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    The EU Clinical Trials Register currently displays   35918   clinical trials with a EudraCT protocol, of which   5893   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2014-003002-32
    Sponsor's Protocol Code Number:2819-MA-1003
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-05-29
    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 ConcernedPoland - Office for Medicinal Products
    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)
    Otwarte badanie oceniające farmakokinetykę fidaksomycyny w
    nieswoistym zapaleniu jelita (IBD) u pacjentów zakażonych Clostridium
    difficile (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 concomitantly an infection of the gut caused by bacteria called Clostridium difficile.
    Otwarte badanie oceniające farmakokinetykę fidaksomycyny w
    nieswoistym zapaleniu jelita (IBD) u pacjentów zakażonych Clostridium
    difficile (CDI).
    A.3.2Name or abbreviated title of the trial where available
    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 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 Europe B.V.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.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)
    Infekcja Clostridium difficile (CDI) powodująca występowanie biegunki
    E.1.1.1Medical condition in easily understood language
    Infection of the gut caused by bacteria called Clostridium difficile
    Infekcja jelit spowodowana bakterią 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 18.1
    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.
    Głównym celem badania jest ocena farmakokinetyki (PK) fidaksomycyny
    (FDX) i jej głównego metabolitu OP-1118 w osoczu u Uczestników z
    nieswoistym zapaleniem jelita (IBD) i infekcją C. difficile (CDI) w dniu 1,
    5 i 10 leczenia.
    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
    Porównanie odpowiedzi klinicznej CDI w stosunku do odpowiedzi mikrobiologicznej pod kątem wielkości obniżenia ogólnej liczby bakterii i
    zarodników C. difficile podczas leczenia FDX, a jeśli osiągnięto
    odpowiedź mikrobiologiczną, czasu do zwalczania drobnoustrojów.
    Określenie czasu do uzyskania negatywnego wyniku testu na obecność
    toksyny CDI w próbkach kału podczas leczenia FDX. Ocena stężenia FDX
    i jej metabolitu OP-1118 w kale z Dnia 1 leczenia, Dnia 5, Dnia 10. Ocena
    długości hospitalizacji, ponownych przyjęć i wykorzystania zasobów u
    Uczestników z IBD przyjmujących FDX w trakcie badania i do
    zakończenia badania (EOS) na Wizycie 8 (D180). Raportowanie
    występowania i nasilenie działań niepożądanych (AE) do zakończenia
    badania (EOS) na Wizycie 8 (D180). Ocena wpływu leczenia na Jakość
    Życia przez ocenę zmian w Krótkim Kwestionariuszu (IBDQ) od wizyty
    wyjściowej do Wizyty 3 (D10), Wizyty 5 (D26), Wizyty 6 (D40) i Wizyty
    7 (D90) do zakończenia badania.
    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.
    1. Uczestnik ma co najmniej 18 lat
    2. Potwierdzona diagnoza IBD lub potwierdzona historia choroby IBD
    przez co najmniej 3 miesiące
    3. Uczestnik cierpi na aktywne IBD definiowane przez CDI potwierdzone
    przez dodatni wynik badania na obecność C. difficile wykonanego
    zgodnie z lokalnymi standardami w ciągu 48 godzin przed randomizacją
    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
    1.Pacjent otrzymał więcej niż jedną dawkę jakiegokolwiek leczenia z powodu CDI na 48 godzin przed włączeniem do badania.
    2. Obecność stomii lub zespołu krótkiego jelita
    3. U pacjenta zdiagnozowano toksyczne rozszerzenie okrężnicy
    4. Pacjent wcześniej uczestniczył w badaniu szczepionki przeciwko CDI
    5. U pacjenta stwierdzono nadwrażliwość na fidaksomycynę lub
    którykolwiek z jej składników
    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.
    Pierwszorzędowymi punktami końcowymi są parametry farmakokinetyczne uzyskane dla stężeń zarówno FDX i OP-1118
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 1, 5 and 10
    W dniu 1, 5 i 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
    ● Odpowiedź kliniczna CDI w dniu 12 (TOC)
    ● Odpowiedź mikrobiologiczna w Dniu 5 i w Dniu 10 w zakresie ogólnej
    liczny bakterii C. difficile, liczby przetrwalników i ujemnego testu na
    toksyny CDI
    ● Stężenia FDX i jej metabolitu OP-1118 w kale podczas leczenia FDX
    ● Długość hospitalizacji, ponowne przyjęcia do szpitala i wykorzystanie
    zasobów szpitalnych
    ● Częstość występowania i nasilenie działań niepożądanych
    ● Krótka skala 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)
    W dniu 1, 5, 10, 12, 26, 40, 90 oraz 180 (w zależności od uzyskania punktów końcowych)
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other 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 concerned4
    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 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
    Czech Republic
    France
    Germany
    Greece
    Italy
    Poland
    Russian Federation
    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 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.
    Pacjenci od których Uzyskanie Świadomej Zgody nastąpi w obecności świadka
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    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.
    Bez różnic w stosunku do standardowego leczenia
    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 Decision2015-07-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-06-03
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-10-24
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