Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   35525   clinical trials with a EudraCT protocol, of which   5839   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2012-005201-48
    Sponsor's Protocol Code Number:1199.93
    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:2013-06-03
    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 number2012-005201-48
    A.3Full title of the trial
    Double blind, randomised, multicentre, phase II study of nintedanib in combination with pemetrexed / cisplatin followed by continuing nintedanib monotherapy versus placebo in combination with pemetrexed / cisplatin followed by continuing placebo monotherapy for the treatment of patients with unresectable malignant pleural mesothelioma
    studio in doppio cieco, randomizzato, di fase II, multicentrico, di Nintedanib in combinazione con Pemetressato/Cisplatino seguito da monoterapia con Nintedanib verso Placebo in combinazione con Pemetressato/Cisplatino seguito da monoterapia con Placebo per il trattamento dei pazienti con mesotelioma pleurico maligno non resecabile.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Nintedanib (BIBF 1120) in Mesothelioma
    Nintedanib (BIBF 1120) nel Mesotelioma
    A.4.1Sponsor's protocol code number1199.93
    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 SponsorBoehringer Ingelheim
    B.1.3.4CountryItaly
    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 supportBoehringer Ingelheim Italia s.p.a.
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBoehringer Ingelheim Pharma GmbH & Co. KG
    B.5.2Functional name of contact pointQRPE PSC CT Information Disclosure
    B.5.3 Address:
    B.5.3.1Street AddressBinger Strasse 173
    B.5.3.2Town/ cityIngelheim am Rhein
    B.5.3.3Post code55216
    B.5.3.4CountryGermany
    B.5.4Telephone number+18002430127
    B.5.5Fax number+18008217119
    B.5.6E-mailclintriage.rdg@boehringer-ingelheim.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 No
    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 nameBIBF 1120 100 mg capsules
    D.3.2Product code BIBF 1120
    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 INNNintedanib
    D.3.9.2Current sponsor codeBIBF 1120
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    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 nameBIBF 1120 150 mg capsules
    D.3.2Product code BIBF 1120
    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 INNNintedanib
    D.3.9.2Current sponsor codeBIBF 1120
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, soft
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, soft
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Unresectable Malignant Pleural Mesothelioma
    pazienti con mesotelioma pleurico maligno non resecabile
    E.1.1.1Medical condition in easily understood language
    Cancer of the pleura (the lining covering the lungs) which cannot be treated by surgery
    pazienti con mesotelioma pleurico maligno non resecabile
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.0
    E.1.2Level PT
    E.1.2Classification code 10059518
    E.1.2Term Pleural mesothelioma malignant
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate progression free survival measured from the time of randomisation to the time of disease progression or death
    L’obiettivo primario dello studio randomizzato, controllato a gruppi paralleli di fase II è di valutare la sicurezza e l’efficacia in termini di sopravvivenza libera da progressione di nintedanib + pemetressato/cisplatino seguito da nintedanib (braccio A) verso placebo + pemetressato/cisplatino seguito da placebo (braccio B) come trattamento di prima linea, per il trattamento dei pazienti con mesotelioma pleurico maligno non resecabile.
    E.2.2Secondary objectives of the trial
    To evaluate safety, overall survival and change from baseline in forced
    vital capacity (pulmonary function)
    Gli obiettivi secondari sono valutare la sopravvivenza globale e valutare i cambiamenti rispetto al basale della capacità vitale forzata in pazienti trattati con il regime nintedanib (braccio A) verso il regime con placebo (braccio B). Inoltre saranno raccolti campioni biologici per la valutazione dei marcatori molecolari e della possibile correlazione con l’esito del trattamento.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Histologically confirmed malignant pleural mesothelioma (MPM) (subtype: epithelioid or biphasic)
    - Life expectancy of at least 3 months in the opinion of the investigator
    - Eastern Cooperative Oncology Group (ECOG) score of 0 or 1
    - Measurable disease according to modified Response
    Evaluation Criteria In Solid Tumours (RECIST) criteria
    1.Pazienti maschi o femmine di età >= 18 anni.
    2.Mesotelioma pleurico maligno (sottotipo: epitelioide o bifasico) confermato istologicamente.
    3.Aspettativa di vita di almeno 3 mesi, in base al giudizio dello sperimentatore.
    4.Punteggio ECOG di 0-1.
    5.Malattia misurabile in base ai criteri RECIST modificati.
    6.Consenso informato datato e firmato prima dell’inclusione nello studio in accordo alle linee guida ICH-GCP e alle normative locali.
    E.4Principal exclusion criteria
    - Previous systemic chemotherapy for MPM
    - Prior treatment with nintedanib or any other VEGFR (Vascular Endothelial Growth Factor Receptor) inhibitor
    - Patients with sarcomatoid subtype MPM
    - Patients with symptomatic neuropathy
    - Radiotherapy (except extremities) within 3 months prior to baseline imaging
    - Active brain metastases (e.g. stable for < 4 weeks)
    - Radiographic evidence of cavitary or necrotic tumours or local invasion of major blood vessels by MPM
    - Significant cardiovascular diseases
    - Inadequate hematologic, renal, or hepatic function
    1.Precedente chemioterapia sistemica per mesotelioma pleurico maligno.
    2.Precedente trattamento con nintedanib o qualsiasi altro inibitore VEGFR.
    3.Pazienti con mesotelioma pleurico maligno di sottotipo sarcomatoide.
    4.Pazienti con neuropatia sintomatica.
    5.Pazienti con lieve o moderata insufficienza renale (clearance della creatinina di 45-79mL / minuto), che assumano FANS a breve emivita che non possano o non vogliano interrompere i FANS per un periodo di 5 giorni.
    6.Pazienti con lieve o moderata insufficienza renale (clearance della creatinina di 45-79mL / minuto) che assumano FANS a lunga emivita che non possano o non vogliano interrompere i FANS per un periodo di 8 giorni.
    7.Ipersensibilita' nota o qualsiasi controindicazione ai farmaci dello studio, compresi pemetressato / cisplatino, ai loro eccipienti o al mezzo di contrasto.
    8.Radioterapia (ad eccezione di quella alle estremità) entro i 3 mesi prima della raccolta delle immagini basali (la radioterapia locale per il sollievo dei sintomi e' permessa se effettuata almeno 2 settimane prima della randomizzazione e la malattia misurabile e' al di fuori dell’area sottoposta a radioterapia).
    9.Persistenza di tossicita' clinicamente significativa correlata alla radioterapia precedente, a giudizio dello sperimentatore.
    10.Pazienti che possano essere eleggibili o che siano considerati eleggibili alla resezione radicale o alla chirurgia di elezione durante il corso dello studio
    11.Chirurgia radicale, entro le 4 settimane prima della randomizzazione.
    12.Metastasi cerebrali attive.
    13.Patologia leptomeningea.
    14.Evidenza radiografica (TAC o RMN) di tumori cavitari o necrotici o di invasione locale dei vasi sanguigni maggiori da parte del mesotelioma pleurico maligno.
    15.Trattamento con altri farmaci sperimentali o trattamento in un altro studio clinico nelle 4 settimane precedenti l’inizio della terapia o durante il corso dello studio.
    16.Terapia anticoagulante (ad eccezione di eparina a basso dosaggio e/o lavaggi con eparina necessari per il mantenimento di un catetere venoso in sede) o terapia antipiastrinica (eccetto terapia a basso dosaggio con acido acetilsalicilico < 325mg al giorno).
    17.Traumi maggiori nelle 4 settimane precedenti l’inizio del trattamento con guarigione non completa delle ferite.
    18.Storia di eventi emorragici o tromboembolici clinicamente significativi, nei 6 mesi prima dello screening.
    19.Nota predisposizione ereditaria al sanguinamento o alla trombosi.
    20.Patologie cardiache significative.
    21.Proteinuria > 1.0 g/24 ore.22. Bilirubina totale al di sopra del limite superiore della norma (ULN).
    23.ALT e / o AST > 1,5 x ULN in pazienti senza metastasi epatiche.
    ALT e / o AST > 2,5 x ULN in pazienti con metastasi epatiche.
    24.Rapporto internazionale normalizzato (INR) > 2.
    25.Tempo di protrombina PT e/o tempo di tromboplastina parziale PTT con deviazione > 50% daULN.
    26.Conta assoluta dei neutrofili (ANC) < 1.500/µl (1,5x109/L).
    27.Piastrine < 100.000/mcrl (100x109/L).
    28.Emoglobina < 9 g/dl o valori che richiedano trasfusioni.
    29.Clearance della creatinina < 45 mL/min calcolata con la formula di Cockcroft e Gault (come sotto indicato) o Tasso di Filtrazione Glomerulare (GFR), misurato tramite il metodo della creatinina serica Tc99m-DPTA (si veda la sinossi per la formula).
    30.Altre patologie maligne nei tre anni precedenti lo screening, ad eccezione del carcinoma basale della pelle o il carcinoma in situ della cervice.
    31.Infezioni gravi attive, in particolare che richiedano terapia sistemica antibiotica o antimicrobica.
    32.Nota infezione attiva o cronica da epatite C e/o B.
    33.Disordini gastrointestinali o anomalie che potrebbero interferire con l’assorbimento del farmaco in studio.
    34.Patologie concomitanti gravi o non oncologiche come malattie neurologiche, psichiatriche, infettive o ulcere attive (tratto gastro intestinale, cute) o anomalie di laboratorio che potrebbero aumentare il rischio connesso con la partecipazione allo studio o la somministrazione del farmaco e che a giudizio dello sperimentatore determinino l’ineleggibilità del paziente allo studio.
    35.Pazienti che siano sessualmente attivi e che si rifiutino di utilizzare un metodo contraccettivo efficace durante lo studio, e per almeno tre mesi dopo la conclusione di nintedanib/placebo e per almeno dodici mesi dopo la cessazione della chemioterapia.
    36.Gravidanza o allattamento.
    37.Fattori psicologici, familiari, sociali o geografici che potenzialmente possano compromettere l’aderenza al protocollo di studio e al follow-up programmato.
    38.Abuso attivo di alcool o farmaci.
    E.5 End points
    E.5.1Primary end point(s)
    1. Progression free survival measured from the time of randomisation to the time of disease progression or death of any cause, whichever occurs earlier
    1. Sopravvivenza libera da progressione, calcolata dalla randomizzazione fino alla progressione o decesso per qualsiasi causa, qualunque evento si verifichi per primo.
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. up to 3 years
    1. fino a 3 anni
    E.5.2Secondary end point(s)
    1. Overall survival measured from the time of randomisation to the time of death of any cause
    2. Change from baseline in forced vital capacity (pulmonary function)
    1. Sopravvivenza globale, calcolata dalla randomizzazione fino al decesso per qualsiasi causa.
    2. Cambiamenti nella capacità vitale forzata (funzione polmonare) rispetto al basale.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. up to 4 years

    2. up to 3 years
    1. fino a 4 anni
    2. fino a 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 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 Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Biomarkers
    Biomarker
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    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 Yes
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA10
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Canada
    Denmark
    France
    Germany
    Italy
    United Kingdom
    United States
    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
    The trial will be considered completed 18 months after the last patient was randomised. The primary analysis of PFS will be conducted and reported when approximately 65 patients have progressed or died. However, it may also be performed with fewer events within approximately 27 months total trial duration. If patients are still ongoing or in follow-up at the time of the clinical trial report for PFS, the clinical trial database will be kept open to collect the additional data.
    Lo studio sara’ considerato completato 18 mesi dopo la randomizzazione dell’ultimo paziente. L'analisi primaria della PFS sara’ effettuata quando circa 65 pazienti saranno in progressione di malattia o deceduti. Tuttavia, l'analisi potra’ anche essere eseguita con meno eventi entro circa 27 mesi (durata totale della sperimentazione). Se i pazienti saranno ancora in trattamento o in follow-up al momento del report per la PFS, il database sara’ mantenuto aperto per raccogliere i dati addizionali
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    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 years2
    E.8.9.2In all countries concerned by the trial months9
    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: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 56
    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 state9
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 41
    F.4.2.2In the whole clinical trial 86
    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)
    Patients will be treated in the trial until cancer progression or undue toxicity. Follow-up treatment after disease progression is at the discretion of the treating physician according to local standard of care.
    If the trial is ended by the sponsor for any reason, patients still being treated with a clinical benefit will be offered treatment in a follow-up trial. In case the trial is terminated by the sponsor for safety reasons, patients will not continue treatment with the trial drug.
    I pazienti saranno trattati in studio fino a progressione o tossicità eccessiva. Il trattamento dopo progressione e' a discrezione del p.i., secondo gli standard locali. Se lo studio sarà terminato dallo sponsor per qualsiasi motivo, ai pazienti ancora in trattamento con beneficio clinico sarà offerto un trattamento in uno studio di follow-up. Nel caso lo studio venga concluso dallo sponsor per motivi di sicurezza, i pazienti non continueranno il trattamento con il farmaco sperimentale.
    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 Decision2013-11-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-06-12
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2019 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA