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   43801   clinical trials with a EudraCT protocol, of which   7272   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:2017-002491-10
    Sponsor's Protocol Code Number:Alofisel-4001
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-03-06
    Trial 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 number2017-002491-10
    A.3Full title of the trial
    Postauthorization Safety Study of the Long-Term Safety and Efficacy of Repeat Administration of Darvadstrocel in Patients With Crohn’s Disease and Complex Perianal Fistula (ASPIRE)
    Estudio de seguridad posautorización para evaluar la seguridad y la eficacia a largo plazo de la administración repetida de darvadstrocel en pacientes con enfermedad de Crohn y fístulas perianales complejas (ASPIRE)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Postauthorization Safety Study of Darvadstrocel Repeat Administration
    Estudio de seguridad posautorización de la administración repetida de darvadstrocel
    A.3.2Name or abbreviated title of the trial where available
    ASPIRE
    ASPIRE
    A.4.1Sponsor's protocol code numberAlofisel-4001
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1237-8388
    A.5.4Other Identifiers
    Name:not applicableNumber:not appliable
    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 SponsorMillennium Pharmaceuticals, Inc (MPI)
    B.1.3.4CountryUnited States
    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 supportMillennium Pharmaceuticals, Inc (MPI)
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMillennium Pharmaceuticals, Inc (MPI)
    B.5.2Functional name of contact pointClinical Science
    B.5.3 Address:
    B.5.3.1Street Address40 Landsdowne Street
    B.5.3.2Town/ cityCambridge MA
    B.5.3.3Post code02139
    B.5.3.4CountryUnited States
    B.5.4Telephone number0018575004680
    B.5.6E-mailSusanna.huh@takeda.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 Alofisel
    D.2.1.1.2Name of the Marketing Authorisation holderTakeda Pharma A/S, Dybendal Alle 10, 2630 Taastrup, Denmark
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/09/667
    D.3 Description of the IMP
    D.3.1Product nameCx601
    D.3.2Product code Cx601
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntralesional use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDarvadstrocel
    D.3.9.2Current sponsor codeAllogenic eASCs
    D.3.9.3Other descriptive nameExpanded human allogenic mesenchymal adult stem cells extracted from adipose tissue (eASCs
    D.3.9.4EV Substance CodeSUB190583
    D.3.10 Strength
    D.3.10.1Concentration unit Other
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5000000
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    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) Yes
    D.3.11.3.1Somatic cell therapy medicinal product Yes
    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
    Perianal fistulising Crohn´s disease
    Fistulización perianal en Enfermedad de Crohn
    E.1.1.1Medical condition in easily understood language
    Treatment for perianal fistulising Crohn´s disease
    Tratamiento para la fistulización perianal en Enfermedad de 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 PT
    E.1.2Classification code 10002156
    E.1.2Term Anal fistula
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the long-term safety of repeat administration of darvadstrocel in subjects with CD and complex perianal fistula by evaluation of AEs, serious adverse events (SAEs), adverse events of special interest (AESIs), and special situation reports (SSRs).
    Evaluar la seguridad a largo plazo de la repetición de la administración de darvadstrocel en sujetos con CD y fístulas perianales complejas, utilizando para ello los acontecimientos adversos (adverse events, AE), acontecimientos adversos graves (SAE), acontecimientos adversos de especial interés (adverse events of special interest, AESI) e informes de situaciones especiales (special situation reports, SSR).
    E.2.2Secondary objectives of the trial
    To evaluate the long-term efficacy of repeat administration of darvadstrocel in subjects with CD and complex perianal fistula.
    Evaluar la eficacia a largo plazo de la repetición de la administración de darvadstrocel en sujetos con CD y fístulas perianales complejas.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. In the opinion of the investigator, the subject is capable of understanding and complying with protocol requirements.
    2. The subject signs and dates a written, informed consent form (ICF) and any required privacy authorization before the initiation of any study procedures.
    3. The subject is male or female and aged 18 years or older.
    4. The subject has current complex, draining, perianal fistulas with controlled or mildly active CD (defined as patient reported outcomes measure derived from CDAI [PRO-2] score <14) who have already received treatment with darvadstrocel, and their physician has planned a repeat administration for the original tract or for a new fistula tract.
    5. A male subject who is nonsterilized* and sexually active with a female partner of childbearing potential agrees to use barrier method of contraception (e.g. condom with or without spermicide)* from signing of informed consent and until 1 year after repeat administration.
    6. A female subject of childbearing potential* who is sexually active with a nonsterilized male* partner agrees to use a highly effective/effective method of contraception* from signing of informed consent and until 1 year after repeat administration.
    1. En opinión del investigador, el sujeto es capaz de comprender y de cumplir los requisitos del protocolo.
    2. Antes del inicio de cualquier procedimiento del estudio, el sujeto firma y fecha un documento de consentimiento informado (informed consent form, ICF) por escrito y toda autorización acerca de la privacidad que se pueda precisar.
    3. El sujeto, de sexo masculino o femenino, tiene 18 o más años de edad.
    4. El sujeto presenta actualmente fístulas perianales complejas, con supuración, y CD controlada o de actividad leve (definida por una puntuación del resultado comunicado por el paciente (patient reported outcome) según el CDAI [PRO-2] <14), tratadas previamente con darvadstrocel, y para las que el médico ha programado la repetición de la administración del producto, en el tracto original o en un nuevo tracto fistuloso.
    5. Si se trata de un varón no sometido a esterilización y activo sexualmente con pareja femenina potencialmente fértil, está de acuerdo en utilizar un método anticonceptivo de barrera (preservativo, con o sin espermicida) desde el momento de la firma del consentimiento informado y hasta 1 año después de la repetición de la administración del producto.
    6. Si se trata de una mujer potencialmente fértil y activa sexualmente con una pareja masculina no esterilizada, la sujeto está de acuerdo en utilizar un método anticonceptivo altamente efectivo/efectivo desde el momento de la firma del consentimiento informado y hasta 1 año después de la repetición de la administración del producto.
    E.4Principal exclusion criteria
    1. The subject has lack of clinical response to prior treatment with darvadstrocel, where clinical response is defined as closure of at least 50% of all treated external fistula openings that were draining at baseline despite gentle finger compression.
    2. The subject has a history of hypersensitivity or allergies to darvadstrocel or related compounds.
    3. The subject has a history of hypersensitivity or allergies to penicillin or aminoglycosides; Dulbecco modified eagle medium; bovine serum; local anesthetics or gadolinium or MRI contrast.
    4. The subject is currently participating in other studies with darvadstrocel.
    5. The subject is currently receiving or has received any other investigational medicinal product (IMP) within the last 3 months before signing the ICF.
    6. If female, the subject is pregnant or breastfeeding, or intending to become pregnant before participating in this study, during the study, or intending to donate ova during such time period.
    7. If male, the subject intends to donate sperm during this study.
    8. The subject has a contraindication to MRI scan (eg, due to the presence of pacemaker, hip replacement, severe claustrophobia, or renal insufficiency as defined by local clinical guidelines).
    9. The subject has a contraindication to the anesthetic procedure.
    10. The subject has severe rectal and/or anal stenosis that would make it impossible to follow the surgery procedure.
    11. The subject has severe proctitis (rectal ulcers >0.5 cm) that would make it impossible to follow the surgery procedure.
    12. The subject has any prior invasive malignancy diagnosed within the last 3 years before screening visit. Subjects with basal cell carcinoma of the skin completely resected outside the perineal region can be included.
    13. The subject has a current or recent (within 6 months before the screening visit) history of severe, progressive, and/or uncontrolled hepatic, hematologic, gastrointestinal (other than CD), renal, endocrine, pulmonary, cardiac, neurologic, or psychiatric disease that may result in subject’s increased risk from study participation and/or lack of compliance with study procedures.
    14. The subject has had major surgery of the gastrointestinal tract within 6 months before screening, including local perianal surgery, other than curettage/draining for the fistula, and/or treatment with darvadstrocel within 6 months before study entry.
    15. The subject does not wish to or cannot comply with study procedures.
    1. El sujeto no ha mostrado respuesta clínica al tratamiento previo con darvadstrocel, definiéndose la respuesta clínica como el cierre, a pesar de su compresión digital suave, de como mínimo el 50% de todas las aperturas fistulosas externas tratadas que supuraban en el momento basal.
    2. El sujeto presenta antecedentes de hipersensibilidad o alergia al darvadstrocel o a productos relacionados.
    3. El sujeto tiene antecedentes de hipersensibilidad o alergia a penicilina o aminoglucósidos, medio de Eagle modificado por Dulbecco, suero bovino, anestésicos locales o gadolinio u otro contraste para la MRI.
    4. El sujeto está participando actualmente en otro estudio con darvadstrocel.
    5. El sujeto está recibiendo actualmente otro producto en investigación (investigational medicinal product (IMP) o lo ha recibido en el plazo de los 3 últimos meses antes de la firma del ICF.
    6. Si se trata de una mujer, la sujeto está embarazada o amamantando o planea quedarse embarazada antes de o durante su participación en el estudio, o desea donar óvulos durante dicho periodo de tiempo.
    7. Si se trata de un varón, el sujeto pretende donar semen durante el estudio.
    8. El sujeto presenta una contraindicación para la MRI (por ejemplo, marcapasos, prótesis de cadera, claustrofobia severa o insuficiencia renal según los criterios clínicos locales).
    9. El sujeto presenta contraindicación para el procedimiento anestésico.
    10. El sujeto presenta una estenosis rectal y/o anal severa que imposibilitaría el procedimiento quirúrgico.
    11. El sujeto presenta una proctitis severa (úlceras rectales >0,5 cm) que imposibilitaría el procedimiento quirúrgico.
    12. Se ha diagnosticado al sujeto una neoplasia maligna invasiva previa en el plazo de los 3 últimos años antes de la visita de selección (screening). Podrán participar en el estudio los sujetos con carcinoma cutáneo de células basales fuera de la región perineal completamente resecado.
    13. El sujeto presenta historia actual o reciente (en el plazo de los 6 meses anteriores a la visita de selección) de enfermedad severa, progresiva y/o no controlada de carácter hepático, hematológico, gastrointestinal (distinta de la CD), renal, endocrino, pulmonar, cardiaco, neurológico o psiquiátrico que puede suponerle un mayor riesgo por su participación en el estudio y/o el incumplimiento con los procedimientos del estudio.
    14. El sujeto ha sido sometido a cirugía mayor del tracto gastrointestinal en el plazo de los 6 meses anteriores a la selección, lo que incluye la cirugía perianal local (distinta del curetaje/drenaje de la fístula) , y/o a tratamiento con darvadstrocel en el plazo de los 6 meses anteriores a la entrada en el estudio.
    15. El sujeto no acepta o no puede cumplir los procedimientos del estudio
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of the study will include assessment of the following safety parameters:
    - Incidence of treatment-emergent adverse events
    - Incidence of treatment-emergent SAEs
    - SSRs (pregnancy)
    - Specific AESIs, including:
    – Immunogenicity/alloimmune reactions
    – Hypersensitivity
    – Transmission of infectious agents
    – Tumorgenicity
    – Ectopic tissue formation
    – Medication errors
    El objetivo principal de la seguridad se evaluará mediante los siguientes parámetros de seguridad:
    ·Incidencia de acontecimientos adversos emergentes en el tratamiento
    ·Incidencia de acontecimientos adversos emergentes en el tratamiento graves
    ·SSR (embarazo)
    ·AESI específicos, incluyendo:
    –Reacción de inmunogenia/aloinmunitaria
    –Hipersensibilidad
    –Transmisión de agentes infecciosos
    –Tumorigenia
    –Formación de tejido ectópico
    –Errores de medicación
    E.5.1.1Timepoint(s) of evaluation of this end point
    Subjects will be assessed before repeat administration at the baseline and preparatory visit, and at Weeks 6 (±8 days), 24 (±15 days), 52 (±15 days), 104 (±30 days), and 156 (±30 days) following repeat administration. The Week 6 assessment will be primarily to capture immunogenicity/donor-specific antibody (DSA)/soluble factors.
    Blood samples for central laboratory tests will be collected at baseline, Weeks 24 (±15 days), 156 (±30 days), and the
    early termination visit. Blood samples for DSA levels and exploratory immunogenicity testing will be collected at the
    baseline visit and at Weeks 6 (±8 days), 24 (±15 days), and 156 (±30 days). Blood samples for these tests will be
    analyzed in batches as the study progresses, and available results will be provided with the interim reports.
    Los sujetos se evaluarán antes de la repetición de la administración en la visita basal y preparatoria, y en las Semanas 6 (±8 días), 24 (±15 días), 52 (±15 días), 104 (±30 días) y 156 (±30 días) después de la repetición de la administración. El objeto principal de la evaluación de la Semana 6 es obtener información sobre inmunogenia/anticuerpos específicos del donante (DSA)/factores solubles.
    Se obtendrán muestras de sangre para estudio en el laboratorio central en el momento basal, Semanas 24 (±15 días) y 156 (±30 días) y en la visita de retirada prematura. Se obtendrán muestras de sangre para niveles de DSA y estudios de inmunogenia exploratorios en la visita basal y en las Semanas 6 (±8 días), 24 (±15 días) y 156 (±30 días).
    Para mas información ver protocolo
    E.5.2Secondary end point(s)
    Efficacy will be assessed by evaluating the following endpoints:
    - Proportion of subjects who achieve combined remission of perianal fistula(s) at Weeks 24 and
    156 after investigational medicinal product (IMP) administration.
    > Combined remission of complex perianal fistula(s) is defined as the closure of all treated
    external openings that were draining at baseline (ie, screening visit), despite gentle finger
    compression,
    AND
    > Absence of collection(s) >2 cm (in at least 2 dimensions) of the treated perianal fistula(s)
    confirmed by central MRI assessment.

    - Proportion of subjects who achieve clinical remission at Weeks 24, 52, 104, and 156 after IMPadministration.
    > Clinical remission is defined as closure of all treated external fistula openings that were draining at baseline despite gentle finger compression.

    - Proportion of subjects who achieve clinical response at Weeks 24, 52, 104, and 156 after IMP
    administration.
    > Clinical response is defined as closure of at least 50% of all treated external fistula
    openings that were draining at baseline despite gentle finger compression.

    - Proportion of subjects with relapse.
    > Relapse is defined as reopening of any of the treated fistula(s) external openings that were
    in clinical remission at Week 24, with active drainage as clinically assessed,
    OR
    > The development of a perianal fluid collection >2 cm (in at least 2 dimensions) confirmed
    by centrally read MRI assessment.

    - Time in days from Week 24 to reopening of any of the treated external openings with active drainage as clinically assessed OR the presence of collection(s) >2 cm (in at least 2 dimensions) of the treated perianal fistulas confirmed by centrally read MRI assessment.

    - Proportion of subjects with new anal abscess in treated fistula.

    - Change from baseline to Weeks 6, 24, 52, 104, and 156 after IMP administration in scores of discharge and pain items of Perianal Disease Activity Index (PDAI) score.
    Se evaluará la eficacia mediante los siguientes criterios de valoración:
    ·Porcentaje de sujetos que alcanzan una remisión combinada de la fístula(s) perianal en las Semanas 24 y 156 tras la administración del IMP.
    > Se define como remisión combinada de la fistula(s) perianal compleja el cierre, a pesar de su compresión digital suave, de todas las aperturas externas tratadas que supuraban en el momento basal (esto es, en la visita de selección),
    Y
    > Ausencia de absceso(s) >2 cm (en como mínimo 2 dimensiones) de la fístula(s) perianal tratada, confirmado por lectura central de la MRI.

    · Porcentaje de sujetos que alcanzan la remisión clínica en las Semanas 24, 52, 104 y 156 tras la administración del IMP.
    > Se define como remisión clínica el cierre, a pesar de su compresión digital suave, de todas las aperturas externas de las fístulas tratadas que supuraban en el momento basal

    · Porcentaje de sujetos que alcanzan la respuesta clínica en las Semanas 24, 52, 104 y 156 tras la administración del IMP
    > Se define como respuesta clínica el cierre, a pesar de su compresión digital suave, de como mínimo el 50% de todas las aperturas externas de las fístulas tratadas que supuraban en el momento basal

    ·Porcentaje de sujetos con recaída.
    > Se define la recaída como la reapertura de la apertura externa de una fistula(s) tratada que se encontraba en remisión clínica en la Semana 24, con evidencia de supuración activa,
    O BIEN
    > El desarrollo de un absceso perianal >2 cm (en como mínimo 2 dimensiones), confirmado por lectura central de la MRI.
    ·Tiempo en días desde la Semana 24 a la reapertura de cualquiera de las aperturas externas tratadas, con evidencia de supuración activa.

    ·Porcentaje de sujetos con un nuevo absceso anal en la fístula tratada.

    ·Variación entre el basal y las Semanas 6, 24, 52, 104 y 156 tras la administración del IMP en las puntuaciones de los elementos de supuración (discharge) y dolor (pain) del Perianal Disease Activity Index (PDAI).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Subjects will be assessed before repeat administration at the baseline and preparatory visit, and at Weeks 6 (±8 days),
    24 (±15 days), 52 (±15 days), 104 (±30 days), and 156 (±30 days) following repeat administration.
    Los sujetos se evaluarán antes de la repetición de la administración en la visita basal y preparatoria, así como en las Semanas 6 (±8 días), 24 (±15 días), 52 (±15 días), 104 (±30 días) y 156 (±30 días) después de la repetición de la administración
    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 Yes
    E.6.13.1Other scope of the trial description
    To assess the effect of darvadstrocel on microbiome diversity (optional).
    Evaluar el efecto de darvadstrocel sobre la diversidad del microbioma (opcional)
    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 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.8.2.4Number of treatment arms in the trial1
    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 EEA25
    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 No
    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 years4
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months10
    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: 42
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 8
    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 No
    F.4 Planned number of subjects to be included
    F.4.1In the member state13
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 50
    F.4.2.2In the whole clinical trial 50
    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)
    No post-trial medication will be provided.
    No será provista ninguna medicación post-ensayo
    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 Decision2020-06-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-06-02
    P. End of Trial
    P.End of Trial StatusOngoing
    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 © 1995-2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA