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    Summary
    EudraCT Number:2017-000862-31
    Sponsor's Protocol Code Number:GLAS
    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:2017-07-12
    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 number2017-000862-31
    A.3Full title of the trial
    A phase Ib/IIa pilot trial of the oral Hedgehog Signalling Inhibitor, Glasdegib, in Patients with sclerotic chronic graft-versus-host disease refractory to second-line treatment
    Ensayo clínico piloto fase Ib/IIa del inhibidor de la vía de señalización Hedgehog, Glasdegib, en pacientes con enfermedad injerto contra huésped crónica esclerodermiforme refractarios a tratamiento de segunda Línea
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Trial of a new drug to prevent the rejection which could occur after a transplantation.
    Ensayo de un fármaco en investigación para prevenir el rechazo tras un trasplante.
    A.4.1Sponsor's protocol code numberGLAS
    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 SponsorGrupo Español de Trasplante Hematopoyético y Terapia Celular (GETH)
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportOwn funding
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUnidad de Investigación Clínica y ensayos Clínicos
    B.5.2Functional name of contact pointUICEC-HUVR
    B.5.3 Address:
    B.5.3.1Street AddressAVENIDA MANUEL SIUROT S/N
    B.5.3.2Town/ citySEVILLA
    B.5.3.3Post code41013
    B.5.3.4CountrySpain
    B.5.4Telephone number0034955013414
    B.5.5Fax number0034954232992
    B.5.6E-mailclaram.rosso.sspa@juntadeandalucia.es
    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.3.1Product nameGlasdegib
    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 INNGlasdegib
    D.3.9.2Current sponsor codePF-04449913
    D.3.9.3Other descriptive name1-((2R,4R)-2-(1H-benzo[d]imidazol-2-yl)-1- methylpiperidin-4-yl)-3-(4-cyanophenyl)urea -2HCl -H2O
    D.3.9.4EV Substance CodeSUB31245
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number50 to 200
    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
    Adult patiens with sclerotic chronic graft-versus-host disease refractory to second-line treatment.
    Pacientes adultos con enfermedad EICHc esclerodermiforme refractaria a tratamiento de segunda línea.
    E.1.1.1Medical condition in easily understood language
    Patients who have received another person's bone marrow transplant and do not respond to available treatments.
    Pacientes que hayan rechazado el trasplante de médula ósea de otra persona y no respondan a los tratamientos disponibles.
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level HLT
    E.1.2Classification code 10074474
    E.1.2Term Transplantation complications
    E.1.2System Organ Class 100000109195
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10067862
    E.1.2Term Allogeneic stem cell transplantation
    E.1.2System Organ Class 100000022080
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10074555
    E.1.2Term Transplantation complication
    E.1.2System Organ Class 10022117 - Injury, poisoning and procedural complications
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10018653
    E.1.2Term Graft-versus-host disease <GVHD>
    E.1.2System Organ Class 100000020501
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10067859
    E.1.2Term Allogenic stem cell transplantation
    E.1.2System Organ Class 100000022080
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To identify the optimal treatment dose of glasdegib when administered to patients with sclerotic cGVHD refractory to second-line therapy.
    Identificar la dosis máxima tolerada (DMT) de glasdegib en pacientes con EICHc esclerodermiforme refractaria a tratamiento de segunda línea.
    E.2.2Secondary objectives of the trial
    • To evaluate the safety and tolerability profiles of glasdegib when administered to patients with sclerotic cGVHD refractory to second-line therapy.
    • To assess the PD and PK of glasdegib when administered to patients with sclerotic cGVHD refractory to second-line therapy.
    • To assess the clinical efficacy of glasdegib when administered to patients with sclerotic cGVHD refractory to second-line therapy.
    • To assess the possibility of dose reduction and/or withdrawal of immunosuppressive treatment in patients with sclerotic cGVHD refractory to second-line therapy under concomitant treatment with glasdegib.
    • To determine the duration of clinical responses in patients with sclerotic cGVHD refractory to second-line therapy under treatment with glasdegib.
    • To evaluate survival in patients with sclerotic cGVHD refractory to second-line therapy under treatment with glasdegib.
    • Evaluar la seguridad y tolerabilidad de glasdegib en pacientes con EICHc esclerodermiforme refractaria a tratamiento de segunda línea.
    • Evaluar el perfil farmacocinético y farmacodinámico de glasdegib en pacientes con EICHc esclerodermiforme refractaria a tratamiento de segunda línea.
    • Evaluar la eficacia clínica de glasdegib en pacientes con EICHc esclerodermiforme refractaria a tratamiento de segunda línea.
    • Evaluar la posibilidad de reducción de dosis y/o retirada del tratamiento inmunosupresor en pacientes con EICHc esclerodermiforme refractaria a tratamiento de segunda línea bajo terapia con glasdegib.
    • Determinar la duración de las respuestas clínicas en pacientes con EICHc esclerodermiforme refractaria a tratamiento de segunda línea bajo terapia con glasdegib.
    • Evaluar la supervivencia en pacientes con EICHc esclerodermiforme refractaria a tratamiento de segunda línea bajo terapia con glasdegib.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Adult (≥ 18 years old) recipients of an allergenic hematopoietic stem cell transplantation with active sclerotic cGVHD without response, in partial response or in relapse after 2 previous lines of treatment including corticosteroids and one of the following second line treatments (as proposed by Dignan et al): Extracorporeal photopheresis (preferably), a calcineurin inhibitor, a mammalian target of rapamycin (mTOR) inhibitor, pentostatin, rituximab, imatinib, ruxolitinib.
    2. ECOG Performance Status 0 to 2.
    3. Adequate organ function as defined by the following:
    - Serum aspartate aminotransferase (AST) and serum alanine aminotransferase (ALT) ≤ 3 x upper limit of normal (ULN).
    - Total serum bilirubin ≤ 2 x ULN (except patients with documented Gilbert’s syndrome).
    - Serum creatinine ≤ 1.5 x ULN or estimated creatinine clearance ≥ 60 mL/min as calculated using the method standard for the institution.
    4. Hematologic malignancy in complete remission.
    5. Resolved acute effects of any prior therapy to baseline severity or Grade ≤ 1 CTCAE except for AEs not constituting a safety risk by investigator judgement.
    6. Serum/urine pregnancy test (for females of childbearing potential) that is negative at screening and immediately prior to initiation of treatment (first dose). Male and female patients of childbearing potential must agree to use highly effective methods of contraception throughout the study and for at least 180 days after the last dose of assigned treatment. A patient is of childbearing potential if, in the opinion of the investigator, he/she is biologically capable of having children and is sexually active.
    7. Evidence of a personally signed and dated informed consent document indicating that the patient (or a legal representative) has been informed of all pertinent aspects of the study.
    8. Willingness and ability to comply with the study scheduled visits, treatment plans, laboratory tests and other procedures.
    1. Adultos (≥ 18 años) receptores de trasplante alogénico con EICHc esclerodermiforme sin respuesta, en respuesta parcial o recaída tras 2 líneas terapéuticas previas, incluyendo corticoides y al menos uno de los siguientes tratamientos: Fotoféresis extracorpórea, un inhibidor de calcineurina, un inhibidor de mTOR, pentostatina, rituximab, imatinib, ruxolitinib.
    2. ECOG Performance Status 0 a 2.
    3. Adecuada función orgánica, definida como:
    - Aspartato aminotransferasa (AST) y alanina aminotransferasa (ALT) ≤ 3 x límite superior de la normalidad (LSN).
    - Bilirrubina sérica total ≤ 2 x LSN (excepto pacientes con síndrome de Gilbert documentado).
    - Creatinina sérica ≤ 1.5 x LSN o ≥ 60 mL/min usando el método de cálculo estándar para el centro.
    4. Enfermedad hematológica en remisión completa.
    5. Efectos agudos adversos de terapias previas ya resueltos (regreso a situación basal o Grado ≤ 1 CTCAE excepto para los efectos adversos que no constituyen un riesgo de seguridad en opinión del investigador).
    6. Test de embarazo en sangre u orina (en mujeres con potencial de embarazo) negativo al screening e inmediatamente antes del inicio del tratamiento (primera dosis). Los hombres y mujeres con potencial reproductivo deberán acceder al uso de métodos de contracepción altamente eficaces durante el estudio y al menos 180 días después de la última dosis administrada del fármaco en estudio. Un paciente se considerará con potencial reproductivo si, en la opinión del investigador, es fértil y sexualmente activo.
    7. Consentimiento informado firmado y datado indicando que el paciente (o el representante legal) ha sido informado de todos los aspectos pertinentes del estudio.
    8. Compromiso y capacidad para cumplir con los procedimientos, visitas y tratamientos programados durante el estudio.
    E.4Principal exclusion criteria
    1. Patients with active malignancy with the exception of basal cell carcinoma, non-melanoma skin cancer or cervical carcinoma-in-situ. Other prior or concurrent malignancies will be considered on a case-by-case basis.
    2. Any one of the following, currently or in the previous 6 months: myocardial infarction, congenital long QT syndrome, torsade de pointes or clinically significant ventricular arrhythmias.
    3. QTc interval >470 milliseconds using the Fridericia (QTcF).
    4. Patients with an active, life threatening or clinically significant uncontrolled systemic infection.
    5. Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness or active Hepatitis B or C infection.
    6. Known malabsorption syndrome or other condition that may impair absorption of study medication (e.g., gastrectomy or lap band).
    7. Major surgery or radiation within 4 weeks of starting study treatment.
    8. Prior treatment with: A hedgehog inhibitor at any time, an investigational agent for the treatment of cGVHD (a three-month wash-out period will be required).
    9. Concurrent treatment with any investigational agent.
    10. Concurrent administration of herbal preparations.
    11. Current use at time of study entry or anticipated need for drugs that are known strong CYP3A4/5 inducers.
    12. Current drug or alcohol abuse.
    13. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study.
    14. Patients who are investigational site staff members or relatives of those site staff members directly involved in the conduct of the trial.
    15. Pregnant females; breastfeeding females; males and females of childbearing potential not using two methods of highly effective contraception or not agreeing to continue two methods of highly effective contraception for at least 180 days after last dose of investigational product.
    16. Recent or active suicidal ideation or behaviour.
    1. Pacientes con enfermedad oncológica activa, con la excepción de carcinoma basocelular, cáncer de piel no-melanoma o carcinoma cervical in situ. Otras enfermedades oncológicas previas serán valoradas de forma individual.
    2. Cualquiera de las siguientes entidades, actualmente o en los 6 meses previos: infarto de miocardio, síndrome QT largo congénito, torsade de pointes o arritmias ventriculares clínicamente significativas.
    3. Intervalo QTc >470 milisegundos usando el método de Fridericia (QTcF).
    4. Pacientes con una infección sistémica no controlada activa, potencialmente letal o clínicamente significativa.
    5. Infección por VIH o infección activa por VHB o VHC.
    6. Síndrome de mal absorción conocido u otra afección que puede afectar la absorción de la medicación del estudio (por ejemplo, gastrectomía o banda de vuelta).
    7. Cirugía mayor o radiación en las 4 semanas previas al inicio del tratamiento.
    8. Tratamiento previo con: Un inhibidor de Hedgehog, un agente investigacional para el tratamiento de la EICHc (será necesario un periodo de lavado de al menos 3 meses).
    9. Tratamiento simultáneo con otro agente investigacional.
    10. Administración simultánea de preparados herbales.
    11. Uso actual en el momento de entrada en el estudio o requerimiento anticipado de fármacos que sean inductores potentes conocidos de CYP3A4/5.
    12. Consumo de drogas o alcohol.
    13. Otras condiciones médicas/psiquiátricas o alteraciones analíticas que puedan aumentar el riesgo asociado a la participación en el estudio o la administración del fármaco experimental, o que puedan interferir en la interpretación de los resultados del estudio, y en opinión del investigador puedan hacer inapropiada la inclusión del paciente en el estudio.
    14. Pacientes que sean empleados del centro o familiares de empleados del centro directamente implicados en la realización del estudio.
    15. Mujeres embarazadas, mujeres lactantes, hombres y mujeres con potencial reproductivo que no usen dos métodos contraceptivos altamente eficaces o no accedan a continuar usándolos durante al menos 180 días después de la última dosis del agente investigacional.
    16. Ideación o comportamiento suicida reciente o activo.
    E.5 End points
    E.5.1Primary end point(s)
    Dose limiting toxicity (DLTs) , maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D).
    Toxicidades limitantes de dosis (TLD), dosis máxima tolerada (DMT) y dosis recomendada para fase 2 (DRF2).
    E.5.1.1Timepoint(s) of evaluation of this end point
    MTD will be defined based on DLTs appearing in the first two cycles of treatment. R2PD will be determined from the analysis of multiple data gathered during the whole duration of the trial
    Las TLD serán evaluadas durante los dos primeros ciclos de tratamiento con glasdegib. La DMT será definida en base a las TLD que aparezcan en los dos primeros ciclos de tratamiento. La DRF2 se determinará a partir de la valoración conjunta de todos los datos obtenidos en el ensayo clínico.
    E.5.2Secondary end point(s)
    - Type, incidence, severity, timing, intensity, and relatedness of adverse events.
    - PD biomarkers and PK parameters of glasdegib.
    - Overall response rate (ORR)
    - Dose reduction and/or withdrawal of concomitantly administered immunosuppressive drugs.
    - Duration of clinical response
    - Overall survival (OS) and progression-free survival (PFS)
    - Tipo, incidencia, gravedad, tiempo de aparición, y relación de los efectos adversos.
    - Biomarcadores y parámetros de farmacovigilancia de glasdegib
    - Tasa global de respuestas (TGR)
    - Reducción de dosis o retirada del tratamiento inmunosupresor concomitante
    - Duración de las respuestas clínicas
    - Supervivencia global (SG) y supervivencia libre de progression (SLP).
    E.5.2.1Timepoint(s) of evaluation of this end point
    According to the variable will be performed in all visits, day 1 of cycles 1, 2 and 4 or day 1 of cycles 1, 2, 4, 7, 10 and at end of treatment.
    Según la variable se realizará en todas las visitas, el día 1 de los ciclos 1, 2 y 4 o el día 1 de los ciclos 1, 2 , 4, 7, 10 y fin del tratamiento.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Searching for optimized dosage.
    Búsqueda de dosis optima.
    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 concerned6
    E.8.5The trial involves multiple Member States No
    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
    28 days after the last dose administration of the last patient included.
    28 días después de la última dosis del último paciente.
    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 days
    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: 19
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 state24
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 24
    F.4.2.2In the whole clinical trial 24
    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)
    Treatment after study as per investigators juice according to GCP
    A juicio del investigador, de acuerdo a las Bueas Prácticas Clínicas
    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 Decision2017-09-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-09-25
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-10-24
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