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    Summary
    EudraCT Number:2014-003002-32
    Sponsor's Protocol Code Number:2819-MA-1003
    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:2021-05-27
    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 number2014-003002-32
    A.3Full title of the trial
    Open label study to evaluate the pharmacokinetics of fidaxomicin in Inflammatory Bowel Disease (IBD) Subjects with Clostridium difficile Infection (CDI)
    Open label study to evaluate the pharmacokinetics of fidaxomicin in Inflammatory Bowel Disease (IBD) Subjects with Clostridium difficile Infection (CDI)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study in which the blood levels of the antibiotic fidaxomicin are studied
    in patients with an inflammation of the intestine and concommitantly an
    infection of the gut caused by bacteria called Clostridium difficile.
    Studio in cui vengono studiati i livelli nel sangue dell'antibiotico fidaxomicina in pazienti affetti da infiammazione dell'intestino e in concomitanza da un'infezione dell'intestino causata da un batterio chiamato Clostridium difficile (CDI)
    A.3.2Name or abbreviated title of the trial where available
    PROFILE
    PROFILE
    A.4.1Sponsor's protocol code number2819-MA-1003
    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 LIMITED
    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.5.4Telephone number00442033798330
    B.5.5Fax number00442033798330
    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 - 200 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE -BLISTER (ALU/ALU) 2X10 COMPRESSE
    D.2.1.1.2Name of the Marketing Authorisation holderASTELLAS PHARMA EUROPE B.V.
    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 compresse rivestite con film
    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 INNFidaxomicina
    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 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
    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)
    infezioni da Clostridium difficile (CDI ¿ Clostridium difficile infections) note anche come diarrea associata a C. difficile (CDAD ¿ C. Difficile ¿associated diarrhoea)
    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 noto come 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 20.1
    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 investigate the plasma
    pharmacokinetics (PK) of fidaxomicin and primary metabolite OP-1118
    in Subjects with Inflammatory Bowel Disease (IBD) and C. difficile
    Infection on Day 1, Day 5 and Day 10 of treatment.
    L¿obiettivo primario dello studio ¿ quello di analizzare il profilo di farmacocinetica plasmatica (PK) della fidaxomicina (FDX) e del suo metabolita primario OP-1118 in soggetti affetti da Malattie Intestinale Infiammatoria (Inflammatory Bowel Disease, IBD) e Infezione da C. difficile (CDI) al Giorno 1, Giorno 5 e Giorno 10 di trattamento.
    E.2.2Secondary objectives of the trial
    The secondary objectives are to:
    ¿ compare CDI clinical response to the microbiological response in terms
    of magnitude of reduction of C. diff total viable count and spore count
    during fidaxomicin treatment and if achieved, the time to microbial
    eradication
    ¿ determine time to negative CDI toxin assay in stool specimens during
    fidaxomicin treatment
    ¿ compare differences in fidaxomicin stool concentrations and metabolite
    OP-1118 throughout therapy from Day 1, Day 5 and Day 10
    ¿ assess the length of hospital stay, readmissions and resource
    utilization for IBD patients receiving fidaxomicin throughout the study
    until Visit 8 (Day 180, EOS)
    ¿ record the incidence and severity of AEs up to EOS Visit 8 (Day 180)
    ¿ document impact of treatment on Quality of Life as measured by the
    changes in Short IBDQ score from Baseline Visit 1 to Visit 3 (Day 10),
    Visit 5 (Day 26), Visit 6 (Day 40) and Visit 7 (Day 90), EOS Visit 8 (Day
    180) and to any confirmed recurrence episode
    ¿confrontare la risposta clinica e microbiologica dell¿infezione da CDI in termini di entit¿ di riduzione della conta totale dei batteri vitali e delle spore di C. difficile durante il trattamento con FDX, e rilevare il tempo all¿eradicazione microbica, se ottenuta.
