Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43851   clinical trials with a EudraCT protocol, of which   7283   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2013-004619-31
    Sponsor's Protocol Code Number:2819-MA-1002
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-08-25
    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 number2013-004619-31
    A.3Full title of the trial
    A phase IIIb/IV randomized, controlled, open label, parallel group study to compare the efficacy of vancomycin therapy to extended duration fidaxomicin therapy in the sustained clinical cure of Clostridium difficile Infection in an older population
    Studio randomizzato, controllato, in aperto, a gruppi paralleli, di Fase IIIb/IV per confrontare l’efficacia della terapia con vancomicina rispetto alla terapia protratta con fidaxomicina nell’ottenere la guarigione clinica duratura dell’infezione da Clostridium difficile in una popolazione di soggetti anziani.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study in which two antibiotics (vancomycin and fidaxomicin) are compared in older patients with infections of the gut caused by bacteria called Clostridium difficile.
    Uno studio in cui due antibiotici (vancomicina e fidaxomicin) sono comparati in pazienti anziani con infezioni dell'intestino causate dal batterio chiamato Clostridium difficile.
    A.3.2Name or abbreviated title of the trial where available
    EXTEND
    EXTEND
    A.4.1Sponsor's protocol code number2819-MA-1002
    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 SponsorAstellas Pharma Europe Ltd.
    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 supportAstellas Pharma Europe Ltd.
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstellas Pharma Europe Ltd.
    B.5.2Functional name of contact pointAndreas Karas
    B.5.3 Address:
    B.5.3.1Street Address2000 Hillswood Drive
    B.5.3.2Town/ cityChertsey
    B.5.3.3Post codeKT16 0RS
    B.5.3.4CountryUnited Kingdom
    B.5.6E-mailandreas.karas@astellas.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 Yes
    D.2.1.1.1Trade name Dificlir
    D.2.1.1.2Name of the Marketing Authorisation holderAstellas Pharma SpA
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameDIFICLIR 200 mg film-coated tablets
    D.3.4Pharmaceutical form Film-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 INNfidaxomicin
    D.3.9.1CAS number 873857-62-6
    D.3.9.2Current sponsor codeOPT-80
    D.3.9.3Other descriptive nameFIDAXOMICIN
    D.3.9.4EV Substance CodeSUB31455
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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.IMP: 2
    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 Yes
    D.2.1.1.1Trade name Vancomycin Capsules 125 MG
    D.2.1.1.2Name of the Marketing Authorisation holderXellia Pharmaceutica ApS. (formerly Alpharma ApS)
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameVancomycin Capsules 125 MG
    D.3.4Pharmaceutical form Capsule
    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 INNVANCOMYCIN
    D.3.9.1CAS number 1404-90-6
    D.3.9.4EV Substance CodeSUB05076MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number125
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Clostridium Difficile Infection (CDI) also known as C. difficile-associated diarrhoea (CDAD)
    Infezione da Clostridium difficile (CDI), nota anche come diarrea associata a C. difficile (CDAD)
    E.1.1.1Medical condition in easily understood language
    Infection of the gut caused by bacteria called Clostridium difficile
    Infezione dell'intestino causata da un batterio chiamato Clostridium difficile
    E.1.1.2Therapeutic area Diseases [C] - Bacterial Infections and Mycoses [C01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level LLT
    E.1.2Classification code 10022661
    E.1.2Term Intestinal infection due to clostridium difficile
    E.1.2System Organ Class 100000004862
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of the study is to evaluate whether the extended duration fidaxomicin therapy is superior to the standard vancomycin therapy in sustained clinical cure of CDI at 30 days after end of treatment (Day 40 or Day 55). Sustained clinical cure is defined as clinical response at Test of Cure (TOC) and no recurrence of CDI from TOC until time of assessment.
