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    Summary
    EudraCT Number:2015-003280-11
    Sponsor's Protocol Code Number:MA29895
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-10-30
    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 ConcernedSpain - AEMPS
    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
    ESTUDIO EXPLORATORIO MULTICÉNTRICO, ABIERTO Y DE UN SOLO GRUPO PARA EVALUAR LA SEGURIDAD Y LA TOLERABILIDAD DE PIRFENIDONA (ESBRIET®) EN COMBINACIÓN CON NINTEDANIB (OFEV®) EN PACIENTES CON FIBROSIS PULMONAR IDIOPÁTICA
    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
    Estudio sobre la seguridad y tolerabilidad de la Pirfenidona (Esbriet) en combinación con Nintedanib (Ofev) en pacientes con Fibrosis Pulmonar Idiopática.
    A.4.1Sponsor's protocol code numberMA29895
    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 SponsorRoche Farma S.A., que representa en España a F. 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/ cityBasel
    B.5.3.3Post code4070
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number34913257300
    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
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Limited
    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/3/04/241
    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 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 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.3.1Product nameOfev
    D.3.2Product code 534-1508
    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 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: 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.3.1Product nameOfev
    D.3.2Product code 534-1508
    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 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
    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)
    fibrosis pulmonar idiopática (FPI)
    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 fibrosis pulmonar es una enfermedad respiratoria en la que se forman cicatrices en los tejidos pulmonares, lo que conduce a problemas respiratorios
    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 18.1
    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
    Proporción de pacientes que completen 24 semanas de tratamiento combinado con pirfenidona en una dosis de 1602-2403 mg/día y nintedanib en una dosis de 200-300 mg/día.
    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)
    ?Proporción de pacientes que suspendan el tratamiento con pirfenidona, nintedanib o ambos fármacos por acontecimientos adversos antes de la visita de la semana 24.
    ?Número total de días-paciente de tratamiento combinado con pirfenidona en una dosis de 1602-2403 mg/día y nintedanib en una dosis de 200-300 mg/día.
    ?Número total de días transcurridos entre el comienzo del tratamiento combinado y la suspensión del tratamiento con pirfenidona, nintedanib o ambos fármacos.
    ?Frecuencia y cronología de los acontecimientos adversos (AA) y acontecimientos adversos graves (AAG).
    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
    -Varón o mujer y edad comprendida entre los 40 y 80 años.
    -Al comienzo de la fase de selección, recepción de pirfenidona durante un mínimo de 16 semanas y recepción de una dosis estable (en este estudio se entenderá por ?dosis estable? una dosis de 1602-2403 mg/día) durante al menos 28 días; previsión de mantener la dosis dentro de ese intervalo durante todo el estudio.
    -Diagnóstico documentado de FPI, según el investigador y conforme a los criterios de las directrices de 2011 de la ATS/ERS/JRS/ALAT.
    -Valores siguientes de los resultados de las pruebas de función respiratoria, porcentaje de la CVF teórica ? 50%, Porcentaje de la DLco (o capacidad de transferencia del monóxido de carbono convertida en DLco) teórica ? 30%.
    -En las mujeres en edad fértil: compromiso de practicar abstinencia (abstenerse de mantener relaciones heterosexuales) o utilizar dos métodos anticonceptivos adecuados, incluido al menos uno con una tasa de fracasos < 1% anual, durante el período de tratamiento y hasta al menos 3 meses después de la visita de seguimiento final.
    -En los varones: compromiso de practicar abstinencia (abstenerse de mantener relaciones heterosexuales) o uso de métodos anticonceptivos y compromiso de abstenerse de donar semen hasta al menos 3 meses después de la visita de seguimiento final.
    E.4Principal exclusion criteria
    - Clinical evidence of active infection
    ?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
    ?Severe hepatic impairment, including end-stage liver disease
    ?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 hemorrhagic 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, 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
    - Datos clínicos de infección activa..
    -En los 28 días previos al comienzo de la fase de selección, cualquier reacción adversa moderada o intensa nueva o persistente que el investigador considere relacionada con pirfenidona o bien una interrupción del tratamiento con pirfenidona durante más de 7 días por cualquier motivo.
    -Cualquier trastorno que es probable que cause la muerte en los 12 meses siguientes al comienzo de la fase de selección.
    -Trasplante de pulmón previsto durante los 12 meses siguientes al comienzo de la fase de selección.
    -Hipersensibilidad conocida al principio activo o a cualquiera de los excipientes de pirfenidona o nintedanib.
    -Insuficiencia hepática grave, incluida una hepatopatía terminal.
    -Insuficiencia renal grave incluida una nefropatía terminal con necesidad de diálisis.
    -Antecedentes o riesgo de perforación digestiva.
    -Antecedentes de cardiopatía o neumopatía (aparte de la FPI) inestable o en situación de deterioro en los 6 meses previos al comienzo de la fase de selección.
    -Electrocardiograma (ECG) con un intervalo QT corregido por la frecuencia cardíaca (corregido con la fórmula de Fridericia, QTcF) ? 500 ms en la fase de selección o antecedentes familiares o personales de síndrome del QT largo.
    -Riesgo de hemorragia: predisposición genética a la hemorragia, episodio hemorrágico en los 12 meses previos al comienzo de la fase de selección o parámetros de coagulación anormales. Quedarán excluidos los pacientes que requieran fibrinólisis, anticoagulación terapéutica en dosis plenas , tratamiento antiagregante en dosis altas u otro tratamiento que pueda aumentar sustancialmente el riesgo de hemorragia.
    -Uso de inhibidores potentes de la enzima CYP1A2 (por ejemplo, fluvoxamina o enoxacino) en los 28 días previos al comienzo de la fase de selección.
    -Antecedentes de alcoholismo o toxicomanía en los 2 años previos al comienzo de la fase de selección.
    -Uso de cualquier producto derivado del tabaco en las 12 semanas previas al comienzo de la fase de selección o falta de disposición a abstenerse de consumirlo hasta la visita de seguimiento final.
    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
    Proporción de pacientes que completen 24 semanas de tratamiento combinado con pirfenidona en una dosis de 1602-2403 mg/día y nintedanib en una dosis de 200-300 mg/día.
    E.5.1.1Timepoint(s) of evaluation of this end point
    ?Up to 24 weeks
    ?Hasta la semana 24.
    E.5.2Secondary end point(s)
    1. Proportion of patients who discontinue pirfenidone, nintedanib, or both study treatments because of adverse events before the Week 24 Visit
    2. Total number of patient days of combination treatment with pirfenidone and nintedanib
    3. Total number of days from the initiation of combination treatment to discontinuation of pirfenidone, nintedanib, or both study treatments
    4. Incidence of adverse events (AE) and Serious Adverse Events (SAEs)
    1.Proporción de pacientes que suspendan el tratamiento con pirfenidona, nintedanib o ambos fármacos por acontecimientos adversos antes de la visita de la semana 24.
    2.Número total de días-paciente de tratamiento combinado con pirfenidona y nintedanib.
    3.Número total de días transcurridos entre el comienzo del tratamiento combinado y la suspensión del tratamiento con pirfenidona, nintedanib o ambos fármacos.
    4. Incidencia de acontecimientos adversos (AA) y acontecimientos adversos graves (AAG).
    E.5.2.1Timepoint(s) of evaluation of this end point
    1-3. Up to 24 weeks
    4. Up to 35 days after completion of combination treatment (approximately 30 weeks)
    1-3. Hasta la semana 24.
    4. Hasta 35 días después de la finalización del tratamiento combinado (aproximadamente 30 semanas).
    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
    Tolerabilidad
    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 concerned7
    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 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
    Canada
    Denmark
    France
    Germany
    Italy
    Netherlands
    Spain
    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 end of this study is defined as the date when the last patient, last visit (LPLV) occurs. LPLV is expected to occur in the 4th quarter of 2017.
    El final del estudio se define como la fecha en que tenga lugar la última visita del último paciente (UVUP). Se espera que la UVUP se produzca en el cuarto trimestre de 2017.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned 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 months3
    E.8.9.2In all countries concerned by the trial days16
    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 state7
    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)
    En la actualidad, el promotor aún no tiene planes definitivos de proporcionar pirfenidona, nintedanib o cualquier otro tratamiento o intervención del estudio a los pacientes que hayan completado el estudio (para más detalles consultar la sección 4.3.4 del protocolo).
    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 Decision2015-12-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-12-03
    P. End of Trial
    P.End of Trial StatusCompleted
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