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    Summary
    EudraCT Number:2014-005364-14
    Sponsor's Protocol Code Number:IEO206
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2021-06-17
    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 number2014-005364-14
    A.3Full title of the trial
    Phase II trial of Afatinib as induction treatment in patients with stage IIIA or stage IIIB N2 requiring neoadjuvant treatment for pN2 non squamous non small cell lung cancer (NSCLC) with EGFR-activating mutations.
    Studio di Fase II di Afatinib come trattamento di induzione nei pazienti con tumore polmonare non a piccole cellule (NSCLC) di tipo non squamoso stadio IIIA o stadio IIIB N2 che richiede un trattamento neoadiuvante pN2 con mutazione attivante del gene EGFR.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The role of Afatinib to come to radical surgery in patients with non-squamous lung cancer with EGFR gene mutation.
    Il ruolo di Afatinib per giungere alla chirurgia radicale in pazienti con tumore polmonare non squamoso con mutazione del gene EGFR
    A.3.2Name or abbreviated title of the trial where available
    NA
    NA
    A.4.1Sponsor's protocol code numberIEO206
    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 EUROPEO DI ONCOLOGIA
    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 supportBoehringer Ingelheim
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationISTITUTO EUROPEO DI ONCOLOGIA
    B.5.2Functional name of contact pointUFFICIO STUDI CLINICI E ATTIVITA' R
    B.5.3 Address:
    B.5.3.1Street AddressVIA ADAMELLO 16
    B.5.3.2Town/ cityMILANO
    B.5.3.3Post code20139
    B.5.3.4CountryItaly
    B.5.4Telephone number0257489848
    B.5.5Fax number0257489781
    B.5.6E-mailufficio.studiclinici@ieo.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 GIOTRIF - 40 MG - COMPRESSA RIVESTITA CON FILM - BLISTER DIVISIBILE (PVC/PVDC) 28X1 COMPRESSE
    D.2.1.1.2Name of the Marketing Authorisation holderBOEHRINGER INGELHEIM INTERNATIONAL GMBH
    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 nameGIOTRIF 40 MG
    D.3.2Product code [GIOTRIF 40 MG]
    D.3.4Pharmaceutical form 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 INNAFATINIB
    D.3.9.2Current sponsor codeBIBW 2992
    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.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 GIOTRIF - 20 MG - COMPRESSA RIVESTITA CON FILM - BLISTER DIVISIBILE (PVC/PVDC) 28X1 COMPRESSE
    D.2.1.1.2Name of the Marketing Authorisation holderBOEHRINGER INGELHEIM INTERNATIONAL GMBH
    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 nameGIOTRIF 20 MG
    D.3.2Product code [GIOTRIF 20 MG]
    D.3.4Pharmaceutical form 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 INNAFATINIB
    D.3.9.2Current sponsor codeBIBW 2992
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin 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 GIOTRIF - 30 MG - COMPRESSA RIVESTITA CON FILM - BLISTER DIVISIBILE (PVC/PVDC) 28X1 COMPRESSE
    D.2.1.1.2Name of the Marketing Authorisation holderBOEHRINGER INGELHEIM INTERNATIONAL GMBH
    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 nameGIOTRIF 30 MG
    D.3.2Product code [GIOTRIF 30 MG]
    D.3.4Pharmaceutical form 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 INNAFATINIB
    D.3.9.2Current sponsor codeBIBW 2992
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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
    Patients with stage IIIA or stage IIIB N2 requiring neoadjuvant treatment for pN2 non squamous non small cell lung cancer (NSCLC) with EGFR-activating mutations
    Pazienti con tumore polmonare non a piccole cellule (NSCLC) di tipo non squamoso stadio IIIA o stadio IIIB N2 che richiede un trattamento neoadiuvante pN2 con mutazione attivante del gene EGFR.
    E.1.1.1Medical condition in easily understood language
    Patients with non-squamous lung cancer with EGFR gene mutation.
    Pazienti con tumore polmonare non squamoso con mutazione del gene EGFR
    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 10029520
    E.1.2Term Non-small cell lung cancer stage IIIA
    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 assess the anti-tumor efficacy of afatinib, in patients with stage IIIA or stage IIIB N2 requiring neoadjuvant treatment for pN2 non squamous non small cell lung cancer (NSCLC), measured as objective response rate (ORR) by pathological down-staging and pathological complete response.
    Valutare l'efficacia anti-tumorale di afatinib, in pazienti con carcinoma polmonare non a piccole cellule (NSCLC) con stadio IIIA o stadio IIIB N2 che richiede un trattamento neoadiuvantepN2, misurata come percentuale di risposta obiettiva (ORR) tramite il down-staging patologico e la risposta patologica completa.
    E.2.2Secondary objectives of the trial
    To assess secondary measures of clinical efficacy including time to relapse (TTR), time to progression (TTP) and overall survival (OS). To assess the safety and tolerability of afatinib in this subset of patients with NSCLC.
    Valutare l’efficacia sulla base del time to relapse (TTR), time to progression (TTP) e overall survival (OS), valutare la sicurezza e tollerabilità del farmaco in questo sottogruppo di pazienti con NSCLC.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients with histologically or cytologically confirmed IIIA or stage IIIB N2 requiring neoadjuvant treatment for pN2 IIIa NSCLC
    Epidermal Growth Factor Receptor (EGFR) mutation-positive result per the institution’s testing methodology.
    male or female patients age =18 years
    Adequate organ function, defined as all of the following:
    Absolute Neutrophil Count (ANC) > 1500/mm3. (ANC >1000/mm may be considered in special circumstances such as benign cyclical neutropenia as judged by the investigator and in discussion with the sponsor).
    Platelet count >75,000/mm3
    Serum creatinine < 1.5 times of the upper limit of normal
    Total Bilirubin < 1.5 times upper limit of (institutional) normal (Patients with Gilbert’s syndrome total bilirubin must be <4 times institutional upper limit of normal).
    Aspartate Amino Transferase (AST) or Alanine Amino Transferase (ALT) < three times the upper limit of (institutional) normal (ULN) (if related to liver metastases < five times ULN).
    ECOG score between 0 - 1
    written informed consent by patient or guardian prior to admission into the trial that is consistent with International Conference on Harmonisation (ICH)- Good Clinical Practice (GCP) guidelines and local law.
    Patients who have not previously received radiotherapy, chemotherapy or target treatments for their disease and are suitable for surgery
    Pazienti affetti da carcinoma polmonare non a piccole cellule (NSCLC) in prima diagnosi con stadio IIIA o stadio IIIB N2 che richiedono un trattamento neoadjuvanteIIIA pN2, portatori di mutazioni attivanti EGFR, ritenuti potenzialmente candidabili ad intervento chirurgico con finalità radicale
    Positività del test di mutazione del recettore del fattore di crescita epidermico (EGFR) effettuato con metodica standard del centro.
    Maschi o femmine di età =18 anni.
    Funzionalità degli organi adeguata, definita come segue:
    Frazione di eiezione ventricolare sinistra (LVEF) >50% o entro i valori normali del centro.
    Conta assoluta dei neutrofili (ANC) > 1.500/mm3. (in alcuni casi specifici, come nella neutropenia benigna ciclica, può essere considerato un valore di ANC >1000/mm3, in base al giudizio clinico dello sperimentatore ed alla discussione con lo sponsor)
    Conta piastrinica >75.000/mm3
    Creatinina serica > 1.5 volte il limite superiore di normalità
    Bilirubina totale < 1.5 volte il limite superiore di normalità del centro (nei pazienti con la sindrome di Gilbert la bilirubina totale deve essere <4 volte il limite superiore di normalità del centro).
    Aspartato Amino Transferasi (AST) o Alanina Amino Transferasi (ALT) < tre volte il limite superiore di normalità (ULN) del centro (se correlato a metastasi epatiche < cinque volte ULN).
    Punteggio ECOG tra 0 – 2
    Consenso informato scritto firmato dal paziente o dal legale rappresentante prima dell’inclusione nello studio .
    E.4Principal exclusion criteria
    Patients with metastatic or advanced lung cancer not suitable for surgery are excluded.
    Patients that had received previous therapy for lung cancer (es. EGFR tyrosine kinase inhibitor (TKI), chemotherapy, radiotherapy)
    Patients are excluded if they had another cancer diagnosis in the last 5 years excepted adeguately treated non melanoma skin cancer or in situ cervical cancer
    major surgery within 4 weeks before starting trial treatment or scheduled for surgery during the projected course of the trial
    known hypersensitivity to afatinib (Giotrif®) or any of its excipients
    history or presence of clinically relevant cardiovascular abnormalities such as uncontrolled hypertension, congestive heart failure New York Heart Association (NYHA) classification of 3 (Refer to Appendix 10.2), unstable angina or poorly controlled arrhythmia as determined by the investigator. Myocardial infarction within 6 months prior to starting trial treatment.
    are Women of Child-Bearing Potential (WOCBP) and men who are able to father a child, unwilling to use adequate contraception prior to trial entry, for the duration of trial participation and for at least 28 days 2 weeks after treatment has ended. Adequate methods of contraception and Women of Child-Bearing Potential ; WOCBP childbearing potential who are nursing or are pregnant or do not agree to submit to pregnancy testing required by this protocol
    any history of or concomitant condition that, in the opinion of the investigator, would compromise the patient’s ability to comply with the trial or interfere with the evaluation of safety for the trial drug
    requiring treatment with any of the prohibited concomitant medications listed in Section 4.2.2 that can not be stopped for the duration of trial participation
    presence of poorly controlled gastrointestinal disorders that could affect the absorption of the trial drug (e.g. Crohn’s disease, ulcerative colitis, malabsorption, or CTC grade =2 diarrhoea of any aetiology) based on investigator assessment.
    Knowed active hepatitis B infection (defined as presence of Hepatitis B (HepB) sAg and/or HepB DNA), active Hepatitis C (HEP C) infection (defined as presence of Hep C RNA) and/or known Human Immunodeficiency Virus (HIV) carrier.
    Precedente trattamento per la neoplasia polmonare riscontrata.
    Trattamento anticancro per altre neoplasie entro le due settimane precedenti l’inizio del trattamento in studio (è consentito l’utilizzo cronico di anti androgeni e/o analoghi della gonadorelina per il trattamento del cancro alla prostata)
    Chirurgia maggiore entro le 4 settimane precedenti prima dell’inizio del trattamento in studio o programmazione di interventi durante lo svolgimento dello studio.
    Ipersensibilità nota ad afatinib o a qualsiasi dei suoi eccipienti.
    Storia o presenza di anomalie cardiovascolari clinicamente rilevanti, come ipertensione non controllata, infarto cardiaco congestizio con classificazione della New York Heart Association (NYHA) di 3, angina instabile o aritmia scarsamente controllata in base al giudizio dello sperimentatore. Infarto del miocardio entro i 6 mesi precedenti l’inizio del trattamento in studio.
    Siano donne in età fertile e uomini in grado di procreare che non vogliano utilizzare una contraccezione adeguata prima di entrare nello studio, per tutta la durata della partecipazione allo studio e per almeno 2 settimane dalla fine del trattamento. I metodi adeguati di contraccezione e la definizione di donne in età fertile sono descritti nel protocollo.
    Siano donne in età fertile in allattamento o in gravidanza o che si rifiutino di effettuare i test di gravidanza richiesti dal protocollo.
    Qualsiasi storia o condizione concomitante che, a giudizio dello sperimentatore, potrebbe compromettere la capacità del paziente di aderire allo studio o interferire con la valutazione della sicurezza del farmaco in studio
    Precedenti o concomitanti tumori in altri siti, eccetto tumori della pelle non-melanoma efficacemente trattati, carcinoma in situ della cervice, carcinoma in situ dei dotti mammari o tumori trattati efficacemente che siano in remissione da più di tre anni e siano considerati risolti.
    Richiedano trattamento con uno qualsiasi dei farmaci concomitanti non consentiti dal protocollo che non può essere interrotto per tutta la partecipazione allo studio
    Presenza di disordini gastrointestinali scarsamente controllati che potrebbero interferire con l’assorbimento del farmaco in studio (per esempio morbo di Crohn, colite ulcerosa, malassorbimento o diarrea di qualsiasi eziologia di grado CTC =2) in base al giudizio dello sperimentatore.
    Infezione attiva da epatite B (definita con la presenza dell’antigene s dell’epatite B (sAg HepB) e/o il DNA di HepB), infezione attiva da epatite C (HEP C) (definita con la presenza di RNA di Hep C) e/o portatori di virus da immunodeficienza acquisita (HIV).
    E.5 End points
    E.5.1Primary end point(s)
    To assess the anti-tumor efficacy of afatinib, in patients with stage IIIA or stage IIIB N2 requiring neoadjuvant treatment for pN2 non squamous non small cell lung cancer (NSCLC) with EGFR-activating mutation, measured as objective response rate (ORR) by pathological down-staging and pathological complete response.
    Valutare l'efficacia anti-tumorale di afatinib in pazienti con carcinoma polmonare non a piccole cellule (NSCLC) con stadio IIIA o stadio IIIB N2 che richiede un trattamento neoadiuvantepN2, portatori di mutazione attivante EGFR, misurata con l’objective response rate (ORR) tramite la valutazione del downstaging patologico e la risposta patologica completa.
    E.5.1.1Timepoint(s) of evaluation of this end point
    at the end of the treatment period and after surgery
    al termine del periodo di trattamento e dopo l'intervento chirurgico
    E.5.2Secondary end point(s)
    To assess secondary measures of clinical efficacy including time to relapse (TTR), time to progression (TTP) and overall survival (OS), to assess the safety and tolerability of afatinib in this subset of patients with NSCLC.
    Valutare l’efficacia sulla base del time to relapse (TTR), time to progression (TTP) e overall survival (OS), valutare la sicurezza e tollerabilità del farmaco in questo sottogruppo di pazienti con NSCLC.
    E.5.2.1Timepoint(s) of evaluation of this end point
    during the whole treatment period (3 periods. of 28 days each). After the end of treatment every 3 months for the first 2 years and every 6 months for the following 3 years.
    durante tutto il periodo di trattamento (3 cicli di 28 giorni. Dopo la fine del trattamento i dati verranno rilevati ogni 3 mesi per i primi 2 anni e ogni 6 mesi per i successivi 3 anni.
    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 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 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 trial1
    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.8.4.1Number of sites anticipated in Member State concerned1
    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 Information not present in EudraCT
    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
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months90
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months90
    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: 37
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 9
    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 state46
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 46
    F.4.2.2In the whole clinical trial 46
    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)
    at the end of the 5 year follow-up period patients will be controlled annualy.
    al termine dei 5 anni di follow-up si proseguirà con controlli annuali
    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 Decision2016-04-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-03-23
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2022-07-11
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