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    Summary
    EudraCT Number:2021-006579-41
    Sponsor's Protocol Code Number:ANG3070-CKD-201
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2022-02-04
    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 number2021-006579-41
    A.3Full title of the trial
    A Phase 2, Multicenter, Double-Blind, Randomized, Placebo-controlled Study of Safety and Efficacy Of ANG-3070 in Patients with Primary Glomerular Disease and Persistent Proteinuria
    Estudio de fase II, multicéntrico, doble ciego, aleatorizado, controlado con
    placebo para evaluar la seguridad y la eficacia de ANG-3070 en pacientes
    con enfermedad glomerular primaria y proteinuria persistente
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 2, Multicenter, Double-Blind, Randomized, Placebo-controlled Study of Safety and Efficacy Of ANG-3070 in Patients with primary proteinuric renal disease
    Estudio de fase II, multicéntrico, doble ciego, aleatorizado, controlado con
    placebo para evaluar la seguridad y la eficacia de ANG-3070 en pacientes
    con enfermedad proteinuria primaria
    A.4.1Sponsor's protocol code numberANG3070-CKD-201
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04939116
    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 SponsorAngion Biomedica Corp.
    B.1.3.4CountryUnited States
    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 supportAngion Biomedica Corp.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAngion Biomedica Corp.
    B.5.2Functional name of contact pointClinical Trials Information
    B.5.3 Address:
    B.5.3.1Street Address51 Charles Lindberg Blvd
    B.5.3.2Town/ cityUniondale, NY
    B.5.3.3Post code11553
    B.5.3.4CountryUnited States
    B.5.6E-mailkjoyce@angion.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.2Product code ANG3070
    D.3.4Pharmaceutical form Capsule
    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 INNAnsornitinib
    D.3.9.1CAS number 1448874-96-1
    D.3.9.2Current sponsor codeANG-3070
    D.3.9.3Other descriptive nameANG-3070 hydrochloride
    D.3.9.4EV Substance CodeSUB253510
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.2Product code ANG3070
    D.3.4Pharmaceutical form Capsule
    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 INNAnsornitinib
    D.3.9.1CAS number 1448874-96-1
    D.3.9.2Current sponsor codeANG-3070
    D.3.9.3Other descriptive nameANG-3070 hydrochloride
    D.3.9.4EV Substance CodeSUB253510
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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
    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
    Primary glomerular disease and persistent proteinuria
    Enfermedad glomerular primaria y proteinuria persistente
    E.1.1.1Medical condition in easily understood language
    Primary proteinuric renal disease
    Enfermedad proteinuria renal primaria
    E.1.1.2Therapeutic area Body processes [G] - Immune system processes [G12]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10037032
    E.1.2Term Proteinuria
    E.1.2System Organ Class 10038359 - Renal and urinary disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of ANG-3070 in patients with primary glomerular disease and persistent proteinuria while on the SOC, as measured by a reduction in the 24-hour urinary protein excretion.
    Evaluar la eficacia de ANG-3070 en pacientes con enfermedad glomerular primaria y proteinuria persistente mientras reciben tratamiento de referencia, medida mediante una reducción de la excreción de proteínas en orina de 24 horas.
    E.2.2Secondary objectives of the trial
    To evaluate the safety and tolerability of ANG-3070 in patients with primary glomerular disease and persistent proteinuria.
    Evaluar la seguridad y la tolerabilidad de ANG-3070 en pacientes con enfermedad glomerular primaria y proteinuria persistente.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female participants aged 18 and older.
    2. Diagnosis of IgA nephropathy or primary FSGS confirmed by a past renal biopsy. Participants with genetic forms of FSGS may be enrolled without a renal biopsy if the clinical picture is consistent with the genetic testing results and they have been on the standard of care therapy for at least 12 weeks prior to enrollment in the study.
    3. Estimated glomerular filtration rate (eGFR) by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) ≥ 40 mL/min/1.73m2.
    4. Urinary protein excretion ≥ 1 g/day on a 24-hour urine collection.
    5. Stable blood pressure ≤ 140/90 mmHg with stable antihypertensive regimen for at least 12 weeks prior to screening.
    6. All participants must be on the SOC therapy including the maximally tolerated/recommended doses of an Angiotensin-converting enzyme inhibitor (ACEi) or ARB, but not both.
