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   43861   clinical trials with a EudraCT protocol, of which   7284   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:2011-006064-43
    Sponsor's Protocol Code Number:Cx601-0302
    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:2012-02-28
    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 number2011-006064-43
    A.3Full title of the trial
    A phase III, randomised, double blind, parallel group, placebo controlled, multicentre study to assess efficacy and safety of expanded allogeneic adipose-derived stem cells (eASCs) for the treatment of perianal fistulising Crohn?s disease over a period of 24 weeks. ADMIRE-CD study.
    Estudio fase III, multicéntrico, aleatorizado, doble ciego, de grupos paralelos y controlado con placebo para evaluar la eficacia y la seguridad de células madre alogénicas expandidas derivadas del tejido adiposo (eASC) para el tratamiento de la enfermedad de Crohn fistulizante perianal tras un periodo de 24 semanas. Estudio ADMIRE-CD.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to assess efficacy and safety of stem cells derived from allogeneic adipose tissue for the treatment of perianal fistulas in patients with Crohn?s disease.
    Estudio para evaluar la eficacia y seguridad de las células madres de tejido adiposo alogénico para el tratamiento de fístula perianal en pacientes con la enfermedad de Crohn
    A.3.2Name or abbreviated title of the trial where available
    ADMIRE-CD study
    Estudio ADMIRE-CD.
    A.4.1Sponsor's protocol code numberCx601-0302
    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 SponsorCELLERIX, S.A
    B.1.3.4CountrySpain
    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 supportCELLERIX, S.A
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCELLERIX, S.A
    B.5.2Functional name of contact pointClinical Operations
    B.5.3 Address:
    B.5.3.1Street AddressC/Marconi, 1. Parque Tecnológico de Madrid.
    B.5.3.2Town/ cityTres Cantos. Madrid
    B.5.3.3Post code28760
    B.5.3.4CountrySpain
    B.5.4Telephone number+3491804 9264
    B.5.5Fax number+3491804 9263
    B.5.6E-maillydia.dorrego@tigenix.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 No
    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 nameSuspensión Cx601 (5 millones de células/ml) para inyección intralesional.
    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.3.9.2Current sponsor codeAllogenic eASCs
    D.3.9.3Other descriptive nameCélulas alogénicas expandidas derivadas del tejido adiposo de adulto (eASC)
    D.3.10 Strength
    D.3.10.1Concentration unit U/ml unit(s)/millilitre
    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) Yes
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSuspension for injection
    D.8.4Route of administration of the placeboIntralesional use
    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
    Enfermedad de Crohn de fístulas perianales
    E.1.1.1Medical condition in easily understood language
    Treatment for perianal fistulising
    Crohn´s desease
    Tratamiento para la Enfermedad de Crohn de fístulas perianales.
    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 14.1
    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
    Evaluate the efficacy and safety of eASCs compared to placebo for the treatment of perianal fistulising Crohn?s disease over a 24-week period.
    Evaluar la eficacia y la seguridad de las eASC en comparación con placebo para el tratamiento de las fístulas complejas en la enfermedad de Crohn perianal fistulizante tras un período de 24 semanas.
    E.2.2Secondary objectives of the trial
    There are not secondary objectives
    No hay objetivos secundarios
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    (1) Signed informed consent.
    (2) Patients with Crohn?s Disease (CD) diagnosed at least 6 months earlier in accordance with accepted clinical, endoscopic, histological and/or radiologic criteria.
    (3) Presence of complex perianal fistulas with a maximum of 2 fistulas (internal openings) and a maximum of 3 external openings, assessed by clinical assessment and MRI. Fistula must have been draining for at least 6 weeks prior to the inclusion.
    A complex perianal fistula is defined as a fistula that met one or more of the following criteria during its evolution:
    ? High inter-sphincteric, trans-sphincteric, extra-sphincteric or supra-sphincteric.
    ? Presence of ? 2 external openings (tracts).
    ? Associated collections
    (4) Non-active or mildly active luminal CD defined by a CDAI ? 220.
    (5) Patients of either sex aged 18 years or older
    (6) Good general state of health according to clinical history and a physical examination.
    (7) For women of a childbearing age, they must have negative serum or urine pregnancy test (sensitive to 25 IU human chorionic gonadotropin [hCG]). Both men and women should use appropriate birth control methods defined by the investigator.
    (1) Consentimiento informado firmado.
    (2) Pacientes con enfermedad de Crohn (EC) diagnosticada al menos con 6 meses de anterioridad según criterios clínicos, endoscópicos, histológicos o radiológicos aceptados.
    (3) Presencia de fístulas perianales complejas, con un máximo de 2 fístulas (orificios internos) y un máximo de 3 orificios externos, valoradas mediante evaluación clínica y RM. Las fístulas deben haber supurado durante al menos 6 semanas antes de la inclusión.
    Una fístula perianal compleja se define como una fístula que cumple uno o más de los criterios siguientes durante su evolución:
    ? Interesfinteriana alta, transesfinteriana, extraesfinteriana o supraesfinteriana.
    ? Presencia de ? 2 orificios externos (tractos fistulosos).
    ? Colecciones asociadas
    (4) EC luminal inactiva o ligeramente activa, definida por un CDAI ? 220.
    (5) Pacientes de ambos sexos de 18 o más años de edad
    (6) Buen estado general de salud según la historia clínica y la exploración física.
    (7) Las mujeres en edad fértil deben tener un resultado negativo en una prueba de embarazo en suero u orina (sensible a 25 UI de gonadotropina coriónica humana [hCG]). Tanto los varones como las mujeres deben usar métodos anticonceptivos adecuados definidos por el investigador.
    E.4Principal exclusion criteria
    (1) Presence of dominant luminal active Crohn?s disease requiring immediate therapy.
    (2) CDAI >220.
    (3) Concomitant rectovaginal fistulas
    (4) Patient naïve to specific treatment for perianal fistulising Crohn?s disease including antibiotics
    (5) Presence of an abscess or collections > 2 cm, unless resolved in the preparation procedure (week -3 to day 0).
    (6) Presence of > 2 fistular lesions.
    (7) Presence of > 3 external openings.
    (8) Rectal and/or anal stenosis and / or active proctitis, if this means a limitation for any surgical procedure.
    (9) Patient who underwent surgery for the fistula other than drainage or seton placement.
    (10) Patient with diverting stomas
    (11) Patient with ongoing steroid treatment or treated with steroids in the last 4 weeks
    (12) Renal impairment defined by creatinine clearance below 60 ml/min calculated using Cockcroft-Gault formula or by serum creatinine ? 1.5 x upper limit of normality (ULN)
    (13) Hepatic impairment defined by both of the following laboratory ranges:
    ? Total bilirubin ? 1.5 x ULN
    ? AST and ALT ? 2.5 x ULN
    (14) Known history of abuse of alcohol or other addictive substances in the 6 months prior to inclusion.
    (15) Malignant tumour or patients with a prior history of any malignant tumour, including any type of fistula carcinoma.
    (16) Current or recent history of abnormal, severe, progressive, uncontrolled hepatic, haematological, gastrointestinal (except CD), endocrine, pulmonary, cardiac, neurological, psychiatric, or cerebral disease.
    (17) Congenital or acquired immunodeficiencies.
    (18) Known allergies or hypersensivity to antibiotics including but not limited to penicillin, streptomycin, gentamicin, aminoglycosides; HSA (Human Serum Albumin); DMEM (Dulbecco Modified Eagle?s Medium); materials of bovin origin; local anaesthetics or gadolinium (MRI contrast).
    (19) Contraindication to MRI scan, (e.g., due to the presence of pacemakers, hip replacements or severe claustrophobia).
    (20) Major surgery or severe trauma within the previous 6 months.
    (21) Pregnant or breastfeeding women.
    (22) Patients who do not wish to or cannot comply with study procedures.
    (23) Patients currently receiving, or having received within 3 months prior to enrolment into this clinical study, any investigational drug.
    (24) Subjects who need surgery in the perianal region for reasons other than fistulas at the time of inclusion in the study, or for whom such surgery is foreseen in this region in the 24 weeks after treatment administration.
    (25) Contraindication to the anaesthetic procedure.
    (1) Presencia de enfermedad de Crohn activa luminal dominante con necesidad de tratamiento inmediato.
    (2) CDAI > 220
    (3) Fístulas rectovaginales concomitantes
    (4) El paciente nunca ha recibido tratamiento específico para la enfermedad de Crohn fistulizante perianal, incluidos antibióticos
    (5) Presencia de un absceso o colecciones > 2 cm, a menos que se resuelvan en el procedimiento de preparación (semana -3 a día 0).
    (6) Presencia de > 2 lesiones fistulosas.
    (7) Presencia de > 3 orificios externos.
    (8) Estenosis rectal o anal o proctitis activa, si esto se supone una limitación para cualquier procedimiento quirúrgico.
    (9) Paciente sometido a una intervención quirúrgica de la fístula distinta de drenaje o colocación de setón.
    (10) Pacientes con estomas derivativos
    (11) Pacientes en tratamiento con esteroides o tratados con esteroides en las 4 semanas precedentes
    (12) Insuficiencia renal definida por un aclaramiento de creatinina inferior a 60 ml/min calculado mediante la fórmula de Cockcroft Gault o una creatinina sérica ? 1,5 x límite superior de la normalidad (LSN)
    (13) Insuficiencia hepática definida por los siguientes intervalos analíticos:
    ? Bilirrubina total ? 1,5 x LSN
    ? AST y ALT ? 2,5 x LSN
    (14) Antecedentes conocidos de abuso de alcohol u otras sustancias adictivas en los 6 meses previos a la inclusión.
    (15) Tumor maligno o pacientes con antecedentes de cualquier tumor maligno, incluido cualquier tipo de carcinoma fistuloso.
    (16) Presencia o antecedentes recientes de enfermedad renal, hepática, hematológica, digestiva (salvo la EC), endocrina, pulmonar, cardíaca, neurológica, psiquiátrica o cerebral anormal, grave, progresiva o no controlada.
    (17) Inmunodeficiencias congénitas o adquiridas.
    (18) Alergia o hipersensibilidad conocida a antibióticos, por ejemplo, penicilina, estreptomicina, gentamicina y aminoglucósidos; HSA (seroalbúmina humana); DMEM (medio de Eagle modificado por Dulbecco); materiales de origen bovino; anestésicos locales o gadolinio (contraste para RM).
    (19) Contraindicación de la RM (p. ej., por la presencia de un marcapasos, artroplastia o claustrofobia grave).
    (20) Intervención de cirugía mayor o traumatismo grave en los 6 meses anteriores.
    (21) Mujeres embarazadas o en periodo de lactancia.
    (22) Pacientes que no deseen o no puedan cumplir los procedimientos del estudio.
    (23) Pacientes que estén recibiendo actualmente cualquier fármaco en investigación, o lo hayan recibido en los 3 meses previos a la inscripción en este estudio clínico.
    (24) Pacientes que requieran cirugía en la región perianal por motivos distintos de las fístulas en el momento de la inclusión en el estudio o que tengan previsto operarse en esta región en las 24 semanas siguientes a la administración del tratamiento.
    (25) Contraindicación del procedimiento anestésico.
    E.5 End points
    E.5.1Primary end point(s)
    Remission of perianal fistulising Crohn?s disease at week 24 confirmed by MRI, defined as the clinical assessment of closure of all the external openings that were draining at baseline despite gentle finger compression at week 24, confirmed by MRI as absence of collections > 2 cm of the treated perianal fistulas at 24 weeks (central blind assessment).
