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    EudraCT Number:2021-001404-14
    Sponsor's Protocol Code Number:QGC001-3QG2
    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:2021-07-08
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2021-001404-14
    A.3Full title of the trial
    A Phase 3, Double-blind, Placebo-controlled and Open-label Efficacy and Long-term Safety Study of Firibastat (QGC001) Administered Orally, Once Daily, for Up to 48 Weeks in Patients with Difficult-to-treat/Resistant Hypertension.
    Estudio de fase III, doble ciego, controlado con placebo y abierto, de la eficacia y la seguridad a largo plazo de Firibastat (QGC001) administrado por vía oral una vez al día durante un máximo de 48 semanas, en pacientes con hipertensión resistente/difícil de tratar
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Randomized study of Extended treatment with Firibastat in treatment-RESistant Hypertension
    Estudio aleatorizado de tratameinto extendido con Firibastat para el tratamiento de Hipertensión RESistente
    A.3.2Name or abbreviated title of the trial where available
    A.4.1Sponsor's protocol code numberQGC001-3QG2
    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 SponsorQuantum Genomics
    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 supportQuantum Genomics
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationQuantum Genomics
    B.5.2Functional name of contact pointBruno Besse
    B.5.3 Address:
    B.5.3.1Street Address33 Rue Marbeuf
    B.5.3.2Town/ cityParis
    B.5.3.3Post code75008
    B.5.4Telephone number+33185 34 7770
    B.5.5Fax number+33185 34 7778
    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 nameFiribastat
    D.3.2Product code QGC001
    D.3.4Pharmaceutical form 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 INNFiribastat
    D.3.9.1CAS number 648927-86-0
    D.3.9.2Current sponsor codeQGC001
    D.3.9.3Other descriptive nameFIRIBASTAT
    D.3.9.4EV Substance CodeSUB33157
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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 placeboTablet
    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
    Treatment of patients with difficult-to-treat and/or treatment-resistant hypertension (HTN)
    Tratamiento de pacientes con hipertensión difícil de tratar y/o resistente al tratamiento (HTN)
    E.1.1.1Medical condition in easily understood language
    Treatment of patients with difficult-to-treat and/or treatment-resistant high blood pressure
    Tratamiento de pacientes con presión arterial elevada difícil de tratar y/o resistente al tratamiento
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10036695
    E.1.2Term Primary hypertension
    E.1.2System Organ Class 100000004866
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the effects of firibastat (QGC001) administered at 1000 mg orally (po) once daily (QD) on blood pressure (BP) over 12 weeks
    Evaluar los efectos de firibastat (QGC001) administrado a una dosis de 1000 mg por vía oral una vez al día sobre la presión arterial (PA) durante 12 semanas.
    E.2.2Secondary objectives of the trial
    • To assess the safety of firibastat (QGC001) administered at 1000 mg po QD over 24 weeks and 48 weeks
    • To assess change in BP over time in subjects with uncontrolled primary HTN who have been treated with at least 2 classes of antihypertensive therapies at the maximum tolerated doses (MTDs) (ie, difficult-to-treat or treatment resistant patients)
    • Evaluar la seguridad de firibastat (QGC001) administrado a una dosis de 1000 mg por vía oral una vez al día durante 24 y 48 semanas
    • Evaluar el cambio en la PA a lo largo del tiempo en pacientes con HTN primaria no controlada que han recibido al menos 2 clases de antihipertensivos a las dosis máximas toleradas (DMT) (es decir, pacientes difíciles de tratar o resistentes al tratamiento).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Able to understand and willing to provide written informed consent, and able to comply with the study procedures and restrictions.
    2. Adult men and women (at Screening).
    3. Diagnosis of primary HTN for at least 6 months prior to Screening and:
    • Currently treated with 2 antihypertensive classes of drug (difficult-to-treat subjects), or currently treated with at least 3 antihypertensive classes of drug including a diuretic (treatment resistant subjects), at the MTDs of those medications (ie, the subject can tolerate the current dose of each medication but higher doses have caused or may worsen side effects), with no change in their antihypertensive regimen (drug, dose, or schedule) for at least 6 weeks, and with medication adherence ≥80% during the Run in Period.
    • Have a systolic AOBP between 140 mmHg and 179 mmHg (inclusive) at Screening while on their current chronic antihypertensive treatments.
    • Have a successful ABPM measurement with a mean systolic daytime ABP >135 mmHg after the Run-in Period while on their current chronic antihypertensive treatments. An ABPM is successful if at least 21 daytime readings and 6 nighttime readings have been successfully recorded.
    4. Women of childbearing potential and nonsurgically sterile male subjects who are sexually active must agree to use an approved highly effective form of contraception from the time of informed consent until 30 days post dose. Approved forms of contraception include hormonal intrauterine devices, hormonal contraceptives (oral birth control pills, depo, patch, or injectable) together with supplementary barrier methods such as condoms or diaphragms with spermicidal gel or foam.
    5. Women of childbearing potential must have a negative serum pregnancy test result at Screening and a negative urine pregnancy test result at the Inclusion Visit (Visit 2B, Day 1).
    1. Capacidad de entender y voluntad de proporcionar el consentimiento informado por escrito y capacidad de cumplir los procedimientos y restricciones del estudio.
    2. Hombres y mujeres adultos (en la selección).
    3. Diagnóstico de HTN primaria al menos 6 meses antes de la selección y:
    • Tratamiento en curso con 2 clases de antihipertensivos (pacientes difíciles de tratar) o con al menos 3 clases de antihipertensivos, incluido un diurético (pacientes resistentes al tratamiento), a las DMT de dichos medicamentos (es decir, el paciente puede tolerar la dosis actual de cada medicamento, pero dosis mayores han causado efectos secundarios o pueden empeorarlos), sin cambios en su pauta antihipertensiva (medicamentos, dosis o posología) durante un mínimo de 6 semanas, y con un cumplimiento terapéutico ≥80 % durante el periodo de preinclusión.
    • PAAC sistólica entre 140 mm Hg y 179 mm Hg (inclusive) en la selección, con los tratamientos antihipertensivos a largo plazo actuales.
    • Registro satisfactorio de MAPA con una PAA sistólica media durante el día >135 mm Hg después del periodo de preinclusión, con los tratamientos antihipertensivos a largo plazo actuales. La MAPA es satisfactoria si se han registrado correctamente un mínimo de 21 mediciones durante el día y 6 durante la noche.
    4. Las mujeres con capacidad de concebir y los varones no esterilizados quirúrgicamente que sean sexualmente activos deben comprometerse a utilizar un método anticonceptivo aprobado muy eficaz desde el momento del consentimiento informado hasta 30 días después de la última dosis. Los métodos anticonceptivos aprobados son los dispositivos intrauterinos de liberación de hormonas, los anticonceptivos hormonales (píldoras anticonceptivas orales, Depo-Progevera, parches o inyectables) junto con métodos de barrera complementarios como preservativo o diafragma con espuma o gel espermicida.
    5. Las mujeres con capacidad de concebir deberán presentar un resultado negativo en la prueba de embarazo en suero en la selección y un resultado negativo en la prueba de embarazo en orina en la visita de inclusión (visita 2B, día 1).
    E.4Principal exclusion criteria
    1. Known or suspected secondary HTN (eg, hyperaldosteronism, renovascular HTN, pheochromocytoma, Cushing’s disease).
    2. Systolic AOBP ≥180 mmHg or DBP ≥110 mmHg at the Screening or Inclusion Visit (Visit 2B, Day 1) and confirmed by a second measurement within 30 minutes to 1 hour.
    3. Known hypertensive retinopathy (Keith-Wagener Grade 3 or Grade 4) and/or hypertensive encephalopathy.
    4. Upper arm circumference that is outside the limits of the study-provided BP cuff associated with either the ABPM and/or AOBP measurement device.
    5. History of spontaneous or drug-induced angioedema.
    6. History of any drug-related allergy or hypersensitivity to any components of the IP (firibastat [QGC001] or placebo).
    7. Known severe aortic stenosis (symptomatic or asymptomatic with valvular indexed surface <0.5 cm²/m²).
    8. Subjects with severe symptomatic heart failure (New York Heart Association [NYHA] Class III or Class IV).
    9. History of acute coronary syndrome (non-ST elevation myocardial infarction [MI], ST elevation MI, and unstable angina pectoris), stroke, or transient ischemic attack within 6 months prior to Visit 2A, Day 0.
    10. Known history of malabsorption syndrome, or has undergone gastrointestinal surgery, including bariatric procedures that induce chronic malabsorption, within 2 years of Screening.
    11. Treatment with anti-obesity drugs or procedures 3 months prior to Screening (ie, surgery, aggressive diet regimen, etc.), leading to unstable body weight.
    12. Female who is breastfeeding, pregnant, or planning to become pregnant during the study period.
    13. Medical history of cancer (except for basal cell carcinoma) and/or treatment for cancer within the last 3 years.
    14. Shift workers who routinely sleep during the daytime and/or whose work hours include midnight.
    15. Subjects with moderate to severe hepatic impairment (Child-Pugh A, B, or C); alanine aminotransferase (ALT), aspartate aminotransferase (AST), or alkaline phosphatase (ALP) >3×upper limit of normal (ULN), or a total bilirubin ≥1.5×ULN (unless secondary to Gilbert’s syndrome), or direct bilirubin >ULN in subjects with Gilbert’s syndrome at Screening.
    16. Estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m2, as calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula (Levey AS, et al. 2009) at Screening.
    17. History of any blood disorder, other than sickle cell trait, causing hemolysis or unstable red blood cells (eg, malaria, babesiosis, hemolytic anemia, thalassemia, sickle cell anemia).
    18. Subjects with documented DI.
    19. Subjects with Type 1 diabetes mellitus.
    20. Subjects with Type 2 diabetes mellitus who:
    • Are poorly controlled, defined as glycosylated hemoglobin A1c (HbA1c) >9% at Screening; OR
    • Are taking short-acting insulin. Use of a stable dose [≥12 weeks prior to Screening] of the following medications, (or any combination of the following medications) is permitted: glucagon like peptide 1 analog, metformin, sulfonylurea, dipeptidyl peptidase-4 inhibitor, and single basal insulin, sodium glucose co-transporter 2 (SGLT2) inhibitors and pioglitazone.
    21. Routine or anticipated treatment with any systemic corticosteroid. Use of topical, inhaled, intra articular or nasal corticosteroids is permitted.
    22. Clinical evidence of thyroid disease, thyroid hormone therapy that is not stable ≥4 weeks prior to Screening, or a thyroid-stimulating hormone (TSH) level <0.75×lower limit of normal or >1.5×ULN at Screening.
    23. History of alcohol or drug abuse (including opioid overuse/misuse) within the 3 months prior to Screening that would interfere with study participation or lead to decreased compliance to study procedures or IP intake in the investigator’s opinion.
    24. Participation in another clinical study involving an investigational drug within 30 days prior to Screening or plans to participate in another clinical study within 30 days of discontinuation of IP.
    25. Any other condition that precludes adequate understanding, cooperation, and compliance with study procedures or any condition that could pose a risk to the subject’s safety, as per the investigator’s judgment.
    26. Subjects with a life expectancy of less than 1 year per investigator’s discretion.
    27. Legal incapacity or limited legal capacity.
    28. Previous participation in any clinical study with firibastat (QGC001).
    29. Subjects with any history of documented allergic reactions or allergic diseases, with the exception of documented seasonal allergies (per the investigator’s decision).
    1. HTN secundaria presunta o confirmada (p. ej., hiperaldosteronismo, HTN renovascular, feocromocitoma, enfermedad de Cushing).
    2. PAAC sistólica ≥180 mm Hg o PAD ≥110 mm Hg en la selección o en la visita de inclusión (visita 2B, día 1) y confirmada por una segunda medición en un plazo de 30 minutos a 1 hora.
    3. Retinopatía hipertensiva conocida (grado 3 o grado 4 de Keith-Wagener) y/o encefalopatía hipertensiva.
    4. Perímetro braquial fuera de los límites del manguito para medir la PA proporcionado en el estudio asociado con el dispositivo de MAPA y/o de medición de la PAAC.
    5. Antecedentes de angioedema causado por medicamentos o espontáneo.
    6. Antecedentes de alergia farmacológica o hipersensibilidad a alguno de los componentes del MI o placebo
    7. Estenosis aórtica grave confirmada (sintomática o asintomática con un área valvular indexada <0,5 cm²/m²).
    8. Insuficiencia cardíaca sintomática grave (clase III o IV según los criterios de la Asociación de Cardiología de Nueva York [NYHA]).
    9. Antecedentes de síndrome coronario agudo (infarto de miocardio sin elevación del ST, IM con elevación del ST y angina de pecho inestable), accidente cerebrovascular o accidente isquémico transitorio en los 6 meses anteriores a la visita 2A, día 0.
    10. Antecedentes conocidos de síndrome de malabsorción o haberse sometido a cirugía gastrointestinal, incluidos procedimientos bariátricos, que induzcan la malabsorción crónica, en los 2 años anteriores a la selección.
    11. Tratamiento con fármacos o procedimientos contra la obesidad en los 3 meses anteriores a la selección (es decir, cirugía, dieta estricta, etc.) que conduzcan a un peso corporal inestable.
    12. Mujeres en periodo de lactancia, embarazadas o que tengan previsto quedarse embarazadas durante el periodo del estudio.
    13. Antecedentes médicos de cáncer (excepto carcinoma basocelular) y/o tratamiento antineoplásico en los últimos 3 años.
    14. Trabajadores a turnos que normalmente duerman durante el día y/o cuyas horas de trabajo incluyan la medianoche.
    15. Insuficiencia hepática de moderada a grave (clase de Child-Pugh A, B o C); ALT, AST o fosfatasa alcalina (FA) >3 × límite superior de la normalidad (LSN) o bilirrubina total ≥1,5 × LSN (salvo en el contexto de un síndrome de Gilbert secundario) o bilirrubina directa >LSN en pacientes con síndrome de Gilbert en la selección.
    16. Tasa de filtración glomerular estimada (TFGe) <30 ml/min/1,73 m2 calculada mediante la fórmula del Grupo Colaborativo de Epidemiología de la Enfermedad Renal Crónica (CKD-EPI) (Levey AS et al. 2009) en la selección.
    17. Antecedentes de trastornos de la sangre, salvo rasgo drepanocítico, causantes de hemólisis o eritrocitos inestables (p. ej., paludismo, babesiosis, anemia hemolítica, talasemia, anemia de células falciformes).
    18. DI documentada.
    19. Diabetes mellitus tipo 1.
    20. Pacientes con diabetes mellitus tipo 2 que:
    • esté mal controlada, lo cual se define por un valor de glucohemoglobina A1c (HbA1c) >9 % en la selección; o
    • que estén recibiendo insulina de acción corta. Se permite el uso de una dosis estable (durante un periodo ≥12 semanas antes de la selección) de los siguientes medicamentos (o cualquier combinación de ellos): análogos del péptido similar al glucagón-1, metformina, sulfonilureas, inhibidores de la dipeptidil peptidasa-4 e insulina basal sola, inhibidores del cotransportador de sodio-glucosa 2 (SGLT2) y pioglitazona.
    21. Tratamiento habitual o previsto con un corticoesteroide sistémico. Se permite el uso de corticoesteroides tópicos, inhalados, intraarticulares o nasales.
    22. Signos clínicos de enfermedad tiroidea, tratamiento hormonal tiroideo que no se haya mantenido estable durante un periodo ≥4 semanas antes de la selección o nivel de tirotropina (TSH) <0,75 × límite inferior de la normalidad o >1,5 × LSN en la selección.
    23. Antecedentes de alcoholismo o drogodependencia (incluido el uso indebido o abuso de opioides) en los 3 meses anteriores a la selección que, en opinión del investigador, pudieran interferir en la participación en el estudio o reducir el cumplimiento de los procedimientos del estudio o la toma del MI.
    24. Participación en otro ensayo clínico con un medicamento en investigación en los 30 días anteriores a la selección o previsión de participar en otro ensayo clínico en los 30 días siguientes a la interrupción del MI.
    25. Cualquier otra afección que, en opinión del investigador, impida el correcto entendimiento, cooperación y cumplimiento de los procedimientos del estudio o que pueda suponer un riesgo para la seguridad del paciente.
    26. Pacientes con una esperanza de vida inferior a 1 año a criterio del investigador.
    27. Incapacidad legal o capacidad legal limitada.
    28. Participación con anterioridad en algún ensayo clínico con firibastat (QGC001).
    29. Antecedentes documentados de reacciones o enfermedades alérgicas, salvo alergias estacionales documentadas (de acuerdo con la decisión del investigador).
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is the change from baseline in systolic AOBP at Week 12.
    El criterio de valoración principal de la eficacia es el cambio con respecto al valor inicial de la PAAC sistólica en la semana 12.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 12
    Semana 12
    E.5.2Secondary end point(s)
    AOBP at every visit.
    24-hour ambulatory BP monitoring (ABPM) assessed at baseline and after 12 weeks (end of double-blind period [Period 1]).
    Biomarker N-terminal pro-B-type natriuretic peptide (NT-ProBNP) - change from baseline to Visit 4B, Day 85 (±3 d).
    Proportion of subjects requiring an increase in the dose of current antihypertensive drugs or addition of another hypertensive drug during the open-label treatment periods (Periods 2 and 3) of the study.
    PAAC en cada visita. PA ambulatoria de 24 horas después de 12 semanas (final del periodo con doble enmascaramiento [periodo 1]). Biomarcador NT-ProBNP en la visita 2B, día 1, y en la visita 4B, día 85 (±3 d). Proporción de pacientes que requieren un aumento de la dosis de los antihipertensivos actuales o la adición de otro antihipertensivo durante los periodos de tratamiento abierto (periodos 2 y 3) del estudio.
    E.5.2.1Timepoint(s) of evaluation of this end point
    AOBP at every visit.
    24-hour ambulatory BP at baseline and after 12 weeks.
    Biomarker NT-ProBNP at Visit 2B, Day 1, and Visit 4B, Day 85 (±3 d).
    PAAC en cada visita.
    PA 24 horas ambulatoria en selección y después de la semana 12
    Biomarcador NT-ProBNP en la visita 2B, día 1, y en la visita 4B, día 85 (±3 d)
    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 No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E. 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 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 Yes
    E. trial design description
    Estudio abierto de eficacia y seguimiento de la seguridad a largo plazo
    Open-label Efficacy and Long-term Safety Study
    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 trial2
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA40
    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
    Korea, Republic of
    Russian Federation
    United States
    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
    Ultima visita del último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days22
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days25
    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: 250
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 500
    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 state35
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 430
    F.4.2.2In the whole clinical trial 750
    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)
    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 Decision2021-08-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-07-22
    P. End of Trial
    P.End of Trial StatusOngoing
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