    7. Renin-angiotensin-aldosterone system (RAAS) blockers and Sodium glucose co-transporter 2 (SGLT-2) inhibitors must be stable for at least 12 weeks prior to screening and projected to remain stable through week 16.
    8. Immunosuppressive or immunomodulatory therapy must be stable for at least 12 weeks prior to screening and projected to remain stable through study week 16.
    9. Both genders of childbearing potential must agree to use adequate contraception, during and for at least 3 months after the last dose of study drug.
    10. Participants must be willing and able to give written Informed Consent and to comply with protocol requirements.
    11. Participants must be judged to be otherwise fit for the study by the Investigator.
    1. Participantes varones o mujeres de 18 años o más.
    2. Diagnóstico de nefropatía por inmunoglobulina A (IgA) o de GEFS primaria confirmada mediante una biopsia renal previa. Podrá incluirse a
    participantes con formas genéticas de GEFS sin necesidad de biopsia renal, si su cuadro clínico concuerda con los resultados de pruebas
    genéticas y hayan estado recibiendo el tratamiento de referencia durante al menos 12 semanas antes de su inclusión en el estudio.
    3. Tasa de filtración glomerular estimada (TFGe) mediante la ecuación de la Chronic Kidney Disease Epidemiology Collaboration (CKD‑EPI) ≥40
    ml/min/1,73 m2.
    4. Excreción de proteínas en orina ≥1 g/día en una muestra de orina de 24 horas.
    5. Presión arterial estable ≤140/90 mmHg con una pauta de tratamiento antihipertensivo estable durante al menos 12 semanas antes
    de la selección.
    6. Todos los participantes deben estar recibiendo el tratamiento de referencia, incluidas las dosis máximas toleradas/recomendadas de
    inhibidores de la enzima convertidora de la angiotensina (iECA) o antagonistas de los receptores de la angiotensina (ARA), pero no ambos.
    7. Los tratamientos con antagonistas del sistema renina-angiotensinaaldosterona (SRAA) e inhibidores del cotransportador sodio-glucosa de
    tipo 2 (SGLT‑2) deben haberse mantenido estables durante al menos 12 semanas antes de la selección y se debe prever que se mantengan
    estables hasta la semana 16.
    8. El tratamiento inmunosupresor o inmunomodulador debe haberse mantenido estable durante al menos las 12 semanas previas a la
    selección y se debe prever que se mantenga estable hasta la semana 16 del estudio.
    9. Los participantes de ambos sexos que puedan tener hijos deben aceptar utilizar un método anticonceptivo adecuado durante el estudio y
    al menos 3 meses después de recibir la última dosis del fármaco del estudio.
    10. Los participantes deben estar dispuestos a y ser capaces de proporcionar su consentimiento informado por escrito y cumplir los
    requisitos del protocolo.
    11. El investigador debe considerar a los participantes, por lo demás, aptos para participar en el estudio.
    E.4Principal exclusion criteria
    Laboratory and Assessments
    1. Positive Hepatitis B (HBV), Hepatitis C (HCV), or human immunodeficiency virus (HIV) viral screening test; historical or during the screening.
    2. Hematologic abnormalities as follows: Hemoglobin (Hb) <8 g/dL, or platelets <50,000, or absolute neutrophil count (ANC) <1000 cells/µL at baseline.
    3. Aspartate Aminotransferase (AST) or alanine Aminotransferase (ALT) or total bilirubin > 2 ULN.
    4. Hemoglobin A1C > 8.5%.
    Excluded Medications
    5. Participants taking non-steroidal anti-inflammatory agents (NSAIDS) chronically (intermittent, i.e., occasional NSAIDS for pain or fever is discouraged, but is not excluded). No NSAIDS allowed within 72 hours of the scheduled lab work to determine eGFR and/or urinary protein and creatinine measurements.
    6. Participants taking strong inducers (e.g., phenytoin, rifampin) or inhibitors (e.g., clarithromycin, itraconazole) of CYP3A4. Please see Appendix 1.
    Bleeding or Thrombosis Risk
    7. Known predisposition to bleeding.
    8. Participants who require fibrinolysis, full-dose therapeutic anticoagulation (e.g. vitamin K antagonists, dabigatran, heparin, hirudin etc.), or high dose antiplatelet therapy.
