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    Summary
    EudraCT Number:2017-002258-36
    Sponsor's Protocol Code Number:RETIPC/01/17
    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:2020-11-05
    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 number2017-002258-36
    A.3Full title of the trial
    A Phase II, multicentre, double-blind, randomised, placebo-controlled study of Rifaximin delayed release 400 mg tablet: clinical efficacy and safety in the prevention of post-operative endoscopic Crohn¿s disease recurrence
    Studio clinico di fase II, multicentrico, randomizzato, in doppio cieco, controllato verso placebo, per la valutazione dell¿efficacia e sicurezza di Rifaximina, compresse a rilascio ritardato da 400 mg, nella prevenzione della recidiva endoscopica post-operatoria in pazienti con malattia di Crohn.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase II clinical trial, conducted in different sites, with random assignation of treatment, where neither the patient or the medical doctor know the assigned treatment, drug or placebo, to evaluate the efficacy and safety of Rifaximin delayed release 400 mg tablet in the prevention of post-operative endoscopic Crohn¿s disease recurrence
    Sperimentazione di fase II, condotto in pi¿ centri sperimentali, con assegnazione random del trattamento da usare, dove n¿ il paziente n¿ il medico conoscono il trattamento assegnato, farmaco o placebo, per valutare dell¿efficacia e sicurezza di Rifaximina, in compresse a rilascio ritardato da 400 mg, nella prevenzione dello sviluppo di recidiva endoscopica post-operatoria in pazienti con malattia di Crohn.
    A.3.2Name or abbreviated title of the trial where available
    STOP-Postoperative Endoscopic Recurrence Study (STOP-PER)
    STOP-PER (Ricorrenza Endoscopppica Post-operatoria)
    A.4.1Sponsor's protocol code numberRETIPC/01/17
    A.5.4Other Identifiers
    Name:NANumber:NA
    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 SponsorALFASIGMA 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 supportAlfasigma S.p.A
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAlfasigma S.p.A
    B.5.2Functional name of contact pointClinical Trials - Clinical Developm
    B.5.3 Address:
    B.5.3.1Street AddressVia Ragazzi del 99-5
    B.5.3.2Town/ cityBologna
    B.5.3.3Post code40133
    B.5.3.4CountryItaly
    B.5.4Telephone number00390516489894
    B.5.5Fax number00390516489671
    B.5.6E-mailcecilia.renzulli@alfasigma.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 nameRifaximina 400 mg compresse rivestite a rilascio ritardato
    D.3.2Product code Rifaximin-EIR
    D.3.4Pharmaceutical form Coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRIFAXIMINA
    D.3.9.2Current sponsor codeRifaximin-EIR
    D.3.9.4EV Substance CodeSUB10312MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1600
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCoated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Post-operative endoscopic Crohn¿s disease recurrence
    Recidiva endoscopica post-operatoria in pazienti con malattia di Crohn
    E.1.1.1Medical condition in easily understood language
    Manifestation of recurrence after surgery in patients with Crohn disease
    Sviluppo di recidiva a seguito di intervento chirurgico in pazienti con malattia di Crohn
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10013099
    E.1.2Term Disease Crohns
    E.1.2System Organ Class 100000004856
    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 efficacy of Rifaximin ¿EIR 400 mg Tablet (800mg /BID, total daily dose 1600 mg) versus placebo in the prevention of endoscopic Crohn¿s disease recurrence following ileocolonic resection.
    Dimostrare l'efficacia della Rifaximina-EIR compresse da 400 mg, (800 mg/due volte al giorno, dose totale giornaliera 1600 mg) rispetto al placebo nella prevenzione della recidiva endoscopica in pazienti con malattia di Crohn a seguito di resezione ileocolica
    E.2.2Secondary objectives of the trial
    To demonstrate the efficacy of Rifaximin-EIR 400 mg Tablet (800mg /BID, total daily dose 1600 mg) versus placebo in the maintenance of clinical remission.

    To evaluate the safety profile of Rifaximin-EIR 400 mg Tablet (800mg /BID, total daily dose 1600 mg)

    Assess the effects of Rifaximin-EIR treatment on biological (inflammatory) markers of disease.

