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    Summary
    EudraCT Number:2015-003280-11
    Sponsor's Protocol Code Number:MA29895
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-05-27
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2015-003280-11
    A.3Full title of the trial
    AN EXPLORATORY MULTICENTER, OPEN-LABEL, SINGLE ARM STUDY OF THE SAFETY AND TOLERABILITY OF PIRFENIDONE (ESBRIET¿) IN COMBINATION WITH NINTEDANIB (OFEV¿) IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS
    STUDIO ESPLORATIVO, MULTICENTRICO, IN APERTO, A BRACCIO SINGOLO, SULLA SICUREZZA E LA TOLLERABILIT¿ DI PIRFENIDONE (ESBRIET¿) IN ASSOCIAZIONE A NINTEDANIB (OFEV¿) IN PAZIENTI AFFETTI DA FIBROSI POLMONARE IDIOPATICA
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of the Safety and Tolerability of Pirfenidone (Esbriet) in Combination with Nintedanib (Ofev) in Patients with Idiopathic Pulmonary Fibrosis
    Studio sulla Sicurezza e Tollerabilit¿ di Pirfenidone (Esbriet) in associazione a Nintedanib (Ofev) in pazienti affetti da Fibrosi Polmonare Idiopatica
    A.3.2Name or abbreviated title of the trial where available
    NA
    NA
    A.4.1Sponsor's protocol code numberMA29895
    A.5.4Other Identifiers
    Name:NANumber:NA
    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 SponsorF. HOFFMANN - LA ROCHE LTD.
    B.1.3.4CountrySwitzerland
    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 supportF. Hoffmann-La Roche Ltd
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationF.Hoffmann-La Roche Ltd
    B.5.2Functional name of contact pointTrial Information Support Line-TISL
    B.5.3 Address:
    B.5.3.1Street AddressGrenzacherstrasse 12
    B.5.3.2Town/ cityBasilea
    B.5.3.3Post code4070
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number0
    B.5.5Fax number0
    B.5.6E-mailglobal.rochegenentechtrials@roche.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 ESBRIET - 267 MG - CAPSULA RIGIDA - USO ORALE - FLACONE (HDPE) 270 CAPSULE
    D.2.1.1.2Name of the Marketing Authorisation holderINTERMUNE UK LTD
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/04/241
    D.3 Description of the IMP
    D.3.1Product nameEsbriet
    D.3.2Product code RO0220912
    D.3.4Pharmaceutical form Capsule, hard
    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 INNPIRFENIDONE
    D.3.9.1CAS number 53179-13-8
    D.3.9.2Current sponsor codeRO0220912
    D.3.9.4EV Substance CodeSUB09907MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number267
    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 RoleComparator
    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.3.4Pharmaceutical 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 code534-1508
    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 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 RoleComparator
    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.3.4Pharmaceutical 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 code534-1508
    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 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
    Idiopathic Pulmonary Fibrosis (IPF)
    Fibrosi polmonare idiopatica
    E.1.1.1Medical condition in easily understood language
    Pulmonary fibrosis is a respiratory disease in which scars are formed in the lung tissues, which leads to breathing problems
    La Fibrosi Polmonare ¿ una malattia respiratoria caratterizzata da formazione di tessuto fibroso nei polmoni, che determina problemi respiratori.
    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 21.1
    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
    Proportion of patients who complete 24 weeks of combination treatment on pirfenidone at a dose of 1602¿2403 milligrams/day (mg/d) and nintedanib at a dose of 200¿300 mg/d
    Percentuale di pazienti che completano le 24 settimane di terapia di combinazione con una dose di pirfenidone di 1602¿2403 mg/die e una dose di nintedanib di 200¿300 mg/die.
    E.2.2Secondary objectives of the trial
    - Proportion of patients who discontinue pirfenidone, nintedanib, or both study treatments because of adverse events before the Week 24 Visit
    - Total number of patient days of combination treatment with pirfenidone at a dose of 1602¿2403 mg/d and nintedanib at a dose of 200¿300 mg/d
    - Total number of days from the initiation of combination treatment to discontinuation of pirfenidone, nintedanib, or both study treatments
    - Frequency and timing of adverse events (AE) and serious adverse events (SAEs)
    - Percentuale di pazienti che interrompono pirfenidone, nintedanib o entrambi i trattamenti in studio a causa di eventi avversi prima della visita della Settimana 24.
    - Numero totale di giorni-paziente di terapia di combinazione con una dose di pirfenidone di 1602¿2403 mg/die e una dose di nintedanib di 200¿300 mg/die.
    - Numero totale di giorni dall'inizio della terapia di combinazione all'interruzione di pirfenidone, nintedanib o di entrambi i trattamenti in studio.
    - Frequenza e tempistica di eventi avversi (AE, Adverse Event) ed eventi avversi gravi (SAE, Serious Adverse Event).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Male or female, and age 40 through 80 years old
    - At the start of screening, on pirfenidone for at least 16 weeks and on a stable dose for at least 28 days (in this study, a stable dose will be defined as 1602–2403 mg/d); the dose must be expected to remain in
    that range throughout the study
    - Documented diagnosis of IPF, per the Investigator per using the criteria of the 2011 American Thoracic Society / European Respiratory Society / Japanese Respiratory Society / Latin American Thoracic
    Association guidelines
    - Pulmonary function test results at screening, percent predicted forced vital capacity (FVC) >=50% and percent predicted carbon monoxide diffusing capacity (DLco) >= 30%
    - For women of childbearing potential: agreement to remain abstinent or use two adequate methods of contraception, including at least one method with a failure rate of < 1% per year, during the treatment
    period and for at least 3 months after the final Follow-up Visit
    - For men: agreement to remain abstinent or use contraceptive measures and agreement to refrain from donating sperm during the treatment period and for at least for at least 3 months after the final Follow-up Visit
    - Essere di sesso maschile o femminile, avere un'età compresa tra i 40 e gli 80 anni (compresi) all'inizio dello screening.
    - All'inizio dello screening, essere in terapia con pirfenidone da almeno 16 settimane e ricevere una dose stabile da almeno 28 giorni (in questo studio per dose stabile si intende una dose compresa nell'intervallo 1602-2403 mg/die); si deve presumere che la dose rimanga in questo intervallo per l'intera durata dello studio.
    - Diagnosi documentata di IPF, secondo il parere dello sperimentatore in base ai criteri del 2011 delle linee guida dell'American Thoracic Society/European Respiratory Society/Japanese Respiratory Society/Latin American Thoracic Association.
    - Risultati degli esami di funzionalità polmonare misurati allo screening (basati su relazioni di laboratorio documentate sulla funzionalità polmonare): Percentuale del teorico della FVC = 50%; Percentuale del teorico della DLco (o capacità di trasferimento del monossido di carbonio convertita in DLco) = 30%.
    - Per le donne potenzialmente fertili: Accordo a praticare l'astinenza (astenersi completamente dai rapporti eterosessuali) o a utilizzare due metodi contraccettivi adeguati, incluso almeno un metodo caratterizzato da un tasso di insuccesso < 1% l'anno, durante il periodo di trattamento e per almeno 3 mesi dopo la visita di follow-up conclusiva.
    E.4Principal exclusion criteria
    - Clinical evidence of any active infection which according to the judgment of the investigator may interfere with study conduct, measurement of pulmonary function, or impact the course of IPF
    - In the 28 days before the start of screening, any new or ongoing moderate or severe adverse reaction considered by the Investigator to be related to pirfenidone, or an pirfenidone treatment interruption > 7 days for any reason
    - Any condition that is likely to result in death in the 12 months after the start of screening
    - Lung transplantation anticipated in the 12 months after the start of screening
    - Known hypersensitivity to the active substance or any excipient of either pirfenidone or nintedanib
    - Mild (Child Pugh A), moderate (Child Pugh B) or severe (Child Pugh C) hepatic impairment
    - Severe renal impairment, including end-stage renal disease requiring dialysis
    - History or risk of gastrointestinal (GI) tract perforation
    - History of unstable or deteriorating cardiac or pulmonary disease in the 6 months before the start of screening
    - Electrocardiogram (ECG) with a heart-rate–corrected QT interval = 500 milliseconds (ms) at screening, or a family or personal history of long QT syndrome
    - Bleeding risk: genetic predisposition to bleeding, a haemorrhagic event in the 12 months before the start of screening, or abnormal laboratory coagulation parameters. Patients who require fibrinolysis, full-dose therapeutic anticoagulation, high-dose antiplatelet therapy, or other therapy that may substantially increase bleeding risk are excluded
    - Use of strong CYP1A2 inhibitors, inhibitors of P-glycoprotein or CYP3A4 or their inducers in the 28 days before the start of screening
    - History of alcohol or substance abuse in the 2 years before the start of screening
    - Use of any tobacco product in the 12 weeks before the start of screening, or an unwillingness to abstain from their use through the final Follow-up Visit
    - Evidenza clinica di qualsiasi infezione attiva che, a giudizio dello sperimentatore, possa interferire con la conduzione dello studio, le misurazioni della funzionalità polmonare o possa avere impatto sul decorso della IPF.
    - Nei 28 giorni precedenti l'inizio dello screening, presenza di una qualsiasi reazione avversa nuova o ancora in atto, di intensità moderata o grave, che lo sperimentatore ritenga correlata al pirfenidone, oppure un'interruzione del trattamento con pirfenidone superiore a 7 giorni per qualsiasi motivo.
    - Qualsiasi patologia che potrebbe provocare il decesso del paziente nei 12 mesi successivi all'inizio dello screening.
    - Prevista necessità di trapianto polmonare nei 12 mesi successivi all'inizio dello screening.
    - Nota ipersensibilità al principio attivo o a uno qualsiasi degli eccipienti di pirfenidone o nintedanib.
    - Insufficienza epatica: lieve (Child Pugh A), moderata (Child Pugh B) o severa (Child Pugh C).
    - Grave insufficienza renale, inclusa nefropatia allo stadio terminale con necessità di dialisi.
    - Presenza in anamnesi o rischio di perforazione del tratto gastrointestinale (GI).
    - Presenza in anamnesi di malattia cardiaca o polmonare (diversa dalla IPF) instabile o in peggioramento nei 6 mesi precedenti l'inizio dello screening.
    - Elettrocardiogramma (ECG) con un intervallo QT corretto per la frequenza cardiaca (corretto con la formula di Fridericia, QTcF) = 500 ms allo screening, oppure una storia familiare o personale di sindrome del QT lungo.
    - Rischio di emorragia: predisposizione genetica all'emorragia, evento emorragico nei 12 mesi precedenti l'inizio dello screening, oppure anomalie nei parametri di laboratorio relativi alla coagulazione. Sono esclusi i pazienti che necessitano di fibrinolisi, anticoagulazione terapeutica a piene dosi.
    - Utilizzo di forti inibitori del CYP1A2 (per es. fluvoxamina, enoxacina) nei 28 giorni precedenti lo screening.
    - Presenza in anamnesi di alcolismo o abuso di sostanze nei 2 anni precedenti l'inizio dello screening.
    - Uso di prodotti a base di tabacco nelle 12 settimane precedenti l'inizio dello screening, o riluttanza ad astenersi dall'uso di tali prodotti fino alla visita di follow-up conclusiva.
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of patients who complete 24 weeks of combination treatment on pirfenidone at a dose of 1602–2403 mg/d and nintedanib at a dose of 200–300 mg/d
    Percentuale di pazienti che completano le 24 settimane di terapia di combinazione con una dose di pirfenidone di 1602–2403 mg/die e una dose di nintedanib di 200–300 mg/die.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Up to 24 weeks
    Fino a 24 settimane
    E.5.2Secondary end point(s)
    Proportion of patients who discontinue pirfenidone, nintedanib, or both study treatments because of adverse events before the Week 24 Visit; Total number of patient days of combination treatment with pirfenidone and nintedanib; Total number of days from the initiation of combination treatment to discontinuation of pirfenidone, nintedanib, or both study treatments; Incidence of adverse events (AE) and Serious Adverse Events (SAEs)
    Percentuale di pazienti che interrompono pirfenidone, nintedanib o entrambi i trattamenti in studio a causa di eventi avversi prima della visita della Settimana 24.; Numero totale di giorni-paziente di terapia di combinazione con pirfenidone e nintedanib; Numero totale di giorni dall'inizio della terapia di combinazione all'interruzione di pirfenidone, nintedanib o di entrambi i trattamenti in studio.; Frequenza e tempistica di eventi avversi (AE, Adverse Event) ed eventi avversi gravi (SAE, Serious Adverse Event).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Up to 24 weeks; Up to 24 weeks; Up to 24 weeks; Up to 35 days after completion of combination treatment
    (approximately 30 weeks)
    Fino a 24 settimane; Fino a 24 settimane; Fino a 24 settimane; Fino a 35 giorni dopo il completamento del trattamento combinatorio (circa 30 settimane)
    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 No
    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 Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    Tollerabilit¿
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    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 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA22
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Canada
    United States
    Denmark
    France
    Germany
    Italy
    Netherlands
    Spain
    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
    LPLV. LPLV is expected to occur in the 4th quarter of
    2017.
    LPLV
    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 months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    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: 36
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 44
    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 state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 45
    F.4.2.2In the whole clinical trial 80
    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)
    Currently, the Sponsor does not have definitive plans yet to provide pirfenidone or nintedanib or any other study treatments or interventions to patients who have completed the study (please see more details in section 4.3.4 of the protocol)
    Attualmente , lo Sponsor non ha piani definitivi per fornire pirfenidone o nintedanib o qualsiasi altro trattamento di studio o terapie per i pazienti che hanno completato lo studio (si vedano i dettagli nella sezione 4.3.4 del protocollo )
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-12-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-12-17
    P. End of Trial
    P.End of Trial StatusCompleted
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