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    Summary
    EudraCT Number:2018-000572-15
    Sponsor's Protocol Code Number:GRASPANC2018-01
    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:2021-01-29
    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 number2018-000572-15
    A.3Full title of the trial
    A Randomized, Phase 3 Study of Eryaspase in Combination with Chemotherapy versus Chemotherapy Alone as Second-Line Treatment in Patients with Pancreatic Adenocarcinoma
    Studio randomizzato di fase 3 su Eryaspase in combinazione con chemioterapia rispetto alla sola chemioterapia come trattamento di seconda linea in pazienti affetti da adenocarcinoma pancreatico. TRYbeCA-1 – TRial of erYaspase in pancreatic CAncer (sperimentazione di eryaspase nel cancro del pancreas)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical study in subjects with pancreatic adenocarcinoma to assess safety and efficacy of investigational product (eryaspase) when added to standard chemotherapy
    Studio clinico in soggetti affetti da adenocarcinoma pancreatico per valutarela sicurezza e l'efficacia di un farmaco in studio (eryaspase) quando aggiunto alla chemioterapia standard
    A.3.2Name or abbreviated title of the trial where available
    TRYbeCA-1 – TRial of erYaspase in pancreatic CAncer
    TRYbeCA-1 – sperimentazione di eryaspase nel cancro del pancreas)
    A.4.1Sponsor's protocol code numberGRASPANC2018-01
    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 SponsorERYTECH PHARMA S.A.
    B.1.3.4CountryFrance
    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 supportERYTECH Pharma
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationERYTECH PHARMA SA
    B.5.2Functional name of contact pointIman El-Hariry
    B.5.3 Address:
    B.5.3.1Street AddressAVENUE ROCKEFELLER 60
    B.5.3.2Town/ cityLyon
    B.5.3.3Post code69008
    B.5.3.4CountryFrance
    B.5.4Telephone number0033478744438
    B.5.5Fax number0033478755629
    B.5.6E-mailvsemareg@erytech.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 numberEU/3/09/633
    D.3 Description of the IMP
    D.3.1Product nameEryaspase
    D.3.2Product code [0000]
    D.3.4Pharmaceutical form Solution for infusion
    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 INNL-ASPARAGINA MONOIDRATO
    D.3.9.2Current sponsor code0000
    D.3.9.4EV Substance CodeSUB181586
    D.3.10 Strength
    D.3.10.1Concentration unit kunit kilo units
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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
    Pancreatic Adenocarcinoma
    Adenocarcinoma pancreatico
    E.1.1.1Medical condition in easily understood language
    Pancreatic Adenocarcinoma
    Adenocarcinoma pancreatico
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10051971
    E.1.2Term Pancreatic adenocarcinoma
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to determine whether the addition of eryaspase to chemotherapy improves overall survival (OS) in secondline treatment of pancreatic adenocarcinoma compared to chemotherapy alone.
    Determinare se l'aggiunta di eryaspase alla chemioterapia migliori la sopravvivenza complessiva (OS, overall survival) nel trattamento di seconda linea dell'adenocarcinoma pancreatico rispetto alla sola chemioterapia.
    E.2.2Secondary objectives of the trial
    To compare (PFS) between the 2 treatment arms. - To compare the (ORR) and (DoR) between the 2 treatment arms. -To compare the (DCR) between the 2 treatment arms. -To evaluate the safety and tolerability of eryaspase in combination with chemotherapy versus chemotherapy alone. - To assess the effect of eryaspase on quality of life using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ C30). -To determine the pharmacokinetics of eryaspase. To assess the immunogenicity of eryaspase in terms of the induction of anti-asparaginase antibodies and neutralizing antibodies. SEE PROTOCOL COMPLETE LIST
    Confrontare la PFS tra i 2 bracci di tratt. - Confrontare l’ORR e la DoR tra i 2 gruppi di tratt. - Confrontare il tasso di controllo della malattia tra i 2 gruppi di tratt. - Valutare la sicurezza e la tollerabilità di eryaspase in comb. con chemioter rispetto alla sola chemioter -Valutare l’effetto di eryaspase sulla QOL utilizzando il questionario principale di mis. della qualità di vita redatto da (EORTC QLQ C30). -Stabilire la farmacocinetica di eryaspase. -Valutare l'immunogenicità di eryaspase in term di induzione di anticorpi anti-asparaginasi e di anticorpi neutralizzanti. PER LISTA COMPLETA FARE RIF AL PROTOCOLLO
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Must be 18 years of age or older.
    2.Must have histologically confirmed pancreatic adenocarcinoma.
    3.Must have Stage III or IV disease (see Appendix 1).
    4.Must have received only one line of systemic chemotherapy in advanced setting with or without targeted agents, immunotherapy, or radiotherapy
    for treatment of advanced pancreatic adenocarcinoma.
