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    Summary
    EudraCT Number:2018-000231-27
    Sponsor's Protocol Code Number:NN8640-4263
    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:2021-07-30
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2018-000231-27
    A.3Full title of the trial
    A trial comparing the effect and safety of once weekly dosing of somapacitan with daily Norditropin® in children with growth hormone deficiency
    Studio clinico di efficacia e sicurezza di somapacitan somministrato una volta a settimana in confronto a Norditropin® somministrato una volta al giorno nei bambini con deficit dell’ormone della crescita.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A research study in children with a low level of hormone to grow. Treatment is somapacitan once a week compared to Norditropin® once a day
    Studio clinico nei bambini con un basso livello di ormone della crescita. Confronto di somapacitan una volta a settimana rispetto a somatropin una volta al giorno.
    A.3.2Name or abbreviated title of the trial where available
    REAL4
    REAL4
    A.4.1Sponsor's protocol code numberNN8640-4263
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1207-9691
    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 SponsorNOVO NORDISK. S.P.A.
    B.1.3.4CountryItaly
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportNovo Nordisk A/S
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovo Nordisk A/S
    B.5.2Functional name of contact pointClinical Disclosure (1452)
    B.5.3 Address:
    B.5.3.1Street AddressNovo Allé
    B.5.3.2Town/ cityBagsværd
    B.5.3.3Post code2880
    B.5.3.4CountryDenmark
    B.5.6E-mailclinicaltrials@novonordisk.com
    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 Yes
    D.2.5.1Orphan drug designation numberEMA/OD/041/18
    D.3 Description of the IMP
    D.3.1Product namesomapacitan 5 mg/1.5ml PDS290
    D.3.2Product code [NN8640]
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNsomapacitan
    D.3.9.1CAS number 1338578-34-9
    D.3.9.2Current sponsor codeN/A
    D.3.9.3Other descriptive nameSOMAPACITAN
    D.3.9.4EV Substance CodeSUB186254
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number3
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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 Yes
    D.2.5.1Orphan drug designation numberEMA/OD/041/18
    D.3 Description of the IMP
    D.3.1Product namesomapacitan 10 mg/1.5ml PDS290S
    D.3.2Product code [NN8640]
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSomapacitan
    D.3.9.1CAS number 1338578-34-9
    D.3.9.2Current sponsor codeN/A
    D.3.9.3Other descriptive nameSOMAPACITAN
    D.3.9.4EV Substance CodeSUB186254
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number6
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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 No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEMA/OD/041/18
    D.3 Description of the IMP
    D.3.1Product namesomapacitan 15 mg/1.5ml PDS290
    D.3.2Product code [NN8640]
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNsomapacitan
    D.3.9.1CAS number 1338578-34-9
    D.3.9.2Current sponsor codeN/A
    D.3.9.3Other descriptive nameSOMAPACITAN
    D.3.9.4EV Substance CodeSUB186254
    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 No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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 RoleComparator
    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.2.1.1.1Trade name Norditropin FlexPro 10 mg/1.5 ml
    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 nameNorditropin FlexPro 10 mg/1.5 ml
    D.3.2Product code [N/A]
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNsomatropin
    D.3.9.1CAS number 12629-01-5
    D.3.9.2Current sponsor codeN/A
    D.3.9.3Other descriptive namesomatropin
    D.3.9.4EV Substance CodeSUB10584MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number6
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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
    Growth hormone deficiency in children
    Deficit di ormone della crescita nei bambini
    E.1.1.1Medical condition in easily understood language
    Growth hormone deficiency in children
    Deficit di ormone della crescita nei bambini
    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 PT
    E.1.2Classification code 10056438
    E.1.2Term Growth hormone deficiency
    E.1.2System Organ Class 10014698 - Endocrine disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the effect of somapacitan vs Norditropin® on longitudinal growth in children with growth hormone deficiency.
    Confrontare l’effetto di somapacitan rispetto a Norditropin® sulla crescita longitudinale nei bambini con un deficit di ormone della crescita.
    E.2.2Secondary objectives of the trial
    To compare the safety of somapacitan vs Norditropin® in children with growth hormone deficiency.
    Confrontare la sicurezza di somapacitan rispetto a Norditropin® nei bambini con deficit di ormone della crescita.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Prepubertal children:
    - Boys:
    - Age greater than or equal to 2 years and 26 weeks and less than 11.0 years at screening
    - Testis volume less than 4 mL
    - Girls:
    - Age greater than or equal to 2 years and 26 weeks and less than 10.0 years at screening
    - Tanner stage 1 for breast development (no palpable glandular breast tissue)
    - Confirmed diagnosis of growth hormone deficiency determined by two different growth hormone stimulation tests performed within 12 months prior to randomisation, defined as a peak growth hormone level of less than or equal to 10.0 ng/mL using the world health organisation (WHO) International Somatropin 98/574 standard
    - Impaired height defined as at least 2.0 standard deviations below the mean height for chronological age and gender at screening according to the standards of Center for Disease Control and Prevention
    - Impaired height velocity, defined as annualised height velocity below the 25th percentile for chronological age and gender according to the standards of Prader calculated over a time span of minimum 6 months and maximum 18 months prior to screening
    - Insulin-like Growth Factor-I (IGF-I) less than -1.0 Standard Deviation Score at screening, compared to age and gender normalized range measured at central laboratory
    - No prior exposure to growth hormone therapy or Insulin-like Growth Factor-I treatment
    -Bambini in età prepuberale:
    a) Maschi:
    • Età = 2 anni e 26 settimane e < 11,0 anni allo screening
    • Volume testicolo < 4 ml.
    b) Femmine:
    • Età = 2 anni e 26 settimane e < 10,0 anni allo screening
    • Fase 1 di Tanner per lo sviluppo del seno (nessun tessuto mammario ghiandolare palpabile)

    - Diagnosi confermata di deficit dell’ormone della crescita determinato da due diversi test di stimolazione dell’ormone della crescita effettuati nei 12 mesi prima della randomizzazione, definito come un picco di ormone della crescita di = 10,0 ng/ml utilizzando lo Standard internazionale per la somatropina 98/574 dell’OMS (Organizzazione Mondiale della Sanità)

    -Altezza insufficiente definita come almeno 2.0 deviazioni standard al di sotto dell’altezza media per età cronologica e sesso allo screening secondo gli standard del Center for Disease Control and Prevention

    -Velocità di crescita ridotta, definita come velocità di crescita annualizzata inferiore al 25° percentile per età e sesso cronologici secondo gli standard Prader calcolati su un periodo di tempo minimo di 6 mesi e massimo di 18 mesi prima dello screening

    - Nessuna precedente esposizione alla terapia con ormone della crescita o trattamento con IGF-I

    - IGF-I < -1.0 SDS allo screening, confrontato con l’intervallo normalizzato di età e genere misurato presso il laboratorio centrale
    E.4Principal exclusion criteria
    - Any known or suspected clinically significant abnormality likely to affect growth or the ability to evaluate growth with standing height measurements
    - Current inflammatory diseases requiring systemic corticosteroid treatment for longer than 2 consecutive weeks within the last 3 months prior to screening
    - Children requiring inhaled glucocorticoid therapy at a dose of greater than 400 µg/day of inhaled budesonide or equivalents for longer than 4 consecutive weeks within the last 12 months prior to screening
    - Diagnosis of attention deficit hyperactivity disorder
    - Concomitant administration of other treatments that may have an effect on growth, e.g., but not limited to methylphenidate for treatment of attention deficit hyperactivity disorder
    - Prior history or presence of malignancy including intracranial tumours
    - Ipersensibilità nota o sospetta al/ai prodotto/i sperimentale/i o ai prodotti correlati

    -Somministrazione di qualsiasi medicinale sperimentale nei 3 mesi precedenti lo screening oppure alla partecipazione ad un’altra sperimentazione clinica al momento della randomizzazione

    - Qualsiasi anomalia clinicamente significativa nota o sospetta che possa influire sulla crescita o sulla capacità di valutare la crescita con misurazioni dell’altezza in piedi:

    - Malattie infiammatorie che hanno richiesto un trattamento sistemico con corticosteroidi per più di 2 settimane consecutive negli ultimi 3 mesi precedenti allo screening

    -Bambini che hanno avuto bisogno di una terapia con glucocorticoidi per via inalatoria ad una dose superiore a 400 µg/die di budesonide o equivalenti per via inalatoria per più di 4 settimane consecutive nei 12 mesi precedenti allo screening

    -Somministrazione concomitante di altri trattamenti che possono avere un effetto sulla crescita, quali, a titolo esemplificativo ma non esaustivo, metilfenidato per il trattamento del disturbo da deficit di attenzione e iperattività (Attention Deficit Hyperactivity Disorder, ADHD)

    - Diagnosi di disturbo da deficit di attenzione e iperattività

    - Anamnesi pregressa o presenza di tumori maligni inclusi i tumori intracranici
    E.5 End points
    E.5.1Primary end point(s)
    Height velocity
    Velocità di crescita
    E.5.1.1Timepoint(s) of evaluation of this end point
    From baseline (week 0) to visit 7 (week 52)
    Dalla visita basale (settimana 0) alla visita 7 (settimana 52)
    E.5.2Secondary end point(s)
    1. Change in bone age
    2. Change in Height Standard Deviation Score
    3. Height Velocity Standard Deviation Score
    4. Change in fasting plasma glucose
    5. Change in homeostatic model assessment
    6. Change in Glycated haemoglobin (HbA1c)
    7. Change in Insulin-like growth factor I (IGF-I) Standard Deviation Score
    8. Change in Insulin-like growth factor binding protein 3 (IGFBP-3) Standard Deviation Score
    1. Cambiamento dell'età ossea
    2. Modifica del punteggio di deviazione standard dell'altezza
    3. Punteggio di deviazione standard della velocità in altezza
    4. Variazione del glucosio plasmatico a digiuno
    5. Modifica della valutazione del modello omeostatico
    6. Modifica dell'emoglobina glicata (HbA1c)
    7. Modifica del punteggio di deviazione standard del fattore di crescita I (IGF-I) insulino-simile
    8. Modifica del punteggio di deviazione standard del fattore di crescita insulino-simile 3 (IGFBP-3)
    E.5.2.1Timepoint(s) of evaluation of this end point
    1 & 4 – 6: From screening (week -2) to visit 7 (week 52), visit 11 (week 104), visit 15 (week 156) and visit 19 (week 208)
    2, 3, 7 & 8: From baseline (week 0) to visit 7 (week 52), visit 11 (week 104), visit 15 (week 156) and visit 19 (week 208)
    1 & 4 – 6: Dallo screening (settimana -2) alla visita 7 (settimana 52), visita 11 (settimana 104), visita 15 (settimana 156) e visita 19 (settimana 208)
    2, 3, 7 & 8: Dalla visita basale ((settimana 0) alla visita 7 (settimana 52), visita 11 (settimana 104), visita 15 (settimana 156) e visita 19 (settimana 208)
    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) 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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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) Yes
    E.8.2.2Placebo No
    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 EEA29
    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
    Algeria
    Canada
    India
    Israel
    Japan
    Korea, Republic of
    Russian Federation
    Switzerland
    Thailand
    Ukraine
    United States
    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
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days15
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months1
    E.8.9.2In all countries concerned by the trial days15
    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) 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) Yes
    F.1.1.5.1Number of subjects for this age range: 8
    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 No
    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 No
    F.4 Planned number of subjects to be included
    F.4.1In the member state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 50
    F.4.2.2In the whole clinical trial 192
    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)
    None
    Nessuna
    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 Decision2019-04-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-04-02
    P. End of Trial
    P.End of Trial StatusOngoing
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