Evaluation of Long-Term Safety of Pirfenidone (Esbriet) in Participants With Idiopathic Pulmonary Fibrosis (IPF)
- Registration Number
- NCT02699879
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
This single arm, post-authorisation study is designed to evaluate the long-term safety of pirfenidone in participants with IPF. The enrolment of participants will be completed within approximately 24 months. Participants will receive pirfenidone according to the physician discretion and will be followed for 2 years. Treating physicians will collect pre-specified data at the baseline and every 3 months thereafter, for the duration of the participants' participation in study.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1009
- A clinical decision has been made, prior to study enrolment, to prescribe Esbriet
- Participants who are newly prescribed Esbriet therapy
- Initiation of Esbriet therapy is not more than 30 days prior to study enrolment
- Participants receiving an investigational agent defined as any drug that has not been approved for marketing for any indication in the country of the participating site
- 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)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Pirfenidone Pirfenidone Participants will receive pirfenidone orally according to the physician discretion.
- Primary Outcome Measures
Name Time Method Percentage of participants with clinically significant ADRs of special interest up to 2 years Percentage of participants with adverse drug reactions (ADRs) and serious adverse drug reactions up to 2 years
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (106)
Medizinische Universitat Innsbruck; Department of Internal Medicine, Pneumology Centre
🇦🇹Innsbruck, Austria
Aarhus University Hospital; Lungemed afd. B
🇩🇰Aarhus, Denmark
LKH Hohenems; Abteilung für Pulmologie
🇦🇹Hohenems, Austria
Gentofte Hospital, Lungemedicinsk Afdeling
🇩🇰Hellerup, Denmark
Evang. Lungenklinik Berlin Klinik für Pneumologie
🇩🇪Berlin, Germany
Hopital Calmette; Pneumologie
🇫🇷Lille, France
CHU de Limoges
🇫🇷Limoges, France
Hopital Nord AP-HM
🇫🇷Marseille, France
Hopital de Pontchaillou; Service de Pneumologie
🇫🇷Rennes, France
Klinik Löwenstein gGmbH Medizinische Klinik II
🇩🇪Löwenstein, Germany
Klinik Maingau
🇩🇪Frankfurt, Germany
Hopital Saint Louis
🇫🇷Paris, France
Chu Site Du Bocage;Pneumologie
🇫🇷Dijon, France
CHU de Grenoble; Medecine Aigue Spec
🇫🇷Grenoble, France
Hopital Nord; Pneumologie
🇫🇷Marseille cedex 20, France
HEGP; Pneumologie
🇫🇷Paris, France
Gemeinschaftskrankenhaus Havelhöhe Klinik f.Innere Medizin Kardiologie Pneumologie
🇩🇪Berlin, Germany
KRH Klinikum Oststadt-Heidehaus; Pneumologie, Intensiv- und Schlafmedizin
🇩🇪Hannover, Germany
Tampere University Hospital; Lung Clinic
🇫🇮Tampere, Finland
Hopital Cote De Nacre; Pneumologie
🇫🇷Caen, France
Universitätsklinikum Jena; Medizinische Klinik I
🇩🇪Jena, Germany
Studienzentrum/Praxis Dr. Keller Frankfurt
🇩🇪Frankfurt, Germany
Hopital Larrey; Pneumologie
🇫🇷Toulouse, France
Hopital Tenon;Pneumologie
🇫🇷Paris, France
CHU Montpellier
🇫🇷Montpellier, France
Chu De Tours,Service de Pneumologie
🇫🇷Tours, France
Helsinki University Central Hospital; Dep. of Pulmonary Medicine
🇫🇮Helsinki, Finland
Hopital de La Cavale Blanche; Service de Medecine Interne & de Pneumologie
🇫🇷Brest, France
Hopital Louis Pradel; Pneumologie
🇫🇷Bron, France
Fachkrankenhaus Coswig GmbH Zentrum f.Pneumologie Beatmungsmedizin Thorax-u.Gefäßchirurgie
🇩🇪Coswig, Germany
Ruhrlandklinik Lungenzentrum der UNI Essen Abt.Pneumologie-Allergologie
🇩🇪Essen, Germany
Carl-Thiem-Klinik Cottbus; Medizinische Klinik
🇩🇪Cottbus, Germany
Turku University Hospital; Dept of Pulmonology
🇫🇮Turku, Finland
Klinkum Coburg GmbH
🇩🇪Coburg, Germany
Hôpital Haut-Lévêque - CHU de Bordeaux - Groupe Hospitalier Sud
🇫🇷Pessac, France
Klinik Schillerhöhe Zentrum f.Pneumologie u.Thoraxchirurgie
🇩🇪Gerlingen, Germany
Hopital Bichat Claude Bernard ; Service de Pneumologie
🇫🇷Paris, France
Lungenklinik Hemer; Abt. Pneumologie
🇩🇪Hemer, Germany
Papworth Hospital NHS Foundation Trust; Respiratory Department
🇬🇧Cambridge, United Kingdom
LungenClinic Grosshansdorf GmbH; Zentrum fur Pneumologie und Thoraxchirurgie
🇩🇪Großhansdorf, Germany
Fachklinik für Lungenerkrankungen
🇩🇪Immenhausen, Germany
Southmead Hospital; Respiratory Department
🇬🇧Bristol, United Kingdom
University College London Hospital; Respiratory Medicine
🇬🇧London, United Kingdom
Medical University Graz; Department for Respiratory Diseases
🇦🇹Graz, Austria
Klinikum Klagenfurt; Abteilung für Pulmologie
🇦🇹Klagenfurt, Austria
Hopital Jean Minjoz; Pneumologie
🇫🇷Besancon, France
St. Johanns-Spital; Abt. Für Lungenkrankungen
🇦🇹Salzburg, Austria
Odense Universitetshospital, Lungemedicinsk Afdeling J
🇩🇰Odense, Denmark
Kuopio University Hospital
🇫🇮Kuopio, Finland
Hopital Avicenne; Pneumologie
🇫🇷Bobigny, France
CHU Angers,Service de Pneumologie
🇫🇷Angers, France
Hopital De La Maison Blanche;Maladies Respiratoires
🇫🇷Reims, France
Chu De Strasbourg; Hopital Civil
🇫🇷Strasbourg, France
Lungenklinik Ballenstedt/Harz gGmbH Lungenklinik Ballenstedt/Harz gGmbH
🇩🇪Ballenstedt, Germany
Zentralklinik Bad Berka GmbH; Pneumologie
🇩🇪Bad Berka, Germany
Charite - Universitätsmedizin Berlin; Campus Virchow-Klinikum, Med. Klinik m. S. Infekt und Pneumo
🇩🇪Berlin, Germany
HELIOS Klinikum Emil von Behring Klinik f.Pneumologie Onkologie u.Infektiologie
🇩🇪Berlin, Germany
Berufsgenossenschaftliches Uni-Klinikum Bergmannsheil GmbH
🇩🇪Bochum, Germany
Klinik Donaustauf Zentrum für Pneumologie
🇩🇪Donaustauf, Germany
Klinikum Esslingen; Klinik für Kardiologie, Angiologie und Pneumologie
🇩🇪Esslingen, Germany
IFS - Interdisziplinäres Facharztzentrum; Institut für klinische Forschung Pneumologie
🇩🇪Frankfurt am Main, Germany
Universitätsmedizin Greifswald Klinik für Innere Medizin B und Poliklinik
🇩🇪Greifswald, Germany
Universitätsklinikum Freiburg, Abteilung Pneumologie
🇩🇪Freiburg, Germany
Medizinische Hochschule Hannover
🇩🇪Hannover, Germany
Universitätsklinikum Standort Gießen Medizinische Klinik II u. Poliklinik Innere Med./Pneumologie
🇩🇪Gießen, Germany
Universitaetsklinikum des Saarlandes; Innere Medizin V
🇩🇪Homburg/Saar, Germany
Universität Leipzig; Medizinische Klinik und Poliklinik I, Abteilung Pneumologie
🇩🇪Leipzig, Germany
Universitaetsklinikum Schleswig-Holstein, Campus Kiel
🇩🇪Kiel, Germany
Lungenklinik Lostau gGmbH; Klinik für Pneumologie II
🇩🇪Lostau, Germany
Klinikum Nuernberg Nord; Medizinische Klinik 3, Schwerpunkt Pneumologie, Allergologie, Schlafmedizin
🇩🇪Nürnberg, Germany
Universitätsklinikum Magdeburg Klinik für Kardiologie Angiologie u.Pneumologie
🇩🇪Magdeburg, Germany
Klinikum der Universität München; Campus Großhadern; Med. Klinik und Poliklinik V
🇩🇪München, Germany
RoMed Klinikum Rosenheim, Medizinische Klinik III
🇩🇪Rosenheim, Germany
Cork University Hospital
🇮🇪Cork, Ireland
Fachkliniken Wangen Medizinische Klinik
🇩🇪Wangen, Germany
Mater Misecordiae University Hospital
🇮🇪Dublin, Ireland
Universitätsklinikum Würzburg, Kinderklinik u. Poliklinik
🇩🇪Wuerzburg, 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
Galway University Hospital; Department of Respiratory Medicine
🇮🇪Galway, Ireland
St Vincents University Hospital
🇮🇪Dublin 4, 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, Lombardia, Italy
A.O. Universitaria San Luigi Gonzaga di Orbassano; Ambulatorio per le Malattie Rare del Polmone
🇮🇹Orbassano (TO), Piemonte, Italy
Azienda Ospedaliero Universitaria Di Sassari; Clinica Pneumologica
🇮🇹Sassari, Sardegna, Italy
Azienda Ospedaliera Universitaria Careggi
🇮🇹Firenze, Toscana, Italy
A.O. Univ. Senese Policlinico S. Maria alle Scotte; UOC Malattie Resepiratorie e Trapianto Polmonare
🇮🇹Siena, Toscana, Italy
St. Olav's Hospital; Lung Clinic
🇳🇴Trondheim, Norway
Oslo University Hospital Rikshospitalet; Lungeavdelingen
🇳🇴Oslo, Norway
Haukeland Hospital - University Of Bergen: Department of Resp Med
🇳🇴Bergen, Norway
Karolinska Universitetssjukhuset Solna; Lung Allergikliniken
🇸🇪Stokholm, Solna, Sweden
Akademiska Sjukhuset; Lungmedicinska Kliniken
🇸🇪Uppsala, Sweden
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
Royal Brompton Hospital; Respiratory Department
🇬🇧London, United Kingdom
St. Mary'S Hospital; Dept of Medicine
🇬🇧London, United Kingdom
Nottingham University Hospitals City Campus
🇬🇧Nottingham, United Kingdom
Wythenshawe Hospital
🇬🇧Manchester, United Kingdom
Northern General Hospital
🇬🇧Sheffield, United Kingdom
Queen Alexandra Hospital; Respiratory Centre
🇬🇧Portsmouth, United Kingdom
University Hospital of North Staffordshire; ILD Clinic
🇬🇧Stoke-on-Trent, United Kingdom