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    Summary
    EudraCT Number:2013-005085-19
    Sponsor's Protocol Code Number:CBGJ398X2204
    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:2014-05-22
    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 number2013-005085-19
    A.3Full title of the trial
    A phase II multicenter, single arm study of oral BGJ398 in adult patients with advanced or metastatic cholangiocarcinoma with FGFR2 gene fusions or other FGFR genetic alterations who failed or are intolerant to platinum-based chemotherapy
    Estudio fase II, multicéntrico, con un único brazo de tratamiento, de BGJ398 oral en pacientes adultos con colangiocarcinoma avanzado o metastásico, con fusiones del gen FGFR2 u otras alteraciones genéticas del FGFR que han progresado o que son intolerantes a quimioterapia basada en platino
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    This is a multi-center, open label, single arm phase II study evaluating BGJ398 anti-tumor activity in advanced or metastatic cholangiocarcinoma patients with FGFR genetic alterations.
    Estudio con un solo brazo de tratamiento de BGJ398 en pacientes adultos con colangiocarcinoma avanzado o metastásico
    A.4.1Sponsor's protocol code numberCBGJ398X2204
    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 SponsorNovartis Farmacéutica, 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 supportNovartis Pharma Services AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovartis Farmacéutica, S.A.
    B.5.2Functional name of contact pointDepartamento Médico Oncología (GMO)
    B.5.3 Address:
    B.5.3.1Street AddressGran Vía de les Corts Catalanes, 764
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08013
    B.5.3.4CountrySpain
    B.5.4Telephone number34900353036
    B.5.5Fax number34932479903
    B.5.6E-maileecc.novartis@novartis.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 BGJ398
    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 INNBGJ398
    D.3.9.1CAS number BGJ398
    D.3.9.2Current sponsor codeBGJ398
    D.3.9.3Other descriptive nameBGJ398
    D.3.9.4EV Substance CodeSUB31319
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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 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 BGJ398
    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 INNBGJ398
    D.3.9.1CAS number BGJ398
    D.3.9.2Current sponsor codeBGJ398
    D.3.9.3Other descriptive nameBGJ398
    D.3.9.4EV Substance CodeSUB31319
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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: 3
    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 Renagel
    D.2.1.1.2Name of the Marketing Authorisation holderGenzyme Europe, Bv
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameRenagel
    D.3.2Product code Renagel
    D.3.4Pharmaceutical form 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 INNSEVELAMER
    D.3.9.1CAS number 52757-95-6
    D.3.9.2Current sponsor codeRenagel
    D.3.9.3Other descriptive nameRenagel
    D.3.9.4EV Substance CodeSUB04381MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number800
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    advanced or metastatic cholangiocarcinoma
    FGFR2 gene fusion,
    FGFR genetic alteration
    colangiocarcinoma avanzado o metastásico
    Fusión de genes FGFR2,
    Alteración genética FGFR
    E.1.1.1Medical condition in easily understood language
    biliary tract cancer
    cáncer del tracto biliar
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level PT
    E.1.2Classification code 10008593
    E.1.2Term Cholangiocarcinoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of single agent BGJ398 in patients with advanced or metastatic cholangiocarcinoma with FGFR2 gene fusions/translocations or other FGFR genetic alterations assessed by investigator as per RECIST v1.1.
    Evaluar la eficacia de BGJ398 en monoterapia en pacientes con colangiocarcinoma avanzado o metastásico con translocaciones/fusiones del gen FGFR2 u otras alteraciones genéticas del FGFR medido por el investigador a través de la tasa de respuesta global según los RECIST v1.1.
    E.2.2Secondary objectives of the trial
    -To further evaluate the efficacy of single agent BGJ398 as measured by
    progression free survival, best overall response, disease control rate,
    overall survival assessed by investigator as per RECIST 1.1
    - To characterize the safety and tolerability of single agent BGJ398 by the type, frequency and severity of AEs & SAEs.
    - To determine selected trough and 2-hr plasma concentrations of BGJ398
    Evaluar mejor la eficacia de BGJ398 en monoterapia, medido con la supervivencia libre de progresión, mejor respuesta global, tasa de control de la enfermedad, supervivencia global, evaluado por el investigador, según los RECIST 1.1
    Caracterizar la seguridad y la tolerabilidad de BGJ398 en monoterapia por tipo, frecuencia y severidad de AAs y de AAGs.
    Determinar las concentraciones seleccionadas valle y a las 2 horas en plasma de BGJ398 y de sus metabolitos
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patients with histologically or cytologically confirmed cholangiocarcinoma at the time of diagnosis.
    - Patients must have received at least one prior regimen containing gemcitabine with or without cisplatin for advanced or metastatic disease. Patient must have evidence of progressive disease following prior regimen.
    Other protocol defined criteria may apply
    Pacientes con colangiocarcinoma confirmado citológica o histológicamente en el momento del diagnóstico.
    Se requiere documentación por escrito de determinación del laboratorio local o central de translocaciones/fusiones del gen FGFR2 u otras alteraciones genéticas de FGFR para preselección. Los pacientes que se identifique que presentan otras alteraciones genéticas de FGFR que no sean fusiones del gen FGFR2 pueden ser elegibles, dependiendo de acuerdo entre Novartis y el investigador.
    Los pacientes deberán haber recibido por lo menos un régimen previo que contenga gemcitabina con o sin cisplatino para la enfermedad avanzada o metastásica. Los pacientes deberán presentar evidencia de enfermedad progresiva tras el régimen previo.
    Estado funcional del ECOG ? 1 (los pacientes con estado funcional del ECOG de 2 pueden considerarse en una base individualizada tras discusión con Novartis).
    E.4Principal exclusion criteria
    - Prior or current treatment with an FGFR inhibitor
    - insufficient organ function ?ANC < 1,000/mm3 [1.0 x 10E9/L] ?Platelets < 75,000/mm3 [75 x 10E9/L] ?Hemoglobin < 9.0 g/dL ?Total bilirubin > 1.5x ULN ?AST/SGOT and ALT/SGPT > 2.5x ULN (AST and ALT > 5x ULN in the presence of liver metastases) ?Serum creatinine > ULN and/or calculated
    or measured creatinine clearance < 75% LLN ?Inorganic phosphorus outside of normal limits ?Total and ionized serum calcium outside of normal limits
    Other protocol defined criteria may apply
    Tratamiento previo o actual con un inhibidor de FGFR.
    Evidencia actual de queratopatía/alteración de la retina o de la córnea significativa incluyendo pero no limitado a, queratopatía en banda/bullosa, abrasión corneal, inflamación/ulceración, queratoconjuntivitis, confirmado con examen oftalmológico.
    Antecedentes y/o evidencia actual de calcificación del tejido extensivo incluyendo, pero no limitado a, el tejido blando, los riñones, el intestino, el miocardio y el pulmón, con la excepción de ganglios linfáticos calcificados, calcificaciones mínimas del parénquima pulmonar y calcificación coronaria asintomática.
    Deterioro de la función gastrointestinal (GI) o enfermedad GI que pueda alterar significativamente la absorción de BGJ398 oral (por ejemplo, enfermedades ulcerosas, náuseas incontroladas, vómitos, diarrea, síndrome de mala absorción, resección del intestino delgado).
    Antecedentes y/o evidencia actual de alteraciones endocrinas de homeostasis del calcio/fosfato, por ejemplo, alteraciones paratiroideas, antecedentes de paratiroidectomía, lisis tumoral, calcinosis tumoral, etc.
    Se excluirán pacientes que reciban tratamiento concurrentemente con agentes que se conozca que son inhibidores o inductores potentes de CYP3A4 y medicaciones que aumenten la concentración de calcio y/o fósforo en suero (remítase al Suplemento 2 para la lista de medicaciones prohibidas).
    E.5 End points
    E.5.1Primary end point(s)
    Overall response rate (ORR) is defined as the proportion of patients with a best overall response of Complete Response (CR) or Partial Response (PR), as
    per RECIST version 1.1.
    Tasa de respuesta global (ORR) se define como la proporción de pacientes con una mejor respuesta global de respuesta completa (CR) o respuesta parcial (PR), como
    por RECIST versión 1.1.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline, then every 8 weeks, until disease progression or study discontinuation
    Línea de base y posteriormente cada 8 semanas hasta la progresión de la enfermedad o de la interrupción del estudio
    E.5.2Secondary end point(s)
    1- Overall survival
    2- Progression free survival
    3- Best overall response
    4- Disease control rate
    5- Number of participants with adverse events (AEs) and serious adverse events (SAEs) as a measure of safety and tolerability
    6-Selected trough and 2-hr Plasma concentration profile
    1 - La supervivencia global
    2 - supervivencia libre de progresión
    3 - Mejor respuesta global
    4 - Tasa de Control de enfermedades
    5 - Número de participantes con aconteciimientos adversos (EA) y los acontecimientos adversos graves (AAG) como una medida de seguridad y tolerabilidad
    A través de 6 seleccionados y 2-hr perfil de concentración de plasma
    E.5.2.1Timepoint(s) of evaluation of this end point
    1- Every 4 months for one year after discontinuation of study treatment
    2- Baseline, then every 8 weeks until disease progression or the initiation of subsequent anticancer therapies or death whichever occurs first
    3- Baseline, then every 8 weeks, until disease progression or study discontinuation
    4- Baseline, then every 8 weeks, until disease progression or study discontinuation
    5- Starting from date of signing the consent form to 30 days afer the last
    dose
    6- From First dose of study treatment
    to study discontinuation
    1 - Cada 4 meses durante un año después de la interrupción del tratamiento del estudio
    2 - Línea de Base y posteriormente cada 8 semanas hasta la progresión de la enfermedad o el inicio de las terapias contra el cáncer posteriores o muerte que ocurra primero
    3 - Línea de Base y posteriormente cada 8 semanas hasta la progresión de la enfermedad o de la interrupción del estudio
    4 - Línea de Base y posteriormente cada 8 semanas hasta la progresión de la enfermedad o de la interrupción del estudio
    5 - A partir de la fecha de la firma del formulario de consentimiento a 30 días después de la última dosis
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA4
    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
    Belgium
    France
    Germany
    Italy
    Japan
    Korea, Republic of
    Russian Federation
    Singapore
    Spain
    Taiwan
    Thailand
    Turkey
    United Kingdom
    United States
    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
    End of study is defined as the time when the last patient completes the survival follow-up as described in the protocol or when the last patient on study has expired, been lost to follow up, or withdraws consent, whichever occurs first or when the study is terminated early.
    Fin del estudio se define como el momento en que el último paciente completa la supervivencia de seguimiento tal como se describe en el protocolo o cuando el último paciente en el estudio ha caducado, se pierde durante el seguimiento o retira su consentimiento, lo que ocurra primero, o cuando el estudio se termina antes de tiempo.
    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 months
    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 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: 22
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 33
    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 state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 10
    F.4.2.2In the whole clinical trial 55
    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
    ninguno
    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 Decision2014-06-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-06-04
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-02-07
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