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    Summary
    EudraCT Number:2016-002429-12
    Sponsor's Protocol Code Number:UC_0160/1613
    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:2018-01-15
    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 number2016-002429-12
    A.3Full title of the trial
    PERSONALIZED TREATMENT OF METASTATIC CASTRATE-RESISTANT PROSTATE CANCER PATIENTS ACCORDING TO CIRCULATING TUMOR CELLS KINETIC DURING CHEMOTHERAPY
    Traitement personnalisé des patients atteints de cancer métastatique de la prostate résistant à la castration en fonction de la cinétique des cellules tumorales circulantes au cours de la chimiothérapie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Not applicable
    Non applicable
    A.3.2Name or abbreviated title of the trial where available
    TACTIK/GETUG AFU 28
    A.4.1Sponsor's protocol code numberUC_0160/1613
    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 SponsorUNICANCER
    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 supportProgramme Hospitalier de Recherche Clinique PHRC
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUNICANCER
    B.5.2Functional name of contact pointFlorence TANTOT, Project Manager
    B.5.3 Address:
    B.5.3.1Street Address101 rue de Tolbiac
    B.5.3.2Town/ cityParis cedex 13
    B.5.3.3Post code75654
    B.5.3.4CountryFrance
    B.5.4Telephone number+33 (0)1 73 77 55 43
    B.5.5Fax number+33(0)1 85 34 33 79
    B.5.6E-mailf-tantot@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 JEVTANA
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi Aventis Groupe
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameCabazitaxel
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNcabazitaxel
    D.3.9.1CAS number 183133-96-2
    D.3.9.3Other descriptive nameCABAZITAXEL
    D.3.9.4EV Substance CodeSUB31282
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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 Taxotere
    D.2.1.1.2Name of the Marketing Authorisation holderAventis Pharma
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDOCETAXEL
    D.3.9.1CAS number 114977-28-5
    D.3.9.4EV Substance CodeSUB12492MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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 Yes
    D.3.11.13.1Other medicinal product typesynthetic medicinal product
    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
    Metastatic castrate-resistant prostate cancer requiring initiation of chemotherapy
    Cancer de la prostate métastatique résistant à la castration nécessitant l'initiation de la chimiothérapie
    E.1.1.1Medical condition in easily understood language
    Not Applicable
    Non applicable
    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
    The primary objective of this study is to compare the biological activity of cabazitaxel (6 cycles) to that of docetaxel (6 cycles) in metastatic castrate-resistant prostate cancer (mCRPC) patients with docetaxel resistant mCPRC defined as ≥ 5CTCs/7.5ml after 2 cycles of docetaxel.
    L’objectif principal de l’étude est de comparer l’activité biologique du cabazitaxel (6 cycles de traitement) à celle du docétaxel (6 cycles de traitement) chez des patients atteints d’un cancer métastatique de la prostate résistant à la castration (CPRCm) et au docétaxel défini par un nombre de CTC ≥ 5 /7,5 ml après 2 cycles de traitement par docétaxel (Groupe II)
    E.2.2Secondary objectives of the trial
    The secondary objectives are the following:
    1. In patients with docetaxel resistant mCRPC (≥5CTCs/7.5ml after 2 cycles of docetaxel), comparison of cabazitaxel (6 cycles) to docetaxel (6 cycles) in terms of:
    - Prostate Specific Antigen PSA progression-free-survival (PSA-PFS)
    - Radiographic progression-free-survival (PFS, as per RECIST v1.1)
    - Time to pain progression
    - Safety profile of each treatment graded according to the NCI CTCAE version 4.0 scale (Appendix 2)
    - Disease specific survival (DSS)
    - Overall survival (OS)

    2. In patients with docetaxel sensitive mCRPC (< 5 CTCs/7.5 ml after 2 cycles of docetaxel):
    - CTC assessment at the end of 6 additional cycles of docetaxel
    - PSA progression-free-survival (PSA-PFS)
    - Radiographic progression-free-survival (PFS, as per RECIST v1.1)
    - Time to pain progression
    - Safety profile of each treatment graded according to the NCI CTCAE version 4.0 scale (Appendix 2)
    - Disease specific survival (DSS)
    - Overall survival (OS)
    1.Patients atteints d’un CPRCm et résistant au docétaxel (nombre de CTC ≥ 5/7,5 ml après 2cycles de traitement par docétaxel) (Groupe II):Comparaison des effets d’un traitement par cabazitaxel (6 cycles) par rapport à traitement par docétaxel (6 cycles)Survie sans progression du taux de PSA,Survie sans progression radiologique selon critères RECIST v1.1,Délai d’apparition de la douleur, Profil de tolérance de chaque traitement évalué selon NCI-CTCAE v4.0, Survie spécifique à la maladie (DSS), Survie globale (SG)
    2.Patients atteints d’un CPRCm et sensible au docétaxel (nombre de CTC < 5 /7,5 ml après 2 cycles de traitement par docétaxel) (Groupe I):Énumération CTC à la fin des 6 cycles de traitement par docétaxel,Survie sans progression du taux de PSA (SSP - PSA),Survie sans progression radiographique (SSPr) selon les critères RECIST v 1.1,Délai d’apparition de la douleur,Profil de tolérance de traitement évalué selon NCI CTCAE v4.0,Survie spécifique à la maladie (DSS) ,globale (SG)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    To be eligible, the patients must fulfill the following inclusion criteria:
    1. Written informed consent signed prior any study-related procedures
    2. Male ≥ 18 years
    3. Histologically confirmed diagnosis of prostate adenocarcinoma
    4. Metastatic disease as evidenced by medical imaging techniques (bone scan, CT scan, MRI and/or PET) according to the RECIST 1.1.
    5. Castrate resistant disease defined by testosterone levels ≤ 50 ng/dl under continuous hormonal treatment with LH-RH agonist/antagonist or after surgical castration
    6. Progressive (biological and/or radiological) disease requiring chemotherapy subsequent to any type of hormonal therapy
    7. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Appendix 1)
    8. Patient with screening CTC count ≥ 5/7.5 ml
    9. Patient must agree to use effective contraception during the trial and for a period of at least 6 months following the last administration of treatment
    10. Patient must be affiliated to the Social Security System
    Pour être éligible à cette étude, les patients doivent répondre aux critères d’inclusion suivants :
    1. Le formulaire de consentement éclairé doit être signé avant la réalisation de toute procédure associée à l’étude
    2. Homme âgé de 18 ans ou plus
    3. Diagnostic d’un adénocarcinome de la prostate confirmé par des analyses histologiques
    4. Maladie métastatique mise en évidence par des techniques d’imagerie médicale (scintigraphie osseuse, TDM, IRM et/ou TEP) selon les critères RECIST v. 1.1.
    5. Maladie résistante à la castration définie par des taux de testostérone ≤ 50 ng/dl sous un traitement hormonal continu par agonistes/antagonistes de la LH-RH ou après castration chirurgicale
    6. Progression de la maladie (biologique et/ou radiologique) nécessitant une chimiothérapie due à la prise de tout type d’hormonothérapie
    7. Indice de performance Eastern Cooperative Oncology Group (ECOG) ≤ 2 (annexe 1)
    8. Patient dont le nombre de CTC ≥ 5 / 7,5 ml à la période de sélection
    9. Le patient doit accepter d’utiliser une méthode de contraception efficace pendant toute la durée de l’essai et ce pendant une période d’au moins 6 mois suivant l’administration de la dernière dose de traitement
    10. Le patient doit être affilié au système de sécurité sociale
    E.4Principal exclusion criteria
    Patient must not be enrolled if he meets any of the following non-inclusion criteria:
    1. Prior chemotherapy for metastatic prostate cancer with the exception of estramustine:
    • < 1 year from the end of adjuvant and/or neoadjuvant chemotherapy for localized disease
    • < 1 year from the end of chemotherapy for de novo metastatic prostate cancer

    2. Prior isotope therapy, radiotherapy to the whole pelvic area or radiotherapy to > 30% of bone marrow
    3. Less than 1 month elapsed from the end of a prior treatment with radiotherapy, surgery and less than 2 weeks from any previous hormonal treatment except for LH-RH agonists/antagonists (which are to be continued). Prior to study entry, patients may be treated with bisphosphonates which should be pursued.
    4. History of brain metastases, uncontrolled spinal cord compression, carcinomatous meningitis or new evidence of brain or leptomeningeal disease
    5. Patient with any of the following abnormal laboratory tests:
    • Bone marrow function: hemoglobin < 10 g/dl, absolute neutrophil count < 1.5 x 109/L, platelets < 100 x 109/L,
    • Hepatic function: AST/SGOT and/or ALT/SGPT > 1.5 x upper limit of normal (ULN), total bilirubin > 1.0 ULN (except patients with liver metastases),
    • Renal function: creatinine clearance < 40 ml/min (MDRD)
    6. History of hypersensitivity to cabazitaxel, to other taxanes or polysorbate 80 or any of its excipients
    7. History of hypersensitivity todocetaxel or polysorbate 80 or any of its excipients
    8. Contraindication to corticosteroids
    9. Peripheral neuropathy grade ≥ 2 according to NCI CTCAE v. 4.0
    10. Ventricular ejection fraction < 50% (echography or scintigraphy)
    11. Any of the following within 6 months prior to study entry: myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, New York Heart Association (NYHA) class III or IV congestive heart failure, stroke or transient ischemic attack
    12. Any of the following within 3 months prior to study entry: treatment resistant peptic ulcer disease, erosive esophagitis or gastritis, inflammatory bowel disease, pulmonary embolism or other uncontrolled thromboembolic event
    13. Other severe acute or chronic medical or psychiatric condition, or laboratory abnormally that would impart, in the judgment of the investigator, excess risk associated with study participation or study drug administration, or which, in the judgment of the investigator, would make the patient inappropriate for entry into this study
    14. Planned vaccination with a live or live-attenuated vaccines
    15. Participation in another clinical trial and any treatment with any investigational drug within 30 days prior to randomization
    16. Any illness or problem including geographic, psychiatric or psychological which is incompatible with being monitored during the trial
    17. Person deprived of their liberty or under protective custody or guardianship
    Le patient ne doit pas être inclus dans l’essai s’il répond à l’un des critères de non-inclusion suivants :
    1. Chimiothérapie antérieure pour le traitement d’un cancer métastatique de la prostate, à l’exception de l’estramustine :
    • < 1 an à compter de la fin de la chimiothérapie adjuvante et/ou néoadjuvante pour traiter une maladie localisée
    • < 1 an à compter de la fin de la chimiothérapie pour traiter un cancer métastatique de la prostate de novo
    2. Traitement antérieur par isotopes, radiothérapie de toute la zone pelvienne ou radiothérapie sur > 30 % de la moelle osseuse
    3. Moins d’1 mois depuis la fin d’un traitement antérieur par radiothérapie ou chirurgie et moins de 2 semaines depuis la fin de tout traitement hormonal antérieur, sauf pour les agonistes/antagonistes de la LH-RH (qui doivent être poursuivis). Avant de participer à l’étude, les patients traités par bisphosphonates peuvent continuer le traitement.
    4. Antécédents de métastases cérébrales, compression médullaire non contrôlée, méningite carcinomateuse ou nouveau signe d’une maladie cérébrale ou leptoméningée
    5. Patient présentant tout résultat anormal aux analyses biologiques suivantes :
    • Fonction médullaire : taux d’hémoglobine < 10 g/dl, neutrophiles < 1,5 x 109/l, plaquettes < 100 x 109/l,
    • Fonction hépatique : ASAT/SGOT et/ou ALT/SGPT > 1,5 x Limite Supérieure de la Normale (LSN), taux de bilirubine totale > 1,0 x LSN (sauf pour les patients présentant des métastases hépatiques),
    • Fonction rénale : clairance de la créatinine < 40 ml/min. (formule MDRD)
    E.5 End points
    E.5.1Primary end point(s)
    Biological activity of chemotherapy as defined as < 5 CTCs per 7.5 ml at the end of 6 cycles of chemotherapy with docetaxel or cabazitaxel. The CellSearch® CTC Test (Janssen) will be used to assess CTCs (Appendix 5). Patients who could not receive the 6 cycles of treatment or the absence of biological activity will be claimed (even in the presence of CTC count).
    Activité biologique de la chimiothérapie définie comme <5 CTC par 7,5 ml à la fin de 6 cycles de chimiothérapie avec docetaxel ou cabazitaxel. Le test CTC CellSearch® (Janssen) sera utilisé pour évaluer les CTC (annexe 5). Les patients qui n'ont pas pu recevoir les 6 cycles de traitement ou l'absence d'activité biologique seront réclamés (même en présence de numération CTC).
    E.5.1.1Timepoint(s) of evaluation of this end point
    4 weeks (with 7 days windows allowed) after the day of the last cycle of treatment.
    4 semaines (avec une fenêtre de tolérance de 7 jours) après le jour du dernier cycle de traitement.
    E.5.2Secondary end point(s)
    RANDOMIZED TRIAL:
    • PSA Progression Free Survival (PFS) is defined as time from randomization until first evidence of PSA progression or until death from any cause, whichever comes first.
    - PSA progression is defined by the criteria of the Prostate cancer Clinical Trials Working Group [23] as an increase of 25% relative to reference PSA value and increase in the absolute value PSA level by at least 5 ng/ml and confirmed by a second value at least 4 weeks later or a ≥ 50% increase over nadir, provided that the increase is a minimum of 5 ng/ml and confirmed by a second value at least 1 week later.
    - PSA values will be assessed at each cycle of chemotherapy.

    • Radiological PFS is defined as time from randomization until first evidence of PSA progression or until death from any cause, whichever comes first.
    - PSA progression is defined by the criteria of the Prostate cancer Clinical Trials Working Group [23] as an increase of 25% relative to reference PSA value and increase in the absolute value PSA level by at least 5 ng/ml and confirmed by a second value at least 4 weeks later or a ≥ 50% increase over nadir, provided that the increase is a minimum of 5 ng/ml and confirmed by a second value at least 1 week later.
    - PSA values will be assessed at each cycle of chemotherapy.

    • Time to pain progression is defined as time from randomization until first evidence of PSA progression or until death from any cause, whichever comes first.
    - PSA progression is defined by the criteria of the Prostate cancer Clinical Trials Working Group [23] as an increase of 25% relative to reference PSA value and increase in the absolute value PSA level by at least 5 ng/ml and confirmed by a second value at least 4 weeks later or a ≥ 50% increase over nadir, provided that the increase is a minimum of 5 ng/ml and confirmed by a second value at least 1 week later.
    - PSA values will be assessed at each cycle of chemotherapy.

    • Time to pain progression is defined as the time from randomization to the first documentation of pain progression.
    - Pain progression is defined as an increase of 1 point in the Median Personal Pain Intensity (PPI) from its nadir noted on 2 consecutive 3-week-apart visits or 25% increase in the mean analgesic score compared with the reference score (noted on 2 consecutive 3-week-apart visits or requirement for local palliative radiotherapy).
    - Evaluation of the PPI & analgesic scores are based on the short-form McGill Pain Questionnaire (Appendix 6) which consists of 15 descriptors which are rated on an intensity scale as 0=none (best) 1=moderate 3=severe (worst) (TOTAL: 0=best 45=worst).
    - Pain will be assessed every 2 cycles of chemotherapy.

    • Disease Specific Survival (DSS) is defined as the delay between the date of randomization and the date of prostate cancer death.
    • Overall Survival (OS) is defined as the delay between the date of randomization and the date of death from any cause.

    PROSPECTIVE COHORT:
    We will rely on the same definitions as for the randomized trial. For survival endpoints, delay will be assessed starting from the date of the CTC count following the 2 cycles of Docetaxel.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Progression or death.
    Progression ou décès.
    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 No
    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 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 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) Yes
    E.8.2.2Placebo No
    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 concerned20
    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 years5
    E.8.9.1In the Member State concerned months6
    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: 119
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 277
    F.2 Gender
    F.2.1Female No
    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 state396
    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)
    Expected normal treatment of that condition.
    Traitement standard.
    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 Decision2018-01-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-01-31
    P. End of Trial
    P.End of Trial StatusOngoing
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