    Prophylactic use of antiplatelet therapy (e.g. acetyl salicylic acid up to 325 mg/d, or
    clopidogrel at 75 mg/d, or equivalent doses of other antiplatelet therapy) is not excluded.
    9. History of hemorrhagic central nervous system (CNS) event within 12 months of the screening visit.
    10. History of active gastrointestinal bleeding within 6 months of the screening visit.
    11. History of thrombotic event (including stroke and transient ischemic attacks) within 12 months of the screening visit.
    Other excluding conditions and medical judgement
    12. Type I diabetes mellitus.
    13. A renal biopsy done no more than 5 years prior to screening showing histopathological evidence of diabetic kidney disease.
    14. Membranous nephropathy.
    15. Myocardial infarction or unstable angina within 6 months of the screening visit.
    16. History of solid organ or hematopoietic cell transplantation.
    17. On an organ transplant waiting list or anticipated organ transplant within 6 months of screening.
    18. History of treated Hepatitis C (HCV).
    19. Participation in any clinical study of an investigational product within 12 weeks from the date of screening.
    20. History or presence of any form of cancer within 2 years of screening except excised basal or squamous cell carcinoma of the skin.
    21. Renal disease secondary to systemic disease including but not limited to: systemic lupus erythematosus, anti-neutrophil cytoplasmic antibodies -associated diseases, anti-glomerular basement disease, secondary forms of focal segmental glomerulosclerosis, renal diseases associated with para-proteinemias, C3 glomerulopathy, and diabetic kidney disease.
    22. Treatment with Anti-CD20 monoclonal antibodies within 6 months prior to screening.
    23. A known systemic disorder that requires, or is expected to require, systemic glucocorticoids or immune modulators during the study.
    24. BMI ≥40 Kg/m2
    25. Pregnant women or women who are breast feeding or of child-bearing potential not willing to use two effective methods of birth control (1 barrier and 1 highly effective non-barrier) during the study from screening until 3 months after end of treatment.
    26. Sexually active males not committing to using condoms during the study (except if their partner is not of childbearing potential) and 3 months after end of treatment.
    Análisis de laboratorio y evaluaciones
    1. Resultado positivo, tanto previo como durante el proceso de selección, en una prueba de detección del virus de la hepatitis B (VHB), el virus de la hepatitis C (VHC) o el virus de la inmunodeficiencia humana (VIH).
    2. Anomalías hematológicas, como las siguientes: hemoglobina (Hb) <8 g/dl, o recuento de plaquetas <50.000 o recuento absoluto de
    neutrófilos (RAN) <1000 células/μl al inicio del estudio.
    3. Aspartato aminotransferasa (AST), alanina aminotransferasa (ALT) o bilirrubina total > 2 veces el límite superior de la normalidad (LSN).
    4. Hemoglobina A1c >8,5 %.
    Medicamentos prohibidos
    5. Participantes que reciban antiinflamatorios no esteroideos (AINE) de forma crónica (el consumo intermitente; es decir, el uso ocasional de
    AINE para tratar el dolor o la fiebre, está desaconsejado, pero no es motivo de exclusión). No se permite el consumo de AINE en las 72 horas
    previas a la realización de los análisis de laboratorio programados para determinar la TFGe, la cantidad de proteínas y creatinina en orina, o
    ambas.
    6. Participantes que tomen inductores (p. ej., fenitoína o rifampicina) o inhibidores (p. ej., claritromicina o itraconazol) potentes del citocromo
    P450 3A4 (CYP3A4). Consulte el Apéndice 1 del protocolo.
    Riesgo de hemorragia o trombosis
    7. Predisposición conocida a las hemorragias.
    8. Participantes que requieren fibrinólisis, tratamiento anticoagulante a dosis completa (p. ej., antagonistas de la vitamina K, dabigatrán,
    heparina, hirudina, etc..) o tratamiento antiplaquetario a dosis elevadas.
    El uso profiláctico de tratamiento antiplaquetario (p. ej., ácido acetilsalicílico hasta una dosis máxima de 325 mg/día, clopidogrel a una dosis de 75 mg/día o dosis equivalentes de otro tratamiento antiplaquetario) no es motivo de exclusión.
    9. Antecedentes de un acontecimiento hemorrágico en el sistema nervioso central (SNC) en los 12 meses previos a la visita de selección.
    10. Antecedentes de una hemorragia gastrointestinal activa en los 6 meses previos a la visita de selección.
    11. Antecedentes de un acontecimiento trombótico (incluido un ictus o un accidente isquémico transitorio) en los 12 meses previos a la visita de
    selección.
    E.5 End points
    E.5.1Primary end point(s)
    Percentage change in 24-hour urinary protein excretion at Week 12.
    Cambio porcentual en la excreción de proteínas en orina de 24 horas en
    la semana 12
    E.5.1.1Timepoint(s) of evaluation of this end point
    24-hour urinary protein excretion is tested at screening, Visit 3 (week 4), Visit 5 (week 12)
    La excrección de proteinas en orina en 24h se analiza en la selección, Visita 3 (semana4), Visita 5 (semana 12)
    E.5.2Secondary end point(s)
    • Percentage change in 24-hour urinary albumin excretion at Week 12.
    • Number of patients with complete remission in proteinuria, defined as a 24-hour urinary protein excretion < 300 mg at Week 12.
    • Number of patients with partial remissions in proteinuria, defined as a 24-hour urinary protein excretion reduction of ≥ 50% from the baseline and a 24-hour urinary protein excretion < 3.5 g/day if the baseline 24-hour urinary protein excretion > 3.5 g at Week 12.
    • Number of patients with ≥ 50% reduction in 24-hour urinary protein excretion from the baseline at Week 12.
    • Number of patients with ≥ 50% reduction in 24-hour urinary albumin excretion from the baseline at Week 12.
    • Percentage change from baseline in creatinine clearance (CrCl) at Week 12.
    • Changes in serum albumin, fasting triglycerides, and cholesterol at Week 12.
    • Cambio porcentual en la excreción de albúmina en orina de 24 horasen la semana 12.
    • Número de pacientes que presenten una remisión completa de la proteinuria en la semana 12, definida como una excreción de proteínas en orina de 24 horas <300 mg.
    • Número de pacientes que presenten una remisión parcial de la proteinuria en la semana 12, definida como una reducción de la excreción de proteínas en orina de 24 horas ≥50 % con respecto al valor inicial y una excreción de proteínas en orina de 24 horas <3,5 g/día si la excreción de proteínas en orina de 24 horas al inicio del estudio era >3,5 g.
    • Número de pacientes que presenten una reducción ≥50 % en la excreción de proteínas en orina de 24 horas en la semana 12 con respecto al inicio del estudio.
    • Número de pacientes que presenten una reducción ≥50 % en la excreción de albúmina en orina de 24 horas en la semana 12 con respecto al inicio del estudio.
    • Cambio porcentual con respecto al valor inicial en el aclaramiento de la creatinina (ACr) en la semana 12.
    • Cambios en los niveles de albúmina sérica, triglicéridos en ayunas y colesterol en la semana 12.
    E.5.2.1Timepoint(s) of evaluation of this end point
    24-hour urinary protein and albumin excretion is tested at screening, Visit 3 (week 4), Visit 5 (week 12);
    Creatinine clearance is tested at screening, Visit 1 (randomization), Visit 2 (week 2), Visit 4 (week 8), Visit 5 (week 12);
    Serum albumin, fasting triglycerides, and cholesterol are tested at screening, Visit 1 (randomization), Visit 2 (week 2), Visit 3 (week 4), Visit 4 (week 8), Visit 5 (week 12)
    Excrección de proteínas en orina y albumina en 24h se analiza durante la seleccion, Visita 3 (semana 4), Visita 5 (semana 12);
    Lavado de la creatina se analiza durante la seleccion, Visita 1 (aleatorización), Visita 2 (semana 2), Visita 4 (semana 8), Visita 5 (semana 12);
    Albúmina sérica, triglicéridos en ayunas y colesterol se analizan en la seleccion, Visita 1 (aleatorización), Visita 2 (semana 2), Visita 3 (semana 4), Visita 4 (semana 8), Visita 5 (semana 12);.
    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 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) 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 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 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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial4
    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 concerned3
    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
    Australia
    Bulgaria
    Georgia
    Lithuania
    Spain
    United States
    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 years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    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: 70
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 state9
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 20
    F.4.2.2In the whole clinical trial 100
    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 Decision2022-06-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-04-05
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2022-08-18
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