    Verificare se la terapia protratta con fidaxomicina sia superiore alla terapia standard con vancomicina nell’ottenere la guarigione clinica duratura dell’infezione da Clostridium difficile (CDI) 30 giorni dopo la fine del trattamento (Giorno 40 o Giorno 55). La guarigione clinica duratura viene definita come risposta clinica al Test per la Conferma della Guarigione (TOC) e assenza di recidiva di CDI dal TOC fino al momento della valutazione
    E.2.2Secondary objectives of the trial
    The secondary objectives of this study are:
    • to compare sustained clinical cure of CDI at Day 40, Day 55 and Day 90
    • to compare clinical response of CDI at 2 days after end of treatment (Day 12 or Day 27)
    • to compare clinical response of CDI at Day 12
    • to compare TTROD in hours
    • to compare recurrence rate of CDI at Day 40, Day 55 and Day 90
    • to compare time to recurrence after end of treatment
    • to compare disease-free survival after Day 10
    • to compare the rate of relapse at Day 90 as determined by whole genome sequencing of C.Difficile isolates from subjects who have documented recurrence after TOC
    • to compare incidence of mortality and severity of adverse events at Day 90
    • to assess change in Health Related Quality of Life from baseline to Day 12, Day 27, Day 40, Day 55 and recurrence using the EQ-5D-5L questionnaire
    • to compare readmissions and length of hospital stay at Day 90
    Gli Ob Sec dello studio sn: •Confront la guarigione clin duratura d CDI al G 40, G 55 e G 90•Confront la risp clin d CDI 2 gg dp la fine del tratt (EOT) al G 12 o al G 27•Confront la risp clin d CDI al G 12•Confront il tasso d recidiva al G 90 determ con sequenz del genoma intero degli isolati dai sogg ke manifestano recidiva dp il test x la conferma della guarigione (TOC)•Confront il temp alla risoluzione della diarrea (TTROD) espresso in ore•Confront il tasso d recidiva d CDI al G 40, G 55 e G 90 •Confront il temp alla recidiva dp la fine del trattamento (EOT) (sl x i sogg cn risp clin)•Confront la sopravvivenza libera da malattia dp il G 10 (sl x i sogg ke hanno present risp clin)•Confront l’incidenza di mortalità e gravità degli EA al G 90•Valut i cambiamenti risp al baseline del punteggio Health Related Quality of Life rilevato al G 12, G 27, G 40, G 55 e alla recidiva mediante il quest EQ-5D-5L •Confrontare il num d nuovi ricoveri osp e della durata della degenza al G 90
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    There are two sub-studies:
    • Pharmacokinetic (Blood) Analysis Sub-Study involving approximately 10 patients, and
    • Stool Microbiome & Fecal Fidaxomicin Concentration Analysis Sub-Study involving approximately 80 patients

    The sub-study objectives are as follows
    • To assess plasma and stool levels of fidaxomicin with extended dose regimen
    • To assess the comparative impact of fidaxomicin versus vancomycin on the microbiome and the lifecycle of C. difficile
    • Il sottostudio di farmacocinetica (sangue) che coinvolgerà approssimativamente 10 pazienti e
    • Il sottostudio del microbioma fecale e della concentrazione di Fidaxomicina nelle feci che coinvolgerà approssimativamente 80 pazienti

    Gli obiettivi dei sottostudi sono i seguenti:
    • valutare i livelli plasmatici e fecali di fidaxomicina con la dose a regime
    protratto
    • valutare l'impatto comparativo della fidaxomicina contro vancomicina sul
    microbioma ed il ciclo di vita del C. difficile
    E.3Principal inclusion criteria
    • Subject is 60 years of age or over.
    • CDI is confirmed by clinical symptoms in the 24 hours prior to randomization and CDI test confirmed positive for presence of C. difficile toxin A or B in stool within 48 hr prior to randomization.
    • Independent Ethics Committee (IEC) approved written Informed Consent and privacy language as per national regulations must be obtained from the subject or legally authorized representative prior to any study-related procedures (including withdrawal of prohibited medication, if applicable).
    • Subject agrees not to participate in another interventional study whilst participating in this study.
    • Soggetto di età pari o superiore a 60 anni.
    • Presenza di CDI confermata da sintomi clinici (>3 scariche di feci diarroiche oppure ≥200ml di feci diarroiche (per i soggetti che utilizzano dispositivi di raccolta delle feci) nelle 24 ore precedenti la randomizzazione e test di ricerca del CDI positivo per la presenza nelle feci di tossine A o B di C. difficile nelle 48 ore precedenti la randomizzazione.
    • Consenso Informato scritto e trattamento dei dati ai sensi della normativa nazionale approvati dal Comitato Etico (CE), devono essere ottenuti dal soggetto o dal suo rappresentante legale prima di eseguire qualsiasi procedura prevista dallo studio (inclusa l’interruzione di farmaci proibiti, se applicabile).
    • Soggetto che acconsente a non prendere parte ad altre sperimentazioni interventistiche durante la propria partecipazione a questo studio.
    E.4Principal exclusion criteria
    • Subject is taking or requiring to be treated with prohibited medications
    • Subject has received more than one day of dosing of any therapy for CDI within the last 48 hours
    • Subject has experienced more than 2 previous episodes of CDI in the 3 months prior to study enrolment
    • Subject is unable to swallow oral study medication.
    • Subject has a current diagnosis of toxic megacolon.
