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    Summary
    EudraCT Number:2017-001996-21
    Sponsor's Protocol Code Number:LEPRE
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-09-09
    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 number2017-001996-21
    A.3Full title of the trial
    Randomized clinical trial to evaluate the effects of different timing of levothyroxine administration in the management of hypothyroid pregnant women suffering from nausea and/or vomiting.
    Studio clinico randomizzato per valutare gli effetti della somministrazione di levotiroxina softgel in diversi momenti della giornata nel trattamento di pazienti ipotiroidee gravide affette da nausea e/o vomito.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Softgel levothyroxine in the management of hypothyroid pregnant women suffering from nausea and/or vomiting. Randomized clinical trial.
    Terapia con levotiroxina softgel in gravide ipotiroidee con nausea/vomito. Studio clinico randomizzato.
    A.3.2Name or abbreviated title of the trial where available
    LEvothyroxine and PREgnancy study (LEPRE study)
    Studio LePre (Levotiroxina softgel in gravide ipotiroidee con nausea/vomito).
    A.4.1Sponsor's protocol code numberLEPRE
    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 SponsorA.O. OSPEDALE DI CIRCOLO E FONDAZIONE MACCHI
    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 supportFondi universitari
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationASST SETTE LAGHI - Ospedale di Circolo e Fondazione Macchi
    B.5.2Functional name of contact pointSegreteria Tecnico-Scientifica CE
    B.5.3 Address:
    B.5.3.1Street AddressViale Borri, 57
    B.5.3.2Town/ cityVarese
    B.5.3.3Post code21100
    B.5.3.4CountryItaly
    B.5.4Telephone number0332393056
    B.5.5Fax number0332393631
    B.5.6E-mailraffaella.cavi@asst-settelaghi.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 TICHE - "25 MICROGRAMMI CAPSULE MOLLI" 30 CAPSULE IN BLISTER PVC-PCTFE/AL
    D.2.1.1.2Name of the Marketing Authorisation holderIBSA FARMACEUTICI ITALIA S.R.L.
    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 nameTICHE
    D.3.4Pharmaceutical form Capsule, soft
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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.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 Yes
    D.2.1.1.1Trade name TICHE - "50 MICROGRAMMI CAPSULE MOLLI" 30 CAPSULE IN BLISTER PVC-PCTFE/AL
    D.2.1.1.2Name of the Marketing Authorisation holderIBSA FARMACEUTICI ITALIA S.R.L.
    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 nameTICHE
    D.3.4Pharmaceutical form Capsule, soft
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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.IMP: 3
    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 TICHE - "75 MICROGRAMMI CAPSULE MOLLI" 30 CAPSULE IN BLISTER PVC-PCTFE/AL
    D.2.1.1.2Name of the Marketing Authorisation holderIBSA FARMACEUTICI ITALIA S.R.L.
    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 nameTICHE
    D.3.4Pharmaceutical form Capsule, soft
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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.IMP: 4
    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 TICHE - "100 MICROGRAMMI CAPSULE MOLLI" 30 CAPSULE IN BLISTER PVC-PCTFE/AL
    D.2.1.1.2Name of the Marketing Authorisation holderIBSA FARMACEUTICI ITALIA S.R.L.
    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 nameTICHE
    D.3.4Pharmaceutical form Capsule, soft
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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.IMP: 5
    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 TICHE - "125 MICROGRAMMI CAPSULE MOLLI" 30 CAPSULE IN BLISTER PVC-PCTFE/AL
    D.2.1.1.2Name of the Marketing Authorisation holderIBSA FARMACEUTICI ITALIA S.R.L.
    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 nameTICHE
    D.3.4Pharmaceutical form Capsule, soft
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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
    SUBCLINICAL HYPOTHYROIDISM DURING PREGNANCY
    IPOTIROIDISMO SUBCLINICO IN GRAVIDANZA
    E.1.1.1Medical condition in easily understood language
    SUBCLINICAL HYPOTHYROIDISM DURING PREGNANCY
    IPOTIROIDISMO SUBCLINICO IN GRAVIDANZA
    E.1.1.2Therapeutic area Diseases [C] - Hormonal diseases [C19]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10000560
    E.1.2Term Acquired hypothyroidism other
    E.1.2System Organ Class 100000004860
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Dosage of Tiche necessary to obtain the therapeutic target (TSH < 2.5 mcU/ml) at the eight month of pregnancy in the treatment group.
    Valutazione della dose di Tiche necessaria al raggiungimento del target terapeutico (TSH < 2.5 mcU/ml) all’ottavo mese di gestazione nel gruppo di trattamento.
    E.2.2Secondary objectives of the trial
    - Dosage of Tiche necessary to obtain the therapeutic target (TSH < 2.5 mcU/ml) at the fifth month of pregnancy in the treatment group.
    - Evaluation of perceived quality of life during pregnancy.
    - Valutazione della dose di Tiche necessaria al raggiungimento del target terapeutico (TSH < 2.5 mcU/ml) al quinto mese di gestazione nel gruppo di trattamento.
    - Valutazione dello stato di salute generale al progredire della gravidanza.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Adult pregnant women (> 18 years)
    • First trimester of pregnancy
    • Subclinical hypothyroidism diagnosed during pregnancy; autoimmune, or in absence of thyroidal autoimmunity; treated with levothyroxine, or not treated
    • Subclinical hypothyroidism diagnosed before pregnancy; autoimmune, or in absence of thyroidal autoimmunity; treated with levothyroxine, or not treated
    • Nausea/vomiting of the pregnancy (mild to moderate)
    • Signed informed consent
    • Pazienti di sesso femminile di età maggiore di 18 anni
    • Al 1° trimestre di gravidanza
    • Affette da ipotiroidismo primitivo subclinico diagnosticato in gravidanza; tale diagnosi sarà basata su una recente valutazione funzionale tiroidea (massimo 45 giorni prima), in accordo con i criteri indicati nelle recenti linee guida
    o ad eziologia autoimmune
    o in assenza di autoimmunità tiroidea
    o in terapia sostitutiva con levotiroxina in qualsiasi formulazione disponibile in commercio
    o non trattate
    • Affette da ipotiroidismo primitivo già noto in epoca pre-concezionale, ad eziologia autoimmune o in assenza di autoimmunità tiroidea, in terapia sostitutiva con levotiroxina in qualsiasi formulazione disponibile in commercio
    • Nausea e/o vomito in gravidanza di intensità lieve-moderata, valutato mediante PUQE Score
    • Consenso informato scritto
    E.4Principal exclusion criteria
    • Intolerance to levothyroxine or to any Tiche excipient
    • Inability to swallow
    • Pregnancy developed by medically assisted procreation
    • Twin pregnancy
    • Premature aberrations of the fetal growht (first trimester)
    • Patients with post-surgical primitive hypothyroidism (due to total thyroidectomy)
    • Patients with post-131I radiotherapy primitive hypothyroidism
    • Patients pre-gestationally affected by: severe obesity (BMI > 40 kg/m2), diabetes, heart diseases, chronic atrophic gastritis, celiac disease, inflammatory bowel diseases
    • Concomitant treatments not allowed
    • Patients that underwent gastro-intestinal surgery with malabsorption
    • Inability to give an informed consent
    • Intolleranza al principio attivo o ad uno qualsiasi degli eccipienti contenuti in Tiche
    • Incapacità a deglutire una capsula molle intera
    • Gravidanza ottenuta mediante tecniche di PMA
    • Gravidanze gemellari
    • Anomalie precoci della crescita fetale (al 1° trimestre)
    • Pazienti con ipotiroidismo primitivo post-chirurgico (secondario ad intervento di tiroidectomia totale)
    • Pazienti con ipotiroidismo primitivo post-terapia radiometabolica con 131I
    • Pazienti affette in epoca pre-concezionale da: obesità severa (BMI > 40 kg/m2), diabete mellito, cardiopatia ischemica, aritmie cardiache, miocardiopatia, gastrite cronica atrofica, celiachia, malattie infiammatorie intestinali
    • Trattamenti concomitanti non consentiti
    • Pregressi interventi di chirurgia gastro-intestinale che possano aver prodotto una condizione malassorbitiva
    • Incapacità di acconsentire a partecipare allo studio
    E.5 End points
    E.5.1Primary end point(s)
    Dosage of Tiche (mcg/kg/die) in the treatment group, versus dosage of Tiche (mcg/kg/die) in the control group necessary to obtain the therapeutic target at the eight month of pregnancy.
    Dose media per kilo di peso corporeo (mcg/kg/die) di Tiche nel gruppo di trattamento, versus dose media per kilo di peso corporeo (mcg/kg/die) di Tiche nel gruppo di controllo necessaria al raggiungimento del target terapeutico all’ottavo mese di gestazione.
    E.5.1.1Timepoint(s) of evaluation of this end point
    8th month of pregnancy
    8° mese di gestazione
    E.5.2Secondary end point(s)
    Dosage of Tiche (mcg/kg/die) in the treatment group, versus dosage of Tiche (mcg/kg/die) in the control group necessary to obtain the therapeutic target at the fifth month of pregnancy.; Percentage of patients with improved QoL in the treatment group.
    Dose media per kilo di peso corporeo (mcg/kg/die) di Tiche nel gruppo di trattamento, versus dose media per kilo di peso corporeo (mcg/kg/die) di Tiche nel gruppo di controllo necessaria al raggiungimento del target terapeutico al quinto mese di gestazione. ; Percentuale di pazienti con miglioramento della QoL, mediante questionario SF-36, nel gruppo di trattamento rispetto al gruppo di controllo, al quinto e all’ottavo mese di gravidanza.
    E.5.2.1Timepoint(s) of evaluation of this end point
    5th month of pregnancy; 5th and 8th month of pregnancy
    5° mese di gestazione; 5° e 8° mese di gestazione
    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 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 Yes
    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 Yes
    E.8.2.3.1Comparator description
    Stesso farmaco, diverso orario di somministrazione
    Same drug, different timing of administration
    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.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States No
    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 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 months24
    E.8.9.1In the Member State concerned days71
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months24
    E.8.9.2In all countries concerned by the trial days71
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    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) 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) Yes
    F.1.2.1Number of subjects for this age range: 70
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 Yes
    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 No
    F.4 Planned number of subjects to be included
    F.4.1In the member state70
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 70
    F.4.2.2In the whole clinical trial 70
    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)
    All patients will continue to be followed up by the attending physicians according to local practice and therapeutic decisions will be left to the discretion of the attending clinician
    Le pazienti continueranno ad essere seguite dai medici responsabili del centro partecipante secondo normale pratica clinica e ogni successiva decisione terapeutica sarà lasciata allo stesso medico di riferimento.
    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 Decision2018-02-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial StatusCompleted
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    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.

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