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    Summary
    EudraCT Number:2021-003301-22
    Sponsor's Protocol Code Number:AC-R6
    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:2021-07-13
    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 number2021-003301-22
    A.3Full title of the trial
    A phase IIB study to explore the efficacy and safety of the concomitant administration of RUTI® immunotherapy with the standard treatment in patients with TB
    (CONSTAN)
    Ensayo clínico Fase IIb para evaluar la eficacia y seguridad de la administración de inmunoterapia RUTI® con el tratamiento standard en pacientes con tuberculosis.
    (CONSTAN)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An exploratory clinical trial to evaluate the efficacy and safety of the treatment with a vaccine against tuberculosis given at the same time as standard treatment in patients with tuberculosis
    Ensayo clínico exploratorio para evaluar la eficacia y la seguridad del tratamiento con una vacuna contra la tuberculosis proporcionada al mismo tiempo que el tratamiento habitual en pacientes con tuberculosis
    A.3.2Name or abbreviated title of the trial where available
    CONSTAN
    CONSTAN
    A.4.1Sponsor's protocol code numberAC-R6
    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 SponsorArchivel Farma S.L.
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportArchivel Farma S.L.
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFundació Institut d'Investigació Germans trias i Pujo (IGTP)
    B.5.2Functional name of contact pointUnitat de Tuberculosi
    B.5.3 Address:
    B.5.3.1Street AddressCamí de les escoles s/n
    B.5.3.2Town/ cityBadalona
    B.5.3.3Post code08916
    B.5.3.4CountrySpain
    B.5.4Telephone number34934978681
    B.5.6E-mailcvilaplana@igtp.cat
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/17/1905
    D.3 Description of the IMP
    D.3.1Product nameRUTI
    D.3.2Product code RUTI
    D.3.4Pharmaceutical form Powder for 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 INNRUTI
    D.3.9.2Current sponsor codeRUTI
    D.3.9.3Other descriptive namePURIFIED, PASTEURISED AND FREEZE-DRIED CELL-WALL FRAGMENTS FROM MYCOBACTERIUM TUBERCULOSIS STRAIN RUTI
    D.3.9.4EV Substance CodeSUB197399
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number33.3
    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) Yes
    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 placeboSolution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Pulmonary Tuberculosis
    Tuberculosis pulmonar
    E.1.1.1Medical condition in easily understood language
    Pulmonary tuberculosis is a contagious bacterial infection that involves the lungs. It may spread to other organs. Pulmonary TB is caused by the bacterium Mycobacterium tuberculosis (M tuberculosis).
    La Tuberculosis es una infección bacteriana contagiosa que compromete los pulmones y que se puede propagarse a otros órganos. Es causada por la bacteria Mycobacterium tuberculosis (M tuberculosis).
    E.1.1.2Therapeutic area Diseases [C] - Bacterial Infections and Mycoses [C01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10044755
    E.1.2Term Tuberculosis
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To explore the efficacy as reduction of bacillary load through the study of early
    bactericidal activity (EBA)
    1. Explorar la eficacia como la reducción de la carga bacilar a través del estudio de la actividad bactericida temprana (EBA, por el inglés Early Bactericidal Activity)
    E.2.2Secondary objectives of the trial
    To evaluate the safety of the vaccine RUTI® (25 μg FCMtb) in patients with TB, when
    given concomitant with the SoC treatment initiation.
    2. Evaluar la seguridad de la vacuna RUTI® (25 μg FCMtb) en pacientes con tuberculosis, administrada de forma concomitante al inicio del tratamiento estándard.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    In order to be eligible to participate in this study, a patient must meet all of the following criteria:
    1.Adults (females and males) aged ≥ 18;
    2.Written informed consent in a language they understand.
    This includes informed consent to be in the trial and informed consent to collect specimens
    3.Laboratory confirmed pulmonary TB (with or without extrapulmonary involvement) defined as a hard copy of a sputum laboratory result that reports Mtb detection by sputum-microscopy smear-positive at least 1+, rapid molecular assay or mycobacterial culture.
    4.Patients who have not received any anti-tubercular treatment in the last 24 hours
    5.Females of non-childbearing potential: at least 2 years post-menopausal or surgically sterile (e.g. tubal ligation);
    6.Females of childbearing potential (including females less than 2 years post-menopausal) must have a negative pregnancy test at enrolment and must agree to use highly effective methods of birth control (i.e. diaphragm plus spermicide or male condom plus spermicide, oral contraceptive in combination with a second method, contraceptive implant, injectable contraceptive, indwelling intrauterine device, sexual abstinence, or a vasectomized partner) while participating in the study;
    7.Males must agree to use a double barrier method of contraception (condom plus spermicide or diaphragm plus spermicide) at least 1 month after RUTI/placebo vaccination; or the male patient or his female partner must be surgically sterile (e.g. vasectomy, tubal ligation) or the female partner must be post-menopausal;
    8.The patient must be willing and able to attend all study visits and comply with all study procedures.
    Para poder participar en este estudio, un paciente deberá cumplir con todos los siguientes criterios:
    1.Adultos (mujeres y hombres) de edad ≥ 18 años.
    2.Consentimiento informado por escrito en una lengua que entienda el paciente. Esto incluye el consentimiento informado para participar en el ensayo y para la recogida de muestras.
    3.Diagnóstico de tuberculosis pulmonar confirmada por laboratorio (con o sin afectación extrapulmonar), definida como copia impresa del resultado de laboratorio que informa la detección de Mtb mediante microscopia de frotis de esputo positiva +1, test rápido molecular o cultivo microbiológico.
    4.Pacientes que no han recibido tratamiento antituberculoso en las últimas 24 horas.
    5.Mujeres no en edad fértil: al menos 2 años de postmenopausia o quirúrgicamente estériles (por ejemplo, mediante ligadura de trompas).
    6.Mujeres en edad fértil (incluidas las mujeres con menos de 2 años de postmenopausia) deben tener a una prueba de embarazo negativa en el momento de la inclusión y deben aceptar utilizar métodos anticonceptivos altamente eficaces (es decir, diafragma más espermicida o condón masculino más espermicida, anticonceptivo oral en combinación con un segundo método, implante anticonceptivo, anticonceptivo inyectable, dispositivo intrauterino permanente, abstinencia sexual o una pareja vasectomizada) mientras participan en el ensayo.
    7.Los hombres deben aceptar usar un método anticonceptivo de doble barrera (condón más espermicida o diafragma más espermicida) al menos un mes antes de recibir la vacuna RUTI/placebo; o el paciente masculino o su pareja femenina deben ser quirúrgicamente estériles (por ejemplo, vasectomía, ligadura de trompas) o la pareja femenina debe estar en postmenopausia.
    8.El paciente debe estar dispuesto y ser capaz de asistir a todas las visitas de estudio y cumplir con todos los procedimientos de estudio.
    E.4Principal exclusion criteria
    A potential patient who meets any of the following criteria will be excluded from participation in this study:
    1. Unable to provide written informed consent;
    2. Women reported, or detected, or willing to be pregnant during the trial period;
    3. Severity of illness precluding full evaluation: expected early death, evidenced by respiratory failure, low blood pressure, WHO performance score 3-4
    4. Bodyweight < 40kg
    5. Evidence of rifampicin resistance via GeneXpert
    6. Unstable Diabetes Mellitus as a poor metabolic control within the past 12 months
    7. For HIV infected subjects if the CD4+ count <250 cells/L
    8. Major co-morbid conditions or any other finding which in the opinion of the investigator would compromise the protocol compliance or significantly influence the interpretation of results (i.e. cancer, immunodeficiency of any nature including treatment with immunosuppressant drugs and excluding HIV infection)
    9. Any of the following laboratory parameters:
    • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3 x upper limit of normal (ULN)
    • Total bilirubin > 2 x ULN
    • Neutrophil count ≤ 500 neutrophils / mm3
    • Platelet count < 50,000 platelets / mm3
    10. Alcohol use: potential participant either self-reports or in the investigator’s opinion that the patient drinks more than an average of four units/day over a usual week or is a binge drinker (men: 5 or more drinks; women: consume 4 or more drinks, in about 2 hours)
    11. Documented allergy to TB vaccines or any of the study treatment excipients, notably, to the RUTI® vaccine
    12. Concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study
    Un paciente potencial que cumpla cualquiera de los siguientes criterios quedará excluido de la participación en este estudio:
    1. Incapacidad para proporcionar el consentimiento informado por escrito.
    2. Mujeres que reportan, o se le detecta, un embarazo, o con intención de quedar-se embarazadas durante el período de ensayo.
    3. Gravedad de la enfermedad que precluye la evaluación completa: muerte temprana esperada, evidenciada por insuficiencia respiratoria, presión arterial baja, puntuación de estado general de la OMS 3-4.
    4. Peso corporal < 40kg.
    5. Evidencia de resistencia a rifampicina a través de GeneXpert.
    6. Diabetes Mellitus inestable, como pobre control metabólico en los últimos 12 meses.
    7. En pacientes infectados por el VIH, recuento de CD4 < 250 células/Litro
    8. Condición de comorbilidad mayor o cualquier otro hallazgo que, en la opinión del investigador, pueda comprometer el cumplimiento del protocolo o influir significativamente en la interpretación de los resultados (por ejemplo, cáncer, inmunodeficiencia de cualquier tipo que incluya tratamiento con medicación inmunosupresora y excluyendo infección por VIH).
    9. Cualquiera de los siguientes parámetros de laboratorio:
    • Aspartato aminotransferasa (AST) o alanina aminotransferasa (ALT) > 3 x límite superior de normal (LSN)
    • Bilirrubina total > 2 x ULN
    • Recuento de neutrófilos ≤ 500 neutrófilos / mm3
    • Recuento de plaquetas < 50.000 plaquetas/mm3
    10. Abuso de alcohol: el participante potencial ya sea autoinformado, o en opinión del investigador, que el paciente bebe más de un promedio de cuatro unidades/día durante una semana habitual o es un bebedor compulsivo (hombres: 5 o más bebidas; mujeres: 4 o más bebidas, en alrededor de 2 horas).
    11. Alergia documentada a las vacunas contra la tuberculosis, en particular, a la vacuna RUTI®.
    12. Participación en otro ensayo clínico, a menos que sea un estudio clínico observacional (sin intervención) o durante el período de seguimiento de un estudio con intervención.
    E.5 End points
    E.5.1Primary end point(s)
    Early Bactericidal Activity (EBA) Measured as the reduction of bacillary load of M. Tuberculosis based upon Time to detection (TTD) signal in MGIT, determined daily between day 0 and day 14 after treatment initiation and RUTI®/placebo vaccination.
    Actividad bactericida temprana (EBA) Medida como la reducción de la carga bacilar de M. tuberculosis según el tiempo de detección (TTD) en MGIT, determinada diariamente entre el día 0 y el día 14 después del inicio del tratamiento y la vacunación con RUTI® / placebo.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Daily between day 0 and day 14 after treatment initiation and RUTI®/placebo vaccination.
    Diariamente entre el día 0 y el día 14 después del inicio del tratamiento y la vacunación con RUTI® / placebo.
    E.5.2Secondary end point(s)
    1. Early Bactericidal Activity (EBA) Measured as the reduction of bacillary load of M. Tuberculosis based upon Time to detection (TTD) signal in MGIT, determined daily between day 2 and day 14 after treatment. initiation and RUTI®/placebo vaccination. Difference between each intervention arm and control group.
    2. Early Bactericidal Activity (EBA) Measured as the reduction of bacillary load of M. Tuberculosis based upon Time to detection (TTD) signal in MGIT, determined daily between day 7 and day 14 after treatment initiation and RUTI®/placebo vaccination.
    3. Early Bactericidal Activity (EBA) Measured as the reduction of bacillary load of M. Tuberculosis based upon Time to detection (TTD) signal in MGIT, determined at week 4, 8, 16 and 24 after treatment initiation and RUTI®/placebo vaccination.
    4. Hazard ratio for stable culture conversion (SCC), [Time Frame: 24 weeks of TB treatment]. Difference between each intervention arm and control group.
    5. Rate of Change in Time to Sputum Culture Positivity (TTP) in Liquid Culture Media (Days 0-14) [Time Frame: 14 days]. Difference between each intervention arm and control group.
    6. Rate of Change in Time to Sputum Culture Positivity (TTP) in Liquid Culture Media (week 4, 8, 16 and 24 ) [Time Frame: up to week 24]. Difference between each intervention arm and control group.
    7. The proportion of patients with AEs between each intervention arm and the control group [Time Frame: Up to week 24]. Difference between each intervention arm and control group.
    8. The proportion of patients with SAEs between each intervention arm and the control group [Time Frame: Up to week 24]. Difference between each intervention arm and control group.
    9. Proportion of patients with CLINICAL, X-ray or LABORATORY worsening [Time Frame: Entire study period]. Difference between each intervention arm and control group.
    10. Proportion of patients with improvement of clinical signs and symptoms, Bandim Tb score [Time Frame: At weeks 2, 8, 24] . Difference between intervention and control group.
    11. Number of patients with improvement of Health-related Quality of Life (HRQoL) comparing baseline measure with that over the course of therapy. [ Time Frame: At week 8, week 24 ]. Difference between each intervention arm and control group.
