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    Summary
    EudraCT Number:2018-003925-27
    Sponsor's Protocol Code Number:Laparoscopica-ECT-LAPC
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2018-12-17
    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 number2018-003925-27
    A.3Full title of the trial
    Prospective phase IIb study to evaluate the efficacy of laparoscopic electrochemotherapy in the treatment of locally advanced pancreatic cancer
    Studio prospettico di fase IIb per valutare l’efficacia dell’Elettrochemioterapia laparoscopica nel trattamento del cancro localmente avanzato del pancreas
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Prospective phase IIb study to evaluate the efficacy of laparoscopic electrochemotherapy in the treatment of locally advanced pancreatic cancer
    Studio prospettico di fase IIb per valutare l’efficacia dell’Elettrochemioterapia laparoscopica nel trattamento del cancro localmente avanzato del pancreas
    A.3.2Name or abbreviated title of the trial where available
    Laparoscopic-ECT-LAPC
    Laparoscopica-ECT-LAPC
    A.4.1Sponsor's protocol code numberLaparoscopica-ECT-LAPC
    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 SponsorISTITUTO NAZIONALE TUMORI - IRCCS FONDAZIONE PASCALE
    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 supportISTITUTO NAZIONALE TUMORI - IRCCS FONDAZIONE PASCALE
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationISTITUTO NAZIONALE TUMORI - IRCCS FONDAZIONE PASCALE
    B.5.2Functional name of contact pointSC Chi Oncologica Epato-Biliare
    B.5.3 Address:
    B.5.3.1Street AddressVia Mariano Semmola, snc
    B.5.3.2Town/ cityNapoli
    B.5.3.3Post code80131
    B.5.3.4CountryItaly
    B.5.4Telephone numberItaly0815903808
    B.5.5Fax numberItalyItaly5903843
    B.5.6E-mailf.izzo@istitutotumori.na.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 Bleoprim
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi SPA
    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 nameBleoprim - Bleomicina
    D.3.4Pharmaceutical form Powder and solution for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product Yes
    D.3.11.13.1Other medicinal product typeAssociato ad elettro chemioterapia
    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 Fluorouracile Teva
    D.2.1.1.2Name of the Marketing Authorisation holderTEVA Italia
    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 nameFluorouracile
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.11 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 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 Campto - Irinotecan
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Italia
    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 nameCAMPTO - Irinotecan
    D.3.4Pharmaceutical form Concentrate for solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 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 Lederfolin – Acido Folico
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Italia
    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 nameLederfolin
    D.3.4Pharmaceutical form Powder and solution for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 5
    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 OXALIPLATINO PFIZER
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Italia
    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 nameOXALIPLATINO PFIZER
    D.3.4Pharmaceutical form Concentrate for solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    locally advanced pancreatic carcinoma
    carcinoma del pancreas localmente avanzato
    E.1.1.1Medical condition in easily understood language
    carcinoma of the unresectable pancreas
    carcinoma del pancreas non resecabile
    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
    Increase of the objective response rate of the lesion treated in the treatment arm compared to the control arm
    Incremento del tasso di risposta oggettiva della lesione trattata nel braccio di trattamento rispetto al braccio di controllo
    E.2.2Secondary objectives of the trial
    a) Evaluate the effect of ECT on disease progression free time and survival.
    b) Evaluate the impact of ECT on quality of life with particular attention to the effect on pain.
    c) Evaluating the toxicity associated with the treatment of Electrochemotherapy.
    a) Valutare l'effetto della ECT sul disease progression free time e survival.
    b) Valutare l'impatto della ECT sulla qualità di vita con particolare attenzione all'effetto sul dolore.
    c) Valutare la tossicità associata al trattamento di Elettrochemioterapia.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    a) Age> 18 years
    b) Good mental health conditions
    c) Ability to sign a specific informed consent in order to be admitted to the study.
    d) Life expectancy in line with the follow-up indicated by the study
    e) Diagnosis of exocrine pancreatic cancer with histological confirmation
    f) Preoperative Staging of locally advanced pancreatic cancer disease: stage III
    g) The subject is not eligible for the "gold-standard" treatment of surgical pancreasectomy and is eligible for a conventional systemic treatment (FOLFOXIRI)
    a) Età > 18 anni
    b) Condizioni di salute mentali buone
    c) Capacità di firmare un consenso informato specifico al fine di essere ammesso allo studio.
    d) Aspettativa di vita in linea con il follow-up indicato dallo studio
    e) Diagnosi di cancro pancreatico esocrino con conferma istologica
    f) Staging Pre-operativo della malattia di cancro pancreatico localmente avanzato: stage III
    g) Il soggetto non è eleggibile per il trattamento "gold-standard" di pancreasectomia chirurgica ed è candidabile a trattamento sistemico convenzionale (FOLFOXIRI)
    E.4Principal exclusion criteria
    a) Age less than 18 years
    b) Absolute contraindication to surgery
    c) Visceral, bone or diffuse metastases
    d) Presence of extrahepatic spread of the disease
    e) Infection and / or heart failure and / or hepatic failure and / or other serious systemic diseases
    f) Clinically significant ascites
    g) Any serious and uncontrolled systemic illness
    h) Acute pulmonary infection
    i) Symptoms of poor lung function
    j) Severe coagulation disorders that can not be corrected
    k) Previous allergic reactions to bleomycin
    l) The cumulative dose of bleomycin of 250 mg / m2 was exceeded
    m) Chronic renal dysfunction (creatinine> 150 μmol / L should be considered a lower administered dose of bleomycin)
    n) Pregnancy or breastfeeding **

    ** Pregnancy has been established prior to enrollment by beta-HCG assay on urine (pregnancy test or urinary beta-HCG) or blood (plasma beta-HCG).
    a) Età inferiore ai 18 anni
    b) Controindicazione assoluta alla chirurgia
    c) Metastasi viscerali, ossee o diffuse
    d) Presenza di diffusione extraepatica della malattia
    e) Infezione e/o insufficienza cardiaca e/o insufficienza epatica e/o altre gravi patologie sistemiche
    f) Ascite clinicamente significativa
    g) Qualsiasi malattia sistemica grave e incontrollata
    h) Infezione polmonare acuta
    i) Sintomi di scarsa funzionalità polmonare
    j) Gravi disturbi della coagulazione non correggibili
    k) Precedenti reazioni allergiche alla bleomicina
    l) È stata superata la dose cumulativa di bleomicina di 250 mg/m2
    m) Disfunzione renale cronica (creatinina>150 μmol/L deve essere considerata una dose somministrata più bassa di bleomicina)
    n) Gravidanza o allattamento**

    **Lo stato di gravidanza è stato accertato prima dall’arruolamento mediante il dosaggio della Beta-HCG sulle urine (Test di gravidanza o beta-HCG urinaria) o sul sangue (beta-HCG plasmatica).
    E.5 End points
    E.5.1Primary end point(s)
    Evaluation of the objective response
    Valutazione della risposta oggettiva
    E.5.1.1Timepoint(s) of evaluation of this end point
    The objective response at 1, 3 and 6 months from ECT will be based on the CT / MR / PET-CT response performed by the radiologist using morphological criteria (RECIST 1.1), densitometrics (mRECIST and CHOI criteria) and functional parameters extracted from the post processing of MRI data and the PERCIST criteria of PET / CT. The long-term objective response of the treatment (9 and 12 months from the procedure) will be evaluated with the mRECIST criteria, which will take into account the difference in size and density, determined by the images obtained by CT perforation of the tumor nodules treated before and after ECT.
    La risposta oggettiva a 1, 3 e 6 mesi dalla ECT sarà basata sul responso TC/RM/PET-TC effettuato dal radiologo mediante criteri morfologici (RECIST 1.1), densitometrici (criteri mRECIST e CHOI) e mediante parametri funzionali estratti dal post processing dei dati di RM e dai criteri PERCIST della PET/TC. La risposta oggettiva a lungo termine del trattamento (9 e 12 mesi dalla procedura) sarà valutata con i criteri mRECIST, che prenderanno in considerazione la differenza di dimensione e densità, determinata dalle immagini ottenute dalla perfusione TC dei noduli tumorali trattati prima e dopo ECT.
    E.5.2Secondary end point(s)
    1) Evaluate the effect of ECT on disease progression free time and survival.
    2) Evaluate the impact of ECT on quality of life with particular attention to the effect on pain.
    3) To evaluate the toxicity associated with the treatment of Electrochemotherapy.
    1) Valutare l'effetto della ECT sul disease progression free time e survival.
    2) Valutare l'impatto della ECT sulla qualità di vita con particolare attenzione all'effetto sul dolore.
    3) Valutare la tossicità associata al trattamento di Elettrochemioterapia.
    E.5.2.1Timepoint(s) of evaluation of this end point
    137/5000
    Evaluation of secondary endpoints will be performed at follow-up visits: 0, 3, 15, 30, 90, 180, 270 and 360 days from treatment
    Sarà effettuata la valutazione degli endpoint secondari alle visite di follow-up: 0, 3, 15, 30, 90, 180, 270 e 360 giorni dal trattamento
    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 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 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 Yes
    E.8.2.3.1Comparator description
    gruppo di controllo terapia sistema FOLFOXIRI
    45/5000 FOLFOXIRI system therapy control group
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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 No
    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
    Duration of the study: 72 months
    2. Time for enlistment: 60 months
    3. Minimum follow-up: 12 months
    Durata dello studio: 72 mesi
    2. Tempo per l’arruolamento: 60 mesi
    3. Follow-up minimo: 12 mesi
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years6
    E.8.9.2In all countries concerned by the trial months0
    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: 55
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 35
    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 state90
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 90
    F.4.2.2In the whole clinical trial 90
    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)
    Subjects will be assisted according to the standard procedures of clinical practice
    I soggetti saranno assistiti secondo le procedure standard della pratica clinica
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-03-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-04-17
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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