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The European Union Clinical Trials Register allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   41189   clinical trials with a EudraCT protocol, of which   6743   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2015-003007-38
    Sponsor's Protocol Code Number:56021927PCR3003
    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:2015-11-05
    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 number2015-003007-38
    A.3Full title of the trial
    A Randomized, Double-blind, Placebo-controlled Phase 3 Study of JNJ56021927 in Subjects with High-risk, Localized or Locally Advanced Prostate Cancer Receiving Treatment with Primary Radiation Therapy
    Estudio fase 3 aleatorizado, doble-ciego y controlado con placebo de JNJ-56021927 en sujetos con cáncer de próstata localizado o localmente avanzado y de alto riesgo que estén recibiendo tratamiento con radioterapia primaria
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An Efficacy and Safety Study of JNJ56021927 (ARN509) in High-risk Prostate Cancer Subjects Receiving Primary Radiation Therapy: ATLAS
    Estudio de eficacia y seguridad de JNJ56021927 (ARN509) en sujetos con cáncer de próstata de alto riesgo que están recibiendo tratamiento con radioterapia primaria
    A.4.1Sponsor's protocol code number56021927PCR3003
    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 SponsorJanssen-Cilag International NV
    B.1.3.4CountryBelgium
    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 supportJanssen-Cilag International NV
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJanssen-Cilag, S.A.
    B.5.2Functional name of contact pointGlobal Clinical Operations Spain
    B.5.3 Address:
    B.5.3.1Street AddressPaseo de las Doce Estrellas, 5-7
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28042
    B.5.3.4CountrySpain
    B.5.4Telephone number34917228100
    B.5.5Fax number34917228628
    B.5.6E-mailagonza45@its.jnj.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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.2Product code JNJ-56021927
    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 INNNot assigned
    D.3.9.1CAS number 956104-40-8
    D.3.9.2Current sponsor codeJNJ-56021927
    D.3.9.3Other descriptive nameJNJ-56021927-AAA
    D.3.9.4EV Substance CodeSUB127215
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    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 Casodex
    D.2.1.1.2Name of the Marketing Authorisation holderActavis Group PTC ehf.
    D.2.1.2Country which granted the Marketing AuthorisationIceland
    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 nameBicalutamide
    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 INNBICALUTAMIDE
    D.3.9.1CAS number 90357-06-5
    D.3.9.4EV Substance CodeSUB05817MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    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
    Low-volume Metastatic Hormone-sensitive Prostate Cancer (mHSPC)
    Cáncer de próstata metastásico hormonosensible (CPmHS) de baja carga tumoral
    E.1.1.1Medical condition in easily understood language
    Prostate Cancer
    Cáncer de Próstata
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level PT
    E.1.2Classification code 10036909
    E.1.2Term Prostate cancer metastatic
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine if JNJ-56021927 plus gonadotropin releasing hormone (GnRH) agonist in subjects with high-risk, localized or locally advanced prostate cancer receiving primary radiation therapy (RT) results in an improvement of metastasis-free survival (MFS) evaluated by blinded independent central review (BICR)
    Determinar si JNJ-56021927 junto con el agonista de la hormona liberadora de gonadotropina (GnRH) en pacientes con cáncer de próstata de alto riesgo localizado o localmente avanzado que están recibiendo radioterapia (RT) primaria produce una mejora de la supervivencia sin metástasis (SSM) evaluada mediante una revisión central independiente y enmascarada (RCIE).
    E.2.2Secondary objectives of the trial
    - To characterize the safety profile of JNJ-56021927 plus GnRH agonist in subjects with high-risk, localized or locally advanced prostate cancer receiving primary RT
    - To determine if JNJ-56021927 plus GnRH agonist in subjects with high-risk, localized or locally advanced prostate cancer receiving primary RT results in an improvement of:
    - Time to local-regional recurrence
    - Time to castration-resistant prostate cancer (CRPC)
    - Time to distant metastasis
    - Overall survival (OS)
    Determinar si JNJ-56021927 junto con un agonista de la GnRH en pacientes con cáncer de próstata de alto riesgo localizado o localmente avanzado que están recibiendo RT primaria produce una mejora de:
    - Tiempo hasta la recurrencia local-regional
    - Tiempo hasta el cáncer de próstata resistente a la castración (CPRC)
    - Tiempo hasta la metástasis a distancia
    - La supervivencia global (SG)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age >= 18 years
    - Indicated and planned to receive primary radiation therapy for prostate cancer
    - Histologically confirmed adenocarcinoma of an intact prostate, and 1 of the following at diagnosis:
    1) Gleason score >=8 and >=cT2c,
    2) Gleason score >=7, PSA >=20 nanogram per mililiters (ng/mL), and >=cT2c
    - Charlson comorbidity index (CCI) <=3
    - An Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) grade of 0 or 1
    - Adequate liver function: aspartate aminotransferase (AST), alanine aminotransferase (ALT), <2 * upper limit of normal (ULN) and total bilirubin <1.5 * ULN
    - Participants who are sexually active (even men with vasectomies) and willing to use a condom and agree not to donate sperm during the trial
    - Signed, written, informed consent
    - Be able to swallow whole study drug tablets
    Varones >= 18 años de edad - Todos los pacientes deben firmar un documento de consentimiento informado (DCI) que indique que entienden el objetivo del estudio y los procedimientos que exige y que están dispuestos a participar en él y a cumplir las prohibiciones y restricciones que se especifican en este protocolo (Sección 4.3).
    - Indicado y previsto que reciba RT primaria para el cáncer de próstata. - Diagnóstico confirmado, histológica o citológicamente, de adenocarcinoma de próstata intacta y una de las siguientes observaciones en el momento del diagnóstico: 1) Puntuación de Gleason >=8 y >=cT2c 2) Puntuación de Gleason >=7, PSA >=20 ng/ml, y >=cT2c - Índice de comorbididad de Charlson (CCI) <=3 (Anexo 1) - Estado funcional (EF) del Eastern Cooperative Oncology Group (ECOG) de 0 o 1 (Anexo 2). 7. Función hepática suficiente determinada por los
    siguientes valores del laboratorio central: Aspartato-aminotransferasa
    (AST)/alanina-aminotransferasa (ALT) < 2 x límite superior de la normalidad (LSN) y Bilirrubina total <1,5 x límite superior de la normalidad (LSN) [NOTA: En los pacientes con síndrome de Gilbert, si la bilirrubina total es >1,5 x LSN, hay que medir la bilirrubina directa e indirecta y, si la bilirrubina directa es 1,5 x LSN, el paciente es apto para el estudio] - Con el fin de evitar el riesgo de exposición al fármaco a través del eyaculado (incluso los varones con vasectomía), los pacientes deben usar un preservativo durante las relaciones sexuales mientras reciban el fármaco del estudio y durante 3 meses después de la última dosis de dicho medicamento. No se permite donar semen durante la fase de tratamiento y en los 3 meses siguientes a la última dosis del medicamento del estudio. - Deben ser capaces de tragar enteros los comprimidos de fármaco del estudio.
    E.4Principal exclusion criteria
    - Presence of distant metastasis, including pelvic nodal disease below the iliac bifurcation >2 cm in the short axis
    - Prior treatment with GnRH analogue or antiandrogen or both for >3 months prior to randomization
    - Bilateral orchiectomy
    - History of pelvic radiation
    - Prior systemic (eg, chemotherapy) or procedural (eg, prostatectomy, cryotherapy) treatment for prostate cancer
    - History of seizure or condition that may predispose to seizure (including, but not limited to prior stroke, transient ischemic attack or loss of consciousness <= 1 year prior to randomization? brain arteriovenous malformation? or intracranial masses such as
    schwannomas and meningiomas that are causing edema or mass effect)
    - Prior treatment with enzalutamide, abiraterone acetate, orteronel, galeterone, ketoconazole, aminoglutethimide, estrogens, megestrol acetate, and progestational agents for prostate cancer
    - Prior treatment with radiopharmaceutical agents (eg, strontium 89) or immunotherapy (eg, sipuleucel-T) for prostate cancer
    - Prior treatment with systemic glucocorticoids ?4 weeks prior to randomization or is expected to require long-term use of corticosteroids during the study
    - Use of 5-alpha reductase inhibitors (eg, dutasteride, finasteride) <=4 weeks prior to randomization
    - Use of any investigational agent <=4 weeks prior to randomization
    - Current chronic use of opioid analgesics for >=3 weeks for oral or >7 days for non-oral
    formulations
    - Major surgery <=4 weeks prior to randomization
    - Current or prior treatment with antiepileptic medications for the treatment of seizures
    - Gastrointestinal conditions affecting absorption
    - Known or suspected contraindications or hypersensitivity to JNJ-56021927, bicalutamide or GnRH agonists or any of the components of the formulations
    - Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the subject
    - Presencia de metástasis a distancia, incluida enfermedad nodal pélvica por debajo de la bifurcación ilíaca > 2 cm en el eje corto - Tratamiento previo con un análogo de la GnRH o antiandrogénico o ambos > 3 meses antes de la aleatorización Orquiectomía bilateral - Antecedentes de irradiación pélvica - Tratamiento previo
    sistémico (por ejemplo, quimioterapia) o mediante algún procedimiento (por ejemplo, prostatectomía, crioterapia) para el cáncer de próstata - Tratamiento previo con enzalutamida, acetato de abiraterona, orteronel, galeterona, ketoconazol, aminoglutetimida, estrógenos, acetato de megestrol y agentesprogestágenos para el cáncer de próstata - Tratamiento previo con agentes radiofarmacéuticos (por ejemplo, estroncio-89) o inmunoterapia (por ejemplo, sipuleucel-T) para el cáncer de próstata - Tratamiento previo con glucocorticoides sistémicos 4 semanas antes de la aleatorización o probabilidad de que vaya a necesitar uso a largo plazo de corticosteroides durante el estudio - Uso de inhibidores de la 5-reductasa (por ejemplo, dutasterida, finasterida) 4 semanas
    antes de la aleatorización - Uso de cualquier fármaco en investigación 4 semanas antes de la aleatorización - Uso crónico presente de analgésicos opioides durante 3 semanas para fármacos orales o 7 días para formulaciones no orales - Cirugía mayor 4 semanas previas a la aleatorización - Antecedentes de crisis convulsiva o de trastorno que predisponga a estas crisis (entre ellos, accidente cerebrovascular
    previo, accidente isquémico transitorio o pérdida del conocimiento 1 año antes de la aleatorización; malformación arteriovenosa cerebral; o masas intracraneales, como schwannoma o meningioma, que produzcan edema o efecto de masa). - Tratamiento actual o previo con antiepilépticos para las crisis convulsivas - Afecciones digestivas que afecten a la absorción - Posibles contraindicaciones o contraindicaciones confirmadas o hipersensibilidad a JNJ-56021927, bicalutamida o a agonistas de la GnRH oa cualquiera de los componentes de las formulaciones - Todo trastorno que, en opinión del investigador, haría que la participación en el estudio no sería lo mejor para el paciente
    E.5 End points
    E.5.1Primary end point(s)
    Metastasis-free survival
    Supervivencia libre de metástasis
    E.5.1.1Timepoint(s) of evaluation of this end point
    72 Months
    72 Meses
    E.5.2Secondary end point(s)
    - Time to Local-regional Recurrence
    - Time to Castration-resistant Prostate Cancer (CRPC)
    - Time to Distant Metastasis
    - Overall Survival (OS)
    - Tiempo hasta la recurrencia local-regional
    - Tiempo hasta el cáncer de próstata resistente a la castración (CPRC)
    - Tiempo hasta la metástasis a distancia
    - Supervivencia global (SG)
    E.5.2.1Timepoint(s) of evaluation of this end point
    - 72 Months
    - 72 Months
    - 72 Months
    - 72 Months
    - 72 Meses
    - 72 Meses
    - 72 Meses
    - 72 Meses
    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 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) 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 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) Yes
    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 concerned12
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA375
    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
    Argentina
    Belgium
    Brazil
    Bulgaria
    Canada
    China
    Czech Republic
    France
    Germany
    Israel
    Italy
    Korea, Republic of
    Malaysia
    Mexico
    Netherlands
    Poland
    Romania
    Russian Federation
    Spain
    Sweden
    Taiwan
    Turkey
    Ukraine
    United Kingdom
    United States
    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
    Última visita del último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years8
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years8
    E.8.9.2In all countries concerned by the trial months7
    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: 1470
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    F.2 Gender
    F.2.1Female No
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 820
    F.4.2.2In the whole clinical trial 1500
    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 that condition
    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 Decision2015-12-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-11-17
    P. End of Trial
    P.End of Trial StatusOngoing
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