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    The EU Clinical Trials Register currently displays   41451   clinical trials with a EudraCT protocol, of which   6809   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2015-004960-12
    Sponsor's Protocol Code Number:VEMUPERTRIAL
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-09-30
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2015-004960-12
    A.3Full title of the trial
    SEQUENTIAL THERAPY WITH VEMURAFENIB AND ELECTROCHEMOTHERAPY FOR IN-TRANSIT MELANOMA METASTASES: A MULTICENTER SINGLE ARM PHASE II CLINICAL PROSPECTIVE STUDY OF THE ITALIAN MELANOMA INTERGROUP (IMI)
    Terapia sequenziale con Vemurafenib ed elettrochemioterapia nei pazienti con melanoma cutaneo e metastasi in transito: Studio prospettico multicentrico di fase II a singolo braccio del gruppo Italiano per lo Studio del Melanoma (IMI)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    EQUENTIAL THERAPY WITH VEMURAFENIB AND ELECTROCHEMOTHERAPY FOR IN-TRANSIT MELANOMA METASTASES
    Terapia sequenziale con Vemurafenib ed elettrochemioterapia nei pazienti con melanoma cutaneo e metastasi in transito
    A.3.2Name or abbreviated title of the trial where available
    Vemuper
    Vemuper
    A.4.1Sponsor's protocol code numberVEMUPERTRIAL
    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 SponsorINTERGRUPPO MELANOMA ITALIANO
    B.1.3.4CountryItaly
    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 supportRoche
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationASST-Papa Giovanni XXIII
    B.5.2Functional name of contact pointUSC Oncologia Medica
    B.5.3 Address:
    B.5.3.1Street AddressPiazza OMS,1
    B.5.3.2Town/ cityBergamo
    B.5.3.3Post code24127
    B.5.3.4CountryItaly
    B.5.4Telephone number0352674663
    B.5.5Fax number0352673077
    B.5.6E-mailmmandala@asst-pg23.it
    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 ZELBORAF - 240 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - BLISTER (ALU/ALU) 56 COMPRESSE
    D.2.1.1.2Name of the Marketing Authorisation holderROCHE REGISTRATION LIMITED
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameZelboraf
    D.3.2Product code EU/1/12/751/001
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.11 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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 BLEOMICINA - 15 U POLVERE E SOLVENTE PER SOLUZIONE INIETTABILE 1 FLACONE POLVERE + 1 FIALA SOLVENTE DA 5 ML
    D.2.1.1.2Name of the Marketing Authorisation holderCRINOS S.P.A.
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 Concentrate for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBLEOMICINA SOLFATO
    D.3.9.1CAS number 11056-06-7
    D.3.9.2Current sponsor code--
    D.3.9.3Other descriptive namebleomicyn
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15000
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 CISPLATINO ACCORD HEALTHCARE ITALIA - 1MG/ML CONCENTRATO PER SOLUZIONE PER INFUSIONE 1 FLACONCINO IN VETRO DA 10 ML
    D.2.1.1.2Name of the Marketing Authorisation holderACCORD HEALTHCARE ITALIA S.R.L.
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 Concentrate for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntralesional use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCISPLATINO
    D.3.9.1CAS number 15663-27-1
    D.3.9.2Current sponsor code--
    D.3.9.3Other descriptive namecisplatinum
    D.3.9.4EV Substance Code239-733-8
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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
    melanoma BRAF V600 mutated
    melanoma BRAFV600 mutato
    E.1.1.1Medical condition in easily understood language
    melanoma
    melanoma
    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 10027480
    E.1.2Term Metastatic malignant melanoma
    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 detect progression free survival of an oral BRAF inhibitor (Vemurafenib) in combination with electrochemotherapy for melanoma patients with in-transit recurrence suitable to be treated with electrochemotherapy.
    Valutare la sopravvivenza libera da progressione con un inibitore orale di BRAF (Vemurafenib) in combinazione con elettrochemioterapia in pazienti affetti da melanoma con recidiva in transit candidabili, nell’ambito di un gruppo multidisciplinare, ad
    elettrochemioterapia.
    E.2.2Secondary objectives of the trial
    • Overall response rate
    • Overall survival
    • Safety evaluation
    • Quality of life: QLQ-C30 and EQ-5D questionnaires
    Exploratory Objectives

    The general objective of the translational studies is to identify positive and negative biomarkers predictive of clinical outcome in tissue specimens of in-transit metastases taken before and after BRAF inhibitor therapy. Hence, the below reported biomarkers will be correlated with ORR, PFS, OS.
    Upon surgical excision, half of each tissue from the in-transit metastasis will be immediately snap-frozen while the other half will be formalin-fixed and paraffin-embedded for conventional histopathological examination and subsequent immunohistochemical and molecular analyses.

    • Il tasso di risposta
    • La sopravvivenza globale
    • La valutazione della sicurezza
    •Valutazione della qualità della vita mediante questionari QLQ-C30 e EQ-5D.
    Obiettivi ancillari
    L'obiettivo generale degli studi traslazionali è quello di identificare i biomarcatori predittivi positivi e negativi di outcome (PFS e OS) in campioni di tessuto prelevati secondo pratica clinica da metastasi in transito prese prima e dopo la terapia con inibitori BRAF. Quindi, i biomarcatori di seguito riportati saranno correlati con ORR, PFS, OS.
    Sulla escissione chirurgica della metastasi in transito, la metà di ogni tessuto dalla metastasi in transito sarà immediatamente congelato, mentre l'altra metà sarà fissato in formalina e incluso in paraffina per l'esame istopatologico convenzionale e successive analisi immunoistochimica e molecolari.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Histologically confirmed diagnosis of melanoma BRAF V600 mutated with in-transit metastases not amenable to excision and confined to a limb;
    2. Presence of instrumentally or clinically measurable or evaluable lesions;
    3. Patients who at the judgement of an expert surgical team are candidate to electrochemotherapy;
    4. Age > 18 with PS ¿ 2 (ECOG);
    5. Life expectancy > 6 months;
    6. Blood tests (hemochromocitometric exam, hepatic and renal function) within the norm or with values not more than 50% above the normal range;
    7. Absence of metabolic, endocrine or neurological diseases that require continuous drug therapy;
    8. Absence of other malignant tumors, excluding carcinoma in situ of the cervix and radically resected early skin cancer;
    9. Staging carried out within 30 days of randomization;
    10. Geographical accessibility;
    11. Written informed consent (including the suggested use of contraceptives for premenopausal women).
    . Conferma istologica di melanoma con mutazione BRAFV600 con metastasi in transito non suscettibili di escissione con intento radicale;
    2. Presenza di lesioni clinicamente e strumentalmente misurabili e valutabili;
    3. Pazienti che secondo il parere di un team multidisciplinare siano candidabili all’elettrochemioterapia: in particolare lesioni in transito non candidabili a chirurgia radicale e suscettibili di trattamento locoregionale mediante elettrochemioterapia
    4. Età> 18 con PS ¿ 2 (ECOG);
    5. Aspettativa di vita> 6 mesi;
    6. Gli esami ematochimici (Emocromo, funzionalità epatica e renale) nella norma o con valori non più del 50% al di sopra del range di normalità;
    7. Assenza di alterazioni metaboliche, endocrine o neurologiche che richiedano terapia farmacologica continua;
    8. Assenza di altri tumori maligni, escludendo il carcinoma in situ della cervice e tumori non melanoma della pelle in stadi precoci radicalmente operati;
