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    Summary
    EudraCT Number:2020-002924-35
    Sponsor's Protocol Code Number:APHP180592
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-10-07
    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 ConcernedFrance - ANSM
    A.2EudraCT number2020-002924-35
    A.3Full title of the trial
    Prenatal treatment of congenital cytomegalovirus infection with letermovir randomized against valaciclovir

    Traitement prénatal de l'infection congénitale à cytomégalovirus par le letermovir randomisé contre le valaciclovir
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Traitement prénatal de l'infection congénitale à cytomégalovirus par le letermovir randomisé contre le valaciclovir
    Traitement prénatal de l'infection congénitale à cytomégalovirus par le letermovir randomisé contre le valaciclovir
    A.3.2Name or abbreviated title of the trial where available
    CYMEVAL III
    CYMEVAL III
    A.4.1Sponsor's protocol code numberAPHP180592
    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 SponsorASSISTANCE PUBLIQUE HÔPITAUX DE PARIS
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportASSISTANCE PUBLIQUE HÔPITAUX DE PARIS
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDirection de la Recherche Clinique et de l’Innovation (DRCI)
    B.5.2Functional name of contact pointshohreh AZIMI
    B.5.3 Address:
    B.5.3.1Street Address1 avenue Claude Vellefaux
    B.5.3.2Town/ cityParis
    B.5.3.3Post code75010
    B.5.3.4CountryFrance
    B.5.4Telephone number33144 84 17 79
    B.5.5Fax number33144 84 17 01
    B.5.6E-mailshohreh.azimi@aphp.fr
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    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 Yes
    D.2.1.1.1Trade name Valaciclovir Arrow 500 mg
    D.2.1.1.2Name of the Marketing Authorisation holderArrow Génériques
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameValaciclovir Arrow
    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 INNvalaciclovir
    D.3.9.3Other descriptive nameVALACICLOVIR HYDROCHLORIDE HYDRATE
    D.3.9.4EV Substance CodeSUB126884
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(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.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Prevymis
    D.2.1.1.2Name of the Marketing Authorisation holderMSD France
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 namePrevymis
    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 INNLETERMOVIR
    D.3.9.1CAS number 917389-32-3
    D.3.9.4EV Substance CodeSUB90389
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number240
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    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
    Step 1: Maternal administration of 1 tablet of Letermovir (240 mg or 480 mg /day) during 3 days before TOP

    Step 2: Maternal daily administration of 240 or 480 milligrams of letermovir (1x240 mg-tablets) or (1x480 mg-tablets) (the dose will be choosen depending on the results obtained on step 1) up-until delivery or TOP
    Étape 1 : Administration maternelle d'un comprimé de Letermovir (240 mg ou 480 mg /jour) pendant 3 jours avant l’IMG
    Étape 2 : Administration quotidienne par la mère de 240 ou 480 milligrammes de létermovir (1x240 mg) ou (1x480 mg) (la dose sera choisie en fonction des résultats obtenus à l'étape 1) jusqu'à l'accouchement ou IMG
    E.1.1.1Medical condition in easily understood language
    Pregnant women with a fetus infected with cytomegaloviru.Test the efficacy of a new antiviral Letermovir on cytomegalovirus infection in the fetus versus the Valaciclovir already used in this context.
    Femmesenceintesavec fœtus infecté par le cytomégaloviruTester l’efficacitéd’unnouvel antiviralleLetermovirsurl’infection cytomégalovirus du fœtus versus le Valaciclovir déjà utilisé dans ce contexte.
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    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
    Step 1:
    Main objective To measure the Letermovir transplacental transfer in the second trimester and its accumulation in the amniotic fluid and the placenta in the second trimester
    Primary end point:
    Concentrations reached in fetal blood relative to EC50 of letermovir.
    Step 2:
    Main objective:
    To demonstrate that Letermovir administered to women carrying a CMV infected fetus following a maternal infection of the first trimester increases the proportion of neonates with a negative CMV PCR in neonatal blood collected in the first day of life or in cord blood in case of termination of pregnancy (TOP) compared to Valaciclovir
    Étape 1 :
    Objectif principal : Mesurer le transfert transplacentaire de Letermovir au cours du deuxième trimestre et son accumulation dans le liquide amniotique et le placenta au cours du deuxième trimestre
    Critère de jugement principal: Concentrations atteintes dans le sang fœtal par rapport à la CE50 du létermovir.
    Étape 2 :
    Objectif principal : Démontrer que le létermovir administré aux femmes porteuses d'un fœtus infecté par le CMV à la suite d'une infection maternelle du premier trimestre augmente la proportion de nouveau-nés présentant une PCR CMV négative dans le sang néonatal prélevé le premier jour de vie ou dans le sang du cordon en cas d’une IMG par rapport au valaciclovir
    E.2.2Secondary objectives of the trial
    Secondary objectives: (step 2)
    The following are to be compared between the 2 arms:
    -Proportion of asymptomatic neonates
    -Overall growth
    -Proportion of long-term sequelae at 2 years
    -Tolerance of treatment for mothers, fetuses and neonates
    -Adherence to treatment
    -Evolution of ultrasound features between Day0 and Week 2, Week 4, and Week 6 of treatment
    -Changes in cerebral and placental features between Day 0 and Week 6 of treatment, using magnetic resonance imaging (MRI).
    -Post-mortem examination in cases with medical termination of pregnancy (TOP)
    -CMV DNA levels in
    amniotic fluid and fetal blood (if done) at diagnosis
    (inclusion)
    amniotic fluid and saliva at birth
    blood at day 3 and at M1 and M4
    saliva at day 3 and at M1
    urine retrieved in the first 3 days of life
    saliva sampled at M4, M12,M18 and M24
    -Anti-viral Letermovir transfer from mother to fetus
    -Search for mutation(s) in CMV genes associated with Letermovir resistance (UL56 and UL89)
    Objectifs secondaires : (étape 2 s)comparaisonentre les 2 bras:Proportion de nouveau-nés asymptomatiques Croissance globale -Proportion des séquelles à long termeà2 ans-Tolérance des traitements pour les mères, les fœtus et les nouveau-nés -Respect du traitement -L'évolution des caractéristiques des ultrasons entre le jour0 et la semaine 2, la semaine 4 et la semaine 6 du traitement-Changements des caractéristiques cérébrales etplacentaires entre le jour 0 et la semaine 6 de traitement, en utilisant l'imagerie par résonance magnétique (IRM).Examen post-mortem dans les cas de IMG-Les niveaux d'ADN du CMV dans .le liquide amniotique et le sang du fœtus au moment du diagnostic (inclusion).le liquide amniotique et la salive à la naissance.le sang au troisième jour et aux niveaux M1 et M4. la salive au troisième jour et M1.l'urine prélevée au cours des 3 premiers jours de vie.échantillons de salive prélevés M4,M12,M18e M24-Transfert de Letermovir de la mère au fœtus-Recherche de mutations
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Step1:
    -Pregnant woman ≥ 18 years old
    - in her second trimester of pregnancy
    - undergoing TOP for any fetal abnormality
    - no evidence of placental dysfunction.
    - - affiliation to a social security regime//health insurance
    - given consent for the study.
    - patient must be able and willing to comply with study visits and procedures

    Step2:
    -Pregnant woman ≥ 18 years old,
    - CMV infection in the 1st trimester
    - with an infected fetus at 18 -28 weeks (positive CMV PCR in the amniotic fluid)
    With a fetus presenting without any severe cerebral ultrasound feature (ventriculomegaly ≥15 mm, hydrocephalus, periventricular hyperechogenicity, microcephaly<-3SD, vermian hypoplasia, porencephaly, lisencephaly, corpus callosum dysgenesis, cystic leukomalacia)
    - affiliation to a social security regime//health insurance
    - Given consent for the study
    - Patient must be able and willing to comply with study visits and procedures
    Étape 1 :
    Femme enceinte ≥ 18 ans,
    au cours du deuxième trimestre de la grossesse
    en cours d’IMG pour toute anomalie fœtale
    aucun signe de dysfonctionnement placentaire.
    Affiliée à un régime de sécurité sociale
    Ayant donné son consentement pour participer à l’étude
    Capable de comprendre et de suivre l’étude et ses procédures

    Étape 2 :
    Femme enceinte > 18 ans
    Femme atteinte d'une infection à CMV au cours du 1er trimestre
    ayant un fœtus infecté à 18-28 semaines (PCR positive pour le CMV dans le liquide amniotique)
    avec un fœtus présentant aucun signe d'échographie cérébrale grave (ventriculomégalie ≥15 mm, hydrocéphalie, hyperéchogénicité périventriculaire, microcéphalie<-3SD, hypoplasie vermienne, porencéphalie, lisencephalie, dysgénésie du corps calleux, leucomalacie kystique)
    Affiliée à un régime de sécurité sociale
    Ayant donné son consentement pour participer à l’étude
    Capable de comprendre et de suivre l’étude et ses procédures
    E.4Principal exclusion criteria
    Step1:
    -Participation to another interventional drug trial (category 1)
    -Subject protected by law under guardianship or curatorship
    -Woman with creatinine clearance <50 ml/mn
    -Woman with liver insufficiency (Child Pugh grade C), AST, ALT 5 x ULN, bilirubin 2 x ULN.
    -Woman with known allergy to Letermovir
    -Contraindication for the administration of Letermovir listed in the SmPC of Prevymis®
    -Woman treated by pimozide, ergot alkaloids , dabigatran, atorvastatin, simvastatin, rosuvastatin, pitavastatine or cyclosporine.
    -Concomitant administration of millepertuis
    -Woman with hereditary intolerance to galactose, with lactose lapp deficiency, glucose or galactose malabsorption syndrome

    Step2 :
    -Participation to another interventional drug trial (category 1)
    -Subject protected by law under guardianship or curatorship
    -Maternal CMV infection after 15 weeks’-creatinine clearance <50 ml/mn
    -liver insufficiency (Child Pugh grade C), AST, ALT 5 x ULN, bilirubin 2 x ULN.
    -Woman with known allergy to Letermovir or Valaciclovir
    -Contraindication for the administration of Letermovir and valaciclovirlisted in the SmPC of Prevymis® and Zelitrex®
    -Concomitant administration of millepertuis
    -woman treated by pimozidee, ergot alkaloids, dabigatran, atorvastatin, simvastatin, rosuvastatin, pitavastatine or cyclosporine.
    -Woman with hereditary intolerance to galactose, with lactose lapp deficiency, glucose or galactose malabsorption syndrome
    Étape 1 :
    - participation à une recherche interventionnelle (catégorie 1)
    - sous un régime de protection (tutelle ou curatelle)
    -Femme avec une clairance de la créatinine <50 ml/mn
    -Femme souffrant d'une insuffisance hépatique (Child Pugh grade C), AST, ALT 5 x ULN, bilirubine 2 x ULN.
    -Femme présentant une allergie connue au létermovir
    - avec une contre-indictaion au Letermovir telle que listée dans le RCP du Prevymis®
    -Femme traitée par pimozide, alcaloïdes de l'ergot, dabigatran, atorvastatine, simvastatine, rosuvastatine, pitavastatine ou cyclosporine
    - administration concomitante avec du millepertuis
    - femme présentant une intolérance héréditaire au galactose, une carence en lactose, un syndrome de malabsorption du glucose ou du galactose

    Étape 2
    - participation à une recherche interventionnelle (catégorie 1)
    - sous un régime de protection (tutelle ou curatelle)
    -clairance de la créatinine <50 ml/mn
    -Insuffisance hépatique (Child Pugh grade C), AST, ALT 5 x ULN, bilirubine 2 x ULN.
