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    The EU Clinical Trials Register currently displays   35535   clinical trials with a EudraCT protocol, of which   5839   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2012-000531-88
    Sponsor's Protocol Code Number:FID-EC-0001
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-01-23
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2012-000531-88
    A.3Full title of the trial
    A Phase IIIb/IV Randomized, Controlled, Double-blind, Double-dummy, Parallel Group Study to Compare the Efficacy of Fidaxomicin to Vancomycin in the Sustained Clinical Cure of Clostridium Difficile Infection in Adults Receiving Immunosuppressive Therapy.
    Estudio en fase IIIb/IV, aleatorizado, controlado, doble-ciego, con doble-enmascaramiento y de grupos paralelos, para comparar la eficacia de Fidaxomicina frente a Vancomicina en relación con la curación clínica sostenida de la infección por Clostridium Difficile en adultos que reciben terapia inmunosupresora
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    This clinical study investigates the effect of fidaxomicin in comparison to vancomycin in adult patients with an infection of Clostridium difficile, and are using medicinal products that suppress the immune system.
    Este estudio clínico investiga los efectos de Fidaxomicina frente a Vancomicina en pacientes adultos que tienen una infección de Clostridium difficile y que reciben terapia inmunosupresora
    A.3.2Name or abbreviated title of the trial where available
    Freedom Study
    Estudio Freedom
    A.4.1Sponsor's protocol code numberFID-EC-0001
    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 pointGemma Waygood
    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 number441784415512
    B.5.6E-mailgemma.waygood@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 BV
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 (fidaxamicin)
    D.3.4Pharmaceutical form Capsule, hard
    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.3.9.3Other 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 Vancocin
    D.2.1.1.2Name of the Marketing Authorisation holderFlynn Pharma Ltd
    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 nameVancocin
    D.3.4Pharmaceutical form Capsule, hard
    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.3.9.3Other descriptive nameVancocin
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    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
    Adult patients with Clostridium difficile infection who are receiving immunosuppressive therapy.
    Pacientes adultos con infeccion Clostridium difficile y están recibiendo terapia inmunosupresora
    E.1.1.1Medical condition in easily understood language
    Adult patients with an infection of Clostridium difficile who are using medicinal products that suppress the immune system.
    Pacientes adultos con infeccion de Clostridium difficile que estan usando productos medicinales que deprimen el sistema inmune
    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 14.1
    E.1.2Level PT
    E.1.2Classification code 10061043
    E.1.2Term Clostridial infection
    E.1.2System Organ Class 10021881 - Infections and infestations
    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 demonstrate superiority of fidaxomicin versus vancomycin for the sustained clinical cure of Clostridium difficile Infection (CDI) in adult patients receiving immunosuppressive therapy. Sustained clinical cure is defined as clinical cure without recurrence within 14 days from Test of Cure (TOC).
    El objetivo principal del estudio es demostrar la superioridad de fidaxomicina frente a vancomicina en relación con la curación clínica sostenida de la infección por Clostridium difficile (ICD) en pacientes adultos que reciben terapia inmunosupresora.La curación clínica sostenida se define como la curación clínica sin recurrencia en los 14 días siguientes a la prueba de curación (TOC).
    E.2.2Secondary objectives of the trial
    not applicable
    No procede
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    A subject is eligible for the study if all of the following apply:
    1. Subject is 18 years of age or over.
    2. CDI is confirmed by clinical symptoms (see Section 5.2.3) and rapid CDI test (see Section 5.7)
    3. Subject has not been treated with medication or other therapy for CDI within the last 10 days.
    4. Subject is:
    ? receiving immunosuppressive therapy (chemotherapy) or is undergoing a stem cell transplant procedure (defined as the time period from the start of conditioning prior to transplant until 6 months after infusion of stem cells) for a hematological malignancy; or
    ? receiving immunosuppressive therapy (chemotherapy) for a solid tumor malignancy or following solid organ transplantation; or
    ? being treated with immunosuppressive and /or anti-TNF therapy for an auto-immune disease
    5. Subject has signed written informed consent.
    6. Any woman of childbearing potential requires negative serum or urine pregnancy test before entry to the study.
    7. Male and female subjects that are sexually active must agree to practice effective birth control during the study and for 30 days after the end of the study. (An effective method of birth control is defined as those which result in a low failure rate (CPMP/ICH/286/95 modified) of less than 1% per year when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intrauterine devices (IUDs), sexual abstinence or vasectomised partner).
    1. Pacientes ?18 años de edad.
    2. Confirmación de la ICD por los síntomas clínicos (véase la Sección 5.2.3) y prueba rápida ICD (véase la Sección 5.7).
    3. Pacientes que no hayan recibido medicación u otro tratamiento para la ICD en los últimos 10 días.
    4. Pacientes que:
    ? estén recibiendo terapia inmunosupresora (quimioterapia) o en proceso de recibir un trasplante de células madre (definido como el periodo de tiempo entre el inicio del acondicionamiento previo al trasplante y 6 meses después de la infusión de las células madre) para una neoplasia hematológica; o
    ? estén recibiendo terapia inmunosupresora (quimioterapia) por un tumor sólido maligno o después de un trasplante de órgano sólido; o
    ? se estén tratando con terapia inmunosupresora y/o anti-TNF para una enfermedad auto-inmune.
    5. Pacientes que hayan firmado el consentimiento informado por escrito.
    6. Cualquier mujer en edad fértil debe hacerse una prueba de embarazo en suero u orina antes de su inclusión en el estudio.
    7. Los hombres y mujeres sexualmente activos deberán utilizar métodos anticonceptivos eficaces durante el estudio y los 30 días siguientes al final del estudio. Se define como método anticonceptivo eficaz aquel que asocia una tasa de fracaso baja (CPMP/ICH/286/95 modificado), de menos del 1% al año, cuando se utiliza de forma constante y correcta, como pueden ser los implantes, los inyectables, los anticonceptivos orales combinados, algunos dispositivos intrauterinos (DIU), la abstinencia sexual o la pareja vasectomizada.
    E.4Principal exclusion criteria
    Subject will be excluded from participation in this study if any of the following apply:
    1. The subject has experienced more than one episode of CDI within the 3 months prior to study inclusion.
    2. Taking or requiring to be treated with prohibited medications listed in Section 5.1.3.2.
    3. Unable to take oral study medication.
    4. Female patients that are pregnant, intend to become pregnant or are breastfeeding.
    5. History of ulcerative colitis or Crohn?s disease.
    6. History or diagnosis of toxic megacolon or pseudomembranous colitis.
    7. Not willing to adhere to the provisions of treatment and procedures specified in the protocol.
    8. Has taken an investigational drug within 28 days 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.
    9. Hypersensitivity to fidaxomicin or any of its components.
    10. Hypersensitivity to vancomycin or any of its components.
    11. Any clinical condition which, in the opinion of the investigator, would not allow safe completion of this study.
    1. Pacientes con más de un episodio previo de ICD en los 3 meses previos a la inclusión en el estudio.
    2. Pacientes que reciben o necesitan recibir tratamiento con alguno de los medicamentos prohibidos incluidos en la Sección 5.1.3.2.
    3. Pacientes incapaces de tomar la medicación del estudio por vía oral.
    4. Pacientes embarazadas, que estén intentando quedarse embarazadas o en periodo de lactancia.
    5. Historial de enfermedad de Crohn o colitis ulcerosa.
    6. Historial o diagnóstico de megacolon tóxico o colitis pseudomembranosa.
    7. Pacientes que no están dispuestos a seguir el tratamiento y los procedimientos especificados en el protocolo.
    8. Pacientes que hayan tomado cualquier fármaco en investigación en los 28 días previos a la inclusión, o que estén participando actualmente en otro estudio clínico que pueda influir en la evaluación de la eficacia y/o seguridad de este estudio, según la opinión del Promotor.
    9. Hipersensibilidad a fidaxomicina o a cualquiera de sus componentes.
    10. Hipersensibilidad a vancomicina o a cualquiera de sus componentes.
    11. Cualquier situación clínica que, en opinión del investigador, no permita la terminación de este estudio en condiciones de seguridad.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint in this study is the rate of sustained clinical cure 14 days after TOC (at Day 26).
    La variable principal en este estudio es la curación clínica sostenida 14 dias después del TOC (día 26)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 26
    Dia 26
    E.5.2Secondary end point(s)
    not applicable
    No procede
    E.5.2.1Timepoint(s) of evaluation of this end point
    not applicable
    No procede
    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 No
    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) 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 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 Yes
    E.8.1.7.1Other trial design description
    doble enmascaramiento
    double dummy
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA40
    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
    Russian Federation
    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
    visit 4 at day 40
    Visita 4, día 40
    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 months0
    E.8.9.1In the Member State concerned days40
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days40
    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: 640
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 512
    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 No
    F.3.3.7Others Yes
    F.3.3.7.1Details of other specific vulnerable populations
    immunocompromised patients
    Pacientes inmunocomprometidos
    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 610
    F.4.2.2In the whole clinical trial 640
    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
    No
    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 Decision2012-10-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-10-05
    P. End of Trial
    P.End of Trial StatusCompleted
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