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    Summary
    EudraCT Number:2014-003326-41
    Sponsor's Protocol Code Number:200719
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2018-02-28
    Trial results View 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 number2014-003326-41
    A.3Full title of the trial
    Randomized, Double-Blind, Multicenter, Phase III Study Comparing the Efficacy and Safety of Retosiban Versus Placebo for Women in Spontaneous Preterm Labor
    Studio di fase III, multicentrico, randomizzato, in doppio cieco, per confrontare l’efficacia e la sicurezza di retosiban versus placebo nelle donne con travaglio pretermine spontaneo
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase III study where the treatment groups are assigned by chance and neither the patient or the study doctor know which treatment the patient will receive that will take place in many sites and will compare the efficacy of Retosiban with placebo in stopping spontaneous preterm labor and prolonging labor
    Studio di fase III in cui i gruppi di trattamento sono assegnati per caso e né il paziente o il medico dello studio sa quale trattamento il paziente riceverà che si svolgerà in molti centri e metterà a confronto l'efficacia di Retosiban con placebo nell'interruzione del travaglio pretermine spontaneo e nel prolungamento del travaglio
    A.3.2Name or abbreviated title of the trial where available
    NEWBORN-1
    NEWBORN-1
    A.4.1Sponsor's protocol code number200719
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN00000000
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00000000
    A.5.3WHO Universal Trial Reference Number (UTRN)U1234-1234-1234
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/194/2015
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorGLAXOSMITHKLINE RESEARCH AND DEVELOPMENT
    B.1.3.4CountryUnited Kingdom
    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 supportGlaxoSmithKline Research & Development Limited
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGlaxoSmithKline Research & Development Limited
    B.5.2Functional name of contact pointRobert Stocken
    B.5.3 Address:
    B.5.3.1Street AddressStockley Park West, 1-3 Ironbridge Road
    B.5.3.2Town/ cityUxbridge, Middlesex
    B.5.3.3Post codeUB11 1BT
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+4400208 990 3879
    B.5.5Fax number+4400208 990 3511
    B.5.6E-mailrobert.c.stocken@gsk.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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameRetosiban
    D.3.2Product code GSK221149
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRetosiban
    D.3.9.1CAS number 820957-38-8
    D.3.9.2Current sponsor codeGSK221149A
    D.3.9.3Other descriptive nameGSK 221149A
    D.3.9.4EV Substance CodeSUB29510
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Preterm Labour
    Travaglio pretermine
    E.1.1.1Medical condition in easily understood language
    retosiban stops premature births and extends pregnancy in women that are at risk of premature birth of an infant
    Retosiban arresta le nascite premature e prolunga la gravidanza in donne che sono a rischio di parto pretermine del loro bambino
    E.1.1.2Therapeutic area Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10036600
    E.1.2Term Premature labour
    E.1.2System Organ Class 10036585 - Pregnancy, puerperium and perinatal conditions
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate the superiority of retosiban to prolong pregnancy and improve neonatal outcomes compared with placebo
    Dimostrare la superiorità di retosiban nel prolungare la gravidanza e migliorare gli esiti neonatali rispetto al placebo
    E.2.2Secondary objectives of the trial
    To describe the maternal, fetal, and neonatal safety profile during and after intravenous (IV) retosiban treatment compared with placebo

    To determine the effect of retosiban treatment compared with placebo on health care resource use for the maternal and neonatal hospitalizations

    To obtain further data on the pharmacokinetics of retosiban in pregnant women, including the effect of covariates such as age, weight, race/ethnicity, and GA on retosiban clearance and volume of distribution
    Descrivere il profilo di sicurezza materno, fetale e neonatale durante e dopo il trattamento con retosiban per via endovenosa (IV) rispetto al placebo
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subject will be eligible for inclusion in this study only if all of the following criteria apply:
    1. Signed and dated written informed consent is required prior to a subject’s participation in the study and the performance of any protocol-specific procedures.
    Subjects will also be asked to sign a release for medical records at the time of consenting to allow access to both the maternal and neonatal records including information about delivery and infant care as well as information collected prior to the consent having been signed NOTE: Prescreening alone does not necessarily require consent as this activity may be accomplished in the absence of study-specific procedures or assessments. In many cases, standard care and standard medical triage will provide sufficient information or evidence as to whether or not the subject is eligible for the study
    2. Females aged 18 to 45 years, with an uncomplicated, singleton pregnancy and intact membranes in preterm (NOTE: Since local laws, customs, and institutional practice vary globally, investigator discretion in the enrollment of pediatric subjects is permitted)
    3. Gestational age between 240/7 and 336/7 weeks as determined by (1) known fertilization date, either in vitro fertilization or intrauterine insemination, (2) last menstrual period confirmed by the earliest ultrasound prior to 240/7 weeks gestation,
    or (3) the earliest ultrasound alone prior to 240/7 weeks gestation, whichever is the most accurate method available for each subject. In situations where prenatal ultrasound records are not available at the time the subject presents, the investigator will make every effort to obtain these records (either via computer records, directly from the subject’s primary care obstetrician, or via telephone). However, in cases in which these records are not readily available (e.g., off hours, holiday), it is within the investigator’s discretion to use GA based on a verbal history from the subject with the intent of getting confirmation from the medical records as soon as possible
    4. Females must be diagnosed with preterm labor according to both of the following criteria:
    a. Regular uterine contractions at a rate of ≥4 contractions of at least 30 seconds’ duration during a 30-minute interval confirmed by tocodynamometry
    AND at least 1 of the following:
    b. Cervical dilation ≥2 cm and ≤4 cm by digital cervical examination OR
    c. If <2 cm dilation by digital cervical examination, a cervical change consisting of an increase of at least 25% effacement or 1-cm dilation
    5. Current or past tocolytic treatment as follows:
    a. Subjects in whom tocolytic treatment has not been initiated prior to consent are eligible for the study
    b. Transferred or referred subjects for whom parenteral magnesium sulfate treatment has been started before Screening are eligible provided they meet all eligibility criteria
    c. Subjects receiving a prohibited tocolytic in this study are eligible only if the treatment is stopped before randomization and provided they meet all eligibility criteria
    d. Subjects with a historical failure of a tocolytic treatment in a previous episode of preterm labor during the current pregnancy are eligible provided they meet all eligibility criteria
    Un soggetto sarà eleggibile all’inclusione in questo studio solo se soddisfa tutti i criteri seguenti:
    1. Il consenso informato scritto datato e firmato è necessario prima della partecipazione allo studio da parte del soggetto e prima che venga eseguita qualsiasi procedura specifica indicata nel protocollo. Alle pazienti verrà inoltre chiesto di firmare un modulo per il rilascio di documentazione medica nel momento in cui acconsentono ad autorizzare l'accesso alle cartelle cliniche materne e del neonato, incluse le informazioni relative al parto e alla cura del bambino nonché alle informazioni raccolte prima della firma del consenso
    NOTA: Il pre-screening da solo non richiede necessariamente il consenso poiché questa attività può essere completata in assenza di procedure o valutazioni specifiche dello studio. In molti casi, le cure standard e il triage medico standard forniscono le informazioni o le prove necessarie per determinare se il soggetto è idoneo per lo studio oppure no
    2. Le donne di età compresa tra i 18 e i 45 anni, con gravidanza singola non complicata e membrane intatte in travaglio pretermine (NOTA: dal momento che le leggi, gli usi e la prassi istituzionale locali variano a livello internazionale, è consentito l'arruolamento di pazienti in età pediatrica a discrezione degli sperimentatori)
    3. Età gestazionale dalla 240/7 alla 336/7 settimana determinata da (1) data di fecondazione nota, fecondazione in vitro o inseminazione intrauterina, (2) ultimo ciclo mestruale confermato dalla prima ecografia eseguita prima della settimana 240/7 di gestazione, o (3) la sola prima ecografia eseguita prima della settimana 240/7 di gestazione, a seconda di quale sia il metodo di valutazione più accurato disponibile per ciascun soggetto. Nelle situazioni in cui le cartelle dell'ecografia prenatale non sono disponibili nel momento in cui la paziente si presenta, lo sperimentatore profonderà tutti gli sforzi possibili per ottenere queste cartelle (attraverso i dati in formato elettronico ottenuti direttamente dall'ostetrico della paziente o per via telefonica). Tuttavia, nei casi in cui le cartelle non siano subito disponibili (es. ore di pausa, vacanze), è a discrezione dello sperimentatore l'uso della GA basata sulla storia verbale della paziente con l'intento di ricevere conferma dalle cartelle cliniche il prima possibile
    4. Alle pazienti deve essere diagnosticato un travaglio pretermine secondo entrambi i criteri seguenti:
