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    Summary
    EudraCT Number:2022-003157-55
    Sponsor's Protocol Code Number:EF-39
    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:2023-03-24
    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 number2022-003157-55
    A.3Full title of the trial
    PANOVA-4: Pilot, Single arm Study of Tumor Treating Fields (TTFields, 150kHz) Concomitant with Atezolizumab, Gemcitabine and Nab-Paclitaxel as First-Line Treatment for Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC)
    PANOVA-4: Estudio preliminar, de un solo grupo, del uso concomitante de campos eléctricos para el tratamiento de tumores (TTFields, 150 kHz) y atezolizumab, gemcitabina y nab-paclitaxel como tratamiento de primera línea del adenocarcinoma ductal pancreático metastásico (ADPm)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical study on the efficacy and safety of Tumor Treating Fields, atezolizumab, gemcitabine and nab-paclitaxel as first line treatment for metastatic pancreatic carcinoma.
    Estudio clínico sobre la eficacia y seguridad de Tumor Treating Fields, atezolizumab, gemcitabina y nab-paclitaxel como tratamiento de primera línea para el carcinoma de páncreas metastásico.
    A.3.2Name or abbreviated title of the trial where available
    PANOVA-4
    PANOVA-4
    A.4.1Sponsor's protocol code numberEF-39
    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 SponsorNovocure GmbH
    B.1.3.4CountrySwitzerland
    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 supportNovocure GmbH
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovocure GmbH
    B.5.2Functional name of contact pointDirector, Global Clinical Operation
    B.5.3 Address:
    B.5.3.1Street AddressBusiness Village D4, Park 6
    B.5.3.2Town/ cityRoot
    B.5.3.3Post code6039
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number+41797556942
    B.5.6E-mailkbruckmann@novocure.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 Yes
    D.2.1.1.1Trade name Tecentriq 840 mg concentrate for solution for infusion
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration GmbH
    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.3.4Pharmaceutical form Concentrate for solution for injection/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 INNAtezolizumab
    D.3.9.1CAS number 1380723-44-3
    D.3.9.4EV Substance CodeSUB178312
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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 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: 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.2.1.2Country 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 nameGemcitabine
    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 INNGemcitabine
    D.3.9.1CAS number 95058-81-4
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive nameGemcitabine hydrochloride
    D.3.9.4EV Substance CodeSUB02324MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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.2.1.2Country 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 nameNab-paclitaxel
    D.3.4Pharmaceutical form Powder 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 INNNab-paclitaxel
    D.3.9.3Other descriptive namePACLITAXEL ALBUMIN-BOUND
    D.3.9.4EV Substance CodeSUB127678
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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
    Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC)
    Adenocarcinoma Ductal Pancreático Metastásico (ADPm)
    E.1.1.1Medical condition in easily understood language
    Pancreatic Cancer
    Cáncer de Páncreas
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10033599
    E.1.2Term Pancreatic adenocarcinoma metastatic
    E.1.2System Organ Class 100000004864
    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 disease control rate (DCR) by RECIST v1.1 in patients with 1L mPDAC treated with TTFields concomitant with atezolizumab, gemcitabine and nab-paclitaxel.
    Evaluar la tasa de control de la enfermedad (TCE) según RECIST v1.1 en pacientes con ADPm tratados en 1L con TTFields concomitantes con atezolizumab, gemcitabina y nab-paclitaxel.
    E.2.2Secondary objectives of the trial
    To evaluate the overall survival (OS) and 1-year survival rate in patients with 1L mPDAC treated with TTFields concomitant with atezolizumab, gemcitabine and nab-paclitaxel.
    To evaluate the safety and tolerability profile of TTFields concomitant with atezolizumab, gemcitabine and nab-paclitaxel in patients with 1L mPDAC.
    To evaluate the progression free survival (PFS) by RECIST v1.1 in patients with 1L mPDAC treated with TTFields concomitant with atezolizumab, gemcitabine and nab-paclitaxel.
    To evaluate the objective response rate (ORR) by RECIST v1.1 in patients with 1L mPDAC treated with TTFields concomitant with atezolizumab, gemcitabine and nab-paclitaxel.
    To evaluate the PFS rate at 6 months (PFS6) in patients with 1L mPDAC treated with TTFields concomitant with atezolizumab, gemcitabine and nab-paclitaxel.
    To evaluate the duration of response (DOR) by RECIST v1.1 in patients with 1L mPDAC treated with TTFields concomitant with atezolizumab, gemcitabine and nab-paclitaxel.
    Evaluar:
    - la supervivencia global (SG) en pacientes con ADPm tratados en 1L con TTFields concomitantes con atezolizumab, gemcitabina y nab-paclitaxel (A, G y N-p).
    - la supervivencia sin progresión (SSP) según RECIST-v1.1 en pacientes con ADPm tratados en 1L con TTFields concomitantes con A, G y N-p.
    - la tasa de supervivencia al año en pacientes con ADPm tratados en 1L con TTFields concomitantes con A, G y N-p.
    - la tasa de respuesta objetiva (TRO) según RECIST v1.1 en pacientes con ADPm tratados en 1L con TTFields concomitantes con A, G y N-p.
    - la SSP a los 6 meses (SSP6) en pacientes con ADPm tratados en 1L con TTFields concomitantes con A, G y N-p.
    -la duración de la respuesta (DdR) según RECIST v1.1 en pacientes con ADPm tratados en 1L con TTFields concomitantes con A, G y N-p.
    - el perfil de seguridad y tolerabilidad de los TTFields concomitantes con atezolizumab, gemcitabina y nab-paclitaxel en pacientes con ADPm tratados en 1L.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Signed Informed Consent Form
    - 18 years of age and older
    - ECOG performance status of 0-1
    - Histologically or cytologically confirmed de-novo diagnosis of metastatic pancreatic ductal adenocarcinoma
    - No prior treatment for PDAC
    - Life expectancy equal to or greater than 3 months
    - Measurable disease in the abdomen, as defined by RECIST v1.1
    - Preferably, tumor accessible for tissue collection. Consent to provide blood and tumor tissue for exploratory study is highly encouraged
    - Amenable and assigned by the investigator to receive therapy with gemcitabine and nab- paclitaxel
    - Adequate hematologic and end-organ function
    - Able to operate the NovoTTF-200T device
    - Firmar el documento de consentimiento informado
    - Tener al menos 18 años
    - Tener un estado funcional del ECOG de 0 o 1.
    - Tener un diagnóstico de adenocarcinoma ductal pancreático metastásico confirmado de novo confirmado histológica o citológicamente.
    - No haber tenido tratamiento anterior contra el ADP.
    - Tener una esperanza de vida de al menos 3 meses.
    - Presentar enfermedad mensurable en el abdomen, según definición de los RECIST v1.1.
    - Presentar preferiblemente un tumor accesible para la obtención de tejidos. Se recomienda encarecidamente que se consienta facilitar muestras de sangre y tejido tumoral para el estudio exploratorio.
    - Ser tributarios y que el investigador les haya asignado a recibir terapia con gemcitabina y nab-paclitaxel.
    - Presentar un funcionamiento hemático y del órgano afectado adecuado
    - Ser capaz de utilizar el dispositivo NovoTTF-200T de manera independiente o con la ayuda de un cuidador.
    E.4Principal exclusion criteria
    - Symptomatic, untreated, or actively progressing CNS metastases
    - History of leptomeningeal disease
    - Uncontrolled tumor-related pain
    - Active or history of autoimmune disease
    - Severe infection within 4 weeks prior to initiation of study treatment
    - History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
    - Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug or device, may affect the interpretation of the results, or may render the patient at high risk from treatment complications
    - Concurrent anti-tumor therapy beyond gemcitabine and nab-paclitaxel
    - Implantable electronic medical devices in the torso, such as pacemakers.
    - Presentar metástasis sintomática, no tratada o con progresión activa en el sistema nervioso central (SNC).
    - Presentar antecedentes de carcinomatosis leptomeníngea.
    - Presentar dolor incontrolado relacionado con el tumor.
    - Tener enfermedad inmunitaria activa o antecedentes de enfermedad inmunitaria
    - Presentar una infección grave en las 4 semanas anteriores al inicio del tratamiento del estudio
    - Tener antecedentes de reacciones alérgicas, anafilácticas o de otro tipo de hipersensibilidad de carácter grave a los anticuerpos quiméricos o humanizados o a las proteínas de fusión
    - Cualquier otra enfermedad, disfunción metabólica, hallazgo en exploración física o hallazgo clínico de laboratorio que contraindique el uso de un medicamento o producto en investigación puede afectar a la interpretación de los resultados o exponer al paciente a un alto riesgo de complicaciones derivadas del tratamiento.
    - Recibir terapia antineoplásica concurrente aparte de gemcitabina y nab-paclitaxel.
    - Llevar dispositivos médicos electrónicos implantables en el tronco, por ejemplo, un marcapasos.
    E.5 End points
    E.5.1Primary end point(s)
    Disease control rate (DCR) by RECIST v1.1 in patients with 1L mPDAC treated with TTFields concomitant with atezolizumab, gemcitabine and nab-paclitaxel, measured as the proportion of patients with stable disease for at least 16 weeks or confirmed PR or CR.
    Tasa de control de la enfermedad (TCE) según RECIST v1.1 en pacientes con ADPm tratados en 1L con TTFields concomitantes con atezolizumab, gemcitabina y nab-paclitaxel, medida por el porcentaje de pacientes con enfermedad estable (EE) durante un mínimo de 16 semanas o con respuesta parcial (RP) o respuesta completa (RC) confirmadas.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Stable disease for at least 16 weeks, or confirmed PR or CR.
    Enfermedad estable (EE) durante un mínimo de 16 semanas o con respuesta parcial (RP) o respuesta completa (RC) confirmadas.
    E.5.2Secondary end point(s)
    • Overall survival (OS) in patients with 1L mPDAC treated with TTFields concomitant with atezolizumab, gemcitabine and nab-paclitaxel, measured as the period between the time of treatment initiation and the time of death.
    • Progression free survival (PFS) by RECIST v1.1 in patients with 1L mPDAC treated with TTFields concomitant with atezolizumab, gemcitabine and nab-paclitaxel, measured from the time of treatment initiation.
    • 1-year survival rate in patients with 1L mPDAC treated with TTFields concomitant with atezolizumab, gemcitabine and nab-paclitaxel, measured as the proportion of patients alive one year after treatment initiation.
    • Objective response rate (ORR) by RECIST v1.1 in patients with 1L mPDAC treated with TTFields concomitant with atezolizumab, gemcitabine and nab-paclitaxel, measured as the proportion of patients with partial or complete response between the time of treatment initiation and the time of death.
    • Progression free survival rate at 6 months (PFS6) by RECIST v1.1 in patients with 1L mPDAC treated with TTFields concomitant with atezolizumab, gemcitabine and nab-paclitaxel, defined as the proportion of patients who are alive and are progression free six months after treatment initiation.
    • Duration of response (DOR) by RECIST v1.1 in patients with 1L mPDAC treated with TTFields concomitant with atezolizumab, gemcitabine and nab-paclitaxel, measured as the time from the first occurance of a documented objective response to disease progression or death from any cause (whichever occurs first).
    • Toxicity profile in 1L mPDAC patients treated with TTFields concomitant with atezolizumab, gemcitabine and nab-paclitaxel, measured by the rate of patients with treatment-emergent adverse events (based on CTCAE V5.0).
    • Supervivencia global (SG) en pacientes con ADPm tratados en 1L con TTFields concomitantes con atezolizumab, gemcitabina y nab-paclitaxel, medida según el periodo transcurrido entre el momento de inicio del tratamiento y el momento de la muerte.
    • Supervivencia sin progresión (SSP) según RECIST-v1.1 en pacientes con ADPm tratados en 1L con TTFields concomitantes con atezolizumab, gemcitabina y nab-paclitaxel, medida desde el momento de inicio del tratamiento.
    • Tasa de supervivencia al año en pacientes con ADPm tratados en 1L con TTFields concomitantes con atezolizumab, gemcitabina y nab-paclitaxel medida por el porcentaje de pacientes vivos un año después del inicio del tratamiento.
    • Tasa de respuesta objetiva (TRO) según RECIST v1.1 en pacientes con ADPm tratados en 1L con TTFields concomitantes con atezolizumab, gemcitabina y nab-paclitaxel, medida por el porcentaje de pacientes con RP o RC entre el momento de inicio del tratamiento y el momento de la muerte.
    • Supervivencia sin progresión a los 6 meses (SSP6) según RECIST v1.1 en pacientes con ADPm tratados en 1L con TTFields concomitantes con atezolizumab, gemcitabina y nab-paclitaxel, definida como el porcentaje de pacientes vivos y sin progresión seis meses después del inicio del tratamiento.
    • Duración de la respuesta (DdR) según RECIST v1.1 en pacientes con ADPm tratados en 1L con TTFields concomitantes con atezolizumab, gemcitabina y nab-paclitaxel, definida como el tiempo transcurrido entre la primera aparición de una respuesta objetiva confirmada y la progresión de la enfermedad o la muerte por cualquier causa (lo que suceda primero).
    • Perfil de toxicidad en pacientes con ADPm tratados en 1L con TTFields concomitantes con atezolizumab, gemcitabina y nab-paclitaxel, medido por la tasa de pacientes con acontecimientos adversos surgidos durante el tratamiento (a partir de los Criterios terminológicos comunes para acontecimientos adversos, CTCAE, versión 5.0).
    E.5.2.1Timepoint(s) of evaluation of this end point
    As stated in E.5.2.
    Como se indica en E.5.2.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled 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.8.2.4Number of treatment arms in the trial1
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA15
    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
    Switzerland
    Czechia
    Germany
    Hungary
    Spain
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LPLV
    Última visita del último sujeto
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    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 years3
    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: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 36
    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 state26
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 69
    F.4.2.2In the whole clinical trial 76
    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)
    Patients will be able to continue on study device and/or drugs if they are receiving study treatment at the time of study closure. Treatment continuation and follow-up will be according to local requirements.
    Los pacientes podrán continuar con el dispositivo y/o los medicamentos del estudio si están recibiendo el tratamiento del estudio en el momento del cierre del estudio. La continuación del tratamiento y el seguimiento se realizarán de acuerdo con los requisitos locales.
    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 Decision2023-06-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-06-07
    P. End of Trial
    P.End of Trial StatusOngoing
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