    ¿determinare il tempo necessario a ottenere la negativit¿ al test delle tossine di CDI nei campioni di feci in corso di trattamento con FDX
    ¿misurare le concentrazioni fecali di FDX e del suo metabolita OP-1118 nel corso della terapia, al Giorno 1, Giorno 5, Giorno 10
    ¿valutare la durata della degenza ospedaliera, il numero di nuovi ricoveri e l¿utilizzo delle risorse nel corso dello studio per i pazienti affetti da IBD in trattamento con FDX, fino alla Visita 8 di fine studio (EOS) (Giorno 180)
    ¿registrare incidenza e gravit¿ degli eventi avversi (AE) fino alla Visita 8 EOS (Giorno 180)
    ¿documentare l¿impatto del trattamento sulla Qualit¿ di Vita in base alla variazione del punteggio del questionario IBDQ
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    ¿ Subject is aged at least 18
    ¿ Confirmed diagnosis or history of IBD for at least 3 months
    ¿ CDI confirmed positive according to local standard testing for the
    presence of C. difficile within 48 hr prior to enrolment.
    ¿Soggetto di età pari o superiore a 18 anni
    ¿Diagnosi confermata o storia di IBD da almeno 3 mesi
    ¿Conferma della positività per CDI nelle 48 ore precedenti l’arruolamento confermata mediante test standard del centro per la ricerca di C. difficile.
    E.4Principal exclusion criteria
    ¿ Subject has received more than one day of dosing of any CDI therapy within the 48 hrs prior to enrolment
    • Presence of an ostomy or short bowel syndrome
    • Subject has a current diagnosis of toxic megacolon
    • Subject has previously participated in a CDI vaccine study
    • Subject has hypersensitivity to fidaxomicin or any of its components
    ¿Soggetto che ha ricevuto più di un giorno di somministrazione di qualsiasi terapia anti CDI nelle 48 ore precedenti all’arruolamento
    ¿Presenza di stomia oppure di sindrome da intestino corto
    ¿Soggetto con diagnosi di megacolon tossico attivo ¿Soggetto che ha partecipato in precedenza a uno studio sul vaccino per CDI
    ¿Soggetto con ipersensibilità a FDX o a qualsiasi fra i suoi componenti

    E.5 End points
    E.5.1Primary end point(s)
    Primary endpoints are the pharmacokinetic parameters derived for
    plasma concentrations of both fidaxomicin and OP-1118.
    Gli endpoint primari sono i parametri di farmacocinetica ottenuti dalle concentrazioni plasmatiche sia di FDX che di OP-1118
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 1, 5 and 10
    Giorno 1, 5 e 10
    E.5.2Secondary end point(s)
    ¿ CDI clinical response at Day 12 (TOC)
    ¿ microbiological response in terms of C. difficile total viable count,spore count and negative CDI toxin assay
    ¿ stool concentrations of fidaxomicin and its metabolite OP-1118
    ¿ length of hospital stay, readmissions and resource utilization
    ¿ incidence and severity of AEs
    ¿ Short IBDQ score
    ¿risposta clinica del CDI al Giorno 12 (TOC)
    ¿risposta microbiologica al Giorno 5 e Giorno 10 in base alla conta totale dei batteri vitali C. difficile, conta delle spore e negativit¿ al test di ricerca delle tossine da CDI
    ¿concentrazioni fecali di FDX e del suo metabolita OP-1118
    ¿durata della degenza ospedaliera, nuovi ricoveri ospedalieri e utilizzo delle risorse nel corso dello studio fino alla Visita 8 EOS (Giorno 180) ¿incidenza e gravit¿ degli AE fino alla Visita 8 EOS (Giorno 180)
    ¿Punteggio del questionario Short IBDQ
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 1, 5, 10, 12, 26, 40, 90 and 180 (depending on endpoint)
    Giorno 1, 5, 10, 12, 26, 40, 90 e 180 (a seconda 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 No
    E.6.4Safety Yes
    E.6.5Efficacy No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    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 No
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA25
    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
    Russian Federation
    Austria
    France
    Germany
    Greece
    Italy
    Poland
    United Kingdom
    Czechia
    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 months9
    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 months9
    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: 20
    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 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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Patients for whom written Informed Consent can only be obtained from
    a legally authorized representative.
    Pazienti per i quali il consenso informato scritto pu¿ essere ottenuto dal rappresentante legale autorizzato.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 31
    F.4.2.2In the whole clinical trial 40
    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)
    Not different from the expected normal treatment of the condition.
    Non sono previsti programmi particolari diversi dal normale trattamento della condizione 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 Decision2015-05-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-03-19
    P. End of Trial
    P.End of Trial StatusCompleted
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    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
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