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    Summary
    EudraCT Number:2020-004176-18
    Sponsor's Protocol Code Number:CHK01-02
    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:2021-02-09
    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 number2020-004176-18
    A.3Full title of the trial
    A Phase 2, Open-Label, Basket Study of Atrasentan in Patients with Proteinuric Glomerular Diseases (The AFFINITY Study)
    Estudio de fase 2, abierto, “en cesta”, de atrasentán en pacientes con enfermedades glomerulares proteinúricas (estudio AFFINITY)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 2, Open-Label, Basket Study of Atrasentan in Patients with Proteinuric Glomerular Diseases (The AFFINITY Study)
    Estudio de fase 2, abierto, “en cesta”, de atrasentán en pacientes con enfermedades glomerulares proteinúricas (estudio AFFINITY)
    A.3.2Name or abbreviated title of the trial where available
    The AFFINITY Study
    estudio AFFINITY
    A.4.1Sponsor's protocol code numberCHK01-02
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04573920
    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 SponsorChinook Therapeutics U.S., Inc.
    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 supportChinook Therapeutics U.S., Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationChinook Therapeutics U.S., Inc.
    B.5.2Functional name of contact pointClinical Trial Information Desk
    B.5.3 Address:
    B.5.3.1Street Address100-1600 Fairview Ave. E.
    B.5.3.2Town/ citySeattle
    B.5.3.3Post codeWA 98102
    B.5.3.4CountryUnited States
    B.5.4Telephone number12064857051
    B.5.6E-mailclinicaltrials@chinooktx.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 nameatrasentan
    D.3.4Pharmaceutical form Film-coated 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 INNatrasentan
    D.3.9.1CAS number 195733-43-8
    D.3.9.2Current sponsor codeCHK-01
    D.3.9.3Other descriptive nameATRASENTAN
    D.3.9.4EV Substance CodeSUB20598
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.75
    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
    Proteinuric glomerular diseases, including:
    Immunoglobulin A nephropathy (IgAN) (with UPCR 0.5 to <1.0 g/g)
    Focal segmental glomerulosclerosis (FSGS)
    Alport Syndrome
    Diabetes kidney disease (DKD) (as add-on to RAS and sodium glucose co-transporter 2 [SGLT2] inhibitors)
    Enfermedades glomerulares proteinúricas, que incluyen:
    Nefropatía por inmunoglobulina A (NIgA) (con UPCR de 0,5 a <1,0 g / g)
    Glomeruloesclerosis focal y segmentaria (GEFS)
    Síndrome de Alport
    Nefropatía diabética (ND) (como complemento de los inhibidores del cotransportador 2 [SGLT2] de glucosa y sodio RAS)
    E.1.1.1Medical condition in easily understood language
    Proteinuric glomerular diseases:
    Immunoglobulin A nephropathy (IgAN)
    Focal segmental glomerulosclerosis (FSGS)
    Alport Syndrome
    Diabetes kidney disease (DKD)
    Enfermedades glomerulares proteinúricas:
    Nefropatía por inmunoglobulina A (NIgA)
    Glomeruloesclerosis focal y segmentaria (GEFS)
    Síndrome de Alport
    Nefropatía diabética (ND)
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    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
    To evaluate the effect of atrasentan on proteinuria/albuminuria levels in subjects at risk of progressive loss of kidney function
    Evaluar el efecto de atrasentán sobre los niveles de proteinuria/albuminuria en los sujetos con riesgo de pérdida progresiva de la función renal
    E.2.2Secondary objectives of the trial
    Not Applicable
    No procede
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Optional pharmacogenetic sub-study
    Subestudio farmacogenético opcional
    E.3Principal inclusion criteria
    Cohort 1 – IgAN
    1. Biopsy-proven IgAN that, in the opinion of the Investigator, is not due to secondary causes.
    - Biopsy could have occurred at any point in time prior to study
    - A diagnostic report must be available for review by the Sponsor or designee
    2. Receiving a maximally tolerated and optimized dose of a RAS inhibitor that has been stable for at least 12 weeks prior to screening.
    3. UPCR > or = 0.5 and < 1.0 g/g (> or =500 mg/g and < 1000 mg/g) based on a central laboratory assessment of first morning void urine collected at screening.
    4. eGFR > or = 30 mL/min/1.73 m2

    Cohort 2 – FSGS
    5. Biopsy-confirmed FSGS or documentation of a genetic mutation in a podocyte protein associated with FSGS.
    6. UPCR >1.5 g/g (> 1500 mg/g) based on a central laboratory assessment of first morning void urine collected at screening.
    7. eGFR > or = 30 mL/min/1.73 m2
    8. Receiving a maximally tolerated and optimized dose of a RAS inhibitor that has been stable for at least 12 weeks prior to screening.
    9. If receiving systemic corticosteroids or calcineurin inhibitors, dose must be stable for 12 weeks prior to start of study drug and anticipated to remain on a stable dose at least through week 12.
    10. Body mass index (BMI) < or = 40 kg/m2

    Cohort 3 – Alport syndrome
    11. Diagnosis of Alport syndrome by genetic testing (documented mutation in a gene associated with Alport syndrome, including COL4A3, COL4A4, or X-linked COL4A5 in the subject or a family member). Or patients with a new mutation, that, in the opinion of the Investigator, has significant supporting evidence of Alport syndrome (biopsy, familial genetics, family history & familial biopsy, microscopic hematuria, hearing loss pattern, fleck retinopathy).
    12. UPCR > 0.5 g/g (>500 mg/g) based on central laboratory assessment of first morning void urine at screening
    13. Receiving a maximally tolerated and optimized dose of a RAS inhibitor that has been stable for at least 12 weeks prior to screening visit
    14. eGFR > or = 30 mL/min/1.73 m2

    Cohort 4 – DKD
    15. Clinical diagnosis of type 2 diabetes mellitus (T2DM) as per guidelines
    16. Diagnosis of DKD, including the presence of the following criteria:
    a. UACR > or = 0.5 g/g (500 mg/g) based on central laboratory assessment of first morning void urine at screening
    b. eGFR > or = 30 mL/min/1.73 m2
    17. Receiving a maximally tolerated and optimized dose of a RAS inhibitor that has been stable for at least 12 weeks prior to the screening visit and stable dose of SGLT2 inhibitor for at least 12 weeks prior to screening
    Age
    18. Age 18 years and older at the time of signing ICF
    Pregnancy and Contraception
    19. Willing to abide with highly effective forms of contraception, as specified in the protocol, throughout the study and for 1 month afterward. In WOCBP, use of hormonal contraceptive agents must have been started at least 1 month prior to baseline.
    Informed Consent
    20. Willing and able to provide written informed consent and comply with all study visits and study procedures.
    Cohorte 1: IgAN
    1. IgAN demostrada mediante biopsia que, en opinión del Investigador, no se debe a causas secundarias.
    •La biopsia podría haber tenido lugar en cualquier momento antes del estudio
    •Debe haber disponible un informe de diagnóstico para su revisión por parte del promotor o representante designado
    2. Recibir una dosis máxima tolerada y optimizada de un inhibidor del RAS que haya permanecido estable durante al menos 12 semanas antes de la selección.
    3. UPCR > o = 0,5 g/g y < 1.0 g/g (> o = 500 mg/g y < 1000 mg/g) basado en una evaluación del laboratorio central de orina de la primera micción de la mañana recogida en la selección.
    4. TFGe > o = 30 ml/min/1,73m 2
    Cohorte 2: GEFS
    5. GEFS demostrada mediante biopsia o documentación de una mutación genética en una proteína podocito asociada a la GESF.
    6. UPCR > 1,5 g/g (> 1500 mg/g) basado en una evaluación del laboratorio central de orina de la primera micción de la mañana recogida en la selección.
    7. TFGe > o = 30 ml/min/1,73m 2
    8. Recibir una dosis máxima tolerada y optimizada de un inhibidor del RAS que haya permanecido estable durante al menos 12 semanas antes de la selección.
    9. Si recibe corticoesteroides sistémicos o inhibidores de la calcineurina, la dosis debe haber sido estable durante 12 semanas antes del inicio del fármaco del estudio y estar previsto que la dosis sea estable al menos hasta la semana 12.
    10. Índice de masa corporal (IMC) < o = 40 kg/m 2
    Cohorte 3: síndrome de Alport
    11. Diagnóstico de síndrome de Alport mediante pruebas genéticas (mutación documentada en un gen asociado con el síndrome de Alport, incluidas COL4A3, COL4A4, o COL4A5 ligada al cromosoma X, en el sujeto o un miembro de su familia) o una mutación de nuevo con indicios de apoyo significativo de síndrome de Alport (biopsia, genética familiar, antecedentes familiares y de biopsia familiar, patrón de pérdida de audición, retinopatía de motas)
    12. UPCR > 0,5 g/g (> 500 mg/g) basado en una evaluación del laboratorio central de orina de la primera micción de la mañana en la selección
    13. Recibir una dosis máxima tolerada y optimizada de un inhibidor del RAS que haya permanecido estable durante al menos 12 semanas antes de la visita de selección
    14. TFGe > o = 30 ml/min/1,73m 2
    Cohorte 4: ND
    15. Diagnóstico clínico de diabetes mellitus de tipo 2 (DMT2) según las directrices
    16. Diagnóstico de ND, incluida la presencia de los siguientes criterios:
    a. UACR > o = 0,5 g/g (500 mg/g) basado en una evaluación del laboratorio central de orina de la primera micción de la mañana en la selección
    b. TFGe > o = 30 ml/min/1,73m 2
    17. Recibir una dosis máxima tolerada y optimizada de un inhibidor del RAS que haya permanecido estable durante al menos 12 semanas antes de la visita de selección y una dosis estable de un inhibidor del SGLT2 durante al menos 12 semanas antes de la selección
    Edad
    18. 18 años de edad y mayores en el momento de la firma del FCI
    Embarazo y anticoncepción
    19. Estar dispuesto a cumplir con métodos anticonceptivos de alta eficacia, como se especifica en el protocolo, a lo largo de todo el estudio y durante 1 mes después de este. En las MEF, el uso de anticonceptivos hormonales debe haberse iniciado al menos un mes antes del inicio.
    Consentimiento informado
    20. Estar dispuesto a dar el consentimiento informado por escrito y a cumplir con todas las visitas y procedimientos de estudio.
    E.4Principal exclusion criteria
    Medical Conditions
    1. Concurrent diagnosis of another cause of CKD or another primary glomerulopathy. Note: hypertensive nephrosclerosis is not exclusionary
    2. Clinical suspicion of rapidly progressive glomerulonephritis (RPGN) based on KDIGO guidelines or clinical suspicion of IgA vasculitis (Henoch-Schonlein Purpura).
    3. History of organ transplantation (subjects with history of corneal transplant are not excluded).
    4. Known history of congestive heart failure, diastolic dysfunction, or prior hospital admissions for conditions relating to fluid overload such as pulmonary edema, uncontrolled peripheral edema, pleural effusion, or ascites.
    5. Known history of clinically significant liver disease or transaminase or bilirubin values >2 times the upper limit of normal (ULN) for Cohorts 1-3; for Cohort 4 (DKD), alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3XULN (subjects with non alcoholic fatty liver disease/non-alcoholic steatohepatitis will be allowed).
    6. Active infection which may warrant systemic treatment
    7. Known history of human immunodeficiency virus (HIV) infection (HIV 1/2 antibodies)
    8. Known active Hepatitis B (defined as hepatitis B surface antigen [HBsAg] reactive); Subjects with successfully treated hepatitis C can be considered for inclusion into the study upon consultation with the Sponsor’s Medical Monitor (or designee).
    9. History of malignancy unless cancer free for at least 5 years or nonmelanoma skin cancer not requiring ongoing treatment. A subject with curatively treated cervical carcinoma in situ is eligible for this study.
    10. Any history within 3 months of screening of clinically significant, unstable, or uncontrolled cardiovascular (including myocardial infarction, unstable angina, cardiovascular revascularization procedure, cerebrovascular accident, or transient ischemic attack), pulmonary, hepatic, renal, gastrointestinal, genitourinary, hematological, coagulation, immunological, endocrine/metabolic, or other medical disorder that, in the opinion of the Investigator or Sponsor’s Medical Monitor (or designee), might confound the results of the study or pose additional risk to the subject by their participation in the study.

    Diagnostic assessments
    11. Brain natriuretic peptide (BNP) value of > 200 pg/mL at screening
    12. Platelet count <80,000 per µL at screening
    13. Hemoglobin below 9 g/dL at screening or prior history of blood transfusion for anemia within 3 months of screening.
    14. Confirmed blood pressure >150 mmHg systolic or >95 mmHg diastolic based on a mean of 3 measurements obtained at screening.
    15. Serum albumin < 3.0 g/dL for patients in the IgAN, Alport Syndrome, and DKD cohorts.
    16. HbA1c > 9.5% in Cohort 4 (DKD), HbA1c > 7.0% in Cohorts 1-3.

    Prior/Concomitant Medications
    17. Except for Cohort 2 (FSGS), use of systemic immunosuppressant medications including systemic steroids (prednisone or equivalent >10 mg/day for more than 2 weeks within 3 months prior to screening), mycophenolate, azathioprine, cyclosporine, tacrolimus, etc. for more than 2 weeks within the past 3 months prior to screening.
    18. Use of rituximab within the past 6 months
    19. Use of mineralocorticoid receptor antagonists such as spironolactone/eplerenone within 3 months prior to screening
    20. With the exception of DKD (Cohort 4), use of an SGLT2 inhibitor within the past 30 days.

    Prior/Concurrent Clinical Study Experience
    21. Have received any investigational agent within 1 month (or 5 half-lives of the agent, whichever is longer) prior to screening. If the investigational agent is a cytotoxic or immunosuppressive agent, then this washout period is 6 months.
    Other Exclusions
    22. History of an alcohol or illicit drug-related disorder within the past 3 years.
    23. Pregnancy, breast feeding, or intent to become pregnant during the study period and at least 1 month afterward for females.
    24. Intent to father a child or donate sperm during the study period and at least 1 month afterward for males.
    Patologías médicas
    1. Diagnóstico concurrente de nefropatía crónica por otra causa u otra glomerulopatía primaria. Nota: la nefroesclerosis hipertensiva no es excluyente
    2. Sospecha clínica de glomerulonefritis de progresión rápida (GNPR) basada en las directrices de la KDIGO o sospecha clínica de vasculitis por IgA (púrpura de Henoch-Schonlein).
    3. Antecedentes de trasplante de órganos (los sujetos con antecedentes de trasplante de córnea no están excluidos).
    4. Antecedentes conocidos de insuficiencia cardíaca congestiva, insuficiencia diastólica, o ingresos hospitalarios previos por afecciones relacionadas con la hipervolemia, como edema pulmonar, edema periférico incontrolado, derrame pleural o ascitis.
    5. Antecedentes conocidos de enfermedad hepática clínicamente significativo o valores de transaminasas o de bilirrubina >2 veces el límite superior de la normalidad (LSN) para las Cohortes 1-3; para la cohorte 4 (ND), alanina aminotransferasa (ALT) o aspartato aminotransferasa (AST) > 3 veces el LSN (los sujetos con esteatosis hepática no alcohólica están permitidos).
    6. Infección activa que pueda necesitar tratamiento sistémico
    7. Antecedentes conocidos de infección por el virus de la inmunodeficiencia humana (VIH) (anticuerpos contra el VIH 1/2)
    8. Conocimiento de hepatitis B activa (definida como antígeno de superficie de la hepatitis B [HBsAg] reactivo); los sujetos con hepatitis C tratada con éxito pueden ser considerados para su inclusión en el estudio previa consulta con el supervisor del promotor (o representante designado).
    9. Antecedentes de neoplasia maligna, a menos que no tenga cáncer durante al menos 5 años o cáncer de piel con excepción del melanoma que no requiera tratamiento continuo. Un sujeto con carcinoma cervicouterino in situ tratado de manera curativa es apto para este estudio.
    10. Antecedentes en los 3 meses previos a la selección de trastorno clínicamente significativo, inestable o no controlado de tipo cardiovascular (incluido infarto de miocardio, angina inestable, procedimiento de revascularización coronaria, accidente cerebrovascular o accidente isquémico transitorio), pulmonar, hepático, renal, gastrointestinal, genitourinario, hematológico, de coagulación, inmunológico, endocrino/metabólico, o cualquier otro trastorno médico que, en opinión del investigador o del supervisor médico del promotor (o representante designado), podría confundir los resultados del estudio o suponer un riesgo adicional para el sujeto por su participación en el estudio.
    Evaluaciones diagnósticas
    11. Valor de péptido natriurético cerebral (PNC) > 200 pg/ml en la selección
    12. Tener un recuento de plaquetas <80 000 por μl en la selección
    13. Hemoglobina por debajo de 9 g/dl en la selección o antecedentes de transfusión de sangre para la anemia en el plazo de 3 meses de la selección.
    14. Tensión arterial confirmada >150 mmHg sistólica o >95 mmHg diastólica basada en una media de 3 mediciones obtenidas en la selección.
    15. Albúmina sérica < 3,0 g/dl para los pacientes de las cohorte de IgAN, síndrome de Alport y ND.
    16. HbA1c > 9,5 % en la cohorte 4 (ND), HbA1c > 7,0 % en las cohortes 1-3.
    Medicamentos previos/concomitantes
    17. Excepto para la cohorte 2 (GEFS), uso de medicamentos inmunodepresores sistémicos incluidos los corticoesteroides sistémicos (prednisona o equivalente > 10 mg/día durante más de 2 semanas en los 3 meses previos a la selección), micofenolato, la azatioprina, ciclosporina, tacrolimús, etc. durante más de 2 semanas en los últimos 3 meses previos a la selección.
    18. Uso de rituximab en los últimos 6 meses
    19. Uso de antagonistas de los receptores de mineralocorticoides como espironolactona/eplerenona en los 3 meses previos a la selección
    20. A excepción de ND (cohorte 4), uso de un inhibidor de SGLT2 en los últimos 30 días.
    Experiencia previa/simultánea en un estudio clínico
    21. Haber recibido algún fármaco en investigación en el plazo de 1 mes (o 5 semividas del fármaco, lo que sea más largo) antes de la selección. Si el fármaco en investigación es un citotóxico o inmunodepresor, este periodo de reposo farmacológico es de 6 meses.
    Otras exclusiones
    22. Antecedentes de abuso de alcohol o de drogas ilícitas en los últimos 3 años.
    23. Embarazo, lactancia, o intención de quedarse embarazada durante el periodo del estudio y al menos 1 mes después de este para las mujeres.
    24. Intención de engendrar un hijo o donar esperma durante el periodo del estudio y al menos 1 mes después de este para los hombres.
    E.5 End points
    E.5.1Primary end point(s)
    Cohorts 1-3:
    Change from baseline at Week 12 in UPCR, based on 24 hour urine collection

    Cohort 4:
    Change from baseline at Week 12 in UACR, based on first morning void (FMV) urine collection
    Cohorte 1-3:
    Cambio con respecto al inicio en la semana 12 en el UPCR (basado en la recogida de orina de 24 horas)

    Cohorte 4:
    Cambio con respecto al inicio en la semana 12 en el cociente de albúmina:creatinina (albumin:creatinine ratio, UACR) en orina (basado en la recogida de orina de la primera micción de la mañana [PMM])
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline to Week 12
    Desde basal a la semana 12
    E.5.2Secondary end point(s)
    Not Applicable
    No procede
    E.5.2.1Timepoint(s) of evaluation of this end point
    Not Applicable
    No procede
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    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.8.2.4Number 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA12
    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
    Korea, Republic of
    United States
    United Kingdom
    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
    LVLS
    Última visita del último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months32
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months32
    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: 76
    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 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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 24
    F.4.2.2In the whole clinical trial 80
    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)
    All subjects will be treated per standard of care by their physicians.
    Todos los sujetos serán tratados por sus médicos según el estándar de atención.
    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 Decision2021-06-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-06-03
    P. End of Trial
    P.End of Trial StatusOngoing
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