    9. Stadiazione di malattia eseguita entro 30 giorni dalla randomizzazione;
    10. Accessibilità geografica;
    11. Consenso informato scritto.
    E.4Principal exclusion criteria
    1. Patients with locally advanced disease judged not to be suitable for electrochemotherapy;
    2. Absence of measurable or evaluable lesions;
    3. Performance Status: ECOG ¿ 3;
    4. Patients previously treated with a BRAF inhibitor;
    5. Patients treated with a MEK inhibitor;
    6. Presence of a concomitant second tumour. Patients with a previous malignancy but without evidence of disease for = 3 years will be allowed to enter the trial;
    7. Patients with QTc >450 msec on screening ECG, history of congenital long QT syndrome, or uncorrectable electrolytes abnormalities
    8. Presence of metabolic, endocrine or neurological diseases that require continuous drug therapy;
    9. Blood tests (hemochromocitometric exam, renal and hepatic function) with values 50% higher or lower than the normal ranges, and/or total bilirubinemia > 2 X ULN;
    10. Previous or ongoing serious cardiovascular diseases;
    11. Absence of written informed consent;
    12. Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent;
    13. Women who are pregnant or breastfeeding.
    1. Pazienti con malattia localmente avanzata giudicati non candidabili all’elettrochemioterapia;
    2. Assenza di lesioni misurabili o valutabili;
    3. Performance Status: ECOG ¿ 3;
    4. Pazienti precedentemente trattati con un inibitore di BRAF;
    5. Pazienti trattati con un inibitore di MEK;
    6. La presenza concomitante di un secondo tumore. I pazienti con un tumore maligno precedente, ma senza evidenza di malattia per = 3 anni potranno essere arruolati nello studio;
    7. I pazienti con QTc> 450 msec sull’ ECG di screening, con sindrome del QT allungato, o con alterazioni degli elettroliti non correggibili;
    8. Presenza di alterazioni metaboliche, endocrine o neurologiche che richiedano terapia farmacologica continua;
    9. Gli esami ematochimici (Emocromo, funzionalità epatica e renale) con valori del 50% sopra il range di normalità e/o bilirubinemia totale > 2 X ULN;
    10. Gravi malattie cardiovascolari precedenti o in corso;
    11. Mancanza del consenso informato scritto;
    12. Condizione medica o psicologica che a giudizio dello sperimentatore, non permetterebbe al paziente di completare lo studio o firmare il consenso informato;
    13. Le donne in gravidanza o in allattamento.
    E.5 End points
    E.5.1Primary end point(s)
    • Progression-Free-Survival (PFS), defined as the time from study registration and the date of first observed disease progression or death due to any cause, if death occurs before progression is documented.
    Sopravvivenza libera da progressione (PFS), definita come il tempo che intercorre dalla registrazione del paziente in studio alla data della progressione della malattia o della morte per qualsiasi causa, nel caso in cui la morte si verifichi prima che la progressione sia documentata.
    E.5.1.1Timepoint(s) of evaluation of this end point
    ate of first observed disease progression or death due to any cause
    data della progressione della malattia o della morte per qualsiasi causa,
    E.5.2Secondary end point(s)
    Overall Response Rate (ORR) defined as the proportion of patients achieving a complete or partial response during the treatment. ORR will be evaluated according to RECIST Criteria version 1.1. The tumor response rate will be defined as the total number of subjects whose best response is partial or complete response, divided by the number of enrolled subjects.; Overall Survival (OS), defined as the time from study registration and the date of death for any cause, or the last date the patient is known to be alive
    Tasso di risposta complessiva (ORR) definito come la percentuale di pazienti che hanno raggiunto una risposta completa o parziale, durante il trattamento. ORR saranno valutati in base ai criteri RECIST versione 1.1. Il tasso di risposta sarà definito come il numero totale di soggetti la cui risposta migliore è parziale o completa, diviso per il numero di soggetti arruolati.; Sopravvivenza globale (OS), definita come il tempo che intercorre tra la registrazione del paziente in studio e la data di morte per qualsiasi causa, o l'ultima data nota in cui il paziente è dichiarato vivo.
    E.5.2.1Timepoint(s) of evaluation of this end point
    last visit of the last patient enrolled; last visit of the last patient enrolled
    ultima visita dell'ultimo paziente arruolato; ultima visita dell'ultimo paziente arruolato
    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 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.8.2.4Number of treatment arms in the trial1
    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 concerned12
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA12
    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 Information not present in EudraCT
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days0
    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: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 13
    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 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 state53
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 53
    F.4.2.2In the whole clinical trial 53
    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)
    not indicated
    non indicato
    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 Decision2016-05-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-02-15
    P. End of Trial
    P.End of Trial StatusOngoing
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