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    Summary
    EudraCT Number:2014-004283-37
    Sponsor's Protocol Code Number:9785-CL-3021
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-06-04
    Trial results View 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 number2014-004283-37
    A.3Full title of the trial
    A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Enzalutamide in Subjects with Advanced Hepatocellular Carcinoma
    Studio di fase 2, randomizzato, in doppio cieco, controllato verso placebo per valutare la sicurezza e l¿efficacia di enzalutamide in pazienti affetti da carcinoma epatocellulare avanzato
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to assess the safety and effectiveness of enzalutamide in patients with advanced hepatocellular carcinoma
    Uno studio per valutare la sicurezza e l'efficacia di enzalutamide in pazienti con carcinoma epatocellulare avanzato
    A.3.2Name or abbreviated title of the trial where available
    NA
    NA
    A.4.1Sponsor's protocol code number9785-CL-3021
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02528643
    A.5.4Other Identifiers
    Name:INDNumber:127011
    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 SponsorASTELLAS PHARMA GLOBAL DEVELOPMENT, INC.
    B.1.3.4CountryUnited States
    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 supportASTELLAS PHARMA GLOBAL DEVELOPMENT, INC.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationASTELLAS PHARMA EUROPE B.V.
    B.5.2Functional name of contact pointSERVICE DESK - GLOBAL CLINICAL DEV.
    B.5.3 Address:
    B.5.3.1Street AddressSylviusweg 62
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333 BE
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+31 71 5455050
    B.5.5Fax number+31 71 5455501
    B.5.6E-mailcontact@nl.astellas.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 Yes
    D.2.1.1.1Trade name XTANDI - "40 MG - CAPSULA MOLLE - USO ORALE - BLISTER (PVC/PCTFE/ALU)" 112 CAPSULE
    D.2.1.1.2Name of the Marketing Authorisation holderASTELLAS PHARMA EUROPE B.V.
    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 Capsule, soft
    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 INNENZALUTAMIDE
    D.3.9.1CAS number 915087-33-1
    D.3.9.2Current sponsor codeMDV3100
    D.3.9.4EV Substance CodeSUB77412
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product 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
    Male and female subjects with HCC of any etiology who have progressed on or were intolerant to sorafenib or other anti-VEGF therapy in the advanced setting.
    Soggetti di sesso maschile e femminile con HCC di qualsiasi eziologia, che hanno manifestato progressione o che erano intolleranti a sorafenib o altra terapia anti-VEGF (fattore di crescita endoteliale vascolare) in fase avanzata.
    E.1.1.1Medical condition in easily understood language
    Male and female subjects with Advanced Hepatocellular Carcinoma.
    Soggetti di sesso maschile e femminile con carcinoma epatocellulare avanzato.
    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 10073071
    E.1.2Term Hepatocellular carcinoma
    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 of enzalutamide in subjects with advanced hepatocellular carcinoma (HCC) as measured by overall survival (OS).
    Valutare l'efficacia di enzalutamide in soggetti con carcinoma epatocellulare avanzato (HCC) misurata in base alla sopravvivenza globale (OS).
    E.2.2Secondary objectives of the trial
    To evaluate:
    - the safety of enzalutamide in subjects with advanced HCC;
    - the pharmacokinetics (PK) of enzalutamide and the active metabolite N-desmethyl enzalutamide in subjects with advanced HCC;
    - the Progression Free Survival (PFS) of enzalutamide as compared to placebo in subjects with advanced HCC.
    Valutare:
    - la sicurezza di enzalutamide in soggetti con HCC avanzato;
    - la farmacocinetica di enzalutamide e il metabolita attivo N-desmetil enzalutamide in soggetti con HCC avanzato;
    - la sopravvivenza libera da progressione (PFS) di enzalutamide rispetto al placebo in soggetti con HCC avanzato.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives

    Pharmacogenomics
    Version: 1.0
    Date: 03/06/2015
    Title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Enzalutamide in Subjects with Advanced Hepatocellular Carcinoma
    Objectives: To evaluate the efficacy of enzalutamide in subjects with advanced hepatocellular carcinoma (HCC) as measured by overall survival (OS).

    Farmacogenomica
    Versione: 1.0
    Data: 03/06/2015
    Titolo: Studio di fase 2, randomizzato, in doppio cieco, controllato verso placebo per valutare la sicurezza e l¿efficacia di enzalutamide in pazienti affetti da carcinoma epatocellulare avanzato
    Obiettivi: Valutare l'efficacia di enzalutamide in soggetti con carcinoma epatocellulare avanzato (HCC) misurata in base alla sopravvivenza globale (OS).
