    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 Yes
    F.1.1Number of subjects for this age range: 130
    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: 130
    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 No
    F.3.3.7Others Yes
    F.3.3.7.1Details of other specific vulnerable populations
    neonati di eta' gestionale inferiore / uguale 28 settimane
    neonati di eta' gestionale inferiore / uguale 28 settimane
    F.4 Planned number of subjects to be included
    F.4.1In the member state130
    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)
    eta' della popolazione: neonati di eta' gestionale inferiore / uguale 28 settimane
    eta' della popolazione: neonati di eta' gestionale inferiore / uguale 28 settimane
    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 Decision2011-04-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-03-15
    P. End of Trial
    P.End of Trial StatusOngoing
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