    5.Must have radiological evidence of disease progression following most recent prior treatment, defined as appearance of any new
    lesion or increase of >20% of one or more existing lesions.
    6.Must have measurable lesion(s) per RECIST version 1.1 by CT scan with contrast (or MRI, if the patient is allergic to CT contrast media).
    oMeasurable disease may be in the field of prior irradiation; however, at least 4 weeks must have elapsed between the completion of radiation therapy and the baseline scan documenting disease status.
    oBone disease is considered radiologically measurable only if there is at least a 50% lytic component.
    NOTE: Bone disease consisting of blastic lesion only is not measurable.
    7.Archival or fresh tumor tissue must be available for evaluating relevant biomarkers. Formalin-fixed paraffin-embedded [FFPE] block preferred, or a minimum of 10 unstained FFPE slides of one archived block is required. NOTE: cytology samples from fine
    needle aspirates or brushing biopsies are not sufficient.
    8.Must have adequate performance status (see Appendix 2 and 3):
    oECOG Performance Status (PS) score of 0, or
    oECOG PS score 1 and score =80 on Karnofsky Performance Status (KPS) scale.
    NOTE: Must have body mass index (BMI) =18.5 kg/m2 (obtained <14 days prior to randomization
    9.Must have life expectancy of >12 weeks according to the Investigator’s clinical judgment.
    10.Females of childbearing potential must have a negative pregnancy test at screening and additional pregnancy test prior to first dose. Males and females of childbearing potential must agree to use a highly effective method of contraception during treatment
    and for at least 6 months after the last dose of study treatment.These include, but not limited to:
    a. combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: i. intravaginal ii. transdermal
    b. progestogen-only hormonal contraception associated with inhibition of ovulation: i. injectable ii. implantable
    c. intrauterine device (IUD) d. bilateral tubal occlusion
    e. vasectomised partner f. sexual abstinence (defined as refraining from heterosexual intercourse
    during the entire period of risk associated with the study treatments) is intended. g. males with partners of childbearing potential must agree to use condoms
    NOTE: Since an indirect interaction between components of the oral contraceptives and ASNase cannot be ruled out, oral contraceptives are
    not considered acceptable as contraceptive methods in the current clinical trial. A method other than oral contraception should be used in women of childbearing potential. NOTE: All chemotherapeutic agents may be teratogenic and excreted in breast milk. Patients who are breast feeding should consider alternative
    methods. Please refer to protocol for complete list
    1. Deve aver compiuto i 18 anni di età.
    2. Deve presentare adenocarcinoma del pancreas confermato istologicamente.
    3. Deve presentare malattia di Stadio III o IV (vedere Appendice 1).
    4. Deve aver ricevuto una sola linea di chemioterapia sistemica in setting avanzato con o senza farmaci target, immunoterapia o radioterapia per il trattamento dell'adenocarcinoma pancreatico avanzato.
    5. Deve presentare evidenza radiologica di progressione della malattia dopo il trattamento precedente più recente, definita come la comparsa di qualsiasi nuova lesione o l'aumento di > 20% di una o più lesioni esistenti.
    6. Deve presentare lesione/i misurabile/i secondo RECIST versione 1.1 mediante TAC con mezzo di contrasto (o RMI, se il paziente è allergico al mezzo di contrasto della TAC).
    o La malattia misurabile può essere nel campo della precedente irradiazione; tuttavia, devono essere trascorse almeno 4 settimane tra il completamento della radioterapia e la scansione basale che documenta lo stato della malattia.
    o La malattia ossea è considerata misurabile radiologicamente solo se è presente almeno un 50% di componente litica.
    NOTA: la malattia ossea costituita solo da lesioni blastiche non è misurabile.
    7. Deve essere disponibile tessuto tumorale d'archivio o recente per la valutazione dei biomarcatori rilevanti. Sono richiesti preferibilmente una porzione fissata con formalina e inclusa in paraffina [FFPE] oppure almeno 10 vetrini FFPE non colorati di una porzione d'archivio. NOTA: non sono sufficienti i campioni citologici da agobiopsia o spazzolato.
    8. Deve presentare stato di performance adeguato (vedere Appendice 2 e 3):
    o Punteggio dello stato di performance (PS) ECOG pari a 0, o
    o Punteggio PS ECOG pari a 1 e punteggio = 80 sulla scala dello stato di performance di Karnofsky (KPS).
    NOTA: Deve avere un indice di massa corporea (BMI) = 18,5 kg/m 2 (ottenuto <14 giorni prima della randomizzazione)
    9. Deve avere un'aspettativa di vita di > 12 settimane secondo il giudizio clinico dello sperimentatore.
    10. Le donne in età fertile devono risultare negative al test di gravidanza eseguito allo
    screening a al test aggiuntivo negativo precedente la prima dose. I soggetti di sesso
    maschile e femminile in età fertile devono accettare di utilizzare un metodo
    contraccettivo altamente efficace durante il trattamento e per almeno 6 mesi dopo
    l'ultima dose di trattamento in studio. Questi comprendono, a titolo esemplificativo ma
    non esaustivo:
    a) contraccettivo ormonale combinato (contenente estrogeni e progestinici) associato
    a inibizione dell'ovulazione:
    i. intravaginale
    ii. transdermico
    b. contraccezione ormonale basata solo su progestinici, associata a inibizione
    dell'ovulazione:
    i. iniettabile
    ii. impiantabile
    c) dispositivo intrauterino (IUD)
    d) occlusione bilaterale delle tube
    e) partner vasectomizzato
    f) astinenza sessuale (definita come astensione da rapporti eterosessuali durante
    l'intero periodo di rischio associato ai trattamenti in studio). L'astinenza totale è
    accettabile quando ciò è in linea con lo stile di vita preferito e abituale del soggetto.
    [L'astinenza periodica (come i metodi del calendario, dell’ovulazione, sintotermico,
    post-ovulazione) e il coito interrotto non sono considerati metodi contraccettivi
    accettabili].
    g) I maschi con partner in età fertile devono accettare di usare il preservativo
    NOTA: poiché un'interazione indiretta tra componenti dei contraccettivi orali e
    asparaginasi non può essere esclusa, i contraccettivi orali non sono considerati
    accettabili come metodi contraccettivi nella sperimentazione clinica attuale. Le donne
    in età fertile devono utilizzare un metodo diverso dalla contraccezione orale.
    NOTA: tutti gli agenti chemioterapici possono essere teratogeni ed escreti nel latte
    materno. Le pazienti che allattano al seno dovranno prendere in considerazione
    metodi alternativi
    PER ELENCO COMPLETO FARE RIFERIMENTO AL PROTOCOLLO
    E.4Principal exclusion criteria
    1.Resectable or borderline resectable pancreatic adenocarcinom at the time of signing theinformed consent.
    2.Histology other than pancreatic adenocarcinoma (for example, but not inclusive: neuroendocrine, adenosquamous, etc.).
    3.More than 1 line of prior treatment in advanced or metastatic setting.
    4.Patient has experienced medically significant acute decline in clinical status including
    a.Decline in ECOG PS to >1 (or KPS <70) between baseline visit and within 72 hours prior to randomization.
    b.Weight loss of =10% during screening.
    5.Presence of active or symptomatic untreated central nervous system (CNS) metastases.
    NOTE: Patients with asymptomatic or stable CNS metastases are eligible, provided that the CNS metastases are radiologically and
    clinically stable, and the patient is off high dose steroid treatment for at least 1 month prior to randomization.
    6.Prior radiotherapy to the only area of measurable disease,
    NOTE: Patients must have completed treatment and recovered from all acute treatment-related toxicities prior to administration of
    the first dose of eryaspase or chemotherapy.
    7.Bone as the only site of metastatic disease from pancreatic cancer (bone-only disease).
    8.History of recent clinical pancreatitis, according to revised Atlanta criteria, within 3 months of randomization.
    NOTE: The revised Atlanta classification [1] requires that two or more of the following criteria be met for the diagnosis of acute pancreatitis: (a) abdominal pain suggestive of pancreatitis, (b) serum amylase or lipase level =3 x ULN, or (c) characteristic imaging findings using CT or MRI.
    9ase including symptomatic congestive
    1. Adenocarcinoma pancreatico resecabile o resecabile borderline al momento della firma del consenso informato
    2. Esame istologico con esito diverso da adenocarcinoma del pancreas (a titolo di esempio: neuroendocrino, adenosquamoso).
    3. Più di 1 precedente linea di trattamento nel contesto avanzato o metastatico.
    4. Il paziente ha manifestato un declino acuto dello stato clinico significativo sotto il profilo medico, tra cui
    a. Riduzione del PS ECOG a >1 (o KPS <70) tra la visita basale e le 72 ore precedenti la randomizzazione.
    b. Perdita di peso =10% durante lo screening.
    5. Presenza di metastasi del sistema nervoso centrale (SNC) non trattate attive o sintomatiche.
    NOTA: i pazienti con metastasi del SNC asintomatiche o stabili sono eleggibili, a condizione che le metastasi del SNC siano radiologicamente e clinicamente stabili e che il paziente non abbia assunto steroidi a dosaggio elevato per almeno 1 mese prima della randomizzazione.
    6. Precedente radioterapia localizzata alla sola area di malattia misurabile,
    NOTA: i pazienti devono avere completato il trattamento ed essersi ristabiliti da tutte le tossicità acute correlate al trattamento prima della somministrazione della prima dose di eryaspase o chemioterapia.