    Evaluate the effects of Rifaximin -EIR treatment on quality of life
    Dimostrare l'efficacia del Rifaximin-EIR 400 mg in compresse rispetto al placebo nel mantenimento della remissione clinica

    Di valutare il profilo di sicurezza del Rifaximin-EIR 400 mg Tablet

    Di valutare gli effetti del trattamento con Rifaximin-EIR sui marcatori biologici (infiammatori) della malattia

    Di valutare gli effetti del trattamento Rifaximin-EIR sulla qualit¿ della vita.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    ¿ Patients of both sexes aged between 18 and 75 years old, inclusively.
    ¿ Patients with diagnosis of CD, who had undergone curative ileocolonic resection, with ileocolonic anastomosis and for whom a randomization within 45 days from surgical intervention is feasible.
    ¿ If the patients had an end or loop ileostomy within 1 year prior to randomization, they can be included, but stoma closure should occur within 45 days prior to randomization.
    ¿ Patients have had faecal stream restoration at least 14 days prior to randomization.
    ¿ Patients must have at least one of the following risk factors for the development of early/severe post-operative endoscopic recurrence of their CD:
    1) qualifying surgery that was their second intestinal resection within 10 years
    2) third or more intestinal resections,
    3) surgery for a penetrating CD complication (e.g., abscess or fistula), or
    4) smoking 10 or more cigarettes per day for the past year.

    ¿ Patients treated with glucocorticosteroids (systemic or topical) must discontinue treatment within 6 weeks after surgery.

    ¿ Patients are capable of and willing to adhere to the study protocol requirements.

    ¿ Patients have provided signed and dated written informed consent.

    ¿ Female patients must be:

    ¿ post-menopausal (at least 2 years without spontaneous menses), or
    ¿ surgically sterile (bilateral tubal ligation, or hysterectomy, or ablation of both ovaries),
    ¿ or have a negative urine pregnancy test result at screening and at randomization and agree to use an acceptable method of contraception throughout their participation in the study. Acceptable methods of contraception include: condom and spermicide; intrauterine device (IUD), diaphragm with spermicide; hormonal methods (oral contraceptives, patches, implants, injectable or ring) with a documented failure rate of less than 1% per year,
    or commit to absolute and continuous sexual abstinence
    Pazienti di entrambi i sessi di età compresa tra 18 e 75 anni (entrambi inclusi);

    ¿ Pazienti con diagnosi di morbo di Crohn (Crohn's Disease, CD) sottoposti a resezione ileocolica curativa, con anastomosi ileocolica e che possono essere randomizzati entro 45 giorni dall'intervento chirurgico;

    ¿ Se i pazienti sono stati sottoposti a ileostomia terminale o ad ansa nell'anno precedente alla randomizzazione possono essere arruolati purché la chiusura dello stomia sia avvenuta entro 45 giorni prima della randomizzazione;

    ¿ Pazienti con ripristino del flusso fecale almeno 14 giorni prima della randomizzazione;

    ¿ Pazienti con almeno uno dei seguenti fattori di rischio di sviluppo di recidiva endoscopica post-operatoria precoce/grave del loro CD:
    1) pazienti per cui la resezione intestinale sia la seconda negli ultimi 10 anni.;
    2) Sottoposti a tre o più resezioni intestinali;
    3) Sottoposti a intervento chirurgico per una complicazione del CD penetrante (ad es. ascesso o fistola), o
    4) Fumatore di 10 o più sigarette al giorno nell'anno passato

    ¿ I pazienti trattati con glucocorticosteroidi (sistemici o topici) devono interrompere il trattamento entro 6 settimane dopo l'intervento chirurgico;

    ¿ Pazienti in grado di e intenzionati a rispettare i requisiti previsti dal protocollo di studio;
    ¿ Pazienti che forniscono il consenso informato scritto firmato e datato;

    ¿ Le pazienti di sesso femminile devono:

    ¿ Essere in post-menopausa (almeno 2 anni senza mestruazioni spontanee); o

    ¿ Essere state sottoposte a sterilizzazione chirurgica (legatura tubarica bilaterale, isterectomia o ablazione di entrambe le ovaie); o

    ¿ Presentare un risultato negativo al test di gravidanza sulle urine allo screening e alla randomizzazione e acconsentire ad usare un metodo anticoncezionale accettabile nel corso dell'intera partecipazione allo studio. I metodi anticoncezionali accettabili sono: preservativo e spermicida; dispositivo intrauterino (IUD); diaframma con spermicida; metodi ormonali (contraccettivi orali, cerotti, contraccettivi impiantabili o iniettabili, o anello) associati a un tasso di fallimento, documentato, inferiore all'1% annuo; o