    • Subject is not willing to adhere to the provisions of treatment and observation specified in the protocol.
    • Subject has been randomized into this study previously, has taken any investigational drug within 28 days or 5 half lives, whichever is longer, prior to enrollment, or is currently participating in another clinical study which may influence the assessment of efficacy and/or safety endpoints of this study, in the opinion of the Sponsor.
    • Subject has previously participated in a CDI vaccine study
    • Subject has hypersensitivity to fidaxomicin, vancomycin or any of its components.
    • Any clinical condition which, in the opinion of the Investigator, would not allow safe completion of this study.
    • Soggetto che è attualmente in trattamento, o che ha necessità di trattamento con uno dei farmaci proibiti elencati nella Sezione 5.1.3
    • Soggetto che ha ricevuto la somministrazione di qualsiasi terapia per CDI per un periodo superiore a un giorno nelle ultime 48 ore
    • Soggetto che ha presentato più di 2 episodi pregressi di CDI nei 3 mesi precedenti l’arruolamento nello studio
    • Soggetto che non è in grado di inghiottire il farmaco sperimentale orale
    • Soggetto con diagnosi di megacolon tossico attivo
    • Soggetto che non è disposto ad attenersi ai requisiti del trattamento e di osservazione specificati nel protocollo.
    • Soggetto che è stato randomizzato in precedenza nell’ambito di questo studio, che ha assunto qualsiasi farmaco sperimentale per un periodo di 28 giorni o 5 emivite, quale dei due periodi sia più lungo, prima dell’arruolamento o che sta attualmente partecipando a un’altra sperimentazione clinica che, a giudizio del Promotore, potrebbe influenzare la valutazione degli endpoint di efficacia e/o di sicurezza per questo studio.
    • Soggetto che ha partecipato in precedenza a uno studio sul vaccino per CDI
    • Soggetto con ipersensibilità alla fidaxomicina, vancomicina o qualsiasi dei rispettivi componenti.
    • Qualsiasi condizione clinica che a giudizio dello Sperimentatore non permetterebbe di completare lo studio in sicurezza.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of this study is sustained clinical cure of CDI
    L’obiettivo primario dello studio è la guarigione clinica duratura dell’infezione da Clostridium difficile (CDI)
    E.5.1.1Timepoint(s) of evaluation of this end point
    30 days after end of treatment (Day 40 or Day 55)
    30 giorni dopo la fine del trattamento (Giorno 40 o Giorno 55)
    E.5.2Secondary end point(s)
    • Sustained clinical cure of CDI at Day 40, Day 55 and Day 90
    • Clinical response of CDI at 2 days after EOT (Day 12 or Day 27)
    • Clinical response of CDI at Day 12
    • TTROD in hours
    • Recurrence rate of CDI at Day 40, Day 55 and Day 90
    • Time to recurrence after end of treatment (only for subjects with clinical response)
    • Disease-free survival after Day 10 (only for subjects with clinical response)
    • Rate of relapse at Day 90 as determined by whole genome sequencing of C.difficile isolates from Subjects who have documented recurrence after TOC
    • Guarigione clinica duratura dell’infezione da Clostridium difficile (CDI) al Giorno 40, Giorno 55 e Giorno 90
    • Risposta clinica del CDI a 2 giorni dopo EOT (Giorno 12 o Giorno 27)
    • Risposta clinica del CDI al Giorno 12
    • Tempo alla risoluzione della diarrea (TTROD) in ore
    • Tasso di recidiva da CDI al Giorno 40, Giorno 55 e al Giorno 90
    • Tempo di recidiva dopo la fine del trattamento (solo per sogetti con risposta clinica)
    • Sopravvivenza libera da malattia dopo il Giorno 10 (solo per i soggetti con risposta clinica)
    • Tasso di recidiva al Giorno 90 come determinato dal sequenziamento dell'intero genoma di C. difficile isolato da soggetti che hanno documentato recidiva dopo TOC
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 12, 27, 40 , 55, 90 depending on treatment and endpoint
    Giorno 12, 27, 40, 55, 90 a seconda del trattamento e dell’endpoint
    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 No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA130
    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 No
    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
    Croatia
    Czech Republic
    Denmark
    Finland
    France
    Germany
    Greece
    Hungary
    Ireland
    Italy
    Norway
    Poland
    Portugal
    Romania
    Russian Federation
    Slovenia
    Spain
    Sweden
    Switzerland
    Turkey
    United Kingdom
    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 years1
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months3
    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: 64
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 300
    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 322
    F.4.2.2In the whole clinical trial 364
    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
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-10-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-09-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-07-18
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Sat Apr 20 05:25:25 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA