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    Summary
    EudraCT Number:2015-000392-28
    Sponsor's Protocol Code Number:1199.214
    National Competent Authority:Greece - EOF
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-10-22
    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 ConcernedGreece - EOF
    A.2EudraCT number2015-000392-28
    A.3Full title of the trial
    A double blind, randomised, placebo-controlled trial evaluating efficacy and safety of oral nintedanib treatment for at least 52 weeks in patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD)
    Μία διπλά-τυφλή, τυχαιοποιημένη, ελεγχόμενη με εικονικό φάρμακο μελέτη αξιολόγησης της αποτελεσματικότητας και της ασφάλειας της θεραπείας με από του στόματος χορηγούμενο nintedanib για τουλάχιστον 52 εβδομάδες σε ασθενείς με ‘Διάμεση Πνευμονοπάθεια σχετιζόμενη με Συστηματική Σκλήρυνση’ (ΣΣκ-ΔΠ)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A trial to compare nintedanib with placebo for patients with scleroderma related lung fibrosis
    Μία μελέτη για τη σύγκριση του nintedanib με το εικονικό φάρμακο για ασθενείς με πνευμονική ίνωση σχετιζόμενη με σκληροδερμία
    A.3.2Name or abbreviated title of the trial where available
    Nintedanib in SSc-ILD
    Nintedanib σε ΣΣκ-ΔΠ
    A.4.1Sponsor's protocol code number1199.214
    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 Ellas SA
    B.1.3.4CountryGreece
    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 Ellas SA
    B.4.2CountryGreece
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBoehringer Ingelheim Pharma GmbH
    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+1800243 0127
    B.5.5Fax number+1800821 7119
    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 Yes
    D.2.1.1.1Trade name Ofev
    D.2.1.1.2Name of the Marketing Authorisation holderBoehringer Ingelheim International GmbH
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameNintedanib
    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.3.9.1CAS number 656247-17-5
    D.3.9.2Current sponsor codeBIBF 1120
    D.3.9.3Other descriptive nameNINTEDANIB
    D.3.9.4EV Substance CodeSUB120728
    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.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 Ofev
    D.2.1.1.2Name of the Marketing Authorisation holderBoehringer Ingelheim International GmbH
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameNintedanib
    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.3.9.1CAS number 656247-17-5
    D.3.9.2Current sponsor codeBIBF 1120
    D.3.9.3Other descriptive nameNINTEDANIB
    D.3.9.4EV Substance CodeSUB120728
    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.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
    Patients with Systemic Sclerosis and associated Interstitial Lung Disease
    Ασθενείς με Διάμεση Πνευμονοπάθεια σχετιζόμενη με Συστηματική Σκλήρυνση
    E.1.1.1Medical condition in easily understood language
    Systemic Sclerosis (SSc) is a disease of unknown etiology. Patients suffer from multiple organ fibrosis whereas lung fibrosis is one of the main driver for mortality.
    Η ΣΣκ είναι μια νόσος άγνωστης αιτιολογίας. Ασθενείς που πάσχουν από ίνωση πολλαπλών οργάνων με την πνευμονική ίνωση να αποτελεί έναν από τους βασικότερους παράγοντες για τη θνησιμότητα.
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10012977
    E.1.2Term Diffuse systemic sclerosis
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10036814
    E.1.2Term Progressive systemic sclerosis
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level PT
    E.1.2Classification code 10042954
    E.1.2Term Systemic sclerosis pulmonary
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10025109
    E.1.2Term Lung involvement in systemic sclerosis
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level PT
    E.1.2Classification code 10042953
    E.1.2Term Systemic sclerosis
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate a reduction in the annual rate of decline in FVC in mL over 52 weeks
    Να αποδειχθεί μια μείωση στον ετήσιο ρυθμό έκπτωσης της FVC σε mL για μια περίοδο 52 εβδομάδες
    E.2.2Secondary objectives of the trial
    To demonstrate efficacy in regard to skin fibrosis at week 52 and to demonstrate an improvement of patient's symptoms at week 52
    Να αποδειχθεί αποτελεσματικότητα σε σχέση με την ίνωση δέρματος την εβδομάδα 52 και να αποδειχθεί βελτίωση των συμπτωμάτων του ασθενούς την εβδομάδα 52
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    • HRCT optional Substudy (Included in Protocol Version 1.0 dated 22 Jul 2015)
    • Skin Biopsy optional Substudy (Included in Protocol Version 1.0 dated 22 Jul 2015)
    • Nailfold capillary microscopy optional Substudy (Included in Protocol Version 1.0 dated 22 Jul 2015)
    • Προαιρετική Υπομελέτη HRCT (Συμπεριλαμβάνεται στο πρωτόκολλο Έκδοση 1.0, 22 Ιουλίου 2015)
    • Προαιρετική Υπομελέτη Βιοψίας Δέρματος (Συμπεριλαμβάνεται στο πρωτόκολλο Έκδοση 1.0, 22 Ιουλίου 2015)
    • Προαιρετική Υπομελέτη Τριχοειδοσκόπησης της κοίτης των ονύχων (Συμπεριλαμβάνεται στο πρωτόκολλο Έκδοση 1.0, 22 Ιουλίου 2015)
    E.3Principal inclusion criteria
    - Age >= 18 years
    - 2013 ACR / EULAR classification criteria for SSc fulfilled
    - SSc disease onset (defined by first non-Raynaud symptom) within 5 years
    - SSc related Interstitial Lung Disease confirmed by HRCT; Extent of fibrotic disease in the lung >= 10%
    - FVC >= 40% of predicted normal
    - DLCO 30% to 89% of predicted normal
    - Ηλικία >= 18 ετών
    - Να πληρούνται τα κριτήρια ταξινόμησης του ACR / EULAR 2013 για τη Συστηματική Σκλήρυνση
    - Έναρξη Συστηματικής Σκλήρυνσης (οριζόμενης ως το πρώτο μη-Raynaud σύμπτωμα) εντός 5 ετών
    - Διάμεση Πνευμονοπάθεια σχετιζόμενη με Συστηματική Σκλήρυνση επιβεβαιωμένη μέσω HRCT, έκταση της ίνωσης στο πνευμονικό παρέγχυμα >= 10%
    - FVC >= 40% της προβλεπόμενης τιμής
    - DLCO 30% έως 89% της προβλεπόμενης τιμής
    E.4Principal exclusion criteria
    - AST, ALT >1.5 x ULN
    - Bilirubin >1.5 x ULN
    - Creatinine clearance <30 mL/min
    - Airway obstruction (pre-bronchodilator FEV1/FVC <0.7)
    - Other clinically significant pulmonary abnormalities
    - Significant pulmonary hypertension
    - Cardiovascular diseases
    - More than 3 digital fingertip ulcers
    - Bleeding risk (such as predisposition to bleeding, fibrinolysis, full-dose anticoagulation, high dose antiplatelet therapy, history of hemorrhagic central nervous system (CNS) event within last year
    - international normalised ratio (INR) >2, prolongation of prothrombin time (PT) and partial thromboplastin time (PTT) by >1.5 x ULN)
    - History of thrombotic event within last year
    - Clinical signs of malabsorption or needing parenteral nutrition
    - Previous treatment with nintedanib or pirfenidone
    - Treatment with prednisone >10 mg/day, azathioprine, hydroxychloroquine, colchizine, D-penicillamine, sulfasalazine, cyclophosphamide, rituximab, tocilizumab, abatacept, leflunomide, tacrolimus, newer anti-arthritic treatments like tofacitinib and ciclosporine A, potassium para-aminobenzoate
    - Unstable background therapy with either mycophenolate mofetil or methotrexate
    - Previous or planned hematopoietic stem cell transplantation
    - Patients with underlying chronic liver disease (Child Pugh A, B, C hepatic impairment)
    - AST, ALT >1,5 x ULN
    - Χολερυθρίνη >1,5 x ULN
    - Κάθαρση κρεατινίνης <30 mL/min
    - Απόφραξη των αεραγωγών (λόγος FEV1/FVC προ βρογχοδιαστολής <0,7)
    - Άλλες κλινικά σημαντικές παθολογικές καταστάσεις του πνεύμονα
    - Σημαντική πνευμονική υπέρταση
    - Καρδιαγγειακά νοσήματα
    - Περισσότερα από 3 έλκη στις ράγες των δακτύλων (ακροδάκτυλα)
    - Αιμορραγικός κίνδυνος (όπως αιμορραγική προδιάθεση, ινωδόλυση, αντιπηκτική θεραπευτική αγωγή πλήρους δόσης, αντιαιμοπεταλιακή θεραπεία υψηλής δόσης, ιστορικό αιμορραγικού επεισοδίου του κεντρικού νευρικού συστήματος (ΚΝΣ) εντός του τελευταίου έτους
    - Διεθνές κανονικοποιημένο πηλίκο (INR) >2, παράταση του χρόνου προθρομβίνης (PT) και του χρόνου μερικής θρομβοπλαστίνης (PTT) >1,5 x ULN
    - Ιστορικό θρομβωτικού επεισοδίου εντός του τελευταίου έτους
    - Κλινικά σημεία δυσαπορρόφησης ή χρήζοντες παρεντερικής διατροφής
    - Προηγούμενη θεραπεία με nintedanib ή πιρφενιδόνη
    - Θεραπεία με πρεδνιζόνη >10 mg/ημέρα, αζαθειοπρίνη, υδροξυχλωροκίνη, κολχικίνη, D- πενικιλλαμίνη, σουλφασαλαζίνη, κυκλοφωσφαμίδη, ριτουξιμάμπη, τοσιλιζουμάμπη, αμπατασέπτη, λεφλουνομίδη, τακρόλιμους, νεώτερες θεραπείες για την αρθρίτιδα όπως τοφασιτινίμπη και κυκλοσπορίνη A, παρα-αμινοβενζοϊκό κάλιο
    - Μη σταθερή βασική θεραπεία με μυκοφαινολική μοφετίλη ή μεθοτρεξάτη
    - Προηγηθείσα ή προγραμματισμένη μεταμόσχευση αρχέγονων αιμοποιητικών κυττάρων
    - Ασθενείς με προϋπάρχουσα χρόνια ηπατική νόσο (ηπατική βλάβη τάξης A, B, C της κλίμακας Child Pugh)
    E.5 End points
    E.5.1Primary end point(s)
    1: Annual rate of decline in FVC in mL
    1: Ετήσιος ρυθμός έκπτωσης της FVC σε mL
    E.5.1.1Timepoint(s) of evaluation of this end point
    1: 52 weeks
    1: 52 εβδομάδες
    E.5.2Secondary end point(s)
    1: Absolute change from baseline in the mRSS
    2: Absolute change from baseline in SGRQ total score
    3: Annual rate of decline in FVC in percent predicted
    4: Absolute change from baseline in FVC in mL
    5: Relative change from baseline (%) of mRSS
    6: Time to all-cause mortality
    7: Absolute change from baseline in DLCO in percent predicted
    8: Absolute change from baseline in digital ulcer net burden
    9: Absolute change from baseline in HAQ-DI score
    10: Absolute change from baseline in FACIT dyspnoea score
    1: Απόλυτη μεταβολή από την έναρξη στη βαθμολογία mRSS
    2: Απόλυτη μεταβολή από την έναρξη στη συνολική βαθμολογία του ερωτηματολογίου SGRQ
    3: Ετήσιος ρυθμός έκπτωσης στην προβλεπόμενη FVC %
    4: Απόλυτη μεταβολή από την έναρξη στην FVC σε mL
    5: Σχετική μεταβολή από την έναρξη (%) στη βαθμολογία mRSS
    6: Χρόνος έως την επέλευση θανάτου από οποιαδήποτε αιτία
    7: Απόλυτη μεταβολή από την έναρξη στην DLCO (% της προβλεπόμενης)
    8: Απόλυτη μεταβολή από την έναρξη στο καθαρό φορτίο των δακτυλικών ελκών
    9: Απόλυτη μεταβολή από την έναρξη στη βαθμολογία του ερωτηματολογίου HAQ-DI
    10: Απόλυτη μεταβολή από την έναρξη στη βαθμολογία του ερωτηματολογίου FACIT-δύσπνοια
    E.5.2.1Timepoint(s) of evaluation of this end point
    1: 52 weeks
    2: 52 weeks
    3: 52 weeks
    4: 52 weeks
    5: 52 weeks
    6: 52 weeks
    7: 52 weeks
    8: 52 weeks
    9: 52 weeks
    10: 52 weeks
    1: 52 εβδομάδες
    2: 52 εβδομάδες
    3: 52 εβδομάδες
    4: 52 εβδομάδες
    5: 52 εβδομάδες
    6: 52 εβδομάδες
    7: 52 εβδομάδες
    8: 52 εβδομάδες
    9: 52 εβδομάδες
    10: 52 εβδομάδες
    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 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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA83
    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
    Belgium
    Canada
    China
    Denmark
    France
    Germany
    Greece
    India
    Ireland
    Israel
    Italy
    Japan
    Netherlands
    Poland
    Portugal
    Spain
    Switzerland
    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
    LVLS
    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 days27
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days27
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    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: 450
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 70
    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 state27
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 384
    F.4.2.2In the whole clinical trial 750
    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)
    After the end of this trial, patients not prematurely withdrawn from treatment will be offered an open label extension trial.
    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 Decision2015-11-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-11-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-11-28
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