    a. Contrazioni uterine regolari con una frequenza di ≥4 contrazioni della durata di almeno 30 secondi durante un intervallo di 30 minuti confermato da tocodinamometro
    E almeno uno dei seguenti:
    b. Dilatazione cervicale ≥2 cm e ≤4 cm secondo l'esame digitale della cervice OPPURE
    c. Se la dilatazione è <2 cm secondo l'esame digitale della cervice, un cambiamento della cervice consistente in un aumento della maturazione almeno del 25% o 1 cm di dilatazione
    5. Trattamento tocolitico attuale o pregresso, come di seguito descritto:
    a. Le pazienti per le quali non è stato avviato un trattamento tocolitico prima del consenso sono eleggibili per lo studio
    b. Le pazienti trasferite o inviate a consulto per le quali è stato avviato un trattamento con solfato di magnesio per via parenterale prima dello Screening sono eleggibili a condizione che soddisfino tutti i criteri di eleggibilità
    c. Le pazienti che ricevono un tocolitico vietato in questo studio sono eleggibili solo se il trattamento viene interrotto prima della randomizzazione e a condizione che soddisfino tutti i criteri di eleggibilità
    d. Le pazienti con una storia di insuccesso di un trattamento tocolitico in un precedente episodio di travaglio pretermine durante la gravidanza attuale sono eleggibili a condizione che soddisfino tutti i criteri di eleggibilità
    E.4Principal exclusion criteria
    A subject will not be eligible for inclusion in this study if any of the following criteria
    apply:
    1. Fever with a temperature >100.4°F (38°C) for more than 1 hour or ≥101°F (38.3°C) in the 24 hours prior to the start of study treatment
    2. Women with maternal-fetal conditions that potentially necessitate the need for delivery, such as pre-eclampsia or fetal compromise
    3. A fetus with any diagnosis, condition, treatment, or other factor that in the opinion of the investigator has the potential to affect or confound assessments of efficacy or safety (e.g., nonreassuring fetal status, intrauterine growth restriction, major
    congenital anomaly)
    4. Preterm premature rupture of membranes
    5. Women with any confirmed or suspected contraindication to prolongation of pregnancy, such as placental abruption, chorioamnionitis, or placenta previa
    6. Evidence of polyhydramnios (amniotic fluid index [AFI] >25 cm) or oligohydramnios (AFI <5 cm) investigator have the potential to complicate the pregnancy course and outcomes, such as uncontrolled hypertension or uncontrolled diabetes (if known, history of glycosylated hemoglobin >8% at any time during pregnancy), or compromise the safety of the subject, such as underlying cardiovascular disorder (specifically ischemic cardiac disease, congenital heart disease, pulmonary hypertension, valvular heart disease, arrhythmias, and (cardiomyopathy)
    8. Women with a history of substance abuse during the pregnancy or urine drug screen positive for cocaine, phencyclidine (PCP), methamphetamine, or amphetamine
    9. Women in whom the combination of history and screening test results is suggestive of abuse or dependency that may have the potential to complicate the pregnancy outcome. NOTE: Exclusion of a subject with a positive findings for substances other than cocaine, PCP, methamphetamine, or amphetamine is at the investigator’s discretion (examples include alcohol, cannabinoids, and opiates)
    10. Women with any diagnosis, condition, treatment, or other factor that, in the opinion of the investigator, has the potential to affect or confound assessments of efficacy or safety
    11. Current active liver or biliary disease (with the exception of Gilbert’s syndrome or asymptomatic gallstones or otherwise stable chronic liver disease per investigator assessment)
    NOTES:
    Stable chronic liver disease should generally be defined by the absence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice, or cirrhosis
    Chronic stable hepatitis B and C (e.g., presence of hepatitis B surface antigen (or positive hepatitis C antibody test result at Screening or within 3 months prior to first dose of study treatment) are acceptable if subject otherwise meets entry criteria
    12. History of sensitivity to any of the IPs or components thereof or a history of drug or other allergy that, in the opinion of the investigator or PPD medical monitor, contraindicates the subject’s participation
    Un soggetto non sarà idoneo all’inclusione in questo studio se soddisfa uno qualsiasi dei criteri seguenti:
    1. Febbre con una temperatura > 38 °C per più di un'ora o ≥ 38,3 °C nelle 24 ore precedenti l'inizio del trattamento dello studio
    2. Donne con condizioni materne-fetali che implichino potenzialmente la necessità di partorire, come preeclampsia o compromissione fetale
    3. Un feto con qualunque diagnosi, condizione, trattamento o altro fattore che secondo l'opinione dello sperimentatore può potenzialmente compromettere o confondere l'efficacia o la sicurezza (es. stato fetale non rassicurante, restrizione della crescita intrauterina, anomalie congenite rilevanti)
    4. Rottura prematura pretermine delle membrane
    5. Donne con sospetta o confermata controindicazione al prolungamento della gravidanza, come nel caso di distacco placentare, corioamniosite o placenta previa
    6. Evidenza di polidramnios (indice liquido amniotico [AFI] >25 cm) o oligoidramnios (AFI <5 cm)
    7. Donne con condizione mediche o ostetriche di co-morbilità che secondo l'opinione dello sperimentatore possano potenzialmente complicare il corso e l'esito della gravidanza, come ipertensione non controllata, diabete non controllato (se nota, anamnesi di emoglobina glicosilata >8% in qualsiasi momento durante la gravidanza), o compromettere la sicurezza della paziente, come nel caso di malattia cardiovascolare preesistente (nello specifico, malattia cardiaca ischemica, malattia cardiaca congenita, ipertensione polmonare, malattia valvolare cardiaca, aritmie e cardiomiopatia)
    8. Donne con anamnesi di abuso di sostanze durante la gravidanza o esame tossicologico delle urine positivo per cocaina, fenciclidina (PCP), metanfetamina o anfetamina
    9. Donne per le quali la combinazione di anamnesi e risultati dei test di screening suggerisce un abuso o una dipendenza che potrebbero complicare l'esito della gravidanza. NOTA: l'esclusione di una paziente con risultato positivo per sostanze diverse da cocaina, PCP, metanfetamina o anfetamina è a discrezione dello sperimentatore (gli esempi comprendono alcol, cannabinoidi e oppiacei)
    10. Donne con qualunque diagnosi, condizione, trattamento o altro fattore che secondo l'opinione dello sperimentatore possa potenzialmente compromettere o confondere le valutazioni di efficacia o di sicurezza
    11. Malattia epatica o biliare attiva in corso (fatta eccezione per la sindrome di Gilbert o i calcoli biliari asintomatici oppure una patologia epatica cronica altrimenti stabile in base alla valutazione dello sperimentatore)
    NOTE:
    • La patologia epatica cronica stabile deve essere generalmente definita dall'assenza di asciti, encefalopatia, coagulopatia, ipoalbuminemia, varici gastriche o esofagee oppure ittero persistente o cirrosi
    • Sono accettabili le infezioni croniche stabili da epatite B e C (ad es. presenza dell'antigene di superficie dell'epatite B o risultato positivo al test degli anticorpi per l'epatite C allo Screening o nei 3 mesi precedenti la prima dose di trattamento in studio) se la paziente soddisfa comunque i criteri di ammissione
    12. Anamnesi di sensibilità ad uno degli IP o ai suoi componenti o anamnesi di allergia a farmaci o di altra allergia che, a giudizio dello sperimentatore o del medical monitor PPD, costituisca una controindicazione alla partecipazione dei soggetti

    E.5 End points
    E.5.1Primary end point(s)
    -Time to delivery or treatment failure, whichever occurs first;
    -Time to delivery will be calculated from the start of study treatment administration until delivery.
    -Tempo prima del parto o prima dell'insuccesso del trattamento, a seconda dell'evento che si verifica per primo;
    -Proporzione di neonati con eventuali diagnosi dal composito di morbilità e mortalità neonatale determinata fino a 28 giorni dopo la data stimata del parto di 400/7 settimane.
    E.5.1.1Timepoint(s) of evaluation of this end point
    48 hours after IP infusion, then every week till delivery.
    48 ore dopo l'infusione del prodotto sperimentale, dopo ogni settimana fino al parto.
    E.5.2Secondary end point(s)
    -Time to delivery;
    -Proportion of births prior to 370/7 weeks'gestation;
    -Proportion of births at term (370/7 to 416/7 weeks' gestation);
    -Length of neonatal hospital stay.
    -Tempo al parto;
    -Proporzione di nascite prima della 370/7 settimana di gestazione;
    -Proporzione di nascite a termine (370/7 alla 416/7 settimana di gestazione);
    -Durata della degenza ospedaliera neonatale.
    E.5.2.1Timepoint(s) of evaluation of this end point
    48 hours after IP infusion, then every week till delivery.
    48 ore dopo l'infusione del prodotto sperimentale, dopo ogni settimana fino al parto.
    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 Yes
    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 Yes
    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 No
    E.8.1.4Double blind Yes
    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 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 Yes
    E.8.5.1Number of sites anticipated in the EEA33
    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
    Brazil
    Canada
    Japan
    United States
    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
    The end of the study is defined as the neonatal record review at 28 days post EDD for the last subject randomly assigned to and treated with IP.
    La fine dello studio è definita come revisione dei dati del nescituro al 28esimo giorno dopo la EDD per l'ultimo soggetto randomizzato ed assegnato al trattamento con il prodotto sperimentale.
    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.1.1Number of subjects for this age range: 1
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 900
    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 state36
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 220
    F.4.2.2In the whole clinical trial 900
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    The investigator is responsible for ensuring that consideration has been given to the poststudy care of the subject's medical condition whether or not GSK is providing specific poststudy treatment.
    Poststudy IP is not provided as part of this protocol.
    Lo sperimentatore è responsabile di assicurare che le cure post sperimentazione siano assegnate ai soggetti in quanto GSK non fornirà alcun trattamento specifico post sperimentazione.
    L'IMP post sperimentazione non sarà fornito come parte di questo protocollo.
    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 Decision2016-04-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-02-04
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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