    1. Actividad bactericida temprana (EBA) Medida como la reducción de la carga bacilar de M. tuberculosis según el tiempo de detección (TTD) en MGIT, determinada diariamente entre el día 2 y el día 14 después del inicio del tratamiento y la vacunación con RUTI® / placebo. Diferencias entre el brazo tratamiento y el control
    2. Actividad bactericida temprana (EBA) Medida como la reducción de la carga bacilar de M. tuberculosis según el tiempo de detección (TTD) en MGIT, determinada diariamente entre el día 7 y el día 14 después del inicio del tratamiento y la vacunación con RUTI® / placebo.
    3. Actividad bactericida temprana (EBA) Medida como la reducción de la carga bacilar de M. tuberculosis según el tiempo de detección (TTD) en MGIT, determinada en las semanas 4,8, 16 y 24 después del inicio del tratamiento y la vacunación con RUTI® / placebo
    4. Razón de riesgo para la conversión de cultivo estable (SCC, por el inglés stable culture conversion) a la semana 24 después del inicio del tratamiento. Diferencia entre brazo intervención y control.
    5. Tasa de cambio en el tiempo hasta la positividad del cultivo de esputo (TTP) en medios de cultivo líquidos (días 0-14) [Marco de tiempo: 14 días]. Diferencia entre brazo intervención y control.
    6. Tasa de cambio en el tiempo hasta el cultivo de esputo positivo (TTP) en medios de cultivo líquidos (semanas 4, 8, 16 y 24) [Marco de tiempo: hasta la semana 24]. Diferencia entre brazo intervención y control.
    7. Proporción de pacientes con acontecimientos adversos (AAs) entre cada brazo de intervención y el grupo de control [Marco de tiempo: hasta la semana 24]. Diferencia entre brazo de intervención y control.
    8. Proporción de pacientes con acontecimientos adversos graves (AAGs) entre cada brazo de intervención y el grupo control [Marco de tiempo: hasta la semana 24]. Diferencia entre brazo de intervención y control.
    9. Proporción de pacientes con empeoramiento CLÍNICO, radiográfico o de LABORATORIO [Marco de tiempo: período de estudio completo]. Diferencia entre brazo de intervención y control.
    10. Proporción de pacientes con mejoría de los signos y síntomas clínicos, puntuación Bandim Tb [Marco de tiempo: en las semanas 2, 8, 24]. Diferencia entre grupo intervención y control.
    11. Número de pacientes con mejoría en cuestionario de calidad de vida de la calidad de vida (Health-related Quality of Life; HRQoL) durante el estudio comparando la evaluación basal [Marco de tiempo: en la semana 8, semana 24]. Diferencia entre brazo de intervención y control.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Daily between day 2 and day 14 after treatment initiation and RUTI®/placebo vaccination
    2. Daily between day 7 and day 14 after treatment initiation and RUTI®/placebo vaccination
    3. Determined at week 4, 8, 16 and 24 after treatment initiation and RUTI®/placebo vaccination
    4. 24 weeks of TB treatment
    5. 14 days after RUTI®/placebo vaccination
    6. At weeks 4, 8, 16 and 24 after RUTI®/placebo vaccination
    7. Up to week 24 after RUTI®/placebo vaccination
    8. Up to week 24 after RUTI®/placebo vaccination
    9. Entire study period
    10. At weeks 2, 8, 24 after RUTI®/placebo vaccination
    11. At weeks 8 and 24 after RUTI®/placebo vaccination
    1. Diariamente entre el día 2 y el día 14 después del inicio del tratamiento y la vacunación con RUTI® / placebo
    2. Diariamente entre el día 7 y el día 14 después del inicio del tratamiento y la vacunación con RUTI® / placebo
    3. Semanas 4,8, 16 y 24 después del inicio del tratamiento y la vacunación con RUTI® / placebo
    4. Semana 24 después del inicio del tratamiento
    5. 14 días después de la vacunación con RUTI® / placebo
    6. En las semanas 4, 8, 16 y 24 después de la vacunación con RUTI® / placebo
    7. En las 24 semanas después de la vacunación con RUTI® / placebo
    8. En las 24 semanas después de la vacunación con RUTI® / placebo
    9. Todo el estudio
    10. Semanas 2, 8 y 24 después de la vacunación con RUTI® / placebo
    11. Semanas 8 y 24 después de la vacunación con RUTI® / placebo
    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 No
    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.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 Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the 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 concerned8
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    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 months18
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 56
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state56
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    No hay
    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 Decision2021-10-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-09-10
    P. End of Trial
    P.End of Trial StatusOngoing
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