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 are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   42336   clinical trials with a EudraCT protocol, of which   6971   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 in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .

    Clinical Trials marked as "Trial now transitioned" were transitioned to the Clinical Trial Regulation 536/2014 and can be further followed in the Clinical Trial Information System  
     
    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:2019-003108-10
    Sponsor's Protocol Code Number:GOING
    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:2019-11-06
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2019-003108-10
    A.3Full title of the trial
    The GOING Study: Regorafenib followed by Nivolumab in patients with Hepatocellular Carcinoma progressing under sorafenib
    Estudio GOING: Regorafenib seguido del Nivolumab en pacientes con progresión de la enfermedad tratados con sorafenib
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Regorafenib followed by Nivolumab in patients with Hepatocellular Carcinoma progressing under sorafenib
    Regorafenib seguido del Nivolumab en pacientes con progresión de la enfermedad tratados con sorafenib
    A.4.1Sponsor's protocol code numberGOING
    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 SponsorFundació Clinic per a la Recerca Biomèdica
    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 supportBAYER
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAPICES SOLUCIONES S.L.
    B.5.2Functional name of contact pointClinical Operations department
    B.5.3 Address:
    B.5.3.1Street AddressAvenida Antonio Lopez 16 1A
    B.5.3.2Town/ cityPinto
    B.5.3.3Post code28320
    B.5.3.4CountrySpain
    B.5.4Telephone number+34918166804
    B.5.5Fax number+34918169172
    B.5.6E-mailana.moreno@apices.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 Yes
    D.2.1.1.1Trade name SITVARGA
    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 nameREGORAFENIB
    D.3.2Product code REGORAFENIB
    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 INNREGORAFENIB
    D.3.9.1CAS number 755037-03-7
    D.3.9.2Current sponsor codeREGORAFENIB
    D.3.9.3Other descriptive nameREGORAFENIB
    D.3.9.4EV Substance CodeSUB73090
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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 Yes
    D.2.1.1.1Trade name OPDIVO
    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 nameNIVOLUMAB
    D.3.2Product code NIVOLUMAB
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNIVOLUMAB
    D.3.9.2Current sponsor codeNIVOLUMAB
    D.3.9.3Other descriptive nameNIVOLUMAB
    D.3.9.4EV Substance CodeSUB122750
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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) 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 OPDIVO
    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 nameNIVOLUMAB
    D.3.2Product code NIVOLUMAB
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNIVOLUMAB
    D.3.9.2Current sponsor codeNIVOLUMAB
    D.3.9.3Other descriptive nameNIVOLUMAB
    D.3.9.4EV Substance CodeSUB122750
    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 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) 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
    Hepatocellular carcinoma
    Carcinoma hepatocelular
    E.1.1.1Medical condition in easily understood language
    Hepatocellular carcinoma
    Carcinoma hepatocelular
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10073071
    E.1.2Term Hepatocellular carcinoma
    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 evaluate the safety of regorafenib in combination with Nivolumab.
    Evaluar el perfil de seguridad de regorafenib en combinacion con nivolumab
    E.2.2Secondary objectives of the trial
    Time to progression (TTP)
    Pattern of progression under early phase of regorafenib and under the combination of regorafenib plus nivolumab
    Overall survival (OS)
    Post-progression survival
    Rate of patients who develop new extra-hepatic spread Objective response rate (ORR)
    Tiempo hasta progresión (TTP)
    Patrón de progresión durante la fase temprana con regorafenib y durante la fase de combinacion con regorafenib y nivolumab
    Supervivencia global
    Supervivencia tras progresión
    Tasa de pacientes que desarrollan una metástasis extrahepática nueva
    Tasa de respuesta objetiva
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female subjects 18 years of age or older.
    2. Heptatocellular carcinoma (HCC) diagnosed according to American Association for the Study of Liver Diseases (AASLD) guideline.
    3. Presence of a naïve target lesion.
    4. Adequate liver function: albumin > 2.8 g/dL; total bilirubin < 3 mg/dL; alanine and aspartate aminotransferases < 5 times the upper limit of the normal range, and Child-Pugh score <7 points.
    5. Performance status 0-1
    6. Controlled arterial hypertension and/or stable peripheral vascular disease
    7. Adequate hematologic profile: platelet count > 60x109/L; haemoglobin > 8.5g/dL; and prothrombin time > 50%.
    8. Adequate renal function: serum creatinine < 1.5 times the upper limit of the normal range.
    9. All but first-line-related dermatologic adverse events must be grade I according to Common Terminology Criteria for Adverse Events (CTCAE) v.5.0. Early dermatologic adverse events related to sorafenib must be resolved before starting regorafenib.
    10. Radiological tumor progression to first-line treatment within the 2 months of inclusion in the study.
    1. Mujeres y hombres de 18 años o mayores
    2. Carcinoma Hepatocelular (HCC) diagnosticado según las guías de la Asociación Americana para el Estudio de la Enfermedad Hepática (AASLD).
    3. Presencia de una lesión diana inicial.
    4. Función hepática adecuada: albúmina > 2,8 g/dL; bilirrubina total < 3 mg/dL; alanina y aspartato aminotransferasas < 5 veces al límite superior de normalidad, y puntuación Child-Pugh < 7puntos.
    5. Estado funcional 0-1.
    6. Hipertensión arterial controlada y/o enfermedad vascular periférica estable.
    7. Perfil hematológico adecuado: recuento de plaquetas > 60x109/L; hemoglobina > 8,5 g/dL; y tiempo de protrombina > 50%
    8. Función renal adecuada: creatinina sérica < 1,5 veces el límite superior de normalidad.
    9. Todos los acontecimientos adversos salvo los dermatológicos deben ser de grado I según CTCAE v 5.0. Los acontecimientos adversos dermatológicos tempranos relacionados con sorafenib deben haberse resuelto antes de comenzar el tratamiento con regorafenib.
    10. Progresión tumoral radiológica al primer tratamiento durante los dos meses previos a la inclusión en el estudio.
    E.4Principal exclusion criteria
    1. Myocardial infarction in the last year or active ischemic heart disease
    2. Acute variceal bleeding in the last month
    3. Severe peripheral arterial disease
    4. Cardiac arrhythmia under treatment with drugs different from beta-blockers or digoxin
    5. Uncontrolled ascites
    6. Encephalopathy
    7. Unfeasibility to fulfill the follow-up Schedule.
    8. Co-infection with hepatitis B (HBV) and C (HCV) as evidenced by detectable HBV surface antigen or HBV DNA and HCV RNA or Hepatitis D infection in subjects with HBV.
    9. Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, prostate cancer without evidence of PSA progression or carcinoma in situ such as the following: gastric, prostate, cervix, colon, melanoma, or breast.
    10. Subjects with any active autoimmune disease or history of known or suspected autoimmune disease except for subjects with vitiligo, resolved childhood asthma/atopic, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
    11. Positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)
    12. Known active drug or alcohol abuse
    13. Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody (or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways);
    14. Prior organ allograft or allogeneic bone marrow transplantation
    15. All but dermatologic toxicities attributed to first-line treatment must have resolved to Grade 1 (NCI CTCAE version 5) or baseline before administration of study drug. Subjects with toxicities attributed to first-line treatment therapy that are not expected to resolve and result in long-lasting sequelad are not permitted. Neuropathy must have resolved to Grade 2 (NCI CTCAE version 5). Dermatologic toxicities must be resolved.
    16. Active bacterial or fungal infections requiring systemic treatment within 7 days.
    17. Use of other investigational drugs (drugs not marketed for any indication) within 28 days or at least 5 half-lives (whichever is longer) before study drug administration.
    18. Known or underlying medical conditions that, in the Investigator’s opinion, would make the administration of the study drug hazardous to the subjects or obscure the interpretation of toxicity determination or adverse events.
    19. Subjects with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.
    20. Laboratory evidence of any underlying medical conditions that, in the Investigator’s opinion, will make the administration of study drug hazardous or obscure the interpretation of toxicity determination or adverse events
    21. History of severe hypersensitivity reactions to other monoclonal antibodies.
    22. History of allergy to study drug components.
    23. Women who are pregnant or breastfeeding.
    24. Women with a positive pregnancy test at enrollment or prior to administration of study medication.
    25. Prisoners or subjects who are involuntarily incarcerated.
    26. Subjects who are compulsorily detained for treatment of either a psychiatric or physical illness (e.g. infectious disease)
    27. Inability to comply with restrictions and prohibited activities/treatments
    1. Infarto de miocardio en el último año o cardiopatía isquémica.
    2. Sangrado de varices agudo en el último mes.
    3. Enfermedad arterial periférica severa.
    4. Arritmia cardiaca tratada con fármacos distintos a beta bloqueantes o digoxina.
    5. Ascitis no controlada.
    6. Encefalopatía
    7. Incapacidad para cumplir el esquema de seguimiento.
    8. Co-infección con hepatitis B (VHB) y C (VHC) evidenciada por la presencia del antígeno de superficie del VHB o DNA de VHB y RNA de VHC o infección con hepatitis D en sujetos con VHB.
    9. Carcinoma previo activo en los últimos 3 años excepto para cánceres localizados curables que hayan sido aparentemente curados, como cáncer de piel de células basales o escamosas, cáncer de próstata sin evidencia de incremento de PSA o carcinoma in situ gástrico, prostático, cervical, colónico, melanómico o mamario.
    10. Sujetos con cualquier enfermedad autoinmune activa o historial de sospecha de enfermedad autoinmune o conocida excepto para pacientes con vitíligo, asma infantil/atópico resuelto, diabetes mellitus tipo 1, hipotiroidismo residual debido a enfermedad autoinmune que solo requiera restitución hormonal, psoriasis que no requiera tratamiento sistémico, o condiciones que no se espera que recurran en la ausencia de un desencadenante externo.
    11. Resultado positivo para el virus de la inmunodeficiencia humana (VIH) o síndrome de la inmunodeficiencia adquirida (SIDA) confirmado.
    12. Confirmación de abuso de alcohol o de sustancias activas.
    13. Tratamiento previo con un anti-PD-1, anti-PDL-1, anti-PD-L2, anti-CD137, o anticuerpo anti-CTLA-4 (o cualquier otro anticuerpo o fármaco con diana específica coestimulante de células T o cascadas de control).
    14. Trasplante previo autólogo o de médula ósea alogénico.
    15. Todas las toxicidades atribuidas a sorafenib excepto las dermatológicas deben haberse resuelto a Grado 1 (NCI-CTCAE versión 5) o a estado basal antes de la administración del fármaco del estudio. Los sujetos con toxicidades atribuidas a tratamiento con sorafenib que no se espera su resolución y acaben en secuelas a largo a plazo pueden participar en el estudio. La neuropatía debe haberse resuelto a Grado 2 (NCI CTCAE versión 5). Las toxicidades dermatológicas deben resolverse.
    16. Infección fúngica o bacteriana activa que requiera tratamiento sistémico en los 7 días previos al inicio del tratamiento.
    17. Uso de otros fármacos en investigación (fármacos no comercializados para esa indicación) en los 28 días previos o al menos 5 semividas (lo que sea superior) a la entrada en el estudio.
    18. Condición médica conocida o subyacente que, en opinión del investigador, aumenta la peligrosidad o interfiere en la identificación de la toxicidad de acontecimientos adversos provocados por la administración del fármaco del estudio.
    19. Los pacientes con una condición que requiera tratamiento sistémico con corticoides (equivalente a > 10 mg de prednisona) u otra medicación inmunosupresora en los 14 días previos a la administración del fármaco del estudio. Los corticoides tópicos o inhalados y dosis de reemplazo adrenal equivalente a > 10 mg de prednisona serán candidatos en ausencia de enfermedad autoinmune.
    20. Las evidencias de laboratorio de cualquier condición médica subyacente que, en opinión del investigador, aumenten la peligrosidad o interfieran en la identificación de la toxicidad de acontecimientos adversos provocados por la administración del fármaco del estudio.
    21. Historial de reacciones de hipersensibilidad severa a otros anticuerpos monoclonales.
    22. Historial de alergia a componentes del fármaco del estudio.
    23. Mujeres que estén embarazadas o en periodo de lactancia.
    24. Mujeres con un test de embarazo con resultado positivo al momento del reclutamiento o antes de la administración del fármaco del estudio.
    25. Prisioneros o pacientes que estén encarcelados involuntariamente.
    26. Pacientes que estén ingresados obligatoriamente por enfermedad física o psiquiátrica (por ejemplo enfermedad infecciosa)
    27. Incapacidad de cumplir las restricciones y tratamientos/actividades prohibidos.
    E.5 End points
    E.5.1Primary end point(s)
    Rate and type of AEs leading to treatment discontinuation
    Rate and type of AEs
    Rated and type of Serious AEs (SAEs)
    Rate of related-AE
    Rate of death.
    Tasa y tipo de Acontecimientos Adversos que provocan discontinuación del tratamiento
    Tasa y tipo de Acontecimientos Adversos
    Tasa y tipo de Acontecimientos Adversos Graves
    Tasa de AA relacionados
    Tasa de Muertes
    E.5.1.1Timepoint(s) of evaluation of this end point
    During treatment and 30 days after the last dose.
    Durante el tratamiento y hasta 30 días posteriores a la última dosis.
    E.5.2Secondary end point(s)
    Time to progression
    Pattern of progression under early phase of regorafenib and under the combination of regorafenib plus nivolumab
    Overall survival
    Post-progression survival
    Rate of patients who develop new extra-hepatic spread Objective Rate Response (ORR)
    Tiempo hasta progresión
    Patrón de progresión durante la fase temprana con regoafenib y durante la fase combinación de regorafenib con nivolumab
    Supervivencia global
    Supervivencia posterior a progresión
    Tasa de pacientes que desarrollan una nueva metástasis extra-hepática
    Tasa de respuesta objetiva
    E.5.2.1Timepoint(s) of evaluation of this end point
    During treatment and follow-up period
    Durante el tratamiento y durante el periodo de seguimiento
    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) 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 concerned7
    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 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
    UVUP
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months0
    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: 50
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 60
    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 Decision2020-01-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-12-12
    P. End of Trial
    P.End of Trial StatusOngoing
    For support, visit the EMA Service Desk , log in using your EMA account and open a ticket specifying "EU CTR" in your request.
    If you do not have an account, please visit the EMA Account management page page click on "Create an EMA account" and follow the instructions.
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2022 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA