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    Summary
    EudraCT Number:2020-004394-49
    Sponsor's Protocol Code Number:LIB003-007
    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:2022-02-02
    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 number2020-004394-49
    A.3Full title of the trial
    Open-Label Extension Phase 3 Study to Evaluate the Long-Term Efficacy and Safety of LIB003 in Patients With Homozygous and Heterozygous Familial Hypercholesterolemia, Cardiovascular Disease, or at High Risk for Cardiovascular Disease, on Stable Lipid-Lowering Therapy Requiring Additional Low-Density Lipoprotein Cholesterol Reduction (LIBerate-OLE)
    Estudio de extensión abierto de fase 3 para evaluar la eficacia y la
    seguridad a largo plazo de LIB003 en pacientes con hipercolesterolemia
    familiar homocigótica y heterocigótica, enfermedad cardiovascular o alto
    riesgo de enfermedad cardiovascular, en tratamiento hipolipemiante
    estable que precisan una reducción adicional del colesterol unido a las
    lipoproteínas de baja densidad (LIBerate-OLE)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to Evaluate the Long-Term Efficacy and Safety of the Investigational Drug LIB003 for the Reduction of Cholesterol in Patients with Homozygous and Heterozygous Familial Hypercholesterolemia, Cardiovascular Disease, or at High Risk for Cardiovascular Disease.
    Estudio para evaluar la seguridad y la eficacia a largo plazo del fármaco en
    investigación LIB003 para la reducción del colesterol en pacientes con
    hipercolesterolemia familiar homocigótica y heterocigótica, enfermedad
    cardiovascular o alto riesgo de enfermedad cardiovascular.
    A.3.2Name or abbreviated title of the trial where available
    LIBerate-OLE
    A.4.1Sponsor's protocol code numberLIB003-007
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/370/2020
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorLIB Therapeutics, LLC
    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 supportLIB Therapeutics, LLC
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLIB Therapeutics, LLC
    B.5.2Functional name of contact pointLIB clinical trials
    B.5.3 Address:
    B.5.3.1Street Address5375 Medpace Way
    B.5.3.2Town/ cityCincinnati, OH
    B.5.3.3Post code45227
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1859653-3141
    B.5.6E-mailLIBtrials@libtherapeutics.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 nameLIB003
    D.3.2Product code lerodalcibep
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLerodalcibep
    D.3.9.1CAS number 2250073-78-8
    D.3.9.2Current sponsor codeLIB003
    D.3.9.3Other descriptive nameLIB003
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients with elevated LDL-C, with homozygous familial hypercholesterolemia (HoFH) and heterozygous familial
    hypercholesterolemia (HeFH), cardiovascular disease, or at high risk for cardiovascular disease.
    Los pacientes con LDL-C elevado, con hipercolesterolemia familiar homocigótica (HoFH) y hipercolesterolemia familiar heterocigótica (HeFH), enfermedad cardiovascular o con alto riesgo de enfermedad cardiovascular.
    E.1.1.1Medical condition in easily understood language
    HoFH and HeFH makes it harder for your body to remove LDL "bad" cholesterol from your blood. It is a disease you are born with. High LDLC increases the risk of heart attacks and strokes.
    La HoFH y la HeFH dificultan la eliminación dl colesterol LDL d la sangre. Enfermedad q se nace. Un nivel elevado d LDLC aumenta el riesgo d sufrir infartos d miocardio y accidentes cerebrovasculares.
    E.1.1.2Therapeutic area Diseases [C] - Nutritional and Metabolic Diseases [C18]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10057079
    E.1.2Term Heterozygous familial hypercholesterolemia
    E.1.2System Organ Class 100000004850
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10057080
    E.1.2Term Homozygous familial hypercholesterolemia
    E.1.2System Organ Class 100000004850
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10007648
    E.1.2Term Cardiovascular disease, unspecified
    E.1.2System Organ Class 100000004849
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objectives of this study are to assess the long-term safety, tolerability, and efficacy after 48 and 72 weeks with monthly (Q4W [≤ 31 days]) dosing of LIB003 300 mg administered subcutaneously (SC). The study includes patients at very-high risk for CVD or at high risk for CVD (including HoFH and HeFH) on a stable diet and maximally tolerated oral LDL-C lowering drug therapy who completed a LIB003 Phase 3 base study.