    ¿ Impegnarsi a praticare l'assoluta e continua astinenza sessuale.
    E.4Principal exclusion criteria
    ¿ Presence of macroscopic evidence for CD proximally or distally to the site of resection (presence of frank erythema, oedema, aphthae, ulcers or wall thickening > 3 mm, or creeping fat) according to the surgeon or previous imaging
    ¿ Patients who had strictureplasties at index surgery
    ¿ Patients with an ileorectal anastomosis
    ¿ Patients with active perianal Crohn’s disease
    ¿ Patients treated with (treatment which was not discontinued at the time of surgery):
    ¿ Aminosalicylates
    ¿ Any biologicals (e.g., TNF-a inhibitor, natalizumab, or
    similar drugs)
    ¿ Azathioprine, 6-mercaptopurine
    ¿ Methotrexate,
    ¿ Cyclosporine, tacrolimus, sirolimus, mycophenolate
    mofetil, or similar drugs
    ¿ antibiotics specific for CD such as metronidazole or
    ciprofloxacin
    ¿ Patients with active infectious, ischemic, or immunological diseases with GI involvement
    ¿ Patients with intestinal obstruction or pseudo-obstruction
    ¿ Patients with diarrhea associated with fever and/or bloody stools.
    ¿ Patients with symptoms attributed to Short Bowel Syndrome (more than cm 100 in total of small bowel resected);
    ¿ Patients with positive Clostridium difficile toxin stool assay .
    ¿ Patients with sepsis or other post-operative complications necessitating use of antibiotics for more than 14 days after surgery.
    ¿ Patients with colorectal stenosis precluding ileocolonoscopy.
    ¿ Patients who had qualifying ileocolonic resection for dysplasia or cancer without ongoing inflammation
    ¿ Hepatic Impairment defined as severe (Child-Pugh C) hepatic impairment or patients with MELD (Model for End-Stage Liver Disease) score > 25.
    ¿ Patients with an alanine transaminase (ALT) or aspartate transaminase (AST) > 2.5 upper limit of normal (ULN) at randomization.
    ¿ Patients with severe cardiac insufficiency (NYHA, New York Heart Association classes 3 – 4).
    ¿ Patient has a history of sensitivity to rifaximin, rifampin, rifamycin antimicrobial agents, or any of the components of Rifaximin -EIR or placebo (see list in the protocol at section 10.2.1).
    ¿ Patients with kidney failure at randomization.
    ¿ Any condition or circumstance that would prevent completion of the study or interfere with analysis of study results, including a history of drug or alcohol abuse, mental illness or non-compliance with treatments or visits, with immunological (including HIV infection), haematological, or neoplastic disease.
    ¿ Pregnant or nursing woman
    ¿ Patients who have donated 250 ml or more of blood in the last 3 months.
    ¿ Patients who have used any investigational drug (except biological therapies) within 3 months prior to screening.
    Presenza di evidenza macroscopica di CD in posizione prossimale o distale rispetto al sito della resezione (presenza di eritema franco, edema, afte, ulcerazioni o ispessimento della parete >3 mm, o estensione del tessuto adiposo mesenterico) secondo il parere del chirurgo o esami di imaging precedenti;
    ¿ Pazienti sottoposti a stricturoplastica durante l'intervento chirurgico;
    ¿ Pazienti con anastomosi ileorettale;
    ¿ Pazienti con morbo di Crohn perianale attivo;
    ¿ Pazienti trattati con (terapia non interrotta al momento dell'intervento chirurgico):
    ¿ Aminosalicilati
    ¿ Prodotti biologici (ad es. inibitori del TNF-a, natalizumab o farmaci analoghi)
    ¿ Azatioprina, 6-mercaptopurina
    ¿ Metotrexato
    ¿ Ciclosporine, tacrolimus, sirolimus, micofenolato mofetile o farmaci analoghi
    ¿ Antibiotici specifici per il CD, quali metronidazolo o ciprofloxacina
    ¿ Pazienti con malattie immunologiche, ischemiche o infettive attive con coinvolgimento gastrointestinale;
    ¿ Pazienti con ostruzione o pseudo- ostruzioni intestinali
    ¿ Pazienti con diarrea associata a febbre e/o sangue nelle feci
    ¿ Pazienti con sintomi attribuiti alla sindrome dell'intestino corto (resezione di oltre 100 cm totali dell'intestino tenue);
    ¿ Pazienti positivi alla tossina Clostridium difficile nel campione di feci
    ¿ Pazienti con sepsi o altre complicazioni post-operatorie che rendono necessario l'uso di antibiotici per oltre 14 giorni dopo l'intervento chirurgico;
    ¿ Pazienti con stenosi colorettale che impedisce di eseguire l'ileocolonscopia;
    ¿ Pazienti sottoposti a resezione ileocolica valida per l'arruolamento ma fatta per displasia o tumore senza infiammazione in corso;
    ¿ Pazienti con compromissione epatica grave (di grado C secondo la classificazione di Child-Pugh) o che presentano un punteggio MELD (Model for End-Stage Liver Disease) >25;
    ¿ Pazienti con livelli di alanina transaminasi (ALT) o aspartato transaminasi (AST) >2,5 volte rispetto al limite superiore normale (Upper Limit of Normal, ULN) alla randomizzazione;
    ¿ Pazienti con insufficienza cardiaca grave (classi 3-4 secondo la classificazione della New York Heart Association, NYHA);
    ¿ Pazienti con precedenti episodi di sensibilità a rifaximina, rifampina, rifamicina, agenti antimicrobici o ad uno qualsiasi dei componenti di rifaximina-EIR o placebo (vedere la lista nella sezione 10.2.1 del protocollo);
    ¿ Pazienti con insufficienza renale alla randomizzazione;
    ¿ Qualsiasi condizione o circostanza che possa impedire il completamento dello studio o interferire con le analisi dei risultati dello studio, ivi compresa l'anamnesi di alcolismo o tossicodipendenza, malattia mentale o mancata aderenza a trattamenti o visite, e la presenza di malattia immunologica (tra cui infezione da HIV), ematologica o neoplastica;
    ¿ Donne in gravidanza o allattamento;
    ¿ Pazienti che hanno donato 250 ml o più di sangue negli ultimi 3 mesi;
    ¿ Pazienti trattati con farmaci sperimentali (fatte salve le terapie biologiche) nei 3 mesi precedenti allo screening.
    E.5 End points
    E.5.1Primary end point(s)
    The primary end point of this trial will be the proportion of patients with endoscopic recurrence at 26 weeks after randomization defined as Rutgeerts score =i2.
    L'endpoint primario di questo studio sarà la proporzione di pazienti con recidiva endoscopia a 26 settimane seguenti la randomizzazione, definita come un punteggio Rutgeerts =i2.
    E.5.1.1Timepoint(s) of evaluation of this end point
    26 weeks
    26 Settimane
    E.5.2Secondary end point(s)
    ¿ Clinical recurrence according to CDAI score (defined as an increase higher than 70 points in CDAI score from baseline and CDAI>220 points; CDAI will be assessed at each visit).; Proportion of patients with clinical symptom remission according to PRO defined by (1) the total number of liquid/very soft stools for the 7 days prior to each visit being = 10 (from CDAI Item 1); AND (2) an abdominal pain rating of = 1(from CDAI Item 2) on each day for the 7 days prior to each visit.; Development of a new/re-draining fistula or abscess by week 26; Time to clinical recurrence; Change from baseline in CRP and fecal calprotectin at each visit during the Treatment Period.; Change from baseline in indices of health outcomes (SF-36¿) at Week 26.; Assessments of safety (vital signs, routine laboratory parameters, adverse events, withdraw due to adverse events)
    ; Patients with endoscopic modified Rutgeerts score = i2a (lesions limited to the anastomosis or maximum of 5 aphthous lesions in the neo-terminal ileum with normal mucosa between the lesions) at 26 weeks after randomization.
    Recidiva clinica secondo il punteggio CDAI (definita come un aumento di oltre 70 punti del punteggio CDAI rispetto al basale e come un punteggio CDAI >220 punti; il CDAI verr¿ valutato in occasione di ciascuna visita);; Proporzione di pazienti con remissione dei sintomi clinici secondo quanto riportato dai pazienti (Patient Reported Outcome, PRO), definita da: (1) un numero totale di evacuazioni di feci liquide/molto molli nei 7 giorni precedenti a ciascuna visita =10 (dalla voce 1 del CDAI); E (2) una valutazione del dolore addominale =1 (dalla voce 2 del CDAI) in ognuno dei 7 giorni precedenti a ciascuna visita;; Sviluppo di una fistola o un ascesso nuovi/ridrenanti entro la Settimana 26; Tempo alla recidiva clinica; Variazione rispetto al basale della PCR e della calprotectina fecale in occasione di ogni visita durante il Periodo di trattamento; Variazione rispetto al basale degli indici degli esiti relativi allo stato di salute (SF-36¿) alla Settimana 26.; Le valutazioni di sicurezza (segni vitali, parametri di laboratorio di routine, eventi avversi, ritiri dovuti agli eventi avversi.
    ; Pazienti con punteggio Rutgeerts endoscopico modificato =i2a (lesioni limitate all'anastomosi o massimo 5 lesioni aftose nell'ileo neo-terminale con mucosa normale tra le lesioni) a 26 settimane dopo la randomizzazione;
    E.5.2.1Timepoint(s) of evaluation of this end point
    At week 4-8-16-26-28; At randomization visit, week 4-8-16-26-28; At week 26; At week 26; At week 4-8-16-26-28; At week 4-8-16-26-28; At randomization visit, week 4-8-16-26-28; At week 26
    A settimana 4-8-16-26-28; Alla visita di randomizzazione, settimana 4-8-16-26-28; A settimana 26; A settimana 26; A settimana 4-8-16-26-28; A settimana 4-8-16-26-28; Alla visita di randomizzazione, settimana 4-8-16-26-28

    ; A Settimana 26
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA27
    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 years0
    E.8.9.1In the Member State concerned months20
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months20
    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: 160
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 180
    F.4.2.2In the whole clinical trial 180
    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)
    Patients will be treated as per standard clinical practice
    I pazienti verranno trattati secondo normale pratica clinica
    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 Decision2017-10-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-09-19
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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