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    Summary
    EudraCT Number:2015-003148-38
    Sponsor's Protocol Code Number:1199.227
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-05-04
    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 ConcernedFrance - ANSM
    A.2EudraCT number2015-003148-38
    A.3Full title of the trial
    A 12-week, double blind, randomised, placebo controlled, parallel group trial followed by a single active arm phase of 40 weeks evaluating the effect of oral nintedanib 150 mg twice daily on change in biomarkers of extracellular matrix (ECM) turnover in patients with idiopathic pulmonary fibrosis (IPF) and limited forced vital capacity (FVC) impairment.
    Etude de 12 semaines en groupe parallèle, en double aveugle, randomisée, contrôlée versus placebo, suivie par une phase de 40 semaines en un seul bras actif évaluant l'effet du nintedanib (150 mg par voie orale deux fois par jour) sur la variation des biomarqueurs du renouvellement de la matrice extracellulaire (MEC) chez des patients atteints de fibrose pulmonaire idiopathique (FPI) ayant une capacité vitale forcée (CVF) préservée.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effect of nintedanib on biomarkers
    Effet du nintedanib sur les biomarqueurs
    A.4.1Sponsor's protocol code number1199.227
    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 France
    B.1.3.4CountryFrance
    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
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBoehringer Ingelheim
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/13/1123
    D.3 Description of the IMP
    D.3.1Product nameOfev 100 mg capsule
    D.3.2Product code nintedanib
    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.3.9.3Other 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.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 Yes
    D.2.5.1Orphan drug designation numberEU/3/13/1123
    D.3 Description of the IMP
    D.3.1Product nameOfev 150 mg capsule
    D.3.2Product code nintedanib
    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.3.9.3Other 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.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
    E.1.1.1Medical condition in easily understood language
    idiopathic pulmonary fibrosis
    Fibrose pulmonaire idiopathique
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level PT
    E.1.2Classification code 10021240
    E.1.2Term Idiopathic pulmonary fibrosis
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of the trial will be to assess the effect of nintedanib on rate of change in extracellular matrix (ECM) turnover biomarker CRPM over 12 weeks which has shown to strongly associate with disease progression in patients with IPF in the PROFILE cohort.
    L'objectif principal de l'essai est d'évaluer sur 12 semaines l'effet du nintedanib sur le taux de variation des biomarqueurs CRPM du renouvellement de la matrice extracellulaire (MEC) qui a montré être fortement associé à la progression de la maladie chez les patients avec FPI dans la cohorte PROFILE.
    E.2.2Secondary objectives of the trial
    A secondary objective is to confirm the observed results from the PROFILE cohort, i.e. to assess the predictive value of change in extracellular matrix (ECM) biomarkers CRPM, C1M and C3M over 12 weeks for disease progression as defined by FVC decline ≥10% or death over 52 weeks.
    Un second objectif est de confirmer les résultats observés dans la cohorte PROFILE, c’est-à-dire d'évaluer la valeur prédictive de variation des biomarqueurs de la matrice extracellulaire (MEC) CRPM, C1M et C3M sur 12 semaines en ce qui concerne la progression de la maladie, définie par une baisse de la CVF ≥10 % ou le décès, sur 52 semaines.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Written informed consent consistent with ICH-GCP and local laws, signed prior to participation in the trial including any study related procedures being performed;
    - Male or female patients aged =40 years at Visit 1;
    - A clinical diagnosis of IPF within the last 3 years from visit 0, based upon the ATS/ERS/JRS/ALAT 2011 guideline;
    - Chest high resolution computed tomography (HRCT) scan performed within 18 months of Visit 0;
    - Combination of HRCT pattern, and surgical lung biopsy pattern (the latter if available) as assessed by central review are consistent with the diagnosis of IPF;
    - FVC =80% of predicted normal at Visit 1.
    - Consentement éclairé signé conformément aux directives BPC-ICH et à la législation locale avant la participation à l'étude y compris la réalisation de toute procédure lié à l’étude (y compris toute période de wash-out requise ainsi que l’envoi de la HRCT et de la biopsie si cette dernière est disponible).
    - Patient de sexe masculin ou féminin, âgés de 40 ans au moins lors de la visite 1.
    - Diagnostic de FPI dans les 3 années précédant la visite 0 selon les directives de l’ATS/ERS/JRS/ALAT 2011.
    - Scanner tomodensitométrique à haute résolution du thorax (HRCT), réalisé dans les 18 mois précédant la visite 0.
    - Présence sur la HRCT et la biopsie (si celle-ci est disponible) de caractéristiques typiques de la FPI avérées par la relecture centralisée
    - CVF ≥ 80% de la valeur normale théorique à la visite 1.
    E.4Principal exclusion criteria
    - ALT, AST > 1.5 fold upper limit of normal (ULN) at visit 1;
    - Total bilirubin > 1.5 fold ULN at visit 1;
    - Patients with underlying chronic liver disease (Child Pugh A, B or C hepatic impairment);
    - Relevant airways obstruction (i.e. pre-bronchodilator FEV1/FVC <0.7 at visit 1);
    - History of myocardial infarction within 6 months of visit 1 or unstable angina within 1 month of visit 1;
    - Bleeding Risk:
    -- Known genetic predisposition to bleeding;
    -- Patients who require fibrinolysis, full-dose therapeutic anticoagulation (e.g. vitamin K antagonists, direct thrombin inhibitors, heparin, hirudin etc.) or high dose antiplatelet therapy;
    -- History of haemorrhagic central nervous system (CNS) event within 12 months prior to visit 1;
    -- History of haemoptysis or haematuria, active gastro-intestinal bleeding or ulcers and/or major injury or surgery within 3 months prior to visit 1;
    -- International normalised ratio (INR) > 2 at visit 1;
    -- Prothrombin time (PT) and partial thromboplastin time (PTT) > 150% of ULN at visit 1;
    - Planned major surgery during the trial participation, including lung transplantation, major abdominal or major intestinal surgery;
    - History of thrombotic event (including stroke and transient ischemic attack) within 12 months of visit 1;
    - Creatinine clearance < 30 mL/min calculated by Cockcroft-Gault formula at Visit 1;
    - Treatment with nintedanib, pirfenidone, azathioprine, cyclophosphamide, cyclosporine, any other investigational drug, n-acetylcysteine, prednisone/prednisolone >15 mg daily or >30 mg every 2 days OR use of other systemic corticosteroids as well as other investigational drugs within 4 weeks of visit 2;
    - Known hypersensitivity to nintedanib, peanut, soya or to any other components of the study medication;
    - Prior discontinuation of nintedanib treatment due to intolerability/ adverse events considered drug related;
    - A disease or condition which in the opinion of the investigator may interfere with testing procedures or put the patient at risk when participating in this trial;
    - Alcohol or drug abuse which in the opinion of the treating physician would interfere with the treatment and would affect patient's ability to participate in this trial;
    - Patients not able to understand and follow study procedures such as but not limited to home spirometry, including completion of self-administered questionnaires without help;
    - Women who are pregnant, nursing, who plan to become pregnant while in the trial or female patients with positive ß-HCG test at visit 1 and/or visit 2;
    - Women of childbearing potential not willing or able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly;
    - Patients with acute IPF exacerbation or any respiratory tract infection in the four weeks prior to Visit 1 or during the screening period.
    Visit 1 and/or Visit 2 should be postponed in case of an IPF exacerbation or respiratory tract infection. Refer to Section 6.1 for information on re-scheduling of visits;
    - Patients who are currently participating in another trial or who have been participating in another trial within one month prior to Visit 1, and patients who have previously been enrolled in this trial.
    - ALT, AST > 1,5 fois la limite supérieure de la normale (LSN) à la visite 1.
    - Bilirubine totale > 1,5 fois la LSN à la visite 1.
    - Patients atteints de maladie chronique du foie sous-jacente (insuffisance hépatique avec un score de Child Pugh A, B ou C)
    - Obstruction importante des voies aériennes (c-à-d rapport VEMS/CVF < 0,7, avant l’administration d’un bronchodilatateur) à la visite 1.
    - Antécédents d’infarctus du myocarde au cours des 6 mois précédant la visite 1 ou d’angor instable au cours du mois précédant la visite 1.
    - Risque hémorragique :
    •Prédisposition génétique connue aux hémorragies
    •Patients requérant une fibrinolyse, un traitement anticoagulant à dose thérapeutique complète (par ex. Anti-vitamines K, inhibiteurs directs de la thrombine, héparine, hirudine, etc.) ou un traitement anti-agrégant plaquettaire à forte dose2.
    •Antécédents d’événement hémorragique du système nerveux central au cours des 12 mois précédant la visite 1.
    •Antécédents d’hémoptysie ou d’hématurie, d’hémorragie ou d’ulcères gastro-intestinaux actifs et/ou de lésion majeure ou d’intervention chirurgicale majeure au cours des 3 mois précédant la visite 1.
    •Ratio normalisé international (INR) > 2 à la visite 1.
    •Temps de prothrombine (PT) et le temps partiel de thromboplastine (PTT)> 150% de la LSN institutionnelle à la visite 1.
    - Intervention chirurgicale majeure prévue pendant la participation à l’étude: transplantation pulmonaire, chirurgie abdominale majeure ou chirurgie intestinale majeure.
    - Antécédents d’événement thrombotique (accident vasculaire cérébral ou accident ischémique transitoire compris) au cours des 12 mois précédant la visite 1.
    - Clairance de la Creatinine < 30 mL/min calculée d’après la formule de Cockcroft–Gault à la visite 1
    - Traitement par nintedanib, pirfenidone, azathioprine, cyclophosphamide, cyclosporine ou tout autre médicament en cours d’expérimentation, n-acetylcysteine, prednisone/prednisolone >15 mg par jour ou > 30 mg tous les 2 jours OU par tout autres corticoïdes systémiques au cours des quatre semaines précédant la visite 2.
    - Hypersensibilité connue au nintedanib, à l’arachide, au soja, ou à tout autre composant des médicaments de l’étude
    - Arrêt définitif de la prise du nintedanib dans le passé en raison d’intolérance/évènements indésirables considérés comme liés au traitement
    - Maladie ou état qui, selon l’investigateur, est susceptible d’interférer avec les procédures de l’étude ou d’exposer le patient à un risque du fait de sa participation à l’étude.
    - Consommation excessive d’alcool ou toxicomanie qui, selon le médecin traitant, pourrait interférer avec le traitement et pourrait affecter la capacité du patient à participer à l’étude.
    - Patient incapable de comprendre et de suivre les procédures de l’étude, notamment l’examen de spirométrie à domicile et le remplissage des auto-questionnaires sans aide.
    - Femmes enceintes, allaitant, qui envisageant une grossesse pendant l’essai ou ayant un test de grossesse positif (β-HCG) à la visite 1 et/ou à la visite 2.
    - Femmes en âge de procréer refusant ou incapables d’utiliser une méthode contraceptive ayant fait ses preuves conformément à l’ICH M3 (R2), donnant un faible taux d’échec, inférieur à 1% par an, et étant utilisée constamment et correctement.
    - Patients ayant eu des exacerbations sévères de la FPI ou toute autre infection des voies respiratoires dans les 4 semaines qui précèdent la visite 1 ou durant la période de screening. La visite 1 et / ou 2 doivent être reportées en cas d'exacerbation de la FPI ou d'infection des voies respiratoires. Se reporter à la Section 6.1 pour obtenir des informations sur la re-programmation des visites.
    - Patients qui sont ou ont participé à un autre essai avec des médicaments expérimentaux dans le mois avant la visite 1 et les patients qui ont déjà été screenés dans cet essai.
    E.5 End points
    E.5.1Primary end point(s)
    1: The rate of change (slope) in blood CRPM from baseline to week 12.
    1: Le critère principal est le taux de variation (pente) de CRPM dans le sang de l’examen initial à la semaine 12.
    E.5.1.1Timepoint(s) of evaluation of this end point
    1: 12 weeks
    1: 12 semaines
    E.5.2Secondary end point(s)
    The key secondary endpoint
    1: Proportion of patients with disease progression as defined by absolute FVC (% predicted) decline ≥10% or death until week 52 based on in clinic supervised spirometry.

    Secondary endpoints:
    2: Rate of change (slope) in blood C1M from baseline to week 12 3: Rate of change (slope) in blood C3M from baseline to week 12.
    Le critère d'évaluation secondaire clé est
    1: la proportion de patients présentant une progression de la maladie telle que définie par la baisse absolue de la CVF (% valeur théorique) ≥10% sur la base des spirométries supervisées à la clinique ou un décès jusqu'à la semaine 52.

    Les critères secondaires sont
    2: le taux de variation (pente) de C1M sanguin de l’examen initial à la semaine 12
    3: le taux de variation (pente) de C3M sanguin de l’examen initial à la semaine 12.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1: 52 weeks
    2: 12 weeks
    3: 12 weeks
    1: 52 semaines
    2: 12 semaines
    3: 12 semaines
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Information not present in EudraCT
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Information not present in EudraCT
    E.6.13Others Information not present in EudraCT
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 Information not present in EudraCT
    E.8.4 The trial involves multiple sites in the Member State concerned Information not present in EudraCT
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA68
    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
    Japan
    Korea, Republic of
    United States
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days26
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months11
    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: 330
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 339
    F.4.2.2In the whole clinical trial 490
    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 may be prescribed and continue taking nintedanib available on the market
    Les patients peuvent se faire prescrire et continuer de prendre le nintedanib disponible sur le marché
    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 Decision2016-04-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-05-24
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-06-08
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