    7. Ossa come unica sede di malattia metastatica da cancro del pancreas (malattia limitata alle ossa).
    8. Anamnesi di pancreatite clinica recente, in base ai criteri di Atlanta rivisti, nei 3 mesi precedenti la randomizzazione.
    NOTA: la classificazione di Atlanta rivista [1] richiede che siano soddisfatti due o più dei seguenti criteri per la diagnosi di pancreatite acuta: (a) dolore addominale che suggerisce presenza di pancreatite, (b) livello di amilasi o lipasi nel siero =3 x ULN o (c) risultati caratteristici negli esami di imaging eseguiti mediante TAC o RMI.
    E.5 End points
    E.5.1Primary end point(s)
    to determine whether the addition of eryaspase to chemotherapy improves overall survival (OS) in secondline treatment of pancreatic adenocarcinoma compared to chemotherapy alone.
    Determinare se l'aggiunta di eryaspase alla chemioterapia migliori la sopravvivenza complessiva (OS, overall survival) nel trattamento di seconda linea dell'adenocarcinoma pancreatico rispetto alla sola chemioterapia.
    E.5.1.1Timepoint(s) of evaluation of this end point
    To be measured from the date of randomization to the date of death from any cause. Patients who are not known to have died will be censored at the date of last contact, and this will apply as of the date of data cut-off for any particular analysis.
    Da misurare a partire dalla data della randomizzazione fino alla data del decesso per qualsiasi causa. I pazienti dei quali non è noto il decesso saranno censurati alla data dell'ultima contatto, e ciò si applicherà a partire dalla data di cut-off dei dati per qualsiasi particolare analisi
    E.5.2Secondary end point(s)
    To compare progression-free survival (PFS) between the 2 treatment arms; To compare the objective response rate (ORR) and duration of response (DoR) between the 2 treatment arms.; To compare the disease control rate (DCR) between the 2 treatment arms; • To evaluate the safety and tolerability of eryaspase in combination with chemotherapy versus chemotherapy alone.; To assess the effect of eryaspase on quality of life using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC
    QLQ-C30).; To determine the pharmacokinetics of eryaspase.
    •Confrontare la sopravvivenza libera da progressione (PFS, progression-free survival) tra i 2 bracci di trattamento.; •Confrontare il tasso di risposta obiettiva (ORR, objective response rate) e la durata della risposta (DoR, duration of response) tra i 2 gruppi di trattamento.; Confrontare il tasso di controllo della malattia (DCR, disease control rate) tra i 2 gruppi di trattamento.; Valutare la sicurezza e la tollerabilità di eryaspase in combinazione con chemioterapia rispetto alla sola chemioterapia.; Valutare l’effetto di eryaspase sulla qualità di vita utilizzando il questionario principale di misurazione della qualità di vita redatto dall'Organizzazione europea per la ricerca e il trattamento del cancro (EORTC QLQ C30).; Determinare la farmacocinetica di eryaspase
    E.5.2.1Timepoint(s) of evaluation of this end point
    PFS will be compared between the 2 treatment arms using the same methods of analysis as for OS.; PFS will be compared between the 2 treatment arms using the same methods of analysis as for OS.; PFS will be compared between the 2 treatment arms using the same methods of analysis as for OS.; PFS will be compared between the 2 treatment arms using the same methods of analysis as for OS.; PFS will be compared between the 2 treatment arms using the same; PFS will be compared between the 2 treatment arms using the same
    La sopravvivenza libera da progressione (PFS) sarà confrontata tra i 2 bracci di trattamento con gli stessi metodi di analisi dell'OS.; La sopravvivenza libera da progressione (PFS) sarà confrontata tra i 2 bracci di trattamento con gli stessi metodi di analisi dell'OS; La sopravvivenza libera da progressione (PFS) sarà confrontata tra i 2 bracci di trattamento con gli stessi metodi di analisi dell'OS; La sopravvivenza libera da progressione (PFS) sarà confrontata tra i 2 bracci di trattamento con gli stessi metodi di analisi dell'OS; La sopravvivenza libera da progressione (PFS) sarà confrontata tra i 2 bracci di trattamento con gli stessi metodi di analisi dell'OS; La sopravvivenza libera da progressione (PFS) sarà confrontata tra i 2 bracci di trattamento con gli stessi metodi di analis
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    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 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
    nessuno
    no comparator
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA85
    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
    Austria
    Belgium
    Czechia
    Denmark
    Finland
    France
    Germany
    Netherlands
    Spain
    Sweden
    United Kingdom
    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
    Last PatientLast Visit
    Last PatientLast Visit
    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 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: 338
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 144
    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 Yes
    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 state49
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 416
    F.4.2.2In the whole clinical trial 482
    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
    nessuno
    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 Decision2018-11-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-09-20
    P. End of Trial
    P.End of Trial StatusOngoing
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