Evaluation of Long-Term Safety of Pirfenidone (Esbriet) in Participants With Idiopathic Pulmonary Fibrosis (IPF)
NCT ID: NCT02699879
Last Updated: 2017-04-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1009 participants
OBSERVATIONAL
2012-02-16
2016-09-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Pirfenidone
Participants will receive pirfenidone orally according to the physician discretion.
Pirfenidone
Pirfenidone will be administered according to the physician discretion as part of standard care.
Interventions
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Pirfenidone
Pirfenidone will be administered according to the physician discretion as part of standard care.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participants who are newly prescribed Esbriet therapy
* Initiation of Esbriet therapy is not more than 30 days prior to study enrolment
Exclusion Criteria
* Participant has received Esbriet therapy 30 days or more prior to current treatment course (e.g., prior participation in clinical trials)
* Participant has any contraindication for the use of Esbriet, according to the current local version of the Summary of Product Characteristics (SPC)
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Medical University Graz; Department for Respiratory Diseases
Graz, , Austria
LKH Hohenems; Abteilung für Pulmologie
Hohenems, , Austria
Medizinische Universitat Innsbruck; Department of Internal Medicine, Pneumology Centre
Innsbruck, , Austria
Klinikum Klagenfurt; Abteilung für Pulmologie
Klagenfurt, , Austria
St. Johanns-Spital; Abt. Für Lungenkrankungen
Salzburg, , Austria
Aarhus University Hospital; Lungemed afd. B
Aarhus, , Denmark
Gentofte Hospital, Lungemedicinsk Afdeling
Hellerup, , Denmark
Odense Universitetshospital, Lungemedicinsk Afdeling J
Odense, , Denmark
Helsinki University Central Hospital; Dep. of Pulmonary Medicine
Helsinki, , Finland
Kuopio University Hospital
Kuopio, , Finland
Tampere University Hospital; Lung Clinic
Tampere, , Finland
Turku University Hospital; Dept of Pulmonology
Turku, , Finland
CHU Angers,Service de Pneumologie
Angers, , France
Hopital Jean Minjoz; Pneumologie
Besançon, , France
Hopital Avicenne; Pneumologie
Bobigny, , France
Hopital de La Cavale Blanche; Service de Medecine Interne & de Pneumologie
Brest, , France
Hopital Louis Pradel; Pneumologie
Bron, , France
Hopital Cote De Nacre; Pneumologie
Caen, , France
Chu Site Du Bocage;Pneumologie
Dijon, , France
CHU de Grenoble; Medecine Aigue Spec
Grenoble, , France
Hopital Calmette; Pneumologie
Lille, , France
CHU de Limoges
Limoges, , France
Hopital Nord AP-HM
Marseille, , France
Hopital Nord; Pneumologie
Marseille, , France
CHU Montpellier
Montpellier, , France
Hopital Saint Louis
Paris, , France
Hopital Bichat Claude Bernard ; Service de Pneumologie
Paris, , France
HEGP; Pneumologie
Paris, , France
Hopital Tenon;Pneumologie
Paris, , France
Hôpital Haut-Lévêque - CHU de Bordeaux - Groupe Hospitalier Sud
Pessac, , France
Hopital De La Maison Blanche;Maladies Respiratoires
Reims, , France
Hopital de Pontchaillou; Service de Pneumologie
Rennes, , France
Chu De Strasbourg; Hopital Civil
Strasbourg, , France
Hopital Larrey; Pneumologie
Toulouse, , France
Chu De Tours,Service de Pneumologie
Tours, , France
Zentralklinik Bad Berka GmbH; Pneumologie
Bad Berka, , Germany
Lungenklinik Ballenstedt/Harz gGmbH Lungenklinik Ballenstedt/Harz gGmbH
Ballenstedt, , Germany
Evang. Lungenklinik Berlin Klinik für Pneumologie
Berlin, , Germany
Charite - Universitätsmedizin Berlin; Campus Virchow-Klinikum, Med. Klinik m. S. Infekt und Pneumo
Berlin, , Germany
Gemeinschaftskrankenhaus Havelhöhe Klinik f.Innere Medizin Kardiologie Pneumologie
Berlin, , Germany
HELIOS Klinikum Emil von Behring Klinik f.Pneumologie Onkologie u.Infektiologie
Berlin, , Germany
Berufsgenossenschaftliches Uni-Klinikum Bergmannsheil GmbH
Bochum, , Germany
Klinkum Coburg GmbH
Coburg, , Germany
Fachkrankenhaus Coswig GmbH Zentrum f.Pneumologie Beatmungsmedizin Thorax-u.Gefäßchirurgie
Coswig, , Germany
Carl-Thiem-Klinik Cottbus; Medizinische Klinik
Cottbus, , Germany
Klinik Donaustauf Zentrum für Pneumologie
Donaustauf, , Germany
Ruhrlandklinik Lungenzentrum der UNI Essen Abt.Pneumologie-Allergologie
Essen, , Germany
Klinikum Esslingen; Klinik für Kardiologie, Angiologie und Pneumologie
Esslingen am Neckar, , Germany
Klinik Maingau
Frankfurt, , Germany
Studienzentrum/Praxis Dr. Keller Frankfurt
Frankfurt, , Germany
IFS - Interdisziplinäres Facharztzentrum; Institut für klinische Forschung Pneumologie
Frankfurt am Main, , Germany
Universitätsklinikum Freiburg, Abteilung Pneumologie
Freiburg im Breisgau, , Germany
Klinik Schillerhöhe Zentrum f.Pneumologie u.Thoraxchirurgie
Gerlingen, , Germany
Universitätsklinikum Standort Gießen Medizinische Klinik II u. Poliklinik Innere Med./Pneumologie
Giessen, , Germany
Universitätsmedizin Greifswald Klinik für Innere Medizin B und Poliklinik
Greifswald, , Germany
LungenClinic Grosshansdorf GmbH; Zentrum fur Pneumologie und Thoraxchirurgie
Großhansdorf, , Germany
Medizinische Hochschule Hannover
Hanover, , Germany
KRH Klinikum Oststadt-Heidehaus; Pneumologie, Intensiv- und Schlafmedizin
Hanover, , Germany
Lungenklinik Hemer; Abt. Pneumologie
Hemer, , Germany
Universitaetsklinikum des Saarlandes; Innere Medizin V
Homburg/Saar, , Germany
Fachklinik für Lungenerkrankungen
Immenhausen, , Germany
Universitätsklinikum Jena; Medizinische Klinik I
Jena, , Germany
Universitaetsklinikum Schleswig-Holstein, Campus Kiel
Kiel, , Germany
Universität Leipzig; Medizinische Klinik und Poliklinik I, Abteilung Pneumologie
Leipzig, , Germany
Lungenklinik Lostau gGmbH; Klinik für Pneumologie II
Lostau, , Germany
Klinik Löwenstein gGmbH Medizinische Klinik II
Löwenstein, , Germany
Universitätsklinikum Magdeburg Klinik für Kardiologie Angiologie u.Pneumologie
Magdeburg, , Germany
Klinikum der Universität München; Campus Großhadern; Med. Klinik und Poliklinik V
München, , Germany
Klinikum Nuernberg Nord; Medizinische Klinik 3, Schwerpunkt Pneumologie, Allergologie, Schlafmedizin
Nuremberg, , Germany
RoMed Klinikum Rosenheim, Medizinische Klinik III
Rosenheim, , Germany
Krankenhaus Bethanien gGmbH
Solingen, , Germany
Krankenhaus vom Roten Kreutz; Klinik fuer Pneumologie
Stuttgart, , Germany
Johanniter-Krankenhaus im Fläming Treuenbrietzen GmbH; Fachklinik Pneumologie/ Thoraxchirurgie
Treuenbrietzen, , Germany
Fachkliniken Wangen Medizinische Klinik
Wangen, , Germany
Universitätsklinikum Würzburg, Kinderklinik u. Poliklinik
Würzburg, , Germany
Cork University Hospital
Cork, , Ireland
Mater Misecordiae University Hospital
Dublin, , Ireland
St Vincents University Hospital
Dublin, , Ireland
Galway University Hospital; Department of Respiratory Medicine
Galway, , Ireland
Ospedale Morgagni-Pierantoni; U.O. Pneumologia
Forlì, Emilia-Romagna, Italy
A.O. Universitaria Policlinico Di Modena; DIP. Malattie Dell'apparato Respiratorio
Modena, Emilia-Romagna, Italy
Universita' Degli Studi Di Milano Bicocca, Ospedale Vecchio; facolta di medicina e chirurgia, dipart
Monza, Lombardy, Italy
A.O. Universitaria San Luigi Gonzaga di Orbassano; Ambulatorio per le Malattie Rare del Polmone
Orbassano (TO), Piedmont, Italy
Azienda Ospedaliero Universitaria Di Sassari; Clinica Pneumologica
Sassari, Sardinia, Italy
Azienda Ospedaliera Universitaria Careggi
Florence, Tuscany, Italy
A.O. Univ. Senese Policlinico S. Maria alle Scotte; UOC Malattie Resepiratorie e Trapianto Polmonare
Siena, Tuscany, Italy
Haukeland Hospital - University Of Bergen: Department of Resp Med
Bergen, , Norway
Oslo University Hospital Rikshospitalet; Lungeavdelingen
Oslo, , Norway
St. Olav's Hospital; Lung Clinic
Trondheim, , Norway
Karolinska Universitetssjukhuset Solna; Lung Allergikliniken
Stokholm, Solna, , Sweden
Akademiska Sjukhuset; Lungmedicinska Kliniken
Uppsala, , Sweden
Southmead Hospital; Respiratory Department
Bristol, , United Kingdom
Papworth Hospital NHS Foundation Trust; Respiratory Department
Cambridge, , United Kingdom
Castle Hill Hospital; Respiratory Medicine
Cottingham, , United Kingdom
Royal Devon and Exeter Hospital (Wonford)
Exeter, , United Kingdom
Southampton General Hospital; Respiratory Department
Hampshire, , United Kingdom
Glenfield Hospital
Leicester, , United Kingdom
University Hospital Aintree; Pulmonary Vascular Diseases Unit
Liecester, , United Kingdom
University College London Hospital; Respiratory Medicine
London, , United Kingdom
Royal Brompton Hospital; Respiratory Department
London, , United Kingdom
St. Mary'S Hospital; Dept of Medicine
London, , United Kingdom
Wythenshawe Hospital
Manchester, , United Kingdom
Nottingham University Hospitals City Campus
Nottingham, , United Kingdom
Queen Alexandra Hospital; Respiratory Centre
Portsmouth, , United Kingdom
Northern General Hospital
Sheffield, , United Kingdom
University Hospital of North Staffordshire; ILD Clinic
Stoke-on-Trent, , United Kingdom
Countries
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References
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Behr J, Nathan SD, Costabel U, Albera C, Wuyts WA, Glassberg MK, Haller H Jr, Alvaro G, Gilberg F, Samara K, Lancaster L. Efficacy and Safety of Pirfenidone in Advanced Versus Non-Advanced Idiopathic Pulmonary Fibrosis: Post-Hoc Analysis of Six Clinical Studies. Adv Ther. 2023 Sep;40(9):3937-3955. doi: 10.1007/s12325-023-02565-3. Epub 2023 Jun 30.
Other Identifiers
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PIPF-025
Identifier Type: OTHER
Identifier Source: secondary_id
WB29908
Identifier Type: -
Identifier Source: org_study_id
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