    Remisión de la enfermedad de Crohn fistulizante perianal en la semana 24 confirmada mediante RM, definida como la verificación clínica del cierre de todos los orificios externos que supuren en el momento basal tras una presión suave con los dedos en la semana 24, confirmada por RM como ausencia de colecciones > 2 cm de las fístulas perianales tratadas a las 24 semanas (evaluación enmascarada centralizada).
    E.5.1.1Timepoint(s) of evaluation of this end point
    24 weeks
    24 semanas
    E.5.2Secondary end point(s)
    Secondary efficacy endpoints will include:
    ? To evaluate the response, defined as closure of at least 50% of all external openings that were draining at baseline.
    ? To assess the time to remission (first visit with closure of all draining tracts despite gentle finger compression as clinically assessed)
    ? To assess the time to response (first visit with closure of at least 50% of all external openings that were draining at baseline).
    ? To evaluate the changes in the Severity of perianal Crohn?s disease, assessed with the Perianal Disease Activity Index (PDAI)-
    ? To evaluate the changes in the Quality of Life (QoL) assessed by the Inflammatory Bowel Disease Questionnaire (IBDQ).
    The safety assessment of the eASCs will be part of the secondary endpoints and it will include adverse events, clinical findings on physical examination, vital signs or laboratory tests, and the Crohn?s Disease Activity Index (CDAI).
    Eficacia:
    ? Respuesta, definida como el cierre de al menos el 50% de todos los orificios externos que supuren en el momento basal.
    ? Tiempo hasta la remisión (primera visita con cierre de todos los orificios externos que supuren en el momento basal, según la evaluación clínica).
    ? Tiempo hasta la respuesta (primera visita con cierre de al menos el 50% de todos los orificios externos que supuren en el momento basal, según la evaluación clínica).
    ? Gravedad de la enfermedad de Crohn perianal, evaluada con el Índice de actividad de la enfermedad perianal (PDAI).
    ? Calidad de vida, evaluada con el Cuestionario de la enfermedad inflamatoria intestinal (IBDQ)
    Seguridad:
    ? Acontecimientos adversos
    ? Exploración física
    ? Constantes vitales
    ? Pruebas analíticas (bioquímica, hematología análisis de orina)
    ? Puntuación del CDAI
    E.5.2.1Timepoint(s) of evaluation of this end point
    at 6, 12, 18 and 24 weeks after the treatment
    Despues de la semana 6, 12, 18 y 24 de tratamiento
    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 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) No
    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 No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    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 concerned11
    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
    Austria
    Belgium
    France
    Germany
    Israel
    Italy
    Netherlands
    Spain
    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
    Final study:Last visit of the last subject undergoing the trial.
    If the study is prematurely terminated or suspended for any reason, the reasons for terminating the study may include, but are not limited to the following:
    ? Incidence or severity of AE indicating a potential health hazard to subjects.
    ? Subject enrolment is unsatisfactory.
    ? Investigator does not adhere to protocol or applicable regulatory guidelines in conducting the study.
    ? Ethical or medical reasons.
    Final del estudio: La última visita del último paciente activo del estudio.Como motivos de terminación prematura del estudio pueden citarse, a título meramente indicativo, los siguientes:
    ? La incidencia o la intensidad de los AA indican un posible riesgo para la salud de los pacientes.
    ? La inclusión de pacientes es insatisfactoria.
    ? El investigador no cumple el protocolo o las disposiciones reglamentarias aplicables al realizar el estudio.
    ? Razones éticas o médicas.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    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 years2
    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: 139
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 69
    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 state55
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 183
    F.4.2.2In the whole clinical trial 208
    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)
    Compasive use
    Uso compasivo
    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 Decision2012-05-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-04-13
    P. End of Trial
    P.End of Trial StatusCompleted
    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-Thu Apr 25 22:45:00 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA