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    Summary
    EudraCT Number:2019-004090-50
    Sponsor's Protocol Code Number:CT-OST-122-02
    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:2019-11-11
    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 number2019-004090-50
    A.3Full title of the trial
    A Phase Ib/IIa, randomized, double blind, placebo controlled, multicenter clinical trial to evaluate the safety, pharmacokinetics and efficacy of oral treatment with OST-122 in patients with moderate to severe ulcerative colitis
    Título del protocolo: Ensayo clínico multicéntrico de fase Ib/IIa (prueba de concepto) aleatorizado, con doble ciego y controlado con placebo para evaluar la seguridad, farmacocinética y eficacia del tratamiento oral con OST-122 en pacientes con colitis ulcerosa de moderada a severa.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical Trial to evaluate the safety and efficacy of oral treatment with OST-122 in patients with moderate to severe ulcerative colitis
    Ensayo clínico para evaluar la seguridad y eficacia del tratamiento oral con OST-122 en pacientes con colitis ulcerosa de moderada a severa
    A.4.1Sponsor's protocol code numberCT-OST-122-02
    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 SponsorONCOSTELLAE S.L.
    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 supportONCOSTELLAE S.L.
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationONCOSTELLAE S.L.
    B.5.2Functional name of contact pointGuido Kurz
    B.5.3 Address:
    B.5.3.1Street AddressRua Lope Gomez de Marzoa s/n
    B.5.3.2Town/ citySantiago de Compostela
    B.5.3.3Post code15705
    B.5.3.4CountrySpain
    B.5.4Telephone number+34617 640 327
    B.5.6E-mailguido.kurz@oncostellae.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.3.1Product nameOST-122
    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 INNNot available yet
    D.3.9.3Other descriptive nameOST-122
    D.3.9.4EV Substance CodeSUB190802
    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.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.3.1Product nameOST-122
    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 INNNot available yet
    D.3.9.3Other descriptive nameOST-122
    D.3.9.4EV Substance CodeSUB190802
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Moderate to severe ulcerative colitis
    Colitis ulcerosa de moderada a severa
    E.1.1.1Medical condition in easily understood language
    Ulcerative colitis
    Colitis ulcerosa
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The trial primary goal will be to evaluate the safety of OST-122 in patients with moderate to severe active ulcerative colitis disease over 28 days
    Evaluación de la seguridad de OST-122 en pacientes con Colitis ulcerosa activa de moderada a grave durante 28 días
    E.2.2Secondary objectives of the trial
    Explore the pharmacokinetics (PK) profile and preliminary therapeutic efficacy associated with OST-122 through biomarker analysis and clinical assessments
    Explorar el perfil de farmacocinética y la eficacia terapéutica preliminar asociada con OST-122 a través del análisis de biomarcadores y la evaluación clínica
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Willing and able to provide written informed consent and capable of understanding and complying with the protocol;
    2. Patients male and female ≥ 18 and ≤ 75 years at the time of consent;
    3. Patient with previous diagnosis of ulcerative colitis: ulcerative proctitis, left-side ulcerative colitis or extensive/pancolitis (E1, E2 and E3 of Montreal Classification, respectively) established at least 3 months prior to screening and determined by standard clinical, endoscopic, and histological procedures;
    4. Demonstrated inadequate response, loss of response, or intolerance to at least one of the following treatments including, aminosalicylates (ASAs), corticosteroids, immunosuppressants, anti-tumor necrosis factor (TNF)-α agents or integrin inhibitor;
    5. If the subject is currently receiving an oral aminosalicylate, he or she is eligible and can stay on that dose of aminosalicylate provided the dose has been stable for at least 1 week prior to screening;
    6. If the subject is currently receiving an oral corticosteroid, he or she is eligible if the dose is equivalent to or less than prednisone 20 mg/day or beclomethasone dipropionate 5 mg/day and stable for at least 1 week prior to screening visit;
    7. Has an endoscopic Mayo subscore of ≥ 2 and a total Mayo score of 5-10 during screening;
    8. Women who are not postmenopausal (at least 12 months) or surgically sterile must have a negative pregnancy test at screening and at the end of study and either abstain from sexual intercourse or use a highly effective method of birth control (double barrier) for the duration of the study and after 12 weeks after the last dose of study drug;
    9. For men: agreement to remain abstinent or use contraceptive measures and agreement to refrain from donating sperm for the duration of the study and after 12 weeks from the last dose of study drug;
    10. Availability for the entire study period, absence of intellectual problems likely to limit the validity of consent to participate in the study or the compliance with protocol requirements; willingness to adhere to the protocol requirements, ability to cooperate adequately and to understand and follow the instructions of the physician or designee
    1. Dispuesto y capaz de proporcionar un consentimiento informado por escrito, así como capaz de comprender y cumplir con el protocolo;
    2. Pacientes masculinos y femeninos de entre 18 a 75 años en el momento del consentimiento;
    3. Paciente con diagnóstico previo de colitis ulcerosa: proctitis ulcerosa, colitis ulcerosa izquierda o pancolitis extensa (E1, E2 y E3 de la Clasificación de Montreal, respectivamente), establecida al menos 3 meses antes del screening y determinada por estándares clínicos, endoscópicos y procedimientos histológicos;
    4. Respuesta inadecuada demostrada, pérdida de respuesta o intolerancia a al menos uno de los siguientes tratamientos: aminosalicilatos (ASA), corticosteroides, inmunosupresores, agentes anti-factor de necrosis tumoral (TNF)-α o inhibidores de integrinas;
    5. El sujeto será elegible si actualmente recibe un aminosalicilato oral y puede permanecer con esa dosis de aminosalicilato siempre que la dosis haya sido estable durante al menos 1 semana antes de la selección;
    6. El sujeto será elegible si recibe actualmente un corticosteroide oral, si la dosis es equivalente o inferior a 20 mg / día de prednisona o dipropionato de beclometasona 5 mg / día y estable durante al menos 1 semana antes de la visita de selección;
    7. Obtener una puntuación en el subscore endoscópico de la clasificación Mayo≥ 2 y una puntuación Mayo total de 5-10 durante el screening;
    8. Las mujeres no postmenopáusicas (al menos 12 meses) o quirúrgicamente estériles deben someterse a una prueba de embarazo que debe ser negativa en el momento del screening y al final del estudio y abstenerse de tener relaciones sexuales o utilizar un método anticonceptivo altamente eficaz (doble barrera) durante todo el estudio y hasta 12 semanas después de la última dosis del fármaco del estudio;
    9. Para los hombres: abstenerse de tener relaciones sexuales o utilizar un método anticonceptivo altamente eficaz (doble barrera) durante todo el estudio y hasta 12 semanas después de la última dosis del fármaco del estudio;
    10. Disponibilidad para todo el período de estudio, ausencia de problemas intelectuales que puedan limitar la validez del consentimiento para participar en el estudio o el cumplimiento de los requisitos del protocolo; voluntad de adherirse a los requisitos del protocolo, capacidad de cooperar adecuadamente y comprender y seguir las instrucciones del médico o la persona designada.
    E.4Principal exclusion criteria
    1. Has fulminant colitis, toxic megacolon, primary sclerosing cholangitis, Crohn's disease, history of moderate to severe colitis-associated colonic dysplasia, active peptic ulcer disease;
    2. Medications of exclusion:
    a. Topical mesalazine or steroids (i.e., enemas or suppositories) within the 7 days prior to Baseline visit
    b. Azathioprine, 6-mercaptopurine, or methotrexate within 10 days prior to Baseline visit,
    c. Intravenous corticosteroids within the 14 days prior to Baseline visit,
    d. Tofacitinib or any other JAK inhibitor within 14 days prior to Baseline visit;
    e. Anti-diarrheal treatment within14 days prior to Baseline Visit.
    f. Received cyclosporine, tacrolimus, mycophenolate mofetil, or thalidomide within 30 days prior to Baseline visit.
    g. Adalimumab within the 30 days prior to Baseline visit
    h. Infliximab, golimumab, etanercept, vedolizumab or certolizumab within the 60 days prior to Baseline visit
    i. NSAIDs on a daily basis withdrawn 7 days previous to Baseline visit
    3. Has a current bacterial, parasitic, fungal, or viral infection
    4. Is positive for hepatitis A, B or C, HIV or tuberculosis, as assessed by method available at each site
    5. Patient who has clinically significant diseases and/or infections captured in the medical history or evidence of clinically significant findings on physical examination and/or clinically significant ordinary laboratory evaluations (haematology, biochemistry, and urinalysis) or ECG.
    6. Participated in another clinical trial of an investigational drug (or medical device) within 30 days prior to Baseline (or within 60 days prior to Baseline if investigational drug was a biologic product)
    7. Demonstrated an inadequate response or loss of response to Tofacitinib or any other JAK inhibitor.
    8. Use of products, food supplements or medical devices, whose composition includes probiotics in the 1 month prior to Baseline visit.
    9. Patient who has prior extensive colonic resection, subtotal or total colectomy or planned surgery for ulcerative colitis
    10. Patient who has past or present fistula or abdominal abscess
    11. Patient who is pregnant or lactating
    12. Inability to comply with study protocol, in opinion of the investigator
    13. History of alcohol, drug or chemical abuse within 6 months prior to Screening visit
    14. History of cancer within the last 5 years. Patients with local basal or squamous cell carcinoma of the skin that has been excised and is considered cured may be included.
    1. Haber padecido o padecer colitis fulminante, megacolon tóxico, colangitis esclerosante primaria, enfermedad de Crohn, antecedentes de displasia colónica asociada a colitis moderada a grave, enfermedad ulcerosa péptica activa;
    2. Medicamentos de exclusión:
    a. Mesalazina o esteroides tópicos (es decir, enemas o supositorios) en los 7 días anteriores a la visita de aleatorización;
    b. Azatioprina, 6-mercaptopurina o metotrexato en los 10 días previos a la visita de aleatorización;
    c. Corticosteroides intravenosos en los 14 días previos a la visita de aleatorización;
    d. Tofacitinib o cualquier otro inhibidor de JAK en los 14 días previos a la visita de aleatorización;
    e. Tratamiento antidiarreico en los 14 días previos a la visita de aleatorización;
    f. Recibir ciclosporina, tacrolimus, micofenolato mofetilo o talidomida en los 30 días previos a la visita de aleatorización;
    g. Adalimumab en los 30 días previos a la visita de aleatorización;
    h. Infliximab, golimumab, etanercept, vedolizumab o certolizumab en los 60 días anteriores a la visita de aleatorización;
    i. Toma diaria de AINEs retirados 7 días antes de la visita de aleatorización;
    3. Padecer actualmente una infección bacteriana, parasitaria, fúngica o viral.
    4. Ser positivo para hepatitis A, B o C, VIH o tuberculosis, (prueba realizada según el método disponible en cada centro).
    5. Tener enfermedades y / o infecciones clínicamente significativas plasmadas en el historial médico o evidencia de hallazgos clínicamente significativos en el examen físico y / o evaluaciones de laboratorio ordinarias clínicamente significativas (hematología, bioquímica y análisis de orina) o ECG.
    6. Participar en otro ensayo clínico de un medicamento en investigación (o dispositivo médico) dentro de los 30 días anteriores a la visita de aleatorización (o dentro de los 60 días anteriores a la aleatorización si el medicamento en investigación era un producto biológico).
    7. Demostrar una respuesta inadecuada o pérdida de respuesta a Tofacitinib o cualquier otro inhibidor de JAK.
    8. Uso de productos, complementos alimenticios o dispositivos médicos, cuya composición incluya probióticos en el mes anterior a la visita de aleatorización.
    9. Paciente con resección colónica extensa previa, colectomía subtotal o total o cirugía planificada para colitis ulcerosa.
    10. Paciente con fístula pasada o presente o absceso abdominal.
    11. Paciente embarazada o en periodo de lactancia.
    12. Incapacidad para cumplir con el protocolo del estudio, en opinión del investigador.
    13. Historia de abuso de alcohol, drogas o químicos dentro de los 6 meses previos a la visita de selección.
    14. Historia de cáncer en los últimos 5 años. Se podrán incluir pacientes con carcinoma local de células basales o escamosas de la piel que se haya extirpado y se considere curado.
    E.5 End points
    E.5.1Primary end point(s)
    Safety:
    - Number, severity, and type of AE, including changes in vital signs, physical examination, safety laboratory values, and ECGs
    - Causality with IMP as assessed by the investigator
    Seguridad:
    - Número, gravedad y tipo de efectos adversos incluyendo cambios en los signos vitales, en examen físico, en valores de laboratorio de seguridad y en los electrocardiogramas
    - Causalidad respecto al producto en investigación según lo evaluado por el investigador
    E.5.1.1Timepoint(s) of evaluation of this end point
    Safety of OST-122 administered for 28 days by assessing the Number, severity, and type of AE, including changes in vital signs, physical examination, safety laboratory values, ECGs and causality with IMP as assessed by the investigator
    Seguridad de OST-122 administrado durante 28 días evaluando el número, gravedad y tipo de efectos adversos incluyendo cambios en los signos vitales, en examen físico, en valores de laboratorio de seguridad, en los electrocardiogramas y la causalidad respecto al producto en investigación según lo evaluado por el investigador
    E.5.2Secondary end point(s)
    Efficacy:
    - Subjects (%) with improvement of rectal bleeding subscore by ≥1 point (Day 28)
    - Subjects (%) with rectal bleeding subscore of 0-1 (Day 28)
    - Subjects (%) with improvement of stool frequency subscore by ≥1 point (Day 28)
    - Subjects (%) with stool frequency subscore of 0-1 (Day 28)
    - Subjects (%) with PRO-2 subscore of 0-1 (Day 28)
    - Subjects (%) with improvement of PRO-2 subscore by ≥1 point (Day 28)
    - Subjects (%) with improvement of endoscopy subscore by ≥1 point (Day 28)
    - Subjects (%) with endoscopy subscore of 0-1 (Day 28)
    - Subjects (%) with clinical response of 0-1 (Day 28)
    - Change from baseline of faecal calprotectin compared to placebo (Day 28)
    - Change from baseline of serum C-reactive protein compared to placebo (Day 28)
    Pharmacokinetics
    - Pharmacokinetics (PK): Cmax in plasma (Time Frame: Day 1 and Day 14; Tmax in plasma [Time Frame: Day 1 and Day 14]; Area under curve (AUC) in plasma [Time Frame: Day 1 and Day 14]; Ctrough in plasma [ Time Frame: Day 1 and Day 14].
    Eficacia:
    - Sujetos (%) con una mejora del subscore de sangrado rectal ≥1 punto (Día 28)
    - Sujetos (%) con un subscore de sangrado rectal de 0-1 (Día 28)
    - Sujetos (%) con una mejora del subscore de número de deposiciones ≥1 punto (Día 28)
    - Sujetos (%) con un subscore de frecuencia de deposiciones de 0-1 (Día 28)
    - Sujetos (%) con un subscore PRO-2 de 0-1 (Día 28)
    - Sujetos (%) con una mejora en el subscore PRO-2 ≥1 punto (Día 28)
    - Sujetos (%) con una mejora en el subscore endoscópico ≥1 punto (Día 28)
    - Sujetos (%) con un subscore endoscópico de 0-1 (Día 28)
    - Sujetos (%) con respuesta clínica de entre 0 y 1 (Día 28)
    - Cambio con respecto al valor basal de la calprotectina fecal en comparación con placebo (Día 28)
    - Cambio con respecto al valor basal de la proteína C reactiva sérica en comparación con placebo (Día 28)
    Farmacocinética
    - Farmacocinética (PK): Cmax en plasma [Marco temporal: Día 1 y Día 14; Tmax en plasma [Marco temporal: Día 1 y Día 14]; Area bajo la curva (AUC) en plasma [Marco temporal: Día 1 y Día 14]; Ctrough en plasma [Marco temporal: Día 1 y Día 14].
    E.5.2.1Timepoint(s) of evaluation of this end point
    Efficacy: All parametres will be assessed Day 1 and Day 28.
    Pharmacokinetics: Cmax in plasma (Time Frame: Day 1 and Day 14; Tmax in plasma [Time Frame: Day 1 and Day 14]; Area under curve (AUC) in plasma [Time Frame: Day 1 and Day 14]; Ctrough in plasma [ Time Frame: Day 1 and Day 14].
    Eficacia: Todos los parámetros se evaluaran el Día 1 y el Día 28.
    Farmacocinética: Cmax en plasma [Marco temporal: Día 1 y Día 14; Tmax en plasma [Marco temporal: Día 1 y Día 14]; Area bajo la curva (AUC) en plasma [Marco temporal: Día 1 y Día 14]; Ctrough en plasma [Marco temporal: Día 1 y Día 14].
    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 Yes
    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) 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
    Evaluate the safety
    Evaluar la seguridad
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    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 concerned10
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    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: 28
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 4
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state32
    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
    No
    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 Decision2020-02-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-12-10
    P. End of Trial
    P.End of Trial StatusOngoing
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