    -Femmes présentant une allergie connue au létermovir ou au valaciclovir
    - avec une contre-indictaion au Letermovir telle que listée dans le RCP du Prevymis® ou au valaciclovir listée dans le RCP du Zelitrex®
    -Femme traitée par pimozide, alcaloïdes de l'ergot, dabigatran, atorvastatine, simvastatine, rosuvastatine, pitavastatine ou cyclosporine
    - administration concomitante avec du millepertuis
    -femmes présentant une intolérance héréditaire au galactose, une carence en lactose, un syndrome de malabsorption du glucose ou du galactose
    E.5 End points
    E.5.1Primary end point(s)
    Primary endpoint:
    Negative CMV PCR (<500 IU/ml) in neonatal blood collected in the first day of life or in cord blood at termination of pregnancy
    Critères de jugement principal : PCR CMV négative (<500 UI/ml) dans le sang néonatal prélevé le premier jour de vie ou dans le sang du cordon ombilical à l'interruption de grossesse
    E.5.1.1Timepoint(s) of evaluation of this end point
    At the end of follow-ups for the last patient
    Fin de suivi de la derniere patient
    E.5.2Secondary end point(s)
    Secondary objectives: (step 2)
    The following are to be compared between the 2 arms:
    -Proportion of asymptomatic neonates
    -Overall growth
    -Proportion of long-term sequelae at 2 years
    -Tolerance of treatment for mothers, fetuses and neonates
    -Adherence to treatment
    -Evolution of ultrasound features between Day0 and Week 2, Week 4, and Week 6 of treatment
    -Changes in cerebral and placental features between Day 0 and Week 6 of treatment, using magnetic resonance imaging (MRI).
    -Post-mortem examination in cases with medical termination of pregnancy (TOP)
    -CMV DNA levels in
    amniotic fluid and fetal blood (if done) at diagnosis
    (inclusion)
    amniotic fluid and saliva at birth
    blood at day 3 and at M1 and M4
    saliva at day 3 and at M1
    urine retrieved in the first 3 days of life
    saliva sampled at M4, M12,M18 and M24
    -Anti-viral Letermovir transfer from mother to fetus
    -Search for mutation(s) in CMV genes associated with Letermovir resistance (UL56 and UL89)

    Secondary endpoints:
    -Number of asymptomatic neonates
    -Birthweight and placental weight
    -Number and type of long-term sequelae at 2 years
    -Maternal: full blood count, renal & liver function
    -Neonatal: gestational age at birth, defects non related to infection, full blood count, renal & liver function
    -Pill count every 2 weeks and at the end of the trial and after ending the double blinding: Valaciclovir or Letermovir concentrations in maternal blood (every 2 weeks and at birth or TOP)
    -Changes in ultrasound features as per 4 groups: 1) stable, 2) disappearance or decrease in symptoms, 3) increase or new non-severe symptoms 4) appearance of severe cerebral symptoms
    -Changes in placental features on MRI, measuring placental T2 relaxation time, diffusion parameters and IVIM
    -Fetal assessment: brain biometrics, gyration disorders, white matter abnormalities, ventriculomegaly, parenchymal abnormalities, hepatomegaly, splenomegaly, intestinal abnormalities, abnormal amniotic fluid volume
    -Classification after pathological cerebral examination in severe and non-severe cases
    - CMV DNA load in fetal, cord blood and neonatal blood, amniotic fluid, saliva and urine by quantitative PCR in IU/ml.
    - Letermovir concentration in cord blood, amniotic fluid, placenta at birth or at TOP and in neonatal blood at day 3 at the end of the trial and after unblinding in the Letermovir arm
    -Sequencing of CMV UL56 and UL89 genes in positive neonates for CMV PCR at the end of the trial and after unblinding in the Letermovir arm
    Objectifs secondaires : (étape 2 seulement)
    Les éléments suivants sont à comparer entre les 2 bras:
    -Proportion de nouveau-nés asymptomatiques
    -Croissance globale
    -Proportion des séquelles à long terme à 2 ans
    -Tolérance des traitements pour les mères, les fœtus et les nouveau-nés
    -Respect du traitement
    -L'évolution des caractéristiques des ultrasons entre le jour 0 et la semaine 2, la semaine 4 et la semaine 6 du traitement
    -Changements des caractéristiques cérébrales et placentaires entre le jour 0 et la semaine 6 de traitement, en utilisant l'imagerie par résonance magnétique (IRM).
    -Examen post-mortem dans les cas d'interruption médicale de grossesse (IMG)
    -Les niveaux d'ADN du CMV dans
    . le liquide amniotique et le sang du fœtus (le cas échéant) au moment du diagnostic (inclusion)
    . le liquide amniotique et la salive à la naissance
    . le sang au troisième jour et aux niveaux M1 et M4
    . la salive au troisième jour et M1
    . l'urine prélevée au cours des 3 premiers jours de vie
    . échantillons de salive prélevés aux points M4, M12, M18 et M24
    -Transfert de Letermovir de la mère au fœtus
    -Recherche de mutation(s) dans les gènes du CMV associés à la résistance au létermovirus (UL56 et UL89)

    Critères de jugements secondaires :
    Nombre de nouveaux-nés asymptomatiques
    -Poids à la naissance et poids du placenta
    -nombre et type de séquelles à long terme à 2 ans
    -Evaluation maternelle : hémogramme complet, fonction rénale et hépatique
    -Evaluation néonatale : âge gestationnel à la naissance, défauts non liés à une infection, hémogramme complet, fonction rénale et hépatique
    -Nombre de pilules toutes les 2 semaines et à la fin de l’essai et après la fin du double aveugle : Concentrations de létermovir dans le sang maternel (toutes les 2 semaines et à la naissance ou IMG)
    -Changements des caractéristiques échographiques selon 4 groupes : 1) stable, 2) disparition ou diminution des symptômes, 3) augmentation ou nouveaux symptômes non graves 4) apparition de symptômes cérébraux graves
    -Modification des caractéristiques du placenta à IRM, mesure du temps de relaxation T2 du placenta, paramètres de diffusion et IVIM
    -Evaluation du foetus : biométrie du cerveau, troubles de la giration, anomalies de la substance blanche, ventriculomégalie, anomalies du parenchyme, hépatomégalie, splénomégalie, anomalies intestinales, volume anormal du liquide amniotique
    -Classification après examen cérébral pathologique dans les cas graves et non graves
    - Charge virale ADN du CMV dans le sang fœtal, le sang de cordon et le sang néonatal, le liquide amniotique, la salive et l'urine par PCR quantitative en UI/ml.
    - Concentration de létermovir dans le sang du cordon, le liquide amniotique, le placenta à la naissance ou au moment de l'accouchement et dans le sang néonatal au jour 3 à la fin de l'essai et après la levée de l'insu dans le bras de létermovir
    - Séquençage des gènes CMV UL56 et UL89 chez les nouveau-nés positifs pour la PCR du CMV à la fin de l'essai et après la levée de l'aveugle dans le bras Letermovir
    E.5.2.1Timepoint(s) of evaluation of this end point
    At the end of follow-ups for the last patient
    Fin de suivi de la derniere patient
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    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 Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) 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 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 concerned5
    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 months65
    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 Yes
    F.1.1Number of subjects for this age range: 46
    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: 46
    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 No
    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 Yes
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women Yes
    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
    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 Decision2021-01-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-11-23
    P. End of Trial
    P.End of Trial StatusOngoing
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