    E.3Principal inclusion criteria
    - Subject is = 18 years of age, or is considered an adult according to local regulation at the time of signing informed consent;
    - Subject has a documented diagnosis of advanced HCC of any etiology.
    - Subject has BCLC stage B or C;
    - Subject’s lesions are not amenable to local therapies which may be beneficial, such as transarterial chemoembolization (TACE), radiofrequency ablation, radiotherapy, etc., and the subject is not a candidate for any curative treatments such as resection or liver transplant;
    - Subject has hepatic function status of Child Pugh Class A at Screening;
    - Subject received prior systemic treatment for HCC with sorafenib or other anti-VEGF therapy and had confirmed disease progression or had discontinued treatment due to a drug-related toxicity. Subject may have received 1 line of systemic investigational therapy before or after sorafenib/anti-VEGF treatment;
    - Subject has adequately recovered from toxicities due to prior HCC therapy to = grade 1;
    - Subject has an ECOG performance status = 1 at Screening and on Day 1;
    - Subject has available formalin-fixed, paraffin-embedded tumor specimen with adequate viable tumor cells in a tissue block or unstained serial slides accompanied by an associated pathology report prior to enrollment. Archival or fresh biopsy tissue is required;
    - Subject has an estimated life expectancy of at least 3 months on Day 1, in the opinion of the Investigator.
    - Female subject is either: -->Not of childbearing potential: ---> postmenopausal (defined as no spontaneous menses for at least 12 consecutive months prior to Screening with follicle stimulating hormone [FSH] > 40 IU/L for women < 55 years of age at Screening), or ---> documented to be surgically sterile or status posthysterectomy (at least 1 month prior to Screening). --> Or, if of childbearing potential: ---> must have a negative urine pregnancy test at Screening and on Day 1 before the first dose of study drug is administered, and ---> must use 2 acceptable methods of birth control* if sexually active from Screening through 3 months after the last dose of study drug.
    [...]
    Open-Label Period additional Inclusion Criteria:
    - Received double-blind enzalutamide study treatment during the main study.
    The full list of inclusion criteria is available in the protocol synopsis.
    - Soggetto di età = 18 anni,o considerato adulto in base alle normative locali al momento della firma del consenso informato;
    - Il soggetto con una diagnosi documentata di HCC avanzato di qualsiasi eziologia.
    - Il soggetto presenta BCLC di stadio B o C;
    - Le lesioni del soggetto non possono essere sottoposte a terapie locali che potrebbero apportare benefici, come chemioembolizzazione transarteriale (TACE), ablazione con radiofrequenza, radioterapia, ecc. e il soggetto non è un candidato per trattamenti curativi, come la resezione o il trapianto di fegato;
    - Il soggetto presenta uno stato di funzionalità epatica di classe A secondo il Child Pugh allo Screening;
    - Il soggetto ha ricevuto un trattamento sistemico precedente per l'HCC con sorafenib o altra terapia anti-VEGF e presentava una progressione della malattia confermata o ha interrotto il trattamento per tossicità legata al farmaco. Il soggetto può aver ricevuto 1 linea di terapia sperimentale sistemica prima o dopo il trattamento con sorafenib/anti-VEGF;
    - Il soggetto si è adeguatamente ripreso dalle tossicità dovute alla precedente terapia per HCC di grado =1;
    - Il soggetto presenta uno stato di validità ECOG = 1 allo Screening, il giorno 1;
    - Per il soggetto sono disponibili campioni di tumore fissati in formalina e inclusi in paraffina con adeguate cellule tumorali vitali in un blocco di tessuto o vetrini seriali non colorati accompagnati da un referto patologico prima dell'arruolamento. Il tessuto bioptico fresco o archiviato è necessario;
    - Il soggetto ha un'aspettativa di vita stimata di almeno 3 mesi il giorno 1, secondo il parere dello sperimentatore.
    - Soggetto di sesso femminile: -->Non in età fertile:
    ---> in post-menopausa (definita come amenorrea per almeno 12 mesi consecutivi prima dello Screening con ormone follicolo stimolante [FSH] > 40 IU/l per donne di età < 55 anni allo Screening), o
    ---> in stato documentato di sterilità chirurgica o di post-isterectomia (almeno 1 mese prima dello Screening). -->O, se in età fertile: --->deve presentare un test di gravidanza delle urine negativo allo Screening e il Giorno 1 prima della somministrazione della prima dose del farmaco dello studio, e ---> se sessualmente attiva, deve usare 2 metodi di controllo delle nascite* accettabili a partire dallo Screening e fino a 3 mesi dopo l'ultima dose del farmaco dello studio.
    [...]
    Criterio di inclusione aggiuntivo per il periodo "open-label":
    -aver ricevuto enzalutamide in doppio-cieco durante lo studio principale.
    L'elenco completo dei criteri di inclusione è disponibile nella sinossi del protocollo.
    E.4Principal exclusion criteria
    - Subject has a severe concurrent disease, infection or comorbidity that, in the judgment of the investigator, would make the subject inappropriate for enrollment;
    - Subject has fibrolamellar variant of HCC;
    - Subject has status of Child Pugh Class B or C at Screening;
    - Subject has a history of organ allograft including liver transplant;
    - Subject has uncontrolled symptomatic ascites;
    - Subject has known or suspected brain metastasis or active leptomeningeal disease;
    - Subject has a history of a non-HCC malignancy with the following exceptions:
    ¿ The subject with a previous history of a noninvasive carcinoma is eligible if in the opinion of the investigator he/she has had successful curative treatment any time prior to Screening and requires no further therapy for the malignancy.
    ¿ For all other malignancies, the subject is eligible if he/she has undergone potentially curative therapy and has been considered disease free for at least 3 years prior to Screening.
    - Subject has inadequate marrow, hepatic, and/or renal function at the Screening Visit defined as:
    ¿ Absolute neutrophil count < 1.5 x109/L (< 1500 cells/mm3)
    ¿ Platelet count < 50 x109/L (< 50,000 cells/mm3)
    ¿ Hemoglobin < 8.5 g/dL (< 5.3 mmol/L)
    ¿ International normalized ratio > 1.7
    ¿ Albumin < 2.8 g/dL (< 28 g/L)
    ¿ Total bilirubinTBL > 2 x ULN
    ¿ AST or ALT > 5 x ULN
    ¿ Creatinine > 1.5 x ULN
    Note: Transfusions/infusions to meet eligibility criteria are not allowed but if in the opinion of the Principal Investigator, it is beneficial, the patient may be rescreened after receiving one of these procedures.
    - Subject has a history of seizure or any condition that may predispose to seizure (e.g., prior cortical stroke, significant brain trauma, encephalopathy within 3 months of Day 1).
    [...]
    Open-Label Period Exclusion Criteria:
    - Received double-blind placebo during the main study
    - Subject has met discontinuation criteria during the main study
    - Subject has any other condition or reason that, in the opinion of the Investigator, interferes with the ability of the subject to participate in the trial or places the subject at undue risk

    The full list of exclusion criteria is available in the protocol synopsis.
    - Il soggetto presenta una grave patologia concomitante, infezione o co-morbilità che a giudizio dello sperimentatore rende il soggetto inidoneo all'arruolamento;
    - Il soggetto presenta una variante fibrolamellare dell'HCC;
    - Il soggetto presenta uno stato di classe B o C secondo il Child Pugh allo Screening;
    - Il soggetto presenta una anamnesi di allotrapianto di organo incluso il trapianto di fegato;
    Il soggetto presenta ascite sintomatica non controllata;
    - Il soggetto presenta malattia leptomeningea attiva o metastasi cerebrale nota o sospetta;
    - Il soggetto presenta una anamnesi di neoplasia non-HCC con le seguenti eccezioni:
    ¿ Il soggetto con pregressa anamnesi di carcinoma non invasivo è idoneo se, secondo il parere dello sperimentatore, è stato sottoposto a trattamento curativo efficace in qualsiasi momento prima dello Screening e non richiede ulteriore terapia per la neoplasia.
    ¿ Per tutte le altre neoplasie, il soggetto è idoneo se è stato sottoposto a potenziale terapia curativa ed è stato considerato libero da malattia per almeno 3 anni prima dello Screening.
    - Il soggetto presenta una funzione del midollo osseo, epatica e/o renale inadeguata alla visita di Screening definita come:
    ¿ Conta assoluta dei neutrofili < 1,5 x109/l (< 1500 cellule/mm3)
    ¿ Conta delle piastrine < 50 x109/l (< 50.000 cellule/mm3)
    ¿ Emoglobina < 8,5 g/dl (< 5,3 mmol/l)
    ¿ Rapporto internazionale normalizzato > 1,7
    ¿ Albumina < 2,8 g/dl (< 28 g/l)
    ¿ Bilirubina totaleTBL > 2 volte ULN
    ¿ AST o ALT > 5 × ULN
    ¿ Creatinina > 1,5 volte ULN
    Nota: non sono consentite trasfusioni/infusioni per soddisfare i criteri di idoneità ma se, secondo il giudizio dello Sperimentatore principale, queste possono apportare dei benefici, il paziente sarà sottoposto di nuovo a screening dopo queste procedure.
    - Il soggetto presenta una anamnesi di attacchi convulsivi o qualsiasi condizione che possa predisporre agli attacchi convulsivi (per es.: pregresso colpo corticale, trauma cerebrale significativo, encefalopatia entro 3 mesi dal Giorno 1).
    [...]
    Criteri di eclusione per il periodo "open-label":
    -aver ricevuto il placebo in doppio-cieco durante lo studio principale.
    -il soggetto ha soddisfatto un criterio di esclusione durante lo studio principale.
    - il soggetto presenta ogni altra condizione o motivazione per cui, su valutazione dello sperimentatore, interferisce con l’abilità del soggetto di partecipare allo studio o espone il soggetto a rischi non giustificati

    L'elenco completo dei criteri di esclusione è disponibile nella sinossi del protocollo.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy variable is overall survival (OS).
    La variabile primaria di efficacia è la sopravvivenza globale.
    E.5.1.1Timepoint(s) of evaluation of this end point
    OS is defined as the time from the date of randomization until date of death from any cause.
    Per sopravvivenza globale si intende il momento dalla data della randomizzazione alla data del decesso per qualsiasi causa.
    E.5.2Secondary end point(s)
    Safety Endpoints:
    The safety of enzalutamide will be assessed on an ongoing basis by evaluation of AEs/serious adverse events, clinical safety laboratory tests, vital signs, and other safety measures.
    Pharmacokinetic Endpoints:
    Predose plasma concentrations of enzalutamide and N-desmethyl enzalutamide will be analyzed.
    Efficacy Endpoints:
    - Time to Progression (TTP);
    - Progression Free Survival (PFS).
    Endpoint di sicurezza:
    La sicurezza di enzalutamide sar¿ valutata in modo continuo mediante valutazione degli eventi avversi seri/AE, dei test clinici di laboratorio di sicurezza, dei segni vitali e di altre misure di sicurezza.
    Endpoint di farmacocinetica:
    Saranno analizzate le concentrazioni nel plasma pre-dose di enzalutamide e N-desmethyl enzalutamide.
    Endpoint di efficacia:
    ¿ TTP;
    ¿ PFS.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Efficacy Endpoints:
    - TTP, defined as the time from the date of randomization until the date of the first radiographically documented disease progression as assessed by the investigator.
    - FS, defined as the time from the date of randomization until the date of documented radiographic disease progression according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 or death from any cause on study, whichever occurs first as assessed by the investigator.
    Endpoint di efficacia:
    - TTP, definito come il tempo dalla data della randomizzazione alla data della prima progressione della malattia documentata da radiografia come stabilito dallo sperimentatore.
    - PFS, definito come il momento dalla data di randomizzazione alla data di progressione della malattia documentata da radiografia secondo i Criteri di valutazione della risposta nei tumori solidi (RECIST) 1.1 o del decesso per qualsiasi causa nello studio, qualunque evento si verifichi per primo secondo il giudizio dello sperimentatore.
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    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 No
    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 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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Canada
    Hong Kong
    Korea, Democratic People's Republic of
    Puerto Rico
    Singapore
    Taiwan
    United States
    France
    Italy
    Spain
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days2
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months1
    E.8.9.2In all countries concerned by the trial days2
    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: 72
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 72
    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 43
    F.4.2.2In the whole clinical trial 144
    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)
    Plans for treatment or care after for the subject is per the treating physician's discretion and what is best for the subject.
    I piani per il trattamento o la cura al termine della partecipazione del soggetto allo studio sono a discrezione del medico sulla base di ci¿ che ¿ meglio per il soggetto.
    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 Decision2015-12-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-02-27
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-02-09
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