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    Summary
    EudraCT Number:2014-001929-32
    Sponsor's Protocol Code Number:2014/2126
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2016-06-22
    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 ConcernedSweden - MPA
    A.2EudraCT number2014-001929-32
    A.3Full title of the trial
    Biological Medicine for Diffuse Intrinsic Pontine Glioma (DIPG) Eradication
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Biological Medicine for Diffuse Intrinsic Pontine Glioma (DIPG) Eradication
    A.3.2Name or abbreviated title of the trial where available
    BIOMEDE
    A.4.1Sponsor's protocol code number2014/2126
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02233049
    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 SponsorGustave Roussy
    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 supportBMS
    B.4.2CountryFrance
    B.4.1Name of organisation providing supportRoche
    B.4.2CountryFrance
    B.4.1Name of organisation providing supportNovartis
    B.4.2CountryFrance
    B.4.1Name of organisation providing supportBarncancerfonden
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGustave Roussy
    B.5.2Functional name of contact pointRegulatory Affairs
    B.5.3 Address:
    B.5.3.1Street Address114, rue Edouard Vaillant
    B.5.3.2Town/ cityVillejuif
    B.5.3.3Post code94800
    B.5.3.4CountryFrance
    B.5.6E-mailSPEC.Affaires.reglementaires@gustaveroussy.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 TARCEVA
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration GmbH (RRG), Grenzach, Germany
    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 nameErlotinib
    D.3.4Pharmaceutical form Film-coated 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 INNERLOTINIB HYDROCHLORIDE
    D.3.9.1CAS number 183319-69-9
    D.3.9.4EV Substance CodeSUB21050
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNERLOTINIB HYDROCHLORIDE
    D.3.9.1CAS number 183319-69-9
    D.3.9.4EV Substance CodeSUB21050
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 VOTUBIA
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm Limited
    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 nameEverolimus
    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 INNEverolimus
    D.3.9.1CAS number 159351-69-6
    D.3.9.3Other descriptive nameEVEROLIMUS
    D.3.9.4EV Substance CodeSUB02065MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.5
    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 SPRYCEL
    D.2.1.1.2Name of the Marketing Authorisation holderBMS Pharma EEIG
    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 nameDasatinib
    D.3.4Pharmaceutical form Film-coated 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 INNDasatinib
    D.3.9.3Other descriptive nameDASATINIB MONOHYDRATE
    D.3.9.4EV Substance CodeSUB23159
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDasatinib
    D.3.9.3Other descriptive nameDASATINIB MONOHYDRATE
    D.3.9.4EV Substance CodeSUB23159
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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
    Diffuse Intrinsic Pontine Glioma and Diffuse midline glioma, K27M mutant
    E.1.1.1Medical condition in easily understood language
    Brain tumour
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10006143
    E.1.2Term Brain stem glioma
    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 evaluate the efficacy in terms of overall survival (OS) of erlotinib, everolimus and dasatinib in combination with radiation therapy in patients with a DIPG, both
    *compared to the other experimental treatments by comparisons between randomised subsets of patients selected according to the biological abnormalities found in their tumour (pairwise comparisons) and
    *compared to historical control
    Utvärdera effekten av erlotinib, everolimus och dasatinib i kombination med strålbehandling på total överlevnad (overall survival, OS) för patienter med diffust ponsgliom både
    - genom jämförelse av de olika behandlingsgrupperna som selekterats beroende på biologiska markörer i tumören och
    - genom jämförelse med historiska kontroller

    E.2.2Secondary objectives of the trial
    *To compare the 2-year OS between randomised subsets of patients with DIPG (pairwise comparisons) and compared to historical controls;
    *To evaluate the safety profile of each of the three drugs when administered in combination with radiotherapy, and over the whole duration of treatment, as well as the feasibility of a continuous administration of these drugs;
    *To evaluate the efficacy in terms of progression-free survival (PFS) of erlotinib, everolimus and dasatinib in combination with radiation therapy, comparatively between randomised subsets of patients with DIPG, and also compared to historical controls;
    *To evaluate the whole strategy by estimating the overall and progression-free survival of the entire cohort of patients with DIPG (by pooling the different treatment arms) and comparing it to historical controls.

    - Jämföra 2-års överlevnaden mellan randomiserade undergrupper av patienter med DIPG och historiska kontroller
    - Utvärdera säkerheten av alla tre läkemedlen i kombination med strålbehandling samt efter avslutad strålbehandling
    - Utvärdera genomförbarheten med kontinuerlig behandling av läkemedlen
    - Utvärdera effekten av erlotinib, everolimus och dasatinib i kombination med strålbehandling som progressionsfri överlevnad (PFS) mellan randomiserade undergrupper av patienter med DIPG och historiska kontroller
    - Utvärdera hela studiestrategin genom jämförelse av progressionsfri överlevnad (PFS) i hela studiekohorten av patienter med DIPG (med sammanslagning av alla behandlingsarmar) och historiska kontroller
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    *Diagnosis of DIPG (clinical and radiological, or histological in case the biopsy was performed before study entry)
    *Non-brainstem diffuse midline gliomas, H3K27M mutant (NB-DMG), will be eligible for the trial after biopsy or surgery
    *DIPG or NB-DMG at diagnosis: no prior chemotherapy for the present cancer; no prior cerebral radiation therapy
    *NB : Metastatic disease allowed. Patient with metastatic disease are eligible for the study (if diagnosis of DIPG/NB-DMG confirmed). In this situation, radiotherapy will have to start within three weeks after the biopsy while targeted treatment will start at the end of the irradiation.
    *Age > 6 months and < 30 years. For children below the age of 3 years, inclusion in the study and medical decisions should be discussed with the coordinating investigator.
    *Eligible for a biopsy, or biopsy performed for diagnostic purpose and material available for the biomarker assessment
    *Eligible for cerebral radiotherapy
    *Written informed consent given by patient and/or parents/legal representative for biomarkers assessment and registration in the study.

    *Eligibility criteria for the study (see above)
    *Confirmed histological diagnosis of diffuse intrinsic pontine glioma (grade II, III, IV WHO), or NB-DMG confirmed by central pathology review.
    *Life expectancy > 12 weeks after the start of study treatment
    *Karnofsky performance status scale or Lansky Play Scale > 50%.
    *Absolute neutrophil count > 1.5 x 109/l, Platelets > 100 x 109/l
    *Total bilirubin < 1,5 x ULN, AST and ALT< 2,5 x ULN
    *Serum creatinine < 1,5 X ULN for age. If serum creatinine > 1,5 ULN, creatinine clearance must be > 70 ml/min/1,73 m² (EDTA radioisotope GFR or 24 hours urines collection)
    *Normal coagulation tests within the local reference ranges
    *No current organ toxicity > grade 2 according to the NCI-CTCAE version 4.0 especially cardiovascular, pulmonary or renal disease (, including but not limited to: congenital long QT syndrome, nephrotic syndrome, glomerulopathy, uncontrolled high blood pressure despite adequate treatment, interstitial lung disease, pulmonary arterial hypertension).
    *Effective and appropriate contraception for patients (male and female) of reproductive potential during their entire participation in the study and during 6 months after the end of treatment
    *Negative pregnancy test evaluated in the last week in sexually active females of reproductive potential
    *Written informed consent given by the patient / legal representative for treatment
    - DIPG diagnos (klinisk och radiologisk eller histologisk om biopsi utförts före inklusion i studien)
    - Icke-hjärnstam diffust medellinjesgliom, H3K27M mutation (NB-DMG), kan vara lämplig för studien efter biopsi eller kirurgi
    - DIPG eller NB-DMG vid diagnos: ingen tidigare given kemoterapi för den aktuella tumören
    NB! Patient med metastaserande sjukdom är inkluderbar i studien. Strålbehandling måste starta inom tre veckor efter biopsin och läkemedelsbehandlingen startar först vid slutet av strålbehandlingen.
    - Ingen tidigare given strålbehandling mot hjärnan
    - Ålder > 6 månader till < 30 år. För barn under 3 år bör inklusion i studien diskuteras med koordinerande prövare.
    - Inga kontraindikationer för tumörbiopsi, eller biopsi redan utförd för diagnostik
    - Inga kontraindikationer för strålbehandling mot hjärnan
    - Skriftligt informerat samtycke för registrering i studien och för utvärdering av biomarkörer.

    - Uppfyllande av inklusionskriterierna för studien (se ovan)
    - Histologisk diagnos DIPG (grad II, III, IV WHO) eller NB-DMG granskad av referenspatolog
    - Förväntad överlevnad > 12 veckor efter studiestart
    - Karnofsky performance status scale eller Lansky Play Scale > 50%
    - Labvärdeskriterier enligt protokoll
    - Ingen organtoxicitet > grad2
    - Inga kontraindikationer mot aktuella studieläkemedel
    - Användande av lämpligt preventivmedel om i fertil ålder (hela studieperioden och till sex månader efter avslut)
    - Negativt graviditetstest (flickor i fertil ålder) taget den senaste veckan
    E.4Principal exclusion criteria
    *Spontaneous massive intratumour bleeding. Patients with post-operative bleeding will be allowed to enter the study provided the hemmorhage is controlled. Same rule applies for the other post-operative complications (infection, CSF-leakage, absence of wound closure, subdural collection...).
    *Any other concomitant anti-cancer treatment not foreseen by this protocol
    *Any other cancer during the last 5 years
    *Uncontrolled intercurrent illness or active infection
    *Any other co-morbid condition that in the investigator’s opinion would impair study participation
    *Unable for medical follow-up (geographic, social or mental reasons)
    *Patient not fulfilling one of the previous eligibility criteria.
    *Patient previously treated with irradiation on the brainstem for another neoplasm
    *Patient with congenital galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
    *Pregnant or breast feeding women
    *PTEN-positivity (evaluated by IHC)
    - Spontan massiv intratumoral blödning. Patienter med post-op blödning kan inkluderas om blödningen är kontrollerad. Samma gäller för andra post-op komplikationer (infektioner, CSF-läckage, om op-sår ej läkt, subdural ansamling).
    - Annan samtidig anticancerbehandling
    - Annan malignitet under de senaste fem åren
    - Okontrollerad annan samtidig sjukdom eller aktiv infektionssjukdom
    - Annat tillstånd som av ansvarig läkare bedöms förhindra studiedeltagande
    - Avsaknad av förutsättningar för medicinsk uppföljning (geografiska, sociala eller mentala)
    - Inklusionskriterier inte uppfyllda
    - Tidigare strålbehandling given mot hjärnstammen för annan tumör
    - Medfödd galaktosintolerans, Lapp laktasbrist eller glukos-galaktos malabsorption
    - Graviditet och amning
    - PTEN-positivitet (utvärderat med IHC)
    E.5 End points
    E.5.1Primary end point(s)
    Overall survival
    E.5.1.1Timepoint(s) of evaluation of this end point
    Overall survival is defined as the time between date of randomisation and death whatever the cause. For the comparison to historical controls, the overall survival is computed from the date of biopsy (or initial surgery). The main analysis will be based on the whole survival curve also.
    E.5.2Secondary end point(s)
    Efficacy endpoints
    *2-year OS
    *Progression-free survival

    Safety
    The safety assessment will be conducted using the NCI-CTC V4 on the whole duration of treatment in all treatment arms, using a list of selected toxicity items for the most frequent expected adverse events and text fields for unexpected events and other less frequent toxicities.
    For each experimental treatment given in combination with radiotherapy, adverse events will be carefully monitored, based on the estimated proportion of patients experiencing Grade 3/4 CTCAE adverse event reported as a SAE, both in the first 8 weeks of treatment and on the whole treatment duration, excluding symptoms that are related to tumour progression or pseudo progression (neurological deterioration, increased intracranial pressure)

    Feasibility
    -duration of treatment and description of the reasons for treatment discontinuation
    -number of treatment temporary stops and dose-reductions and the description of the reasons for these treatment modifications, and
    -estimate of mean dose per week over the whole treatment duration

    Translational study
    Response to therapy (PFS and OS) will be correlated to the biomarkers identified before the start and during the course of the study (including whole exome sequencing and RNAsequencing).

    Correlation of Multimodal Imaging with Response to Therapy
    The value of multimodal imaging to predict response to therapy will be evaluated.
    -T1-weighted post-gadolinium imaging will be correlated with outcome since the presence of enhancement could be correlated with survival in one recent study (Hipp 2011).
    -MRS: monovoxel or multivoxel proton spectroscopy will be used to assess metabolic profile especially citrate as well as Cho:Cr and Cho:NAA ratios, the latter being correlated to prognosis (Hipp 2011, Steffen-Smith 2011 & 2012).
    -DCE-MRI: dynamic contrast-enhanced MRI will be used to assess perfusion since increased perfusion could predict survival (Hipp 2011); the sequences will be analysed centrally with the OLEA software.
    -ASL: arterial spin-labelling perfusion MRI will be assessed as a possible surrogate for DCE-MRI. Guidelines from the "ASL Network" (http://www.asl-network.org) will be implemented.
    -DWI: diffusion-weighted imaging will be used to assess the apparent diffusion coefficient as a surrogate of tumour cellularity (Gauvain 2001).

    E.5.2.1Timepoint(s) of evaluation of this end point
    Efficacy endpoints
    - 2-year OS
    - Progression free survival from the date of biopsy/initial surgery (or date of randomisation for the comparison of randomised groups) to the date of unequivocal or radiological progression, or death whatever the cause.

    Safety
    For each experimental treatment given in combination with radiotherapy, toxicity will be carefully monitored, based on the estimated proportion of patients experiencing Grade 3/4 CTCAE adverse event reported as a SAE, both in the first 8 weeks of treatment and on the whole treatment duration.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled 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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA62
    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
    Austria
    Belgium
    Denmark
    Finland
    France
    Ireland
    Italy
    Netherlands
    Spain
    Sweden
    Switzerland
    United Kingdom
    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 years6
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days6
    E.8.9.2In all countries concerned by the trial years8
    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: 315
    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) Yes
    F.1.1.4.1Number of subjects for this age range: 13
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 268
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 25
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 9
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations 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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Subjects under age incapable of giving consent personally
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 315
    F.4.2.2In the whole clinical trial 315
    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 Decision2016-08-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-08-03
    P. End of Trial
    P.End of Trial StatusOngoing
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