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    Summary
    EudraCT Number:2019-003357-29
    Sponsor's Protocol Code Number:PROICM2019-08INT
    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:2019-10-21
    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 number2019-003357-29
    A.3Full title of the trial
    Intensive intraperitoneal therapy in advanced ovarian cancer combining cytoreductive surgery with hyperthermic intraperitoneal chemotherapy (HIPEC) and postoperative intraperitoneal chemotherapy (IPC).
    Intensification intrapéritonéale dans la prise en charge initiale des cancers de l’ovaire en carcinose péritonéale par Chimiohyperthermie Intrapéritonéale Peropératoire (CHIP) et chimiothérapie intrapéritonéale postopératoire (CIP).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Intensive intraperitoneal therapy in advanced ovarian cancer combining cytoreductive surgery with hyperthermic intraperitoneal chemotherapy (HIPEC) and postoperative intraperitoneal chemotherapy (IPC).
    Intensification intrapéritonéale dans la prise en charge initiale des cancers de l’ovaire en carcinose péritonéale par Chimiohyperthermie Intrapéritonéale Peropératoire (CHIP) et chimiothérapie intrapéritonéale postopératoire (CIP).
    A.3.2Name or abbreviated title of the trial where available
    INTENS-IP
    INTENS-IP
    A.4.1Sponsor's protocol code numberPROICM2019-08INT
    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 SponsorInstitut Régional du Cancer de Montpellier (ICM)
    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 supportInstitut Régional Du Cancer de Montpellier (ICM)
    B.4.2CountryFrance
    B.4.1Name of organisation providing supportGIRCI GSO (DGOS)
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationInstitut Régional Du Cancer de Montpellier (ICM)
    B.5.2Functional name of contact pointDr Jean-Pierre BLEUSE
    B.5.3 Address:
    B.5.3.1Street Address208 rue des apothicaires
    B.5.3.2Town/ cityMontpellier
    B.5.3.3Post code34298
    B.5.3.4CountryFrance
    B.5.4Telephone number0033467613102
    B.5.5Fax number0033467613023
    B.5.6E-maildrci-icm105@icm.unicancer.fr
    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 Yes
    D.2.1.1.1Trade name CISPLATIN
    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.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntraperitoneal use
    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 PACLITAXEL
    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.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntraperitoneal use
    Intravenous use
    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: 3
    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 CARBOPLATINE
    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.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntraperitoneal use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patient with high-grade serous (high grade according to MD Anderson, grade II and III according to Silverman) ovarian or tubal or primitive peritoneal histologically proven cancer
    Patiente présentant un cancer séreux de haut grade (haut grade selon MD Anderson, grade II et III selon Silverman) ovarien ou tubaire ou primitif péritonéal histologiquement prouvé
    E.1.1.1Medical condition in easily understood language
    Patient with high-grade serous (high grade according to MD Anderson, grade II and III according to Silverman) ovarian or tubal or primitive peritoneal histologically proven cancer
    Patiente présentant un cancer séreux de haut grade ovarien ou tubaire ou primitif péritonéal histologiquement prouvé
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the success including both feasibility and tolerance of the HIPEC and CIP combination after a complete interval tumor reduction surgery in 1st-line treatment of stages B-C and IV A ovarian cancers, with minimal or moderate pleural effusion
    Evaluer le succès combinant faisabilité et tolérance de l’association d’une CHIP et d’une CIP après une chirurgie de réduction tumorale d’intervalle complète dans le traitement de 1ère ligne des cancers de l’ovaire de stades III B-C et IV A avec épanchement pleural minime ou modéré
    E.2.2Secondary objectives of the trial
    - To evaluate the morbidity and renal toxicity of hyperthermic intraperitoneal chemotherapy (HIPEC) in first-line treatment of advanced ovarian cancer patients receiving an interval surgery after 3 to 4 cycles of CNA,
    - To evaluate the toxicity (mainly digestive and renal) of intraperitoneal postoperative chemotherapy (IPC) after performing HIPEC.
    - To assess the number of intraperitoneal chemotherapy courses administered after HIPEC realization.
    - To assess the therapeutic efficacy of the combination of HIPEC and IPC.
    - To evaluate the patients' quality of life.
    - Evaluer la morbidité et la toxicité rénale de la chimio-hyperthermie intrapéritonéale (CHIP) en première ligne dans la prise en charge du cancer de l’ovaire avancé chez les patientes recevant une chirurgie d’intervalle après 3 à 4 cures de CNA,
    - Evaluer la toxicité (notamment digestive et rénale) de la chimiothérapie intrapéritonéale postopératoire (CIP) après la réalisation d’une CHIP,
    - Evaluer le nombre de cures de chimiothérapie intrapéritonéale administrées après la réalisation d’une CHIP,
    - Evaluer l’efficacité thérapeutique de l’association CHIP et chimiothérapie intrapéritonéale postopératoire (CIP),
    - Evaluer la qualité de vie des patientes recevant le traitement.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patients aged 18 to 75 years,
    - Patients with high-grade serous (high grade according to MD Anderson, grade II and III according to Silverman) ovarian or tubal or primitive peritoneal histologically proven cancer,
    - Initial laparoscopy confirming the histological type, evaluating the extent of the disease by PCI score and confirming the initial non-resectability,
    - Stage III B-C (FIGO 2014) or stage IVA with minimal or moderate pleural effusion,
    - Complete interval cytoreduction surgery,
    - Indication of 3 to 4 cures of neoadjuvant chemotherapy based on the Carboplatin-Paclitaxel (carbo-taxol) combination,
    - The delay between the last course of NAT and the surgery must be between 4 and 8 weeks,
    - Hematologic function, hemoglobin ≥ 10 g / dl; PNN ≥ 1 x 109 / L, platelets ≥ 100 x 109 / L,
    - Total bilirubin ≤ 1.5 LSN, ALT or AST ≤ 3 ULN,
    - Absence of renal insufficiency (creatinine clearance ≤ 70 ml / min) according to the MDRD method,
    - Informed consent signed before any specific procedure under consideration,
    - Patients affiliated to the French social security scheme or equivalent.
    - Patiente âgée de 18 à 75 ans,
    - Patiente présentant un cancer séreux de haut grade (haut grade selon MD Anderson, grade II et III selon Silverman) ovarien ou tubaire ou primitif péritonéal histologiquement prouvé,
    - Cœlioscopie initiale confirmant le type histologique, évaluant l’extension de la maladie par score PCI et confirmant la non-résécabilité initiale,
    - Stades III B-C (FIGO 2014) ou stade IVA avec épanchement pleural minime ou modéré,
    - Chirurgie d’intervalle de cytoréduction complète,
    - Indication de 3 à 4 cures de chimiothérapie néo adjuvante à base d’association Carboplatine-Paclitaxel (carbo-taxol),
    - Le délai entre la dernière cure de chimiothérapie néo-adjuvante et la chirurgie doit être comprise entre 4 et 8 semaines,
    - Fonction hématologique, Hémoglobine ≥ 10 g/dL; PNN >= 1x109 /L, plaquettes >= 100x109 /L,
    - Bilirubine totale ≤ 1.5 LSN, ALT ou AST ≤ 3 LSN,
    - Absence d’insuffisance rénale (clairance de la créatinine ≤ 70 ml/min) selon la méthode MDRD,
    - Consentement éclairé signé avant toute procédure spécifique à l’étude,
    - Patiente affiliée à un régime français d’assurance maladie.
    E.4Principal exclusion criteria
    - Performance Index (WHO) ≥ 2,
    - Stage IV B or IV A with significant pleural effusion,
    - Renal impairment (clearance <70 ml / min) according to the MDRD method,
    - General contraindication to the realization of a tumor reduction surgery or HIPEC (contraindication or history allergic reaction to any treatments components),
    - Hepatic insufficiency (bilirubin > 1.5 x normal, ASAT & ALAT > 3 x upper limit of normal),
    - Serious life-threatening co-existing condition at stake,
    - Cardio-respiratory pathology indicating hyper hydration, to be implemented for HIPEC,
    - Patient who has already been treated with chemo-hyperthermia for ovarian cancer,
    - History of cancer, except basal cell carcinoma of the skin or carcinoma in situ of cervix having recurred within five years prior to entry into this trial,
    - Any severe untreated infectious disease,
    - Peripheral sensory neuropathy ≥ grade 2 at the inclusion time,
    - Patients whose regular follow-up is a priori impossible for psychological, family, social or geographical reasons,
    - Pregnant and / or nursing women,
    - Subjects under tutelage, curatorship or safeguard of justice.
    - Indice de performance (OMS) ≥ 2,
    - Stade IV B ou IV A avec épanchement pleural important,
    - Insuffisance rénale (clairance < 70 ml/min), selon la méthode MDRD,
    - Contre-indication générale à la réalisation d’une chirurgie de réduction tumorale, d’une CHIP, (Contre-indication ou antécédents de réaction allergique à l'un des composants du traitement),
    - Insuffisance hépatique (bilirubine > 1.5 x la normale, ASAT & ALAT > 3 x la limite supérieur de la normale),
    - Affection co-existante grave mettant le pronostic vital en jeu,
    - Pathologie cardio-respiratoire contre indiquant une hyper hydratation, devant être mise en place pour la CHIP,
    - Patiente ayant déjà été traitée par Chimiohyperthermie pour un cancer ovarien,
    - Antécédents de cancer, sauf un carcinome baso-cellulaire cutanée ou un carcinome in situ du col utérin) ayant récidivé dans les 5 ans précédant l’entrée dans l’essai,
    - Toute maladie infectieuse sévère non traitée,
    - Neuropathie sensorielle périphérique ≥ grade 2 au moment de l’inclusion
    - Femme enceinte et/ou allaitante,
    - Patiente dont le suivi régulier est a priori impossible pour des raisons psychologiques, familiales, sociales ou géographiques,
    - Sujet sous tutelle, curatelle ou sauvegarde de justice.
    E.5 End points
    E.5.1Primary end point(s)
    The success of the combination of HIPEC and IPC will be evaluated with two co-primary endpoints: the feasibility rate and the toxicity rate.
    - Feasibility of HIPEC and IPC combination will be defined by the administration of at least 3 courses of intraperitoneal chemotherapy during the 6 months following complete interval cytoreductive surgery with HIPEC.
     Feasibility endpoint will be evaluated 6 months after interval surgery with HIPEC.

    - Safety will be assessed by the surveillance of the following criteria:
    o HIPEC tolerance:
     Significant deterioration of the renal function (reduction of creatinine clearance > 20%, assessed before and 15 days following interval surgery)
     A delayed start of chemotherapy > 60 days after surgery (reflecting surgical complications)
    o CIP Tolerance : major side-effects requiring IP treatment discontinuation before 3 adjuvant IP cycles :
     Abdominal pain (grade 3) requiring treatment discontinuation before the 3 IP cycles,
     Severe complications of the IP treatment: catheter removal, intestinal perforation, intestinal obstruction, chemical peritonitis.

     HIPEC tolerance will be assessed at the first cycle of adjuvant chemotherapy. CIP tolerance will be monitored at each cycle and assessed at the end of the third cycle of IP chemotherapy.
    Le succès de l’association CHIP et CIP sera évalué avec deux co-critères de jugement principaux : le taux de faisabilité et le taux de tolérance.

    - La faisabilité de l’association CHIP et CIP chez les patientes bénéficiant d’une chirurgie de réduction tumorale maximale complète (chirurgie d’intervalle après 3 à 4 cures de chimiothérapie néo-adjuvante) pour un cancer de l’ovaire de stades III B-C et IV A avec épanchement pleural minime ou modéré est définie par l’administration d’une CIP postopératoire d’au moins 3 cures dans les 6 mois suivant la date de la chirurgie d’intervalle comportant une CHIP.
     Le critère de faisabilité sera évalué 6 mois après la chirurgie d’intervalle avec CHIP.

    - L’appréciation de la tolérance comprendra la surveillance des facteurs de toxicité sévère suivants :
    o Tolérance de la CHIP :
     Altération significative de la fonction rénale (diminution de la clairance de la créatinine de plus de 20%, mesurée avant et 15 jours après la chirurgie)
     Délai entre la chirurgie et la première cure de chimiothérapie adjuvante qui devra être inférieur ou égal à 60 jours (un délai plus long attestera de la survenue de complications postopératoires).
    o Tolérance de la CIP : effet secondaire lié au traitement nécessitant l’arrêt du traitement IP avant 3 cures :
     Douleurs abdominales de grade 3 nécessitant l’arrêt définitif du traitement IP avant 3 cures,
     Complications grave du traitement IP avant 3 cures: dépose du cathéter, perforation intestinale, occlusion intestinale, péritonite chimique.
     La tolérance de la CHIP sera évaluée à la première cure de chimiothérapie adjuvante. La tolérance de la CIP sera monitorée à chaque cure et évaluée à la fin de la 3ième cure de CIP postopératoire.
    E.5.1.1Timepoint(s) of evaluation of this end point
    - 6 months post-surgery for feasibility
    - after each cycle of intraperitoneale chemotherapy for tolerance
    - 6 mois après la chirurgie pour la faisabilité
    - après chaque cycle de chimiothérapie intrapéritonéale pour la tolérance
    E.5.2Secondary end point(s)
    - Morbidity of reductive surgery combined with HIPEC assessed up to 60 postoperative days, according to the CLAVIEN and DINDO score,
    - HIPEC toxicities reported according to the CTC-AE v5.0 scale, especially renal toxicities,
    - Period of time between HIPEC and the first IPC course,
    - IPC toxicities reported according to the CTC-AE v5.0 scale, especially renal toxicities,
    - Complications due to intraperitoneal catheters (obstruction, infection, deposition, occlusion) after interval surgery with HIPEC.
    - Number of IPC courses administered after interval surgery with HIPEC.
    - Relapse-Free survival,
    - Time up to peritoneal recurrence,
    - Overall survival,
    Quality of life questionnaire (QLQ-C30 & QLQ-OV28).
    - Morbidité de la chirurgie de réduction tumorale d’intervalle avec CHIP évaluée jusqu’au 60ième jour post opératoire selon la classification de CLAVIEN et DINDO,
    - Toxicités de la CHIP selon l’échelle CTC-AE v5.0 en particulier les toxicités rénales,
    - Délai entre la réalisation de la chirurgie d’intervalle avec CHIP et la première cure de CIP,
    - Toxicité de la CIP selon l’échelle CTC-AE v 5.0 en particulier les toxicités rénales,
    - Complications des cathéters intrapéritonéaux (obstruction, infection, dépose, occlusion) après chirurgie d’intervalle avec CHIP,
    - Nombre de cure de CIP administrée après chirurgie d’intervalle avec CHIP,
    - Survie sans récidive,
    - Temps jusqu’à récidive péritonéale,
    - Survie globale.
    - Qualité de vie évaluée par le questionnaire EORTC QLQ-C30 & QLQ-OV28.
    E.5.2.1Timepoint(s) of evaluation of this end point
    -Morbidity is assessed up to 60 postoperative days, according to the CLAVIEN and DINDO score,
    -HIPEC toxicities are reported according to the CTC-AE v5.0 scale
    -Period of time between HIPEC and the first IPC course,
    -IPC toxicities reported according to the CTC-AE v5.0 scale
    -Complications after interval surgery with HIPEC.
    -Number of IPC courses administered after interval surgery with HIPEC.
    -Relapse-Free survival is defined from the date of inclusion to the date of death
    -peritoneal recurrence is defined from the date of inclusion to the date of recurrence,
    -Overall survival is defined from the date of inclusion to the date of death,
    - QLQ-C30 & QLQ-OV28 at baseline, 30 days post operative, 3 months, 12 months and 24 months post surgery.
    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 No
    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 Yes
    E.6.13.1Other scope of the trial description
    Feasibility and tolerance
    Faisabilité et tolérance
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 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 years7
    E.8.9.1In the Member State concerned months
    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: 55
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 55
    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 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 state55
    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 Decision2019-12-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-11-19
    P. End of Trial
    P.End of Trial StatusOngoing
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