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    Summary
    EudraCT Number:2017-001940-37
    Sponsor's Protocol Code Number:EFC15246
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2017-09-01
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2017-001940-37
    A.3Full title of the trial
    Randomized, Open Label, Multicenter Study Assessing The Clinical Benefit Of Isatuximab Combined With Carfilzomib (Kyprolis®) And Dexamethasone Versus Carfilzomib With Dexamethasone In Patients With Relapse And/Or Refractory Multiple Myeloma Previously Treated With 1 to 3 Prior Lines
    Randomizált, nyílt, multicentrikus vizsgálat a karfilzomibbal (Kyprolis®) és dexametazonnal kombinált isatuximab, valamint a karfilzomib és dexametazon kombinációs kezelés klinikai előnyeinek összehasonlítására, relabáló és/vagy kezelésre nem reagáló myeloma multiplexben szenvedő olyan betegek körében, akik előzetesen már 1-3 vonalbeli kezelésben részesültek
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Multinational Clinical Study Comparing Isatuximab,Carfilzomib And Dexamethasone To Carfilzomib And Dexamethasone In Relapse And/Or Refractory Multiple Myeloma Patients
    Nemzetközi klinikai vizsgálat a karfilzomibbal és dexametazonnal kombinált isatuximab, valamint a karfilzomib és dexametazon kombinációs kezelés összehasonlítására, relabáló és/vagy kezelésre nem reagáló myeloma multiplexben szenvedő betegek körében
    A.3.2Name or abbreviated title of the trial where available
    IKEMA
    A.4.1Sponsor's protocol code numberEFC15246
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1195-5957
    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 SponsorSanofi-aventis recherche & développement
    B.1.3.4CountryFrance
    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 supportSanofi-aventis recherche & développement
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationsanofi-aventis Zrt.
    B.5.2Functional name of contact pointNA.
    B.5.3 Address:
    B.5.3.1Street AddressTó utca, 1-5.
    B.5.3.2Town/ cityBUDAPEST
    B.5.3.3Post code1045
    B.5.3.4CountryHungary
    B.5.6E-mailkapcsolat@sanofi.com
    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/3/14/1268
    D.3 Description of the IMP
    D.3.1Product nameisatuximab
    D.3.2Product code SAR650984
    D.3.4Pharmaceutical form Concentrate for 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 INNIsatuximab
    D.3.9.2Current sponsor codeSAR650984
    D.3.9.3Other descriptive nameSAR650984
    D.3.9.4EV Substance CodeSUB119676
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    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 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 Kyprolis
    D.2.1.1.2Name of the Marketing Authorisation holderAmgen Europe B.V.
    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 Powder for 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 INNCarfilzomib
    D.3.9.1CAS number 868540-17-4
    D.3.9.4EV Substance CodeSUB32911
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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) 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 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 Dexamethasone 3.3 mg/mL solution for injection
    D.2.1.1.2Name of the Marketing Authorisation holderhameln pharmaceuticals ltd
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameDexamethasone
    D.3.4Pharmaceutical form Solution for injection
    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 INNDexamethasone
    D.3.9.3Other descriptive nameDEXAMETHASONE BASE
    D.3.9.4EV Substance CodeSUB125563
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3.3
    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: 4
    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 Dexamethason 4 mg JENAPHARM®
    D.2.1.1.2Name of the Marketing Authorisation holderJENAPHARM
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameDexamethasone
    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 INNDEXAMETHASONE
    D.3.9.3Other descriptive nameDEXAMETHASONE BASE
    D.3.9.4EV Substance CodeSUB125563
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    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
    Plasma cell myeloma
    plazmasejtes mielóma
    E.1.1.1Medical condition in easily understood language
    Plasma cell myeloma
    plazmasejtes mielóma
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10035226
    E.1.2Term Plasma cell myeloma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate the benefit of isatuximab in combination with carfilzomib and dexamethasone in the prolongation of Progression Free Survival (PFS) as compared to carfilzomib and dexamethasone in patients with relapsed and/or refractory multiple myeloma (MM) previously treated with 1 to 3 lines of therapy.
    A karfilzomibbal és dexametazonnal kombinált isatuximab által a progressziómentes túlélés (PFS) meghosszabbítására kifejtett kedvező hatás igazolása a karfilzomib és dexametazon kombinációja ellenében, olyan relabáló és/vagy kezelésre nem reagáló myeloma multiplexben (MM) szenvedő betegek körében, akik előzetesen már 1-3 vonalbeli kezelésben részesültek.
    E.2.2Secondary objectives of the trial
    -To evaluate the Overall Response Rate (ORR), rate of very good partial response(VGPR) or better and complete response (CR) rate in both arms using IMWG criteria.
    -To evaluate rate of VGPR or better with minimal residual disease (MRD) negativity in both arms using IMWG criteria.
    -To evaluate the Overall Survival (OS) in both arms.
    -To evaluate safety in both arms.
    -To evaluate duration of response in both arms.
    -To evaluate the Time To Progression (TTP) in both arm.
    -To evaluate time from the date of randomization to the date of second
    PD or death from any cause, whichever happens first (PFS2) in both arms.
    - To evaluate time to first response in both arms
    - To evaluate time to best response in both arms.
    -To determine the PK profile of isatuximab+carfilzomib.
    -To evaluate the immunogenicity of isatuximab.
    -To assess disease-specific and generic health-related quality of life, disease and treatment-related symptoms, health state utility, and health status in both arms.
    -Az általános válaszarány (ORR), a nagyon jó részleges válasz (VGPR) vagy ennél jobb válasz, valamint a (CR) arányának értékelése mindkét vizsgálati karon az IMWG kritériumai alapján.
    -A nagyon jó részleges válasz (VGPR) vagy ennél jobb válasz arányának értékelése az MRD negativitásának tekintetében mindkét karon IMWG kritériumok alapján.
    -A teljes túlélés (OS) értékelése mindkét karon.
    - A biztonságosság értékelése mindkét karon.
    - A válasz időtartamának (DOR) értékelése mindkét karon.
    -A progresszióig eltelt idő (TTP) értékelése mindkét vizsgálati karon.
    -A betegség 2. progressziójáig vagy a halálig eltelt idő (PFS2) értékelése mindkét karon.
    -A karfilzomib és isatuximab kombináció fk profiljának meghatározása.
    -Az isatuximab immunogenitásának értékelése az isatuximab karon.
    -Az általános egészséggel összefüggő, betegség- és kezelésspecifikus életminőség (HRQL), a HRQL-t érintő változások, az egészségi állapot hasznosulásának és az egészségi állapotnak az értékelése.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Patients with multiple myeloma previously treated with prior 1 to 3 lines and with measurable serum M-protein (≥ 0.5 g/dL) and/or urine M-protein (≥ 200 mg/24 hours).
    Myeloma multiplexben (MM) szenvedő betegek, akik előzetesen már 1-3 vonalbeli kezelésben részesültek és mérhető szérum M-protein szintjük (≥0,5 g/dl) és/vagy vizelet M-protein szintjük (≥200 mg/24 h) dokumentált.
    E.4Principal exclusion criteria
    -Patients previously pretreated with carfilzomib, who never achieved at least one minor response during previous therapies and/or last previous therapy completed within 14 last days.
    -Patients with serum free light chain (FLC) measurable disease only.
    -Patients less than 18 years old, patients with Eastern Cooperative Oncology Group performance status more than 2.
    -Patients with inadequate biological tests.
    -Patients with myocardial infarction, sever/unstable angina pectoris, coronary/peripheral artery bypass graft, New York Heart Association class III or IV congestive heart failure, superior or equal to grade 3 arrhythmias, stroke or transient ischemic attack within last 6 months, and/or left ventricular ejection fraction lower than 40%.
    -Patients with previous cancer unless disease free for more than 5 years or in situ cancer curatively treated.
    -Patients with known acquired immunodeficiency syndrome related illness (AIDS) or human immundeficiency virus (HIV) requiring antiretroviral treatment, or hepatitis A, B, or C active infection.
    -Women of childbearing potential or male patient with women of childbearing potential who do not agree to use highly effective method of birth control.
    - A beteg korábban karfilzomib kezelésben részesült, vagy a beteg a korábbi kezelések során sosem ért el legalább minimális választ, vagy a legutóbbi kezelése a randomizációt megelőző 14 napon belül ért véget.
    - A betegnél csak a szérumban található szabad könnyűlánc meghatározásával mérhető a betegség.
    - A beteg még nem érte el a 18 éves kort
    -Az ECOG teljesítmény skála értéke 2 feletti
    -A betegnek nem megfelelőek a biológiai vizsgálati értékei
    -A következők bármelyike a randomizálás előtti 6 hónap során: miokardiális infarktus, súlyos/instabil angina pectoris, a koszorúér/perifériás artéria bypass graft műtétje, a New York Heart Association szerinti III. vagy IV. súlyossági fokú pangásos szívelégtelenség, legalább 3. súlyossági fokú aritmiák, stroke vagy tranziens ischaemiás attak, illetve a bal kamrai ejekciós frakció <40%.
    - Korábbi rosszindulatú daganatos megbetegedés, kivéve, ha több, mint 5 éve tünetmentes a beteg. In situ malignitás kuratív kezelést követően megengedett.
    - Ismert szerzett immunhiányos tünetegyüttessel (AIDS-szel) összefüggő betegségek vagy vírusellenes kezelést igénylő ismert HIV-betegség, vagy aktív hepatitis A-, B- vagy C-fertőzés.
    - Olyan fogamzóképes nőbetegek, vagy olyan fogamzóképes partnerrel rendelkező férfibetegek, akik nem hajlandóak nagy hatékonyságú fogamzásgátló módszerrel védekezni.
    E.5 End points
    E.5.1Primary end point(s)
    Progression Free Suvival (PFS): The length of time between treatment allocation and a patient lives with the disease but it does not get worse.
    E.5.1.1Timepoint(s) of evaluation of this end point
    up to approximately 36 months
    E.5.2Secondary end point(s)
    1) Overall Response Rate (ORR): The proportion of patients that have a response to their disease: stringent complete response (sCR), complete response (CR), very good partial response (VGPR) or partial response (PR)
    2) Rate of VGPR or better: The proportion of patients with sCR, CR and VGPR
    3) CR rate: The proportion of patients with sCR and CR
    4) Rate of VGPR or better with MRD (Minimal Residual Disease) negativity: The proportion of patients with VGPR, CR or sCR and for whom MRD assessed by sequencing is negative.
    5) Overall Survival (OS): The length of time from the treatment allocation for a disease that patients are still alive
    6) Time to Progression (TTP): How long the study treatment last before disease progression occurs
    7) Second Progression Free Survial (PFS2): The length of time between treatment allocation and second progression disease
    8) Duration of response (DOR): How long from the first response is observed until disease progression
    9) Number of patients with adverse events according to the National Cancer Institute - Common Toxicity Criteria(NCI- CTC) version 4.03 grading scaling: To evaluate how many adverse events occur while taking study treatment
    10) Patient-reported outcome measured with Quality of Life questionnaire : To evaluate change in your daily activities from screening
    11) Pharmacokinetics of isatuximab: To evaluate the plasma concentration of isatuximab
    12) Pharmacokinetics of carfilzomib: To evaluate the plasma concentration of carfilzomib in 12 patients
    13) Immunogenicity (ADA): To evaluate if presence of anti-drug antibodies against isatuximab
    E.5.2.1Timepoint(s) of evaluation of this end point
    1), 2), 3), 4), 6), 7), 8) up to approximately 36 months
    5) up to approximately 72 months
    9) Up to 30 days after last study treatment administration
    10) Screening to 90 days after last study treatment administration
    11) up to approximately10 months
    12) up to 1 month
    13) Up to 13 months
    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 Yes
    E.6.7Pharmacodynamic Yes
    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) 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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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) 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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA33
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Brazil
    Canada
    Czech Republic
    France
    Greece
    Hungary
    Italy
    Japan
    Korea, Republic of
    New Zealand
    Russian Federation
    Spain
    Turkey
    United Kingdom
    United States
    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
    Approximately 3 years after analysis of primary endpoint
    Az elsődleges végpont analízist követően kb. 3 év múlva
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years6
    E.8.9.2In all countries concerned by the trial months1
    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: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 200
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 140
    F.4.2.2In the whole clinical trial 300
    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 Decision2017-10-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-10-03
    P. End of Trial
    P.End of Trial StatusOngoing
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