    Los objetivos primarios de este estudio son evaluar la seguridad, la tolerabilidad y la eficacia a largo plazo después de 48 y 72 semanas con una dosis mensual (Q4W [≤ 31 días]) de LIB003 300 mg administrada por vía subcutánea (SC). El estudio incluye a pacientes con muy alto riesgo de ECV o con alto riesgo de ECV (incluyendo HoFH y HeFH) con una dieta estable y un tratamiento farmacológico oral reductor de LDL-C de máxima tolerancia que completaron un estudio base de fase 3 de LIB003.
    E.2.2Secondary objectives of the trial
    There are not secondary objectives in this study.
    En este estudio no hay objetivos secundarios.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patient has received study drug through the end of study (EOS) with a complete EOS Visit in 1 of the Phase 3 base studies, LIB003-003, 004, -005, -006, -008, -011, and -012, without SAEs related to LIB003;
    2. Patient has the provision of written and signed informed consent prior to any study-specific procedure;
    3. Women of childbearing potential must continue using a highly effective form of birth control if sexually active and have a negative urine pregnancy test on Day 1 prior to dosing;
    o Note: Highly effective methods of birth control include refraining from heterosexual sexual intercourse during the entire period of risk, birth control pills or patches, intrauterine devices (IUDs), sexual activity with a male partner who has had a vasectomy, or IUD, oral, implantable, or injectable contraceptives. Menopause is defined as 1 year of spontaneous and continuous amenorrhea in a female ≥55 years old, or 1 year of spontaneous and continuous amenorrhea with a follicle-stimulating hormone (FSH) level >40 IU/L (or according to the definition of “postmenopausal range” for the laboratory involved) in a female <55 years old unless the patient has undergone bilateral oophorectomy. Birth control should be maintained for 60 days after the last dose of study drug (ie, 30 days after the last study visit).
    o Note: WOCBP will also have a pregnancy test at every visit to the clinic for the duration of the study.
    4. Male patients will either be surgically sterile or agree to continue to use the following forms of contraception if their partner is of childbearing potential and not using a highly effective form of birth control as defined in Inclusion Criterion #3: male or female condom with spermicide and a female partner who is sterile or who agrees to use the following contraceptives; diaphragm or cervical cap with spermicide; or IUD, oral, implantable, or injectable contraceptives;
    5. Male patients must refrain from sperm donation until 90 days following the last dose of study drug;
    6. Patient is willing to maintain appropriate diet and stable dose of current LLT, including statins, ezetimibe, bile acid sequestrants, niacin, lomitapide, bempedoic acid, bezafibrate or fenofibrate, and/or OM-3 compounds; and
    o Note: Use of lomitapide will be allowed in patients from LIB003-003.
    o Note: Use of bempedoic acid will be allowed in patients from LIB003-004, -005, and -006.
    o Note: Patients still requiring apheresis may add the procedure after Week 12.
    7. Patient is considered by the Investigator to be otherwise healthy, based on medical history review, a defined complete physical examination, as well as vital sign measurements, ECGs, and laboratory test results in the base trial.
    1. El paciente ha recibido el fármaco del estudio hasta el final del estudio (EOS) con una visita EOS completa en 1 de los estudios base de fase 3, LIB003-003, 004, -005, -006, -008, -011 y -012, sin SAE relacionados con LIB003;
    2. El paciente cuenta con el consentimiento informado escrito y firmado antes de cualquier procedimiento específico del estudio;
    3. Las mujeres en edad fértil deben seguir utilizando un método anticonceptivo altamente eficaz si son sexualmente activas y tener una prueba de embarazo negativa en orina el día 1 antes de la administración;
    o Nota: Los métodos anticonceptivos altamente efectivos incluyen la abstención de las relaciones sexuales heterosexuales durante todo el período de riesgo, las píldoras o parches anticonceptivos, los dispositivos intrauterinos (DIU), la actividad sexual con una pareja masculina que se haya sometido a una vasectomía o los anticonceptivos DIU, orales, implantables o inyectables. La menopausia se define como 1 año de amenorrea espontánea y continua en una mujer ≥55 años, o 1 año de amenorrea espontánea y continua con un nivel de hormona foliculoestimulante (FSH) >40 UI/L (o según la definición de "rango posmenopáusico" para el laboratorio correspondiente) en una mujer <55 años, a menos que la paciente se haya sometido a una ooforectomía bilateral. El control de la natalidad debe mantenerse durante 60 días después de la última dosis del fármaco del estudio (es decir, 30 días después de la última visita del estudio).
    o Nota: WOCBP también tendrá una prueba de embarazo en cada visita a la clínica durante la duración del estudio.
    4. Los pacientes masculinos serán quirúrgicamente estériles o aceptarán seguir utilizando las siguientes formas de anticoncepción si su pareja está en edad fértil y no utiliza una forma altamente efectiva de control de la natalidad como se define en el Criterio de Inclusión #3: condón masculino o femenino con espermicida y una pareja femenina que sea estéril o que acepte utilizar los siguientes anticonceptivos; diafragma o capuchón cervical con espermicida; o DIU, anticonceptivos orales, implantables o inyectables;
    5. Los pacientes masculinos deben abstenerse de donar esperma hasta 90 días después de la última dosis del fármaco del estudio;
    6. El paciente está dispuesto a mantener una dieta adecuada y una dosis estable del tratamiento de larga duración actual, incluidas las estatinas, la ezetimiba, los secuestradores de ácidos biliares, la niacina, la lomitapida, el ácido bempedoico, el bezafibrato o el fenofibrato, y/o los compuestos OM-3; y
    o Nota: Se permitirá el uso de lomitapida en pacientes de LIB003-003.
    o Nota: Se permitirá el uso de ácido bempedoico en pacientes de LIB003-004, -005 y -006.
    o Nota: Los pacientes que sigan necesitando aféresis podrán añadir el procedimiento después de la semana 12.
    7. El investigador considera que el paciente está por lo demás sano, basándose en la revisión de la historia clínica, un examen físico completo definido, así como las mediciones de los signos vitales, los ECG y los resultados de las pruebas de laboratorio en el ensayo base.
    E.4Principal exclusion criteria
    1. Failure to receive study drug through the EOS or to complete the EOS Visit in the Phase 3 base study (LIB003-003, -004, -005, -006, -008, -011, or -012) and/or had an SAE that was considered related to study drug during the Phase 3 base study;
    2. Development since the final visit in the Phase 3 base study (LIB003 003, 004, 005, 006, 008, or -011) of any concomitant clinical condition or acute and/or unstable systemic disease compromising patient inclusion, at the discretion of the Investigator, including but not limited to, the following: a history or presence of clinically significant pulmonary, hepatic, gallbladder or biliary tract, hematologic, gastrointestinal, endocrine (excluding diabetes), immunologic, dermatologic, neurologic, or psychiatric disease, which in the Investigator’s opinion would not be suitable for the study from a patient safety consideration or could interfere with the results of the study;
    3. Use of prohibited oral lipid lowering agents, PCSK9 mAbs, mipomersen, lomitapide, gemfibrozil, or bempedoic acid, started since completion of the base study;
    o Note: Use of lomitapide is not approved for, and will be prohibited in, patients from LIB003-004, -005, -006, -008, -011, and -012.
    o Note: Use of bempedoic acid is not approved for, or will be prohibited in, patients from LIB003-003, -008, -011, and 012.
    4. Not available for protocol-required study visits or procedures, to the best of the patient’s and Investigator’s knowledge;
    5. Has any other new findings since the completion of the base study which, in the opinion of the Investigator, would compromise the patient’s safety or participation in the study; or
    6. Is an employee or family member of the Investigator or study site personnel.
    1. No haber recibido el fármaco del estudio a través del EOS o no haber completado la visita del EOS en el estudio base de fase 3 (LIB003-003, -004, -005, -006, -008, -011, o -012) y/o haber tenido un SAE que se consideró relacionado con el fármaco del estudio durante el estudio base de fase 3;
    2. Desarrollo, desde la última visita del estudio base de fase 3 (LIB003 003, 004, 005, 006, 008, o -011), de cualquier condición clínica concomitante o enfermedad sistémica aguda y/o inestable que comprometa la inclusión del paciente, a criterio del Investigador, incluyendo, pero sin limitarse a, lo siguiente antecedentes o presencia de enfermedades pulmonares, hepáticas, de la vesícula biliar o del tracto biliar, hematológicas, gastrointestinales, endocrinas (excluyendo la diabetes), inmunológicas, dermatológicas, neurológicas o psiquiátricas clínicamente significativas, que en opinión del Investigador no serían adecuadas para el estudio desde el punto de vista de la seguridad del paciente o podrían interferir con los resultados del estudio;
    3.Uso de agentes hipolipemiantes orales prohibidos, mAbs de PCSK9, mipomersen, lomitapide, gemfibrozil o ácido bempedoico, iniciado desde la finalización del estudio base;
    o Nota: El uso de lomitapida no está aprobado y estará prohibido en los pacientes de LIB003-004, -005, -006, -008, -011 y -012.
    o Nota: El uso de ácido bempedoico no está aprobado para, o estará prohibido en, pacientes de LIB003-003, -008, -011, y 012.
    4. No está disponible para las visitas o procedimientos del estudio requeridos por el protocolo, según el leal saber y entender del paciente y del Investigador;
    5. Tiene cualquier otro hallazgo nuevo desde la finalización del estudio base que, en opinión del investigador, podría comprometer la seguridad del paciente o su participación en el estudio; o
    6.Es un empleado o familiar del investigador o del personal del centro del estudio.
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy Endpoints
    • LDL-C change (absolute and percent) compared to original baseline LDL-C at Day 1 in the base study calculated by both Friedewald and Hopkins formulas and preparative ultracentrifugation at Weeks 48 and 72 for patients entering the OLE directly from studies LIB003 004, -005, -006, -008, -011, and -012. For patients entering from the LIB003-011 and -012 studies, LDL-C efficacy will also be assessed at Week 12 and compared to the Week 12 or Day 270 of the base studies, respectively;
    • LDL-C change (absolute and percent) compared to original baseline LDL-C at Day 1 in the base study calculated by both Friedewald and Hopkins formulas and preparative ultracentrifugation at Weeks 48 and 72 for patients entering the OLE directly from study LIB003-003;
    • LDL-C change (absolute and percent) compared to final LDL-C at the last visit of the base study calculated by both Friedewald and Hopkins formulas and preparative ultracentrifugation at Weeks 48 and 72 for only the base study placebo patients entering the OLE directly from studies LIB003 004, 005, 006, and -008;
    • Effects of LIB003 at Weeks 48 and 72 on serum lipids, including TC, HDL-C, non–HDL-C, VLDL-C, and TG;
    • Effects of LIB003 at Weeks 48 and 72 on apo B and Lp(a) serum concentrations. For patients entering from the LIB003-011 and -012 studies, effects on apo B and Lp(a) will also be assessed at Week 12 compared to Week 12 or Day 270 of the base studies, respectively;
    • Effects of LIB003 at Weeks 48 and 72 on serum unbound (free) PCSK9 concentration; and
    • The percentage of patients achieving current ESC/EAS guidelines.

    Immunogenicity Endpoints
    Anti-LIB003 antibodies will be initially measured at Week 72/Early Termination [ET]. Other visits including Weeks 12, 24, 36, 48, and 60 will be measured in response to ADAs at Week 72/ET or as indicated by the Data Safety Monitoring Board (DSMB).

    Exploratory Endpoints
    • LDL-C change (absolute and percent) compared to baseline based on underlying FH genetic variants at Week 72 for all patients with FH and those with known pathogenic variants; and
    • Absolute and percent change in other lipid and CV risk biomarkers as appropriate at Week 72.

    Pharmacokinetic Endpoints
    The PK concentration for LIB003 will be measured at Week 72/ET in support of ADAs. Other visits including Weeks 12, 24, 36, 48, and 60 will be measured in response to ADAs at Week 72/ET or as indicated by the DSMB.
    Criterios de valoración de la eficacia
    - Cambio en el LDL-C (absoluto y porcentual) en comparación con el LDL-C inicial en el día 1 del estudio base, calculado mediante las fórmulas de Friedewald y Hopkins y la ultracentrifugación preparativa en las semanas 48 y 72 para los pacientes que entren en la OLE directamente desde los estudios LIB003 004, -005, -006, -008, -011 y -012. Para los pacientes que entren desde los estudios LIB003-011 y -012, la eficacia del LDL-C también se evaluará en la Semana 12 y se comparará con la Semana 12 o el Día 270 de los estudios base, respectivamente;
    - El cambio de LDL-C (absoluto y porcentual) en comparación con el LDL-C original de la línea de base en el día 1 del estudio base, calculado mediante las fórmulas de Friedewald y Hopkins y la ultracentrifugación preparatoria en las semanas 48 y 72 para los pacientes que entren en el OLE directamente desde el estudio LIB003-003;
    - Cambio de LDL-C (absoluto y porcentual) en comparación con el LDL-C final en la última visita del estudio base, calculado mediante las fórmulas de Friedewald y Hopkins y el ultracentrifugado preparatorio en las semanas 48 y 72 para los pacientes de placebo del estudio base que entraron en la OLE directamente desde los estudios LIB003 004, 005, 006 y -008;
    - Efectos del LIB003 en las semanas 48 y 72 sobre los lípidos séricos, incluidos el CT, el C-HDL, el C-no-HDL, el C-VLDL y los TG;
    - Efectos del LIB003 en las semanas 48 y 72 sobre las concentraciones séricas de apo B y Lp(a). En el caso de los pacientes que entren en los estudios LIB003-011 y -012, también se evaluarán los efectos sobre la apo B y la Lp(a) en la semana 12 en comparación con la semana 12 o el día 270 de los estudios de base, respectivamente;
    - Los efectos de LIB003 en las semanas 48 y 72 sobre la concentración sérica de PCSK9 no ligada (libre); y
    - El porcentaje de pacientes que alcanzan las directrices actuales de la ESC/EAS.

    Criterios de valoración de la inmunogenicidad
    Los anticuerpos anti-LIB003 se medirán inicialmente en la semana 72/terminación temprana [ET]. Otras visitas, incluyendo las semanas 12, 24, 36, 48 y 60, se medirán en respuesta a los ADA en la semana 72/ET o según lo indique el Consejo de Supervisión de la Seguridad de los Datos (DSMB).

    Criterios de valoración exploratorios
    - Cambio en el C-LDL (absoluto y porcentual) en comparación con el valor inicial según las variantes genéticas de HF subyacentes en la semana 72 para todos los pacientes con HF y aquellos con variantes patogénicas conocidas; y
    - Cambio absoluto y porcentual en otros biomarcadores lipídicos y de riesgo CV, según corresponda, en la semana 72.

    Criterios de valoración farmacocinética
    La concentración PK para LIB003 se medirá en la Semana 72/ET en apoyo de los ADA. Otras visitas, incluyendo las semanas 12, 24, 36, 48 y 60, se medirán en respuesta a las ADAs en la semana 72/ET o según lo indique el DSMB.
    E.5.1.1Timepoint(s) of evaluation of this end point
    weeks 12, 48 and 72
    Semanas 12, 48 y 72
    E.5.2Secondary end point(s)
    There are not secondary endpoints in this study.
    En este estudio no hay criterios de valoración secundarios.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Weeks 12 and 72
    Semanas 12, 48 y 72
    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 Yes
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA28
    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
    Canada
    France
    Germany
    India
    Israel
    New Zealand
    Norway
    South Africa
    Spain
    Turkey
    United Kingdom
    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
    UVUS
    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 months10
    E.8.9.1In the Member State concerned days27
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months5
    E.8.9.2In all countries concerned by the trial days13
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 17
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 2
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 15
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 1250
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 733
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Parent or legal guardian for children <18 years of age
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state155
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 967
    F.4.2.2In the whole clinical trial 2000
    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
    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 Decision2022-03-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-03-28
    P. End of Trial
    P.End